Combined Treatments to Optimize Functional Recovery in Veterans With Chronic Low Back Pain
Phase: NA
Conditions: Low Back Pain
Sponsor: VA Office of Research and Development

Combined Treatments to Optimize Functional Recovery in Veterans with Chronic Low Back Pain 
[MIRB # 01676] 
Funding Agency: VA RR&D 
Principal Investigator: Pradeep Suri MD MS 
V7.0 
3.12.2020 
Human Subjects Protocol 
VA Puget Sound IRB 
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Abstract 
 
Objective: 
Combining procedural and behavioral treatments may have great potential for achieving large magnitude 
treatment effects for CLBP in Veterans. This is a pilot clinical trial to evaluate the effects of treatment 
combinations among Veterans with chronic lower back pain (CLBP) with four possible treatment arms: lumbar 
medial branch nerve radiofrequency ablation (LRFA), targeted steroid injections to the facet nerves with 
simulated LRFA, video telehealth tablet- and PC-based Activity Tracker-Informed Video-Enabled Cognitive 
Behavioral Therapy (AcTIVE-CBT), and telephone-based self-directed CBT and education (TBSCE). 
Research Design and Methodology: 
The proposed research uses a 2 x 2 factorial randomized control trial (RCT) design to examine the individual 
and combined effects of LRFA and AcTIVE-CBT. The primary outcome is participant-reported back-related 
functional limitations (mobility and activities of daily living [ADLs]) at 3 months, as measured by the Roland-
Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain 
intensity, reduction in opioid use, and quality of life. The randomized control trial will include up to 30 patients 
from the VA Puget Sound Health Care System (VAPSHCS) Pain Clinic aged 18 and older with a history of 
CLBP and eligibility for a LRFA procedure, of whom we expect 20 participants will be randomized and 
complete 3-month data collection. Appropriate LRFA candidates will be offered to participate according to the 
same criteria used for determining LRFA eligibility in usual clinical care (including responses to 2 sets of medial 
branch blocks [MBBs]). The provision of LRFA, targeted steroid injections to the facet nerves, AcTIVE-CBT, 
and TBSCE treatments are not considered to be research, since these treatments are usual clinical care or 
modifications to usual clinical care. All aspects of treatment will involve credentialed providers already working 
at VAPSHCS. These clinical treatments will be coordinated within the framework of the study procedures and 
processes.  
Participants will schedule a date for their lumbar procedure (LRFA or targeted steroid injections to the facet 
nerves with simulated LRFA). Computer-generated concealed block randomized assignment lists will be 
created, and baseline study assessments will take place on the day of the lumbar procedure. AcTIVE-CBT and 
TBSCE treatments will take place over 3-months post-randomization. Participants would be blinded to whether 
they are receiving the study ‘interventions’ or ‘controls’, over the first 3 months of follow-up. Follow-up study 
assessments will happen 1 month, 2 months, and 3 months post-procedure. The main outcome time point is 3-
month follow-up. After the 3-month main study period, participants will be offered the option to either be 
unblinded to their treatment allocations or to remain blinded to their assigned treatments for up to 9 additional 
months of optional monthly study outcome assessments. Unblinded participants may make subsequent 
treatment decisions as they wish, so optional assessments after the study period may be affected by 
unblinding and other changes in treatment and are not truly randomized comparisons. Participants who did not 
receive LRFA during the main 3-month period of follow-up may elect to pursue LRFA as part of normal clinical 
care. 
Relevance to VA Mission: 
The potential for learning about effective treatment combinations for CLBP yielded by this research is directly 
relevant to the clinical care of Veterans with this condition. These findings may inform clinical care practices, 
and/or future research to more definitively characterize the specific and combined effects of the treatments 
studied here. 
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List of Abbreviations 
 
VA 
Veterans Affairs 
CLBP 
Chronic Low Back Pain 
AHRQ 
Agency for Health Research and Quality 
RCT 
Randomized Control Trial 
LRFA 
Lumbar Radiofrequency Ablation 
AcTIVE-CBT 
Activity Tracker-Informed Video-Enabled CBT 
CBT 
Cognitive Behavioral Therapy 
PC 
Personal Computer 
VAPSHCS 
VA Puget Sound Health Care System 
MBB 
Medial Branch Block 
TBSCE 
Telephone-Based Self-directed CBT and Education 
ADLs 
Activities of Daily Living 
PI 
Principal Investigator 
Co-I 
Co-investigator 
TREWI 
Telerehabilitation Enterprise-Wide Initiative 
VAPS 
VA Puget Sound 
CPRS 
Computerized Patient Record System 
RFA 
Radiofrequency Ablation 
PM&R 
Physical Medicine & Rehabilitation 
UW 
University of Washington 
ACGME 
Accreditation Council for Graduate Medical Education 
HIPAA 
Health Insurance Portability and Accountability Act 
NRS 
Numerical Rating Scale 
ICF 
Informed Consent Form 
ERIC 
Epidemiologic Research and Information Center 
TICS 
Telephone Interview for Cognitive Status 
RMDQ 
Roland-Morris Disability Questionnaire 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
NIH 
National Institutes of Health 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
DMC 
Data Monitoring Committee 
SAE 
Serious Adverse Event 
CRF 
Case Report Form 
ED 
Emergency Department 
ICU 
Intensive Care Unit 
UAP 
Unanticipated Problem 
ADE 
Adverse Device Effect 
UPIRTSO 
Unanticipated AND Related Problem Involving Risk to Subjects or 
Others 
PHI 
Protected Health Information 
HSR&D 
Health Services Research & Development 
 
 
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Contents 
Protocol Title: ..................................................................................................................................... 5 
1.0 
Study Personnel ...................................................................................................................... 5 
2.0 
Introduction ............................................................................................................................. 7 
3.0 
Objectives ............................................................................................................................. 10 
4.0 
Resources and Personnel ..................................................................................................... 10 
5.1 Study Design .......................................................................................................................... 12 
5.2 Recruitment Methods.............................................................................................................. 26 
5.3 Informed Consent Procedures ................................................................................................ 36 
5.4 Inclusion/Exclusion Criteria ..................................................................................................... 40 
5.5 Study Evaluations ................................................................................................................... 42 
5.6 Data Analysis ......................................................................................................................... 46 
5.7 Withdrawal of Subjects ........................................................................................................... 47 
5.0 
Reporting ............................................................................................................................... 48 
6.0 
Privacy and Confidentiality .................................................................................................... 52 
7.0 
Communication Plan ............................................................................................................. 52 
8.0 
Information Security and Data Storage/Movement ................................................................ 53 
9.0 
References ............................................................................................................................ 53 
 
 
 
 
 
 
 
 
 
 
 
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Protocol Title: 
Combined Treatments to Optimize Functional Recovery in Veterans with Chronic Low 
Back Pain 
 
Lay Title: Selecting Effective Combinations of Treatment for Low Back Pain (SELECT LBP or 
‘SELECT’) 
1.0 
Study Personnel 
 
Principal Investigator: Pradeep Suri, MD, MS 
Staff Physician, VA Puget Sound Health Care System  
Associate Professor, Department of Rehabilitation Medicine, University of Washington 
Rehabilitation Care Services/Seattle Epidemiologic Research and Information Center (ERIC), 
VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Co-investigators: 
Rhonda Williams, PhD 
VA Puget Sound Health Care System Rehabilitation Care Services, 1660 S. Columbian Way, 
Seattle, WA, 91808 
Isuta Nishio, MD, PhD 
VA Puget Sound Health Care System Pain Clinic, 1660 S. Columbian Way, Seattle, WA, 
91808 
Timothy Dawson, MD 
VA Puget Sound Health Care System Pain Clinic, 1660 S. Columbian Way, Seattle, WA, 
91808 
Amy Hsu, MD 
VA Puget Sound Health Care System Pain Clinic, 1660 S. Columbian Way, Seattle, WA, 
91808 
Bosco Soares, MD 
VA Puget Sound Health Care System Rehabilitation Care Services, 1660 S. Columbian Way, 
Seattle, WA, 91808 
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Collaborator: 
Janna Friedly, MD (at UW, no affiliation with VA or work/activities in the VA, and has no contact with 
participants or study data other than in aggregate form such as published in medical journals, not 
covered under the VA IRB approval. Due to this lack of engagement from a human subjects 
perspective, Dr. Friedly is not listed on IRB or R&D documents other than the protocol). 
Associate Professor, Department of Rehabilitation Medicine, University of Washington 
 
Study Staff: 
Anna Korpak, PhD 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Andrew Timmons, MS 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Julieann Marshall, MSPH 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Adrienne Tanus, MPH 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Amanda Garcia, MPH 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Jessi Libbing, MPH 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Bianca Irimia, MPH 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Molly Woerner 
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Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Yarizel Herrera 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Kathryn Moore, PhD 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Daniel Morelli, BA 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Chris Forsberg, MS 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Alexandra Fox, MSIS 
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808 
Rosemarie Reyno-rac, RN, BSN  
VA Puget Sound Health Care System Pain Clinic, 1660 S. Columbian Way, Seattle, WA, 91808 
2.0 
Introduction 
Back pain is the most common pain location and reason for chronic opioid use in Veterans.12,16 It is also 
the most common reason for new VA disability compensation after tinnitus and hearing loss.32 Due to the 
high prevalence of disabling back pain in Veterans and the functional impact of CLBP in particular, 
improvement in treatments for CLBP has tremendous potential for improving functional recovery in the 
Veteran population, perhaps greater than that for any other health condition.   
A major barrier to mitigating the impact of CLBP on the Veteran population is the fact that most CLBP 
treatments have only small magnitude effects. In a review commissioned by the Agency for Health 
Research and Quality (AHRQ), we found improvements in pain of ≤10% for most first-line rehabilitative 
treatments for CLBP, such as exercise therapy (including physical therapy), yoga, and tai chi.6 
Improvements in functional limitations were generally even smaller than improvements in pain.6 For these 
reasons, combining pain treatments in future VA research emerged as a core recommendation in 
2016 from a VA State of the Art conference on non-pharmacologic pain management (SOTA #13). 
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Similar suggestions were also made in 2016 by other US agencies including AHRQ,6 the Patient-
Centered Outcomes Research Institute,28 and joint research initiatives by the National Institutes of 
Health, VA, and Department of Defense.27  
An important 
unanswered question 
is “Which treatments 
should be combined?”. 
In the context of the 
stepped-care model of 
pain treatment applied 
in the VA and many US 
settings,1,34 it may be 
impractical or unethical 
to combine first-line CLBP treatments (such as physical therapy) with second-line treatments (such as 
invasive spine procedures or surgeries), since failure of first-line treatment is typically a prerequisite for 
invasive second-line CLBP treatments. Another vital consideration is which intervention combinations are 
most likely to produce larger magnitude treatment effects than that of individual treatments alone. In 
approaching this question, we applied the theoretical framework of the Nagi disablement model, in which 
back pain is considered an impairment on the pathway to disability (Figure 1). Functional recovery and 
minimizing disability are the end goals of rehabilitative care. We reason that combining treatments that 
target distinct points in the disablement pathway are more likely to achieve large effects on functional 
recovery, as compared to treatments targeting the same underlying mechanisms (which might lead to 
redundancy and diminishing returns). Procedural interventions for CLBP aim primarily to address 
proximal stages in the disablement pathway, such as the underlying lumbar spine pathoanatomy and low 
back pain. In contrast, behavioral interventions for CLBP also target factors over which patients have 
some control, such as the way patients think about pain, or how pain affects their behavior. By modifying 
these things, behavioral interventions may affect distal stages in the disablement pathway and achieve 
effects on functional recovery that are not necessarily dependent on an improvement in pain. Therefore, 
we theorize that a combination of procedural and behavioral treatments may have the greatest 
potential for realizing large magnitude treatment effects for CLBP in Veterans.    
Towards this end, this study will use a 2 x 2 factorial randomized controlled trial (RCT) design to 
investigate the individual and combined effects of 1) lumbar medial branch nerve radiofrequency 
ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a 
telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled 
Cognitive Behavioral Therapy program (which we call “AcTIVE-CBT”), a behavioral intervention 
designed primarily to target functional limitations both secondary to, and independent of, improvements in 
pain. AcTIVE-CBT is a modification of standard CBT delivered by video telehealth, which places a 
greater emphasis on increasing physical activity, and uses current activity tracker technology to support 
physical activity and an active lifestyle more broadly. For each of these 2 treatments, we will compare 
outcomes with another standard of care treatment that either poses 1) less risk, or 2) less inconvenience 
to the Veteran participant, but with potentially comparable or equivalent treatment benefits. The factorial 
RCT design of this study will inform as to whether ‘stacking’ disparate CLBP treatments can 
result in greater treatment effects than that of each treatment alone. This study will produce valid 

Multiple potential targets of combined procedural/behavioral interventions along the disablement pathway:  
Lumbar radiofrequency ablation (LRFA) +  
Activity Tracker-Informed Video-Enabled CBT (‘AcTIVE-CBT’) 
Lumbar 
spine 
pathology 
Low back 
pain 
Back-related 
functional 
limitations 
 
Disability 
The primary target of 
rehabilitation efforts  
Targets of procedural interventions 
Targets of behavioral interventions  
Figure1. A conceptual model of back-related disability, and potential targets of CLBP treatments
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effect size estimates that will inform a definitive future large-scale multicenter RCT to determine the 
efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.  
LRFA is a minimally invasive non-pharmacologic procedure offered at many VA pain clinics, and it is 
standard care at the VAPSHCS Pain Clinic. It can be used in patients for which CLBP is isolated as 
coming from the lumbar facet joints, defined by pain relief (‘positive responses’) to local anesthetic medial 
branch blocks (MBBs) along the dorsal ramus medial branch nerves (which we refer to informally here as 
the ‘facet nerves’).7,17,22,23,30 Unlike most CLBP treatments, LRFA may result in large-magnitude 
improvements (≥75% for pain and functional limitations) in properly selected patients.10 However, LFRA 
is a neurodestructive procedure involving the temporary destruction of the facet nerves, and there is 
conflicting evidence regarding its efficacy.2,5,9,11,18,19,21,26,29-31,33 In particular, it is unknown whether LRFA 
achieves greater improvements in functional limitations when compared to other active procedure 
treatments such as injections targeting the facet joints that do not destroy the facet nerves.17 In this 
proposed research, outcomes for participants receiving the LRFA procedure will be compared to 
outcomes for participants receiving a simulated LRFA procedure, in which targeted steroid injections are 
administered to the involved facet nerves that would otherwise have been destroyed (that is, no nerve 
destruction is performed).   
Although cognitive-behavioral therapy (CBT) is an accepted treatment with demonstrated efficacy for 
CLBP, 3,4 conventional CBT is not widely available, particularly in rural areas,14 and incurs substantial 
travel burdens for Veterans. Our AcTIVE-CBT modification to standard CBT will allow rehabilitation 
psychologists to deliver CBT directly to Veterans in their homes using video-enabled tablets or PCs, 
facilitating greater compliance and access. The AcTIVE-CBT intervention also applies unique approaches 
to promote sustainable behavior change towards a more active lifestyle, including use of the Fitbit activity 
tracker to provide accurate, objective feedback on activity levels and step counts to Veterans and 
providers and inform goal setting and progress. Such an approach may facilitate the improvements in 
functional limitations and activity that have been elusive in RCTs of procedural interventions such as 
LRFA. An important unanswered question is whether still more efficient (i.e. fewer treatments) programs 
of CBT and more convenient options for CBT (self-paced and self-directed programs) may result in 
similar improvements, at still greater efficiency and ease for Veteran access. In this proposed research, 
outcomes for participants receiving AcTIVE-CBT will be compared to outcomes for participants receiving 
‘telephone-based self-directed CBT and education’ or TBSCE, a brief and efficient form of telehealth 
CBT. The TBSCE treatment involves a single telephone-based counseling session between the Veteran 
participant and a psychologist with a structured 3-month plan of education and lessons pertaining to 
principles of CBT and training to develop active habits of CBT guided by printed materials that we will 
provide. The structured plan is designed to be self-paced and convenient, allowing for some flexibility 
while covering all the main components of traditional CBT. These will be supplemented by a supportive 
contact at the approximate midpoint of the 3-month period and ad hoc availability of the psychologist if 
requested by the participant.  
The expected age range of study participants is 18 years of age and older. We expect the general health 
status of the subject population to be about average for Veterans’ ages. Patients with severe and major 
active medical or psychiatric comorbidities will not be eligible for the study due to not being clinical 
candidates for the lumbar procedures and/or CBT and/or candidates for the study procedures. We will not 
include patients from special classes of subjects or vulnerable populations such as pregnant women, 
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children, cognitively impaired persons, or prisoners due to possible coercion. We will not otherwise make 
any exclusions based on gender, sex, race, ethnicity, or any minority group designation. VA employees 
may be enrolled in the study; however, if enrolled, they cannot complete assessments on their VA paid 
time. ‘Assessments’ or ‘questionnaires’ as referred to in this Protocol are delivered as interviews and do 
not fall under the definition of “surveys” as used in the Survey Guidance document. As such, OASC and 
local VAPS HR will not be notified if a VA employee enrolls in this study. 
3.0 
Objectives 
 
Study Aim: To estimate the individual and combined treatment effects of 1) LRFA (vs. simulated 
LRFA with targeted steroid injections to the facet nerves) and 2) AcTIVE-CBT (vs. a telephone-
based self-directed CBT and education control) in up to 30 Veterans at 3-month follow-up. The 
primary outcome is participant-reported back-related functional limitations (mobility and ADLs) as 
measured by the Roland-Morris Disability Questionnaire at 3 months. Secondary outcomes include daily 
step counts, back pain intensity, reduction in opioid use, and quality of life.  
Hypotheses: 1) Each individual treatment will result in improvements in back-related functional limitations 
and secondary outcomes compared to control, and 2) Combined treatment will produce greater treatment 
effects than each of the individual treatments alone.   
4.0 
Resources and Personnel 
 
• This research will be conducted by Dr. Pradeep Suri and the following 
individuals entirely at VA Puget Sound Health Care System (VAPSHCS) 
• Dr. Suri is the PI and will be responsible for study planning and broad 
oversight; supervising study procedures; integrity of data collection; 
interpretation of findings; and all subsequent steps including manuscript 
preparation and submission. He will have access to protected health 
information. 
• Dr. Williams is co-I and will be responsible for study planning and oversight of 
any aspects related to CBT; supervising study procedures; interpretation of 
findings; and subsequent steps including manuscript preparation and 
submission. She will have access to protected health information.  
• Dr. Nishio is co-I and will be responsible for study planning and oversight of 
any aspects related to LRFA or simulated LRFA with targeted steroid 
injections; interpretation of findings; and subsequent steps including 
manuscript preparation and submission. He will not have access to protected 
health information.  
• Dr. Soares is co-I (non-key personnel) and will be responsible for some 
aspects of oversight related to LRFA or simulated LRFA with targeted steroid 
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injections; and subsequent steps including manuscript preparation and 
submission. He will not have access to protected health information.  
• Dr. Dawson is co-I (non-key personnel) and will be responsible for some 
aspects of LRFA or simulated LRFA with targeted steroid injection procedures; 
and subsequent steps including manuscript preparation and submission. He 
will not have access to protected health information.  
• Dr. Hsu is co-I (non-key personnel) and will be responsible for some aspects 
of LRFA or simulated LRFA with targeted steroid injection procedures; and 
subsequent steps including manuscript preparation and submission. She will 
not have access to protected health information.  
• Dr. Korpak is the study biostatistician. She will be involved in data analysis; 
and in manuscript preparation and submission. She will not have access to 
protected health information. 
• Mr. Timmons is the study biostatistician. He will be involved in performing data 
analysis and be involved in manuscript preparation and submission. He will not 
have access to protected health information.  
• Dr. Moore will function as the data manager. She will obtain data from the Corporate Data 
Warehouse and assemble that data into a format ready for analyses. She will not have 
access to protected health information.  
• Ms. Fox is the data analyst. She will obtain data from the Corporate Data Warehouse and 
assemble that data into a format ready for analyses. She will not have access to 
protected health information. 
• Mr. Morelli is the data administrator. He will obtain data from the Corporate Data 
Warehouse and assemble that data into a format ready for analyses. He will not have 
access to protected health information. 
• Mr. Forsberg is the biostatistician. He will be involved in performing data analysis and in 
manuscript preparation and submission. He will not have access to protected health 
information. 
• Ms. Marshall is the program manager. She will supervise other administrative 
staff below. She will not have access to protected health information.  
• Mrs. Garcia is the Fitbit coordinator. She will be involved in administrative tasks and 
coordination of Fitbit-related tasks. She will have access to protected health information. 
• Ms. Tanus is the research coordinator. She will be involved in recruiting subjects; 
obtaining informed consent; and administering questionnaires/interview procedures. She 
will have access to protected health information.  
• Ms. Jang is the research assistant. She will be involved in recruiting subjects; obtaining 
informed consent; and administering questionnaires/interview procedures. She will have 
access to protected health information. 
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• Ms. Libbing is the research assistant. She will be involved in recruiting subjects; obtaining 
informed consent; and administering questionnaires/interview procedures. She will have 
access to protected health information. 
 
5.1 Study Design 
 
We will conduct a 2 x 2 factorial pilot RCT to investigate the individual and combined effects of 1) lumbar 
radiofrequency ablation (LRFA) vs. simulated LRFA control with targeted steroid injections to the facet 
nerves, and 2) Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy (AcTIVE-CBT) vs. 
TBSCE. For simplicity of language, henceforth in this protocol we frequently refer to simulated LRFA with 
targeted steroid injections to the facet nerves as ‘simulated LRFA’. All treatments that will be allocated as 
part of this research are standard-of-care, “active” treatments expected to improve function and pain in 
those with CLBP. The study will recruit up to 30 Veterans, with the goal of having 20 Veterans with chronic 
low back pain (CLBP) who provide complete data for the main study outcome at 3-month follow-up post-
randomization (the Roland-Morris Disability Questionnaire), with a minimum of 4 completers of the main 3-
month follow-up outcome in each of the 4 ‘cells’ for treatment (see Figure 2). Participants would be 
blinded to whether they are receiving the study ‘interventions’ or ‘controls’, over the first 3 months of 
follow-up. Following the main period of data collection of 3 months of follow-up post-randomization, for 
those participants who wish to continue with the study, we will continue to collect observational data 
monthly thereafter for the duration of the funding period (up to 9 additional months); such data collection 
will continue with or without unblinding to participant group assignments per the randomization, according 
to what the participant decides. Unblinded participants may make subsequent treatment decisions as they 
wish, so optional assessments after the study period may be affected by unblinding and other changes in 
treatment and are not truly randomized comparisons. Participants who did not receive LRFA during the 
main 3-month period of follow-up may elect to pursue LRFA as part of normal clinical care, and those who 
receive TBSCE may elect to pursue standard video telehealth CBT (a typical ‘extended’ course of CBT). 
All aspects of intervention and control treatments will be conducted within the context of existing standard 
of care clinical processes at the VAPSHCS Pain Clinic, the Rehabilitation Care Services division, and the 
VAPSHCS Telerehabilitation Enterprise-Wide Initiative (TREWI) program (which offers video and 
telephone telehealth services for a variety of target conditions, including CBT for CLBP). Both LRFA and 
targeted steroid injections to the facet nerves are commonly performed and standard of care procedures 
for chronic low back pain in the US.17,24,25 Although there are no significant differences with respect to 
improvement in functional limitations between LRFA and targeted steroid injections in randomized 
controlled trials, 17,20 targeted steroid injections to the facet nerves likely have a lower risk profile than 
LRFA, given that no nerve destruction occurs.  
CBT is also widely accepted as standard of care treatment for chronic pain and CLBP, although there are 
major limitations on the availability of this treatment in the US, and for Veterans.3,4 The AcTIVE-CBT and 
TBSCE treatment arms in this study correspond to extended and brief courses of CBT, respectively. We 
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expect that the two telehealth treatments to be used in this study, if effective, will be a step toward 
providing better options to mitigate these limitations in availability for Veterans and non-Veterans alike.  
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· M o nt hl y a s s e s s m e nt s t hr o u g h e n d
of  th e f un di n g  p er io d  
· N o t tru e  ra n d o m iz e d  c o m p a ris o n s
 
 
Fi n a l S c re e ni n g  
· I nf or m e d Co n s e nt
· R e c e iv e  F itb it Z ip  
I nitia l S c re e n i ng  
Pr o c e d u ra l T re a tm e n t 
· L R F A v s. si m ul at e d L R F A
· O n  s a m e  d a y a s ra n d o m iz a tio n
 
B e h a v io ra l T re a tm e n t 
· A c TI V E- C B T or T B S C E
o v er  3-m o nt h f oll o w- u p
 
 
Fi g ur e 2  
V A P u g et S o u n d I R B A p pr o v e d 
0 3/ 1 2/ 2 0 2 0

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Description of Risks and Risk vs. Benefit 
 
Anticipated risk with this study is minimized because, from the standpoint of interventional spinal procedures 
offered as part of this study, eligible participants for this study will be identified from among patients receiving 
MBBs for the purpose of obtaining LRFA in the future. Thus, no individuals who were not already seeking to 
obtain LRFA as part of usual clinical care services offered at VAPS will be candidates for this study. Potential 
physical risks from participating in the study involve the same therapeutic risks that would normally be involved 
with undergoing the LRFA procedure in usual clinical practice (if patients are randomized to the LRFA 
procedures), or less expected risk than LRFA (if they are randomized to the simulated LRFA procedure, which 
includes targeted facet nerve injections but will not involve the nerve destruction that is part of LRFA). In other 
words, risk with simulated LRFA may be less than LRFA, since simulated LRFA does not involve the 
destruction of the facet nerves. Potential benefits of the study include receiving benefit in CLBP and functional 
limitations from simulated LRFA and targeted steroid injections and not having to undergo nerve destruction 
with LRFA.  
There are no physical risks associated with the AcTIVE-CBT and TBSCE treatments. There is potential benefit 
in terms of improving CLBP and functional limitations with both treatments; benefits in the TBSCE treatment 
(‘brief CBT’) will involve substantially fewer treatment sessions and may be more convenient than AcTIVE-CBT 
(‘extended CBT’). 
Other specific risks of the clinical treatments as routinely provided in usual clinical care are provided below in 
plain language typical of what is included in the consent form. Although in some situations, the risks associated 
with usual clinical care that take place within the contexts of a research study might not be described in the 
research protocol itself, in this instance we describe in detail the risks associated with LRFA. This is done for 
two main reasons: 1) To avoid any situations in which study participants might not be aware of the attendant 
risks/benefits of LRFA, a procedure they have sought for treatment of CLBP as part of their normal clinical 
care. This is relevant because in routine clinical care patients often have misconceptions about what LRFA 
involves and what the extensive typical screening process for LRFA typically involves; and 2) Because 
simulated LRFA with targeted steroid injections in the context of this study represents a less invasive (not 
neurodestructive) procedure which may eliminate or avoid the need for LRFA, and thus, an accurate sense of 
risk/benefit and relative risk/benefit relies on knowledge of both procedures.  
 
Physical risks:  
The LRFA procedure entails applying anesthetic around the nerve to the facet joint and applying heat to 
selectively destroy the nerve that supplies the facet joint. This may result in relief of pain (the goal of the 
procedure) until the nerve regenerates over the course of several months, after which time low back pain 
related to the facet joints would be expected to resume. 
LRFA involves the use of x-rays to guide the procedure, and the x-ray radiation amounts involved with 
LRFA are low. The average amount of radiation exposure from these x-rays will be between 1-8% of the 
average exposure any person receives from the environment per year. Common risks of LRFA include 
having no reduction of pain, numbness at the procedure site, temporarily increased back pain, lowering of 
your blood pressure, facial flushing, or increases in blood sugar levels. Less commonly patients can have 
nausea; bleeding, persistent redness, or swelling at the procedure site; temporary changes in mood or 
hormone levels; or brief (lasting minutes to hours) numbness, weakness, or paralysis of the back or legs. 
In rare instances, cardiac arrest; irregular heartbeat; seizure; nerve injuries; infections; unexpected allergic 
reactions; bone problems such as bone necrosis; permanent areas of numbness, weakness, worsened 
pain, or paralysis; spinal cord damage; stroke; and death have been reported with LRFA.   
 
If a participant were to receive simulated LRFA with targeted steroid injections to the facet nerves without 
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destroying the facet nerves as part of this research study, the possible physical risks are the same as 
LRFA, but are generally expected to be less likely than that which would be involved in LRFA, since the 
nerves are not destroyed. Targeted steroid injections to the facet nerves involve the use of x-rays to guide 
the procedure, and the x-ray radiation amounts involved are low. The average amount of radiation 
exposure from these x-rays will be between 1-8% of the average exposure any person receives from the 
environment per year.  
 
Common risks of simulated LRFA with targeted steroid injections to the facet nerves include no reduction 
of pain, temporary increased back pain, lowering of your blood pressure, facial flushing, or increases in 
blood sugar levels. Less commonly, patients can have temporary changes in mood or hormone levels, 
bleeding, persistent redness, or swelling at the procedure site, or brief (lasting minutes to hours) 
numbness, weakness, or paralysis of back or legs. In rare instances, cardiac arrest; irregular heartbeat; 
seizure; nerve injuries; infections; unexpected allergic reactions; bone problems permanent areas of 
numbness, weakness, worsened pain, or paralysis; spinal cord damage; stroke, and death have been 
reported with procedures of this type.   
 
Psychological risks:  
Any physical changes as a result of the LRFA or simulated LRFA procedures may in theory result in 
psychological distress that is expected to be short-term, since any LRFA-related side effects are usually 
short-term and self-limited.   
 
Psychological risks with AcTIVE-CBT or TBSCE are the same risks involved in ‘usual care’ behavioral 
treatments for pain (such as conventional CBT, mindfulness-based stress reduction, hypnosis, etc.). 
Participants may experience fatigue and/or boredom while completing the research interviews and/or the 
AcTIVE-CBT or TBSCE control treatment sessions. Some participants may also experience mild anxiety, 
frustration, and/or stress while reporting on their mood and psychologic symptoms, during assessment 
procedures, and/or during the course of treatment. The two types of behavioral treatment (AcTIVE-CBT or 
TBSCE control) involve discussions between the provider/research staff and the participant about pain 
and related topics that may make some individuals feel uncomfortable. However, the AcTIVE-CBT or 
TBSCE control treatments are not expected to involve any serious or long-term risks to an individual’s 
health. 
 
Social, Legal, Privacy, and Other Risks:  
There are research risks to participants’ privacy associated with inappropriate disclosure of data. 
Specifically, there is a risk that a participant’s identity and participation in the study may be discovered by 
an outside party. However, we will take various steps as described elsewhere in the study documents to 
ensure that the likelihood of such risk is negligible. 
 
Description of Study Population/Expected Enrollment/Vulnerable Populations: 
We expect to recruit up to 30 Veterans in the proposed study in order to obtain 20 Veterans who complete 
3-month follow-up for the primary outcome (improvement in functional limitations), and at least 4 out of 5 
participants in each cell of the 2x2 contingency table (see Figure 2) completing 3-month follow-up for the 
primary outcome. All Veteran participants will be patients recruited from VAPSHCS who are seeking to 
have the LRFA procedure for CLBP. There are no other categories of participants allowed in the study. 
Further details of inclusion/exclusion criteria are provided below in Table 4 (this is placed below in Section 
5.4 as specified by the Protocol Template format). The expected age range of study participants is 18 
years of age and older. We will not include patients from special classes of subjects or vulnerable 
populations such as pregnant women, children, cognitively impaired persons, or prisoners, due to possible 
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coercion. We will not otherwise make any exclusions based on gender, sex, race, ethnicity, or any minority 
group designation.   
 
Randomization:  
 
MBBs will be performed as per usual clinical care processes in the VAPSHCS Pain Clinic. Following 
usual clinical practice after the 2nd set of MBBs, once a participant is determined eligible based on the 
Final Screening criteria, including responses to the 2nd set of MBBs, he/she will be scheduled for a 
procedure slot when LRFA or simulated LRFA will be performed. The specific procedural treatment to 
be received (LRFA vs simulated LRFA) will not be known to the participant or the research staff at the 
time of scheduling.  
 
Description of randomization procedures below mention the “treating interventional spine provider” and 
the “2nd interventional spine attending physician”. The “treating interventional spine provider” is the 
provider who is in charge of a patient’s procedural care in the course of usual practice in the VAPSHCS 
pain clinic. The “2nd interventional spine attending physician” will be another VAPS interventional spine 
attending physician who is separate from the “treating interventional spine provider” previously 
mentioned. Both these physicians will participate in the LRFA and simulated LRFA procedures as 
described further below; however, the 2nd interventional spine attending physician will be engaged as 
part of the research procedures, and the treating interventional spine provider will not be engaged as 
part of the research procedures. Further description of these two different roles is provided below. 
 
The randomization process involves: 
1. Treatment assignments will be stored centrally electronically in a secure database at VAPSHCS. 
Envelopes containing the treatment assignments (hardcopies) will also be pre-generated. 
2. We will utilize computer-generated permuted-block randomization to achieve roughly balanced 
groups. We will use random blocks that are not divulged to the research staff involved in 
recruitment in order to avoid bias in the recruitment process. Randomization will be stratified by 
MBB block responses (50-79% vs. ≥80%).  
3. Reminder emails will be sent to the clinical assistant (Pati Irish) and the 2nd interventional spine 
attending physician the day before the scheduled procedure to remind them that they will need to 
obtain the randomization allocation on the day of the procedure, prior to the procedure. The 2nd 
interventional spine attending physician is the second interventional spine attending physician- 
other than the treating spine provider, who will be in the room during LRFA or simulated LRFA and 
take part in these procedures. Similar emails will be sent on the morning of the procedure. 
4. Prior to the lumbar procedure, the clinical assistant and the 2nd interventional spine attending 
physician will open the envelopes which reveal the procedural and behavioral treatment 
allocations. A non-blinded research staff member will be present to facilitate this and be aware of 
the treatment allocations. These assignments contained in the envelopes will direct the 2nd 
interventional spine attending physician whether to perform a standard LRFA or the simulated 
LRFA, and whether the participant will receive AcTIVE-CBT or TBSCE. A primary function of the 
clinical assistant is to make sure that the 2nd interventional spine attending physician knows and 
performs the allocated treatment on the day of the procedure. 
5. On the day of the procedure, once the randomization status is known, the non-blinded research 
staff member and the PI, Dr. Suri, will communicate regarding the participant’s assignment to 
AcTIVE-CBT or TBSCE. Dr. Suri will then place clinical orders in CPRS for telehealth CBT for pain. 
These orders will specify whether the order is for a brief course of CBT for pain with education and 
self-directed plan for progression (TBSCE) or an extended course of CBT for pain (AcTIVE-CBT). 
The non-blinded research staff member will also communicate directly with the treating CBT 
provider to clarify that the patient is a study participant. The participant will then be scheduled for 
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the first session of AcTIVE-CBT or TBSCE, which generally will take place within 1-3 weeks of the 
procedure date whenever possible. 
6. On the day of the procedure, prior to revealing each participant’s randomization assignment, we will 
ensure that we have completed the following aspects of data collection and/or report forms: 
participant contact Information, the Screening Log (described further below) 
Informed Consent (Attachment T – Consent, described further below), and baseline questionnaires 
(the baseline study assessment, pre-randomization, described further below in ‘Study Measures’). 
The Screening Log is a tracking document used for internal study purposes. 
 
Description of LRFA and simulated LRFA control procedures: 
After the treatment allocation for a given participant is known to the clinical assistant and 2nd 
interventional spine provider, that participant will undergo their lumbar procedure (LRFA or simulated 
LRFA). Two experienced board-certified pain medicine attending physicians, one of whom is the 
participant’s ‘treating’ physician who performed the screening MBBs (the ‘treating interventional spine 
provider’), will perform each LRFA procedure. To permit provider blinding, the treating interventional 
spine provider will place LRFA electrodes at each spinal level to be treated, and will then leave the 
procedure room, subsequently remaining blinded to allocation. The 2nd interventional spine attending 
physician (unblinded, not involved in data collection or further care of the participant) will then administer 
the allocated LRFA treatment or simulated control. For the LRFA group, this involves making a 
radiofrequency lesion, repositioning the electrode, and making a 2nd RFA lesion, at each medial branch 
target. For the simulated LRFA group, this involves the placement of electrodes as would normally be 
done during LRFA, but without making RFA lesions.   
The 2nd interventional spine attending physician who will conduct most LRFA and simulated LRFA 
procedures in this study will be Dr. Bosco Soares, a board-certified Physical Medicine and Rehabilitation  
(PM&R) physician with subspecialty accreditation in Pain Medicine. For study participants whose treating 
physician is Dr. Soares, the 2nd interventional spine attending physician will be Dr. Nishio or Dr. Dawson. 
Drs. Nishio and Dawson are board-certified anesthesiologist physicians with subspecialty accreditation in 
Pain Medicine. Drs. Soares, Nishio, and Dawson teach LRFA procedures to Pain Medicine fellows in the 
UW Accreditation Council for Graduate Medical Education (ACGME)-accredited Pain Medicine 
fellowship. As shown in Table 2, Dr. Soares will not be blinded to randomization unless (for a given 
participant) he is the treating interventional spine provider, in which case he WILL be blinded. 
Conversely, Dr. Nishio will be blinded to randomization status, unless (for a given participant) he is acting 
as the 2nd interventional spine attending physician (Dr. Nishio will often be the 2nd interventional spine 
attending physician in those instances when Dr. Soares is the treating interventional spine 
provider).Similarly, Dr. Dawson will be blinded to randomization status, unless (for a given participant) he 
is acting as the 2nd interventional spine attending physician (Dr. Dawson will sometimes be the 2nd 
interventional spine attending physician in those instances when Dr. Soares is the treating interventional 
spine provider). 
 
 
 
 
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LRFA Technique: 
The LRFA technique to be used in this research is consistent with current practices among our 
VAPSHCS LRFA providers and with the highest clinical standards available, including those detailed 
in the Spinal Intervention Society Practice Guidelines for Spinal Diagnostic and Treatment 
Procedures, 2nd edition. Briefly, LRFA involves initially positioning a spinal needle at each ‘facet 
nerve’ (medial branch of the dorsal ramus) that will be ablated, in the same manner in which medial 
branch blocks are typically performed, and administering local anesthetic to the nerve and the 
immediately surrounding muscles, covering a volume consistent with the expected size of the region 
to be ablated. The needle is then left in place, serving as a pointer to the nerve target site. A 
radiofrequency electrode is then placed along the course of the medial branch, using a fluoroscopic 
declined view approach with cross-table obliquity as needed to achieve electrode placement parallel 
to the medial branch, to the target point marked by the spinal needle tip. Once the electrode is 
positioned, sensory stimulation is performed at 50 Hz up to 1 millivolt until the patient reports axial 
and no extremity sensation to further confirm appropriate location of the electrode. The intensity of 
sensory stimulation where the patient reports sensation will be noted by the clinical assistant and 2nd 
interventional spine attending physician. Motor stimulation is performed at 2 Hz up to 4 volts (but 
typically no more than 2 volts) to confirm that there is no motor stimulation of the ventral nerve root 
causing muscle contraction. If there is motor stimulation of the ventral nerve root, the electrode is 
repositioned and the stimulation sequence is repeated until the correct electrode position is 
confirmed. If unable to achieve sensory stimulation, a lesion would not be attempted at that level. 
Once the electrode is in correct position and stimulation testing completed, a lesion is generated by 
raising the temperature at about 1°C per second, from 37°C to an operating temperature between 
80°C and 85°C, which is maintained for 90 seconds. The electrode will then be repositioned slightly 
by withdrawing or repositioning parallel to the 1st ablation site, or by rotating the electrode, and a 2nd 
lesion will be made. If at any time during the raising of the temperature, or during the coagulation, 
the patient reports adverse sensations, the generator will be immediately turned off and the 
sensation evaluated. Depending on provider preference as part of routine clinical care, local 
corticosteroid injections may be used to decrease the likelihood and/or severity of a post-LRFA 
‘neuritis’, worsening of back pain that can be due to the nerve ablation/lesioning itself. This process 
is then repeated for each medial branch nerve that is targeted (typically 2 or more medial branches 
per LRFA procedure).  
Simulated LRFA with targeted steroid injections technique: 
The simulated LRFA control will be performed in an identical fashion to LRFA as above, except that 1) 
after electrode positioning, a neurodestructive lesion is not made; 2) a targeted corticosteroid injection 
will be administered at each targeted medial branch prior to the 1st simulated lesioning; 3) a pre-
recorded audio recording of the procedure will be played by the clinical assistant (out of view of the 
patient, immediately adjacent to the RFA machine) in order to simulate the beeping and other sounds 
of the machine and to ensure the appropriate length of the simulated procedure, and 4) the 2nd 
interventional spine attending physician will turn on sensory stimulation for a short period of at least 3 
seconds towards the end of the simulated lesion time, maintaining stimulation intensity no higher than 
the level where sensory input was initially noted by the patient during testing. The electrode will remain 
in place for the full 90 seconds that lesioning would normally require, but without heat application. The 
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electrode will then be repositioned to simulate a second lesion, also of duration 90 seconds. This 
process would then be repeated for each medial branch nerve that is targeted (2 or more medial 
branches per simulated LRFA procedure). Targeted corticosteroid injections will consist of a total 
injectate quantity per patient not to exceed the equivalent of 40-80 mg triamcinolone, divided equally 
among medial branch sites to be targeted. Lower doses of corticosteroid may be used as per the 
providers’ clinical discretion.  
 
Description of AcTIVE CBT vs. TBSCE CBT treatments 
The AcTIVE-CBT treatment involves eight 60-minute treatment sessions spaced over 3 months, delivered 
via clinical video telehealth methods by clinical psychologists to Veterans in their homes. Psychologists 
will refer to Fitbit output during the initial evaluation and each treatment session, including reminders and 
tips about Fitbit use, evaluating step count homework, and tracking overall progress towards goals; the 
protocol for AcTIVE-CBT is provided as Attachment KK – AcTIVE-CBT Workbook. The TBSCE treatment 
involves an initial 60-minute telephone education session by a psychologist including education on CBT 
principles; the provision of an educational book for CBT self-management (‘Managing Pain Before It 
Manages You’ by Margaret A. Caudill PhD) and orientation to the workbook;43 and a structured plan for 
weekly reading and homework using the workbook43. The content of TBSCE interactions in the one initial 
60-minute session is as per Attachment MM, but can be adapted to follow psychologists’ typical practices 
for patients beginning CBT for pain who are interested in the treatment but are unable to continue with 
further sessions. In addition, the psychologist providing TBSCE will contact the participant at the 
approximate midpoint of the 3-month follow-up period to reinforce key concepts as needed, encourage 
continued participant-directed use of the plan for weekly reading and workbook use, and answer 
questions. The psychologist will also be available by phone to address any areas of concern or participant 
questions during follow-up. TBSCE represents a focused yet ‘active’ treatment beyond what is normally 
provided after LRFA. Around the time of the start of behavioral treatments for participants in both the 
AcTIVE-CBT and TBSCE arms, research staff will provide a written summary of certain data elements 
from Visit 0 and 1, reflecting the same type of information that would be obtained during an initial clinical 
evaluation for CBT. This written information will be shared in the form of Attachment NN (‘Brief Summary 
Baseline Data’ form). The purpose of this is to provide information to the therapist that will be useful in 
understanding the participant’s baseline status and thus providing effective clinical care. These data 
elements will include report of pain intensity, number of pain locations, treatment expectancy, hours 
missed from work or volunteer activities, CLBP-related functional limitations, and past treatments for 
CLBP. The Brief Summary Baseline Data form (Attachment NN) will be generated by research staff and 
sent to the clinical therapist using the secure VHA Privacy Act/HIPAA Envelope or fax or encrypted email. 
If a fax is sent, once the fax receipt has been confirmed at the destination location (confirmed by the 
therapist), the original form will be destroyed via placement in a designated shredding bin (by the research 
staff member). If the therapist is located at Seattle campus, the research staff can come to the clinical 
area for a direct handoff of the Brief Summary Baseline Data form. Once the form is handed to the clinical 
therapist, the therapist can review this information and record whatever information they would normally 
do as per their usual clinical practice, in the medical record. The clinical therapist will then destroy the form 
via placement in a designated shredding bin, not retaining the record for future use, so as to limit potential 
risk for privacy issues. 
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In order to avoid imparting biases regarding which treatment is the ‘intervention’ and which the ‘control’, 
AcTIVE-CBT is referred to as ‘extended CBT’ in the Informed Consent documents and all discussions with 
the patient, and TBSCE treatment is referred to as ‘brief CBT’ in the Informed Consent documents and all 
discussions with the participant. 
 
The AcTIVE CBT and TBSCE control conditions will both be delivered by licensed Clinical Psychologists 
with specific expertise in cognitive-behavioral therapy and its application to the treatment of chronic pain. 
Both treating psychologists have appointments within Rehabilitation Care Services at VAPSHCS and are 
approved for clinical telehealth service modalities. Both study psychologists will be instructed by Dr. 
Williams in the aspects of clinical CBT treatment to be provided for participants in this study, but are 
considered clinical staff providing standard-of-care clinical services for chronic pain, and thus not actively 
engaged in the research procedures. Participants receiving a given treatment (AcTIVE CBT or TBSCE) 
will generally receive the same information; however, we expect some variation in the amount of time 
spent on each topic and the specific language used to convey materials. As per usual clinical practice, 
psychologists will tailor the information in whatever way is indicated to ensure understanding of the 
content, and to provide individualized support based on personalized goals, barriers, and abilities. If 
patients specifically request to have one or more in-person sessions of either AcTIVE-CBT or TBSCE in 
lieu of video telehealth or telephone (respectively), therapists will accommodate such requests as their 
clinical schedules and availability allow.  
ACTIVE-CBT  
Psychologists providing the AcTIVE-CBT intervention will receive reports on a participant’s Fitbit output 
and compliance in advance of each treatment session. We will strive to schedule the AcTIVE-CBT 
sessions at consistent days/times within the week if possible, to facilitate routine and attendance. We will 
also attempt to schedule sessions evenly across the 3-month follow-up period, to ensure adequate 
practice time for patients between sessions. AcTIVE-CBT sessions will generally begin with a review of 
the Fitbit-related output provided by research staff, to gauge activity since the prior session. Sessions will 
typically include activity plans, expectations, and goals for the next session and long-term. The schedule, 
scope, and content of treatment as part of the AcTIVE-CBT are similar in scope and content to typical 
CBT for chronic pain as provided in the RCS service line, but have been specifically tailored for low back 
pain based on the results of recent successful RCT.3,4 Some key differences between AcTIVE-CBT and 
the standard video-based CBT treatment available at VAPSHCS include a greater focus on encouraging 
walking and physical activity, using the Fitbit Zip units, and greater emphasis on understanding flare-ups 
and relapse prevention. The components of AcTIVE-CBT are presented in Table 1 below and details of 
the treatments are found in the patient workbook (Attachment KK – AcTIVE-CBT Workbook). Please note 
that patient workbook is distinct from the therapist/psychologist manual (Attachment JJ – AcTIVE-CBT 
Manual). AcTIVE-CBT is meant to be responsive to clinical needs and realities, and if needed, the timing, 
order, and intensity of these components may vary slightly depending on the specifics of the individual 
participant, but all will be covered during the 3-month treatment period. AcTIVE-CBT may include audio 
content. These materials were previously submitted to the IRB with the initial submission. This audio 
content can be provided to participants in CD format and/or by accessing the content on the VA Seattle 
ERIC website. The audio content is not copyrighted and we have obtained permission from the audio 
content creators to use the content without restriction. We have also obtained permissions from the 
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VAPSHCS privacy officer (Weivoda), information systems security officer (Biggs), area manager for end 
user operations for IT (Gibson) (see correspondence submitted, including also the IRB Director [Marsh]). 
TBSCE  
Participants in the TBSCE arm will also receive the Fitbit Zip units, but education and treatment will not be 
specifically structured around the Fitbit. TBSCE will begin with a 60-minute educational session by a 
rehabilitation psychologist conducted over the telephone. It will be followed by one brief phone call (10-20 
minutes in length) from the rehabilitation psychologist to the participant between 1-2 months after the 
initial TBSCE session. TBSCE steps follow the structured CBT program included in the book “Managing 
Pain Before It Manages You” by Caudill, supplemented by a workbook that we have developed for 
TBSCE. The Caudill book taken together with the workbook are sufficiently detailed that a participant can 
independently learn the concepts and complete exercises. The workbook includes many of the same 
topics covered in the AcTIVE-CBT treatment, but in a different order, and without a specific focus on 
physical activity.  Participants will be encouraged to set weekly goals for working through the sessions in 
the book and completing the assigned readings. At the introductory phone consultation, psychologists will 
advise participants in setting up a specific written schedule for completing the workbook sections and 
activities over the 3-month period that the participant will record in their treatment manual (with specific 
dates when completion of content for a session is expected to be completed). Long-term activity goals and 
weekly activity goals will be discussed, and these will also be recorded by the patient in the patient 
treatment manual (Attachment LL – TBSCE Manual (Instructions)). Weekly workbook homework will 
include: 1) education on chronic pain, 2) theories of pain and diaphragmatic breathing, 3) progressive 
muscle relaxation and visual imagery, 4) automatic thoughts and pain, 5) cognitive restructuring, 6) stress 
management, 7) time-based pacing, 8) pleasant activity scheduling, 9) anger management, 10) sleep 
hygiene, and 11) relapse prevention and flare-up planning.  
We may make non-substantive changes to AcTIVE-CBT and TBSCE manuals, workbooks, and provider 
scripts as the study proceeds. Any substantive changes will be submitted to the IRB for further review. 
Quality Assurance 
After each session of AcTIVE-CBT, therapists will complete a brief checklist to document the content 
areas covered in each session (see Attachment OO). These checklists will be used to assess the quality 
of the AcTIVE-CBT treatment and that major content areas have been covered. Checklists will be retained 
in a locked file cabinet in the therapist’s locked treatment room/office until the last treatment session is 
completed. After the last treatment session is completed, the therapist will send the checklist to research 
staff using the secure VHA Privacy Act/HIPAA Envelope or fax or encrypted email. If a fax is sent, once 
the fax receipt has been confirmed at the destination location (confirmed by discussion or email with 
research staff), the original checklist will be destroyed via placement in a designated shredding bin (by the 
therapist). If the therapist is located at Seattle campus, the research staff can come to the clinical area for 
a direct handoff of the checklist.  
Checklists will be collected by research staff and used to track treatment quality/content covered for each 
participant. These checklists will be treated in the same manner as study questionnaires, using the same 
methods for data security.   
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Table 1: Overview of Content in AcTIVE-CBT and TBSCE treatments* 
 
AcTIVE-CBT 
TBSCE  
General 
descriptions 
and content 
prior to first 
session with 
psychologist  
All sessions conducted by video 
telehealth and psychologist-delivered.  
Participant will receive basic instruction 
on Fitbit Zip use from research staff prior 
to randomization. 
Participant will receive ongoing research 
staff support regarding Fitbit use post-
randomization, including telephone 
contacts by research staff at 
approximately 2 weeks, 6 weeks, and 10 
weeks post-randomization. 
Research staff will produce regular 
reports on participant Fitbit output and 
compliance prior to each treatment 
session, which will be made available to 
the psychologist and the data relayed to 
participants during the treatment 
sessions.  
TBSCE is an active yet lower-dose intensity 
treatment as compared to AcTIVE-CBT. 
TBSCE will include pain education and 
CBT-related education and guidance 
through Dr. Margaret Caudill’s CBT 
‘Managing Chronic Pain’ workbook 
(referred to as ‘‘Caudill’ below)  
Participant will receive basic instruction on 
Fitbit Zip use from research staff prior to 
randomization. 
Participant will receive ongoing research 
staff support regarding Fitbit use post-
randomization including telephone contacts 
by research staff at approximately 2 weeks, 
6 weeks, and 10 weeks post-randomization.  
Session 1  
Welcome and Introductions; Pain and 
the Brain 
60 min. session by rehabilitation 
psychologist 
Welcome and Introduction; Introduction to 
Materials (TBSCE Manual and ‘Managing 
Pain Before It Manages You’ workbook by 
Caudill); Overview of the Treatment 
Structure; Questions 
 
Reading Assignments  
• Chapter 1 (Beginning to Take Control of 
Your Pain) 
• Chapter 2 (Understanding Pain) 
 
Topics: 
• Education about different types of pain 
• Self-assessment about how you currently 
cope with pain.  
60 min. telephone session by 
rehabilitation psychologist 
Session 2  
Getting Active! Goal-Setting, Pacing, and 
Managing Flare-Ups 
60 min. session by rehabilitation 
psychologist. 
Reading Assignments  
• Chapter 3 (The Mind-Body Connection) 
 
Topics: 
• Pain as a form of Chronic Stress 
• Relaxation Response 
 
Session 3  
Thoughts, Feelings, and Pain 
60 min. session by rehabilitation 
psychologist 
Reading Assignments  
• Chapter 4 (The Body-Mind Connection) 
 
Topics: 
• Increasing activities 
• How doing activity improves your mood 
• Pleasant activities 
 
Session 4  
Challenging Automatic Thoughts: Part I 
Reading Assignments: 
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60 min. session by rehabilitation 
psychologist 
• 
Chapter 5 (The Power of the Mind, 
pages 97-112) 
 
Topics: 
• 
How to use powerful cognitive 
techniques to change your mood. 
• 
Recognize your “self-talk”, or 
“automatic thoughts” 
• 
Recognize thought distortions 
  
Session 5  
Challenging Automatic Thoughts: Part II 
60 min. session by rehabilitation 
psychologist 
Reading Assignments: 
Chapter 5 (The Power of the Mind).  
 
Topics: 
• 
How to use powerful cognitive 
techniques to change your mood. 
• 
Recognize your “self-talk”, or 
“automatic thoughts” 
• 
Recognize thought distortions 
 
10-20 min psychologist contact by 
phone conducted between 1-2 months 
after the initial TBSCE session, to 
encourage progress with written 
materials and self-directed 
progression. 
Session 6  
Thinking about Thoughts: Review and 
Trouble-Shooting 
60 min. session by rehabilitation 
psychologist 
Reading Assignments: 
Chapter 6 (Adopting Healthy Attitudes) 
 
Topics: 
• 
Health attitudes 
 
Session 7  
Pain Beliefs and Behaviors: Skill Review 
and Sleep 60 min. session by 
rehabilitation psychologist 
Reading Assignments: 
Chapter 8 (Effective Communication) 
 
Topics: 
• 
Assertiveness 
• 
Active Listening 
 
Session 8  
Maintaining Gains and Coping with 
Setbacks 60 min. session by 
rehabilitation psychologist 
Reading Assignments: 
• Chapter 9 (Effective Problem Solving) 
• Chapter 10 (The End of The Beginning) 
 
Topics: 
• Setting Goals 
• Applying your coping skills to problems 
• Relapse Prevention 
• Coping with Pain During Flare-Ups 
 
*See the AcTIVE-CBT manual and workbook, and the TBSCE manual (for participants) for details of treatment. The 
timing, order, and intensity of these components may vary depending on the specifics of the individual participant, but 
all will be covered during the 3-month treatment period. Changes made to content above during the study period; 
updates to the protocol document and attachments will not be routinely submitted to the IRB for further review unless 
the changes made are substantive. 
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Blinding Strategy: 
Blinding with respect to the lumbar procedures (LRFA vs. simulated LRFA): 
1. Participants and treating interventional spine providers will be blinded to the status of LRFA vs. 
simulated LRFA. The PI Dr. Suri and Dr. Williams will not be blinded, since they are the overseeing 
study clinicians. Further details are provided below in Table 2.  
2. For blinding purposes, both LRFA and simulated LRFA will be performed in an identical fashion with 
the exception of medial branch lesioning, which will not be done in the simulated LRFA group, as 
described above. Duration and sounds of both the LRFA and simulated LRFA procedures will be 
similar. Both LRFA and simulated LRFA will apply all safety precautions normally used in our facility 
such as not using general anesthesia, and the use of both sensory and motor stimulation to avoid 
incorrect electrode placement (described further below).  
3. During the procedure (LRFA or simulated LRFA), the treating interventional spine provider will 
make initial placements of all LRFA electrodes to be used in that procedure as he/she would do 
normally for LRFA. Once the treating interventional spine provider has placed all LRFA electrodes, 
the treating interventional spine provider will leave the room and subsequently remain blinded to the 
procedure allocation (i.e. the randomization to LRFA vs. simulated LRFA). The 2nd interventional 
spine attending physician will take over the procedure once the treating interventional spine provider 
leaves the room; the 2nd interventional spine attending physician will not be blinded to the procedure 
allocation. After the treating interventional spine provider leaves the room, the 2nd interventional spine 
attending physician will either use the radiofrequency machine in the appropriate manner for standard 
LRFA by lesioning the nerve, or administer the therapeutic MBB (for the control procedure) and apply 
the simulated LRFA lesion. During simulated LRFA, a recording will be played (Attachment X – 
Simulated LRFA Recording), by either the 2nd interventional spine attending physician or the clinical 
assistant, to simulate the typical sounds of LRFA. Additionally, the 2nd interventional spine attending 
physician will turn on sensory stimulation for a short period of at least 3 seconds towards the end of 
each simulated lesion time, maintaining stimulation intensity no higher than the level where sensory 
input was initially noted by the patient during testing. The 2nd interventional spine attending physician 
will then make a slight repositioning of the LRFA needle to a 2nd location, and administer the 2nd 
lesion (or the simulated 2nd lesion). If the simulated LRFA procedure is performed, the 2nd 
interventional spine attending physician or clinical assistant will turn on the audio recording of the 
LRFA at any times that the lesioning of the nerves would normally occur. Additionally, the 2nd 
interventional spine attending physician will again turn on sensory stimulation for a short period of at 
least 3 seconds towards the end of each simulated lesion time, maintaining stimulation intensity no 
higher than the level where sensory input was initially noted by the patient during testing.  
4. The patient and the treating interventional spine provider are therefore blinded to the procedural 
treatment received. We will employ several strategies to ensure patients are not able to determine 
which intervention they receive based on the sounds and length of the procedure:  
i.  We will enroll only patients who have not had prior LRFA 
ii.  The electrode will remain in place for the full 90 seconds (and repositioned to simulate a 
second lesion) for each simulated lesion site. 
iii.  We will use a pre-recorded audio recording of an LRFA procedure in order to simulate the 
sounds made by the machine during the ablation. We will pre-test this recording several 
times in the pain clinic in advance of the first randomization. 
iv. We will use a brief period of sensory stimulation during the simulated LRFA lesion as 
described above. 
5. 
In some clinical situations, it may be impossible for a 2nd interventional spine attending to be on 
hand to complete a LRFA or simulated LRFA procedure, and maintain blinding of the treating 
interventional spine provider.  For instance, a clinical situation may call that provider away or detain 
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that individual.  In such an instance, the treating interventional spine provider will become 
unblinded.  
6. 
In the event that participants who are randomized to LRFA vs. simulated LRFA subsequently wish 
to go on to receive the treatment they were not randomized to, or wish to go on to another lumbar-
related procedure that for some reason necessitates that the participant become unblinded to the 
treatment they were randomized to, prior to the end of the 3-month main follow-up period of data 
collection, we will unblind participants to their treatment status.  This will be done by informing the 
treating interventional spine provider of the procedural treatment received (LRFA vs. simulated 
LRFA) prior to a clinical appointment with the participant. The Veteran participant and their provider 
will then have the information needed to confer and make a fully informed decision about the next 
clinical treatment steps that are most appropriate for the Veteran.  
 
 
 
Blinding with respect to CBT treatments (AcTIVE-CBT vs. TBSCE): 
7. 
It is not possible to blind patients and rehabilitation psychologists to whether or not they are 
receiving AcTIVE-CBT or TBSCE. To limit the potential for influencing participants’ perceptions of the 
interventions as more or less likely to be effective, participants will not be specifically told which of the 
AcTIVE-CBT or TBSCE treatments represents the intervention of interest or the control treatment in 
the current study. They will however have full advance knowledge of what the treatments will actually 
entail. 
 
Table 2: Blinding Status of Research Staff 
 
Blinded/Unblinded and Reason 
When blinded 
Dr. Pradeep Suri (PI) 
  
Not blinded (main study physician responsible for 
clinical issues) 
 N/A 
Dr. Rhonda Williams 
Not blinded (study physician responsible for 
clinical issues pertaining to mental health) 
 N/A 
Drs. Isuta Nishio, Tim 
Dawson, Amy Hsu 
Yes; blinded when not acting as the 2nd 
interventional spine attending physician (which 
he/she will be in cases when another spine 
provider is the treating interventional spine 
providera) 
Entire study, see 
superscript ‘a’ to the left 
Dr. Bosco Soares 
Not blinded; except when he is acting as the 
treating interventional spine provider (in which 
instances he will be blindedb) 
Entire studyb 
Dr. Janna Friedly 
Blinded and no contact with individual-level study 
data at any point  
Entire study 
5.2 Recruitment Methods 
We will recruit up to 30 participants from among Veterans seeking evaluation for LRFA in the VAPSHCS 
Pain Clinic. The eligibility and exclusion criteria (see Table 4 below) are specifically defined to capture the 
medically eligible target population who are likely to benefit from the LRFA procedure, are candidates for 
cognitive-behavioral therapy (CBT), are capable of describing changes in function and pain that serve as the 
markers for effectiveness, and are able to be compliant with participation in a research study.  
 
 
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Brief Overview of Recruitment (see Figure 2) 
Determination of participant eligibility, recruitment, and the major steps prior to randomization include the 
following: 
• 
Stage 1 Initial Screening: for confirmation of a) clinical eligibility to receive LRFA vs. simulated LRFA 
with targeted steroid injections, b) clinical eligibility for AcTIVE CBT vs. TBSCE, and c) other aspects 
related to eligibility to participate in study.  
• 
Stage 2 Final Screening (Visit 1): for confirmation of a) continued clinical eligibility to receive LRFA 
vs. simulated LRFA with targeted steroid injections and appropriate ‘positive responses’ to the 2nd 
set of MBBs, b) continued clinical eligibility for AcTIVE CBT vs. TBSCE, and c) other aspects related 
to continued eligibility to participate in study. 
o Informed Consent is offered if patient passes Stage 2 Final Screening 
• 
Run-in period (between Visit 1 and Visit 2): to identify participants likely to have poor compliance 
with study procedures defined by a) those unable to be contacted by research staff, or b) unable to 
use the Fitbit Zips. The length of the run-in period will be at least 1 week; this period of time for the 
run-in is substantially shorter than the typical period involved in current clinical care in the VAPS Pain 
Clinic between the 2nd/last set of MBBs and the date of LRFA (~ weeks on average), and thus will be 
nested within usual clinical scheduling practices.  
• 
Randomization (Visit 2): to reevaluate whether there have been any changes to the Final Screening 
Criteria, reassessed on the day of randomization 
o Participants will not be randomized if they fail Final Screening criteria  
o If a study participant is not able to be reached by phone or in-person at least one time during 
the run-in period, they will not be randomized 
o If a study participant is unable to use the Fitbit Zips, they will be categorized as ‘non-Fitbit-
compliant’.  They will be able to continue in the study, but the randomization will be stratified 
by ‘Fitbit-compliant’ vs. ‘non-Fitbit-compliant’ status. 
 
Those ineligible for the study, those who decline to participate, and those who participate but later are 
deemed ineligible and are not randomized (i.e. those who fail the run-in period) will continue to be seen in the 
VAPSHCS Pain Clinic and will continue to receive appropriate care for CLBP, which may include LRFA or 
cognitive behavioral therapy (CBT) for pain for appropriate patients. 
 
Usual Care for MBBs and LRFA at VAPSHCS:  
Usual practice in the VAPSHCS Pain Clinic involves screening patients with CLBP for LRFA eligibility with 2 
separate sets of MBBs. This is done because the temporary pain relief that happens with MBBs (temporary 
anesthetic blocks of the ‘medial branch nerves’) simulates the type of pain relief that should occur with LRFA 
(when the nerves are ablated [destroyed]). At VAPSHCS these 2 sets of MBBs are scheduled, on average, 
about 3 weeks apart. Individuals who have ‘positive’ responses to MBBs (temporary resolution or marked 
improvement of CLBP) on both occasions, and meet other clinical criteria, are eligible for LRFA. Those who 
do not have positive responses to MBBs, or do not meet other clinical criteria, are not eligible for having 
LRFA because they will not benefit from the procedure. 2 sets of screening MBBs are the highest standard of 
care for selected LRFA candidates in the US because up to 50% of patients who have positive responses to 
1 set of screening MBBs are having ‘false positive’ responses and would not respond to LRFA. The 
performance of MBBs in usual clinical practice always requires fluoroscopy (x-rays) to position the spinal 
needles in the appropriate locations; fluoroscopy is always needed for LRFA for the same reason in usual 
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clinical practice. At VAPSHCS, LRFA is typically scheduled for a time within 3 weeks after the 2nd set of 
MBBs.   
Usual care in the VAPSHCS Pain Clinic requires that MBB candidates meet several clinical criteria for 
safety/appropriateness reasons. Exclusion criteria are 1) possible pregnancy or other condition that 
precludes fluoroscopy use, 2) contraindications to MBBs, such as allergy to local anesthetic or contrast, 3) 
other contraindications to receiving MBBs, and 4) any contraindications to LRFA itself (for example, patients 
on anticoagulation which cannot be held or bridged appropriately for the LRFA procedure).  
 
Pre-Screening:  
We have a HIPAA waiver to be able to screen patients for preliminary eligibility among those who are 
scheduled to receive lumbar MBBs for chronic axial low back pain in the VAPSHCS Pain Clinic. Study staff 
will review Computerized Patient Record System (CPRS) records of all patients scheduled for lumbar MBBs 
in the VAPSHCS Pain Clinic. This initial medical record screening protocol involves assessment of those 
criteria from Table 4 which can be assessed by CPRS record review. Ideally, potential participants will be 
identified prior to the 1st set of MBBs that is typically performed in routine interventional spine clinical care for 
those with CLBP in the VAPSHCS Pain Clinic. When patients are identified who meet preliminary eligibility 
criteria on the medical record screening, staff will alert the “treating interventional spine provider” (the 
interventional spine physician in the Pain Clinic who is performing the MBB procedure). Research staff would 
contact the treating interventional spine provider via encrypted email, telephone, or in-person to alert them 
when a particular Veteran who appears to be eligible for the study based on medical record screening 
protocol will be attending an upcoming appointment. Due to typical clinical procedures in the Pain Clinic, we 
do not anticipate that providers will attempt to recruit any patients in situations where they have not received 
an alert from research study staff that a patient has passed pre-screening and may be an appropriate 
participant. That visit, and the MBB procedure, would take place in the normal fashion for clinical care. 
Treating interventional spine providers will have available in their clinic rooms a list of the major clinical 
criteria for study inclusion (Attachment J – Interventional Spine Provider Checklist); this list is a reference to 
aid the clinician in recognition of eligible participants, and is not used for data collection. After the MBB 
procedure, if the treating interventional spine provider believes the patient to be eligible for study 
participation, the provider will briefly introduce the study (this will serve as the introduction by non-study 
personnel) and can provide a flyer with study information (Attachment K - Recruitment Flyer). If the patient 
expresses interest in being contacted and learning more about the study, the treating interventional spine 
provider will alert study staff to initiate contact with the patient. Research staff will initiate contact with the 
Veteran by one of two methods: 1) in-person contact with the Veteran potential participant while they are in 
the VAPSHCS Pain Clinic area, either after the 1st set of MBBs, or before/after the 2nd set of MBBs, and/or 2) 
by telephone (if the potential participant has given verbal permission for subsequent phone contacts by study 
staff). At the time of an in-person contact with the Veteran participant, research staff will provide each 
potential participant with a copy of a ‘What to Expect’ (Initial Contact) informational form (Attachment PP) and 
a blank copy of the study consent, so the participant can read more about what the study would entail, at 
their leisure. If initial contact is begun in clinic and later completed by telephone, the ‘What to Expect’ (Initial 
Contact) informational form (Attachment PP) and a blank copy of the study consent will be sent by mail to the 
participant.  
Additionally, interested Veterans who are given contact information related to the study by the treating 
interventional spine provider may contact research staff to initiate eligibility screening or assessments at any 
time.  
 
 
 
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Screening:  
We define chronic low back pain as low back pain present for at least 3 months.8 Low back pain is defined as 
occurring between the lower posterior margin of the rib cage and the horizontal gluteal fold. Low back pain 
intensity is measured using the numerical rating scale (NRS), with NRS ≥ 4 for study inclusion (i.e., NRS 
must be 4 or higher). See Table 4 (placed in Section 5.4 as required by the Protocol format) below for a 
complete and detailed list of inclusion and exclusion criteria, and rationale/indications for exclusion criteria.   
Among other criteria, eligible patients will be identified based on their responses to MBBs performed 
according to routine clinical practice in the VAPSHCS Pain Clinic. Interventional providers in the VAPSHCS 
Pain Clinic use either lidocaine or bupivacaine anesthetic. Table 3 lists technical details that must be met for 
MBBs to be counted as ‘positive responses’. These criteria will be assessed by research staff, with 
clarifications as needed by the PI and the treating interventional spine provider. Table 3 and Table 4 assume 
that the 1st set of MBBs is performed with lidocaine and the 2nd set of MBBs is performed with bupivacaine as 
per our usual practice. However, clinicians may, for clinical reasons, elect to perform the 1st set of MBBs with 
lidocaine and the 2nd with bupivacaine, both the 1st and 2nd sets with lidocaine, or both the 1st and 2nd sets 
with bupivacaine. Any of these combinations are acceptable for the purposes of this study provided that 2 
sets of MBBs are used for screening (Table 3). 
Table 3. Aspects of medial branch blocks needed to characterize responses 
 
1st set of MBBs (part of Initial 
Screening criteria) 
2st set of MBBs (part of Final 
Screening criteria) 
Anesthetic Type 
Lidocaine 
Bupivacaine 
Anesthetic volume 
0.5 cc  
0.5 cc  
Use of contrast to confirm proper 
positioning at the medial branch 
and absence of intra-vascular 
placement 
Yes 
Yes 
Time window for onset of relief of 
typical low back pain symptoms 
within 30 mins  
within 30 mins 
Expected duration of pain relief 
<12 hours 
<36 hours 
End of the duration of pain relief is marked by the point where the 
majority of the pre-block pain intensity levels (>50%) have returned.  
For instance, if a potential participant reports 6/10 pain pre-MBBs, and 
achieves 1/10 pain post-MBBs, pain relief would be considered to be 
ongoing at the point where pain intensity was reported as 3/10, but not 
at the point where pain intensity was reported as 4/10. Depending on 
the distribution of recruited participants’ MBB responses (50-79% vs. 
≥80%) after the initial period of recruitment, we may restrict study 
participation in the participant selection phase in order to oversample 
participants who have ≥80% relief with MBBs.    
Other follow-up assessments 
Phone call 2-5 days after 1st set of 
MBBs, to assess for return of 
typical low back pain, with or 
Phone call 2-5 days after 2nd set of 
MBBs, to assess for return of 
typical low back pain, with or 
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without patient referring to their 
pain diary results. If a clinical 
phone call or other assessment 
has been made to assess MBB 
response by clinical staff or the 
treating interventional spine 
provider, the information from that 
assessment will be used instead 
of the phone call by study staff.   
 
without patient referring to their 
pain diary results. If a clinical 
phone call or other assessment 
has been made to assess MBB 
response by clinical staff or the 
treating interventional spine 
provider, the information from that 
assessment will be used instead of 
the phone call by study staff.   
 
 
Relief of pain 
≥50% improvement in typical low back pain symptoms 
For both the 1st and 2nd set of MBBs, we will calculate % pain 
improvement based on patient reported pre-procedure 0-10 pain 
numeric rating scale score for typical low back pain, minus the post-
procedure 0-10 pain numeric rating scale scores for typical low back 
pain, divided by the pre-procedure 0-10 pain numeric rating scale 
scores for typical low back pain. Patients will be blinded to the 
thresholds of % improvement that define a ‘positive response’.    
 
A. Initial Screening: We will pre-arrange permission to approach patients with chronic low back pain 
presenting to the VAPSHCS system Pain Clinic, who meet the Initial Screening criteria from Table 4 
(including but not limited to ≥50% pain improvement with MBBs as performed in routine clinical practice 
in our institution). Patients who appear to meet Initial Screening criteria will be approached to participate 
in this trial by research staff. 
i. 
Research staff will identify patients scheduled for a 1st set of lumbar MBBs (either notified at 
the time of scheduling by the clinic scheduling coordinator or from scanning the upcoming clinic 
schedule) that appear to meet Initial Screening criteria, as described above. A pre-screening 
checklist will be used (Attachment L - Screening Checklist). 
ii. 
If a potential participant is identified in pre-screening, research staff will then inform the treating 
spine provider who is scheduled to perform the 1st set of MBBs, to alert them that an upcoming 
patient might be a potential study participant. This will remind the treating spine provider to 
consider whether the patient might be a potential study participant once the normally 
scheduled clinical evaluation has been completed.   
iii. 
The normally scheduled clinical evaluation, including MBBs, will take place. After the 1st set of 
MBBs is performed for a patient, as per usual clinical practice, the provider will elicit an initial 
post-MBB assessment of typical low back pain intensity using a 0 to 10 numerical rating scale 
(NRS), which will be compared to the pre-MBB assessment of low back pain intensity using a 0 
to 10 NRS. Comparison of the post- and pre-MBB NRS scores will yield a proportion for % 
improvement of typical low back pain. As per usual clinical practice, the provider will also apply 
the other criteria as described in Table 3 in determining whether a positive response to MBBs 
is present. Treating spine providers will also have available a ‘checklist’ of the major clinical 
eligibility criteria, so they can easily be reminded of the main points that would identify a 
potential study participant. If they feel such is clinically appropriate, and participants are 
interested in learning more about the study, the provider will notify the research staff member 
that a potential participant can be approached. Research staff will be stationed in an adjacent, 
yet separate, clinical area, and will be available to talk to the potential participant in a private 
area, to learn more about the study. If a potential participant is only interested in receiving 
written information, they will be provided with a study flyer.  
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iv. 
Research staff will describe the study, answer any questions, and elicit information to complete 
the Initial Screening assessment (see Table 4 for inclusion/exclusion criteria) and collect basic 
demographic data only. Those patients who are interested in participation and meet study 
criteria will be followed to determine continued eligibility as per study criteria over time. 
Potential participants will be informed that they will also be re-contacted by phone within 2-5 
days after the day when the 1st set of MBBs was completed, and that at a later time (when 
and/or after they return for their next routine clinical appointment for their 2nd set of MBBs) they 
will be reassessed to complete final screening. This includes the outcome of the 2nd set of 
MBBs that would normally be offered as part of clinical care to patients who have positive 
responses to a 1st set of MBBs. As part of usual care processes post-MBBs in the VAPSHCS 
Pain Clinic, patients complete a written pain diary to record low back pain intensity using a 0 to 
10 NRS for up to 2 days after the procedure. As part of usual care, patients post-MBBs also 
receive a follow-up phone call from a nurse coordinator within 1 week of their MBBs (and 
usually within several days). In addition to phone contacts with potential participants, research 
staff will refer to this clinical information as needed to ascertain if ‘positive’ MBB responses 
have occurred.  
v. 
If a potential participant who is approached after the 1st set of MBBs does not wish to speak to 
research staff or cannot do so at the time of their clinical appointment, we will offer those 
individuals a phone call to continue providing information about the study, determine eligibility, 
and obtain information about positive responses to the 1st set of MBBs. Those who are unsure 
about providing permission to speak to research staff by telephone will be provided written 
information about the study, and asked to contact research study staff if they are interested in 
the study, ideally within 2-5 days of their 1st set of MBBs. 
vi. 
If research staff is unable to make contact with a potentially eligible patient on the day when the 
1st set of MBBs is completed, contacts will be made by telephone as mentioned above, by staff 
within 2-5 days of the 1st set of MBBs. In those cases, research staff will inquire retrospectively 
about responses to MBBs in the initial hours and days after the 1st set of MBBs. Research staff 
will refer to clinical information from pain diaries and the nurse coordinator follow-up phone call 
as needed to ascertain if ‘positive’ MBB responses occurred and to identify individuals with 
non-concordant responses to MBBs (for example, pain lasting >24 hours after a 1st set of 
MBBs using lidocaine). Individuals with non-concordant responses to MBBs will not be eligible 
for participation.  
vii. 
Participants who decline study participation at any stage in Screening (Initial or Final) may be 
asked whether they would answer questions (up to 6 questions) about their reasons for non-
participation. Such questions would be recorded in a non-identifiable format, without links to 
any patient identifiers of any kind.  
viii. 
Depending on the distribution of recruited participants’ MBB responses (50-79% vs. ≥80%) 
after the initial period of recruitment, we may restrict study participation in the participant 
selection phase in order to oversample participants who have ≥80% relief with MBBs (which 
would affect both the Initial and Final Screening criteria for potential participants).    
ix. 
If a potential participant is identified after their MBBs have already been completed, or not 
approached at the usual time of an initial or final screening for another reason, we will send the 
participant an approach letter (Attachment ZZZ – Approach Letter) and a FAQ document with 
information about the study (Attachment ZZZ2 – Approach Letter FAQ).  These documents will 
prompt the Veteran to contact research study staff if they wish to hear more information about 
the study, or if he/she is not interested in the study.  If we do not hear back from Veterans who 
are mailed the approach letter and FAQ within 4 business days, we will make attempts to 
contact the Veteran by telephone until a contact is made, leaving voicemail messages as 
needed.  
 
 
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B. 
Final Screening (Visit 1): The final screening process takes place after the potential RCT 
participant has undergone the 2nd set of MBBs.  
i. 
Initial Screening Criteria will be repeated, as per Table 4.  
ii. 
Eligible participants will be offered Informed Consent. They will be informed that they will be 
likely trial participants, unless subsequent selection criteria render them ineligible in the run-in 
period between the time of Informed Consent, and the day of their LRFA or simulated LRFA 
procedure when they will be randomized. Further details regarding Informed Consent are 
provided below. 
iii. 
If participants decide to participate in the study and complete Informed Consent, in most cases, 
participants will be scheduled for a future date for their lumbar procedure (LRFA procedure or 
simulated control procedure) at the time of their 2nd set of MBBs, generally within 1-3 weeks, as 
per usual clinical practice and using usual clinical processes for scheduling. Research staff will 
coordinate with clinical staff about scheduling specifics as needed in order to facilitate this and 
make these transitions smooth for the participant. If for an individual participant, their physician 
elects to not schedule a future procedure date until a later time, research staff will monitor 
clinical processes and plan around the future procedure date at the time it is decided upon.  
iv. 
After the time when the future lumbar procedure date is decided upon, patients will be 
scheduled for their 1st assessment with a rehabilitation psychologist for AcTIVE-CBT or TBSCE 
control, which will generally begin within 1-3 weeks of the LRFA procedure. Such scheduling 
will also be done through usual clinical processes for scheduling. Research staff will coordinate 
with clinical staff about scheduling specifics as needed in order to facilitate that this is done 
smoothly. 
v. 
Participants will be provided with a Fitbit Zip unit and instructed on how to use the unit. We will 
assign subjects a login name (e.g., FitbitSel165, FitbitSel672, etc.) and a password for the 
Fitbit website, and guide the participant through processes for using the website so they can 
become familiarized with how it works. We will create a Gmail account for the participant, which 
matches the Fitbit login name, to be used for the duration of this study. Fitbit will use the email 
address provided to send system-generated weekly updates about the subject’s activity levels. 
The Fitbit account will use the participants login name rather than their actual name. The Fitbit 
website displays the following data to each user: the number, intensity, and timing of steps 
taken per day, distance covered, and calories burned. We will request participants not to make 
edits to their Fitbit accounts during their participation in the study, but to contact research staff 
who will make such changes for them. An example of this might be if a participant forgets their 
password information or wishes to change their password; if this happens, the participant 
would call research staff to change to a new password. We will ask the participants to set up 
their Fitbit profile so that others cannot view their personal information for the 3-month main 
period of data collection. During the initial set-up we will verify that the Privacy Settings on each 
participant’s Fitbit profile are set so that no one other than the subject can view their personal 
information (age, height, weight, etc.). Participants will be instructed on how to upload (‘sync’) 
their Fitbit data regularly (ideally, every other day, but at least once every 7 days). 
vi. 
After instructing subjects on how to use the Fitbit, we will mask the Fitbit display screen by 
turning it around in its case, and we will ask subjects to wear the Fitbit with the display screen 
covered for the duration of the run-in period. This will allow us to establish how many steps 
they typically take when not receiving feedback from the Fitbit device or website (i.e., their 
baseline). Data from the first 7-day period during the run-in period where the Fitbit is used on at 
least 3 out of 7 days, for at least 6 hours during waking hours on each of those 3 days, will 
constitute the baseline assessment for step counts. During the run-in period, we will ask 
participants to try to use the website as little as possible or to only use the Fitbit website when 
syncing the Fitbit, and to try to not view their Fitbit data on the website. On the day of 
randomization, we will ask subjects to reveal their display screen by turning their Fitbit around 
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in its case.  
vii. 
Participants will be given a study participation pledge form (Attachment M - Pledge Run-In). 
The pledge describes the study rules and procedures and states that the subject will do his/her 
best to follow them. It will remind participants about frequent syncing, maintain the masking, 
and limiting use of the Fitbit website as possible. Participants will have a chance to read the 
pledge and ask questions, and confirm verbally that they understand the pledge and agree to 
its content. Participants can keep the pledge form.   
viii. 
We will also provide participants with the option to meet with designated research staff at 
VAPSHCS Seattle campus at any time during the first 3 months after randomization that they 
wish, to review Fitbit related questions, syncing practices, and/or get a refresher demonstration 
on how to use their devices and the Fitbit website.  
ix. 
As part of routine clinical practice in the Pain Clinic, in order to determine longer-term response 
to MBBs, and assess for non-concordant responses, participants are provided with a pain diary 
and asked to record NRS rating for typical low back pain intensity as done during the initial 
screening. 
x. 
Research staff will call the patient by telephone 2-5 days after the 2nd set of MBBs. At this time, 
they will review ratings of low back pain intensity since the 2nd set of MBBs, referring to the 
clinical pain diary as needed. This information will be used to identify individuals with non-
concordant responses to MBBs (for example, pain lasting >36 hours after a 2nd set of MBBs 
with bupivacaine).  
xi. 
If a potential participant is identified after their MBBs have already been completed, or not 
approached at the usual time of an initial or final screening for another reason, we will send 
the participant an approach letter (Attachment ZZZ – Approach Letter) and a FAQ document 
with information about the study (Attachment ZZZ2 – Approach Letter FAQ).  These 
documents will prompt the Veteran to contact research study staff if they wish to hear more 
information about the study, or if he/she is not interested in the study.  If we do not hear back 
from Veterans who are mailed the approach letter and FAQ within 4 business days, we will 
make attempts to contact the Veteran by telephone until a contact is made, leaving voicemail 
messages as needed. In instances where potential participants are identified via approach 
letters in this manner, baseline study assessments can be completed as needed in in person 
in coordination with clinical appointments or by telephone, or during in-person research 
assessments. 
 
C. Run-in period of Fitbit Use (between Visit 1 and Visit 2) 
The purpose of the run-in period is 1) to identify those participants who are able to use the Fitbit a 
minimum amount which we consider to be ‘Fitbit-compliant’, so that this variable can be adjusted for 
analytically , and 2) exclude participants who fail Final Screening criteria or who are determined to 
be highly unlikely to be able to participate in study procedures (i.e. those who cannot be contacted 
by phone or in-person at least one time during the run-in period, indicating that they would not be 
able to complete subsequent telephone questionnaires). During the run-in period, research staff will 
be available to receive phone calls or visits from the participants so as to help them with any Fitbit 
related questions they have, or their ability to sync their data. Once it seems that a participant is 
able to use the Fitbit and sync it (which in many cases may be immediately after Visit 1), the 
research staff will begin a “test period” of 7 days. The earliest possible start of a test period would 
be the day after the randomization. If a participant has not synced their Fitbit by day 3 or 4 of the 
test period, they will receive a telephone call from research staff to offer help and answer questions, 
and to remind the participant to sync the Fitbit. On days 5, 6, or 7, participants will receive up to one 
telephone contact/reminder and/or voicemail message left, in order to remind the participant to sync 
their Fitbit by the end of the 7th day after the start of the test period. If a life issue or barrier presents 
that interferes with ability to use the Fitbit unit, or the participant encounters a technological hurdle 
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of some type (such as device failure) the test period may be restarted at any time, and the process 
repeated. In addition, the test period can be extended as needed due to holidays or absences 
(either for the participant or research staff) on an ad hoc basis. However, if a full test period elapses 
without the participant syncing their Fitbit, this would constitute a failure of the run-in period.   
i. 
Research staff will monitor the frequency of participant Fitbit use, and whether they are able to 
periodically upload their data. Participants who do not use their Fitbit, or do not upload data at 
least once during the run-in period, will receive reminder phone calls. 
ii. 
Research staff will make telephone contacts as needed with participants to help participants 
learn how to use their Fitbits.  
iii. 
Participants who do wear their Fitbit unit on at least 3 of 7 days during the test period, for 6 
hours at least each day during the participant’s regular waking hours will be classified as being 
‘Fitbit-complaint’. Participants who do NOT wear their Fitbit unit on at least 3 of 7 days during 
the test period, for 6 hours at least each day during the participant’s regular waking hours will 
be classified as ‘non-Fitbit compliant’.   
iv. 
Participants who cannot be contacted at least once during the run-in period will be considered 
to have failed the run-period. They will be excluded from study participation and will not be 
randomized. 
 
D. Reassessment of study criteria on the day of randomization (Visit 2): 
i. 
Initial Screening Criteria will be repeated, as per Table 4 (but not including MBBs). Individuals who 
no longer meet screening criteria will not be randomized and will not be followed further as part of 
the study. 
ii. 
Randomization will take place as described further below. 
iii. 
The lumbar procedure (LRFA or simulated LRFA) will be performed as per the processes described 
below.  
iv. 
Subjects will be given a 2nd study participation pledge form. This version of the pledge form will 
include the items listed on the 1st pledge form, without information pertinent to the run-in period, but 
will also include additional details that are specific to each participant’s CBT allocation (AcTIVE-
CBT vs. TBSCE). Specifically, the AcTIVE-CBT pledge form will encourage the participant to use 
their Fitbit, and try to gradually increase their daily walking while in the study (Attachment O – 
Pledge Visit 2 Extended). As previously, subjects will have a chance to read the pledge and ask 
questions, and confirm verbally that they understand the pledge and agree to its content. The 
participant can keep the pledge form. TBSCE participants will also read a pledge form (Attachment 
N – Pledge Visit 2 Brief), which is the same as (Attachment O – Pledge Visit 2 Extended), except it 
does not specifically encourage active Fitbit engagement, and recommends against using the Fitbit 
Group or Friend functions. 
v. 
At the time the 2nd study pledge form is provided by a research staff member, the staff member will 
will ask the “Post-procedure questions”.  These involve 1-4 questions, which inquire about the 
participant’s immediate impression of whether they received LRFA, or simulated LRFA.  
 
 
E. 
Approach Letters.  
i. 
In certain situations, potential participants for SELECT may not be captured by the pre-screening 
and screening processes as described above. Therefore, they may be identified at some point after 
their 1st set of MBBs have been completed, but when they no longer have an upcoming clinical 
appointment scheduled when it is possible to approach them in person about the study. In some 
cases, this may occur between their 2nd set of MBBs and the time of their lumbar RFA procedure.  For 
Veterans who meet this criteria and are identified during the screening process, we will follow the 
steps below. 
ii. 
If potential Veteran participants are identified as above, the PI will send an encrypted email to the 
treating interventional spine provider for the potential participant, and/or contact by telephone. The 
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interventional spine provider will 1) decide whether the Veteran appears to meet criteria for the study, 
and 2) approves research staff contacting the patient.  Either the interventional spine provider will 
complete the Interventional Provider Checklist, or the PI will complete based on information from the 
interventional spine provider and/or the medical record.  
  
iii. 
If the Veteran is a potential participant and approved by the interventional spine provider, research 
staff will mail an approach letter.  
iv. 
If we do not receive an inquiry from a potential participant within 7 days after the letter was sent, 
research staff will begin attempts to contact the potential participant. We will leave voicemail 
messages as needed. If the Veteran is reached, research staff will talk to them at that time or arrange 
another time to do so, over the phone, or in person.  That discussion can be scheduled around the 
time of an upcoming appointment at the Seattle campus, if convenient for Veteran. 
v. 
At the time arranged to talk, research staff will provide Veteran with basic information as you would 
at the initial contact (Visit 0). If a Veteran is not interested and wants to stop talking, staff will end the 
call.  If a Veteran is interested, research staff would proceed with the screening checklist as typically 
done during a Visit 0.    
vi. 
If Veteran passes the screening checklist, we would mail him/her the same info he/she would 
normally get at a Visit 0 (a What to Expect form [approach letter version] and a blank consent) 
vii. 
If Veteran passes the screening checklist, research staff would try to arrange an in-person Visit 1 in 
order to complete study procedures and informed consent. Visit 1 would need to happen at least 2 
days before the time when their LRFA is scheduled.  Ideally this would be scheduled to coincide with 
another clinical visits or time when he/she is already coming to the medical center. We will inform 
Veterans that the Visit 1 would be for research, and that there is no “travel compensation” for this visit. 
However, there is study-related compensation for completing Visit 1, including informed consent, as 
well as for our other study assessments.  Visit 1 would otherwise take place exactly as described 
above, including distribution of Fitbits, and a ‘run-in period’ after visit 1. The run-in requirement for 
Fitbit use can be waived for Veterans recruited via Approach Letter, if there is insufficient time 
between Visit 1 and Visit 2 for Fitbit wear and syncing.  
 
F. 
COVID-19 Pre-Screening Measures 
i. 
SELECT staff will specifically inquire with the Pain Clinic physician treating a patient about whether 
the patient has active symptoms of fever, cough, or shortness of breath, and/or is potentially at-risk for 
COVID-19, prior to interactions with a participant/potential participant. SELECT staff will not engage in 
face-to-face interactions with participants/potential participants if they are thought to have any of these 
symptoms or historical features by the Pain Clinic treating physician.  In those cases, we may conduct 
screening by phone (for participants in the study) or via our existing ‘approach letter’ pathway (for 
potential participants- which includes screening by phone). We will apply these procedures until there 
is further specific guidance from R&D about what to do in response to contacts potentially involving 
those at-risk for COVID-19, or until such screening is no longer needed. 
ii. 
SELECT staff will only approach patients if they feel comfortable doing so. Until COVID-19 
screening at VA Puget Sound is lifted, or until further guidance from R&D regarding patient contact, 
the Study Coordinator will serve as a back-up for all in-person contact visits, and will conduct in-person 
contact visits in lieu of any staff who wish to refrain from patient contact during this time. SELECT staff 
will reach out to the Study Coordinator directly if they wish to refrain from in-person contact. 
 
Patients who Decline:  
We will enter data for all patients screened into the study database and assign a screening ID. The system will 
assign a screening ID for all screened patients, including those who are ineligible or eligible and refused to 
enroll. Research staff will collect basic demographic information using the demographic information form from 
all patients who are deemed eligible to participate yet decline to participate. These data will be collected to 
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determine if there are significant differences between eligible participants who enroll and those who do not. If 
an eligible patient refuses to participate in the study, research staff member will ask the patient about the 
reason for declining study participation and record it on the patient Screening Form. Patients who decline but 
meet eligibility criteria will continue usual clinical care in the VAPSHCS Pain Clinic for interventional spine 
procedures, including LRFA, as they would normally do.  
 
Understanding the reasons why Veteran patients are not interested in study participation is an essential step 
towards making the research process acceptable to Veterans in the future. Patients who decline will be asked 
verbally whether they would be willing to answer up to 6 questions about why they are not interested in study 
participation. We will inform patients that any answers they provide will be recorded without reference to any 
identifying information about them, so there would be no way to discern by looking at this information from 
what patient the information came from. Thus, this type of answering questions is different than what would be 
in a research study, and we will assure the patient that answering these questions does not constitute 
participation in the study. We provide the script for these questions as Attachment QQ (‘Questions to Non-
participants’) 
 
Study participants will be compensated for their time spent completing the research procedures for this study, 
which include the time spent in the Informed Consent process, and completing the study assessments (in 
person or telephone questionnaires). They are not compensated for the lumbar procedures (LRFA or simulated 
LRFA with targeted steroid injections) or CBT (AcTIVE-CBT or TBSCE) they receive during the 3 months of 
main study follow-up, since these are usual clinical care processes appropriate for LRFA-eligible individuals 
with chronic low back pain. Compensation will be made by checks mailed to participants. Payments will 
happen after the study visits on the day of randomization, the 3-month follow-up, and again at the end of the 
optional period of more extended follow-up after 3-months, unless participants express that they would wish 
instead to be paid monthly. Compensation will be by check, which will usually be mailed to participants within 
4-8 weeks after completing each component. However, due to possible delays, participants will be told it could 
be up to 4 months after completing each component that they will receive payment. Compensation is as 
follows: 
• VISIT 1: Information session, informed consent, and pre-assessment ($ 35) 
• VISIT 2: The ‘baseline’ study assessment, which involves completing questionnaires ($ 25) 
• VISIT 3: A questionnaire completed by telephone ($ 10) 
• VISIT 4: A questionnaire completed by telephone ($ 10) 
• VISIT 5: A questionnaire completed by telephone ($ 25) 
• Additional compensation for completing all 3 sets of telephone assessments ($ 15) 
• An ‘interim survey’ questionnaire that may be offered in the event that a participant elects a major 
change to the interventional spine treatment or behavioral treatment regimen prior to the expected 
earliest point of unblinding at the 3-month follow-up ($ 10) 
 
Optional study visits 
• VISITS 6-14: If participant decides to continue participation in this study after Visit 5, these are study 
visits that will take place over the telephone ($ 10 for each monthly telephone questionnaire). We will 
clarify that optional study visits will not take place after the formal end of the study, so some participants 
recruited late during the study will have fewer “optional” study visits that they can complete.  
In sum, participants may be reimbursed up to $120 for completing all study assessments processes over 
3 months. In addition, participants may be reimbursed up to a maximum of $30-90 for optional study 
assessments between months 4 and 12 and an additional $10 if an ‘interim survey’ is completed. 
5.3 Informed Consent Procedures 
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A Waiver of Informed Consent was obtained to cover screening/recruitment procedures. Informed consent 
for study participation is as described below.  
 
A. Informed Consent:  
We will obtain written consent from potential study participants following the final screening, after 
completion of the 2nd set of MBBs.   
 
During Informed Consent, potential RCT participants will: 
 
i. Receive basic information concerning the overall study goals, which involve simultaneous 
randomization to 2 types of active treatment: procedural treatments that target the lumbar 
facet joints, and behavioral treatments based on principles of CBT for chronic pain. 
ii. Receive detailed information concerning the study procedures; 
iii. Have the opportunity to consider all available options for treatment of pain; 
iv. Receive adequate time to raise questions and voice concerns; 
v. Be questioned to assure that they understand all information provided; 
vi. Provide written voluntary consent to participate in continued screening processes. 
 
B. Detailed Description of Informed Consent: 
In the section below, all uses of the word ‘patients’ prior to completion and signing of the informed 
consent form (ICF) refers to potential candidates for study participation beyond the Informed Consent. 
Please see the Informed Consent documents themselves. 
 
Patients will be informed during the consenting process that if they are determined to be fully eligible 
for the study and choose to participate, they will be randomized to LRFA or a simulated LRFA 
procedure including targeted steroid injections to the facet nerves, and to two types of telehealth-
administered behavioral treatments for pain (one brief, one extended). All treatments (both the 
procedural treatments and behavioral treatments) are “active” treatments expected to improve pain 
and/or pain-related functional limitations, and all are standard of care treatments in the US. 
 
Because in routine clinical practice our experience has been that patients receiving invasive lumbar 
pain procedures such as LRFA and lumbar steroid injections are often unclear of some specifics of 
these procedures and their risks, our informed consent document differs from typical 
recommendations in that it enumerates the specific physical risks of these procedures, even though 
these involve the same risks as performed in routine clinical care. We have chosen this route to 
ensure that participants are fully informed. However, if the IRB reviewers’ have further questions or 
recommend that these risks of usual care practices are omitted, we will be happy to provide further 
information and/or revise accordingly.  
  
Study staff will describe that radiofrequency ablation (LRFA) is a widely used therapy for relieving low 
back pain, but that there remains debate about its effectiveness, whether other less invasive 
procedures may be equivalent (such as steroid injections) and whether long-term negative sequelae 
from LRFA can involve the joints, adjacent muscles or intervertebral discs. Patients will be informed 
that there is some possibility that at least some of the pain-relieving effect of LRFA may not be due to 
the nerve destruction itself, but due to the local anesthesia used, the direct mechanical effect of the 
needles/electrodes on the tissues in the back, nonspecific effects, or other things that we do not know 
yet. Patients will also receive a description of the targeted steroid injections that will be administered 
as part of the simulated LRFA control procedure, and how these procedures may have therapeutic 
effects, without possible long-term negative sequelae from nerve destruction (as in LRFA) involved 
joints, or adjacent muscles or intervertebral discs. Patients will also be informed that there is also 
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uncertainty about the true effectiveness of targeted steroid injections, similar to the situation with LRFA 
effectiveness. The risks of the LRFA procedure will be discussed, including that it entails applying heat 
to a nerve that supplies the facet joint (which destroys the nerve at least temporarily) and applying 
anesthetic around the nerve to the facet joint. Risks will be noted, including infection, bleeding, nerve 
damage, pain at the injection site, allergic reaction, and worsening of back pain. The risks of the 
simulated LRFA control procedure with targeted steroid injections will also be discussed, which 
generally involve the same possible risks as LRFA, but with a lower expected frequency of such risks 
since the nerves are not destroyed. Patients will be informed that, if they meet all inclusion criteria and 
are ultimately randomized, they will have a 50% chance (1:1 randomization) that they will not receive 
LRFA initially, but will receive simulated LRFA with targeted steroid injections instead. Potential risks 
of enrolling in the trial and being randomized to the control procedure will be discussed, including the 
possibility that they may continue to experience back pain. Potential benefits of enrolling in the trial 
and being randomized to the control procedure will be discussed, including the possibility that the 
patient may have back pain improvement and avoid the need for LRFA, surgery or other interventions 
for pain and that closer follow-up than usual will be given.  
 
Study staff will also describe to potential participants that many behavioral treatments for CLBP are 
available, and some (such as CBT) have evidence of effectiveness. However, we don’t know what 
components of CBT-related treatments create these positive effects. We will explain moreover that 
CBT, even video-based CBT such as the AcTIVE-CBT intervention, consumes substantial Veteran 
time which may not result in any effects beyond those of the initial education, the provision of written 
materials, and the formal structure needed for a patient-directed graded, progressive, education and 
self-management program. Therefore, this study involves comparing two programs of CBT which are 
delivered by telehealth methods, intended to make it easier for Veterans to access CBT, without the 
burdens of travel and transportation to repeated face-to-face appointments. One program is an 
‘extended CBT’ program, which involves a program requiring more appointments and video-based 
sessions with a psychologist (ACTIVE-CBT). The other program is a ‘brief CBT’ program, which 
involves a single telephone-based session with a psychologist, and a structured program for education 
and for the patient to apply the concepts of CBT independently and at their own pace, using formal 
written materials, with subsequent check-ins by the psychologist as needed (TBSCE). Patients will be 
informed that, if they meet all inclusion criteria and are ultimately randomized, they will also have a 
50% chance (1:1 randomization) of receiving one of these 2 treatments. The extended CBT treatment 
(AcTIVE-CBT) will involve eight 1-hour video sessions with a psychologist and the provision of 
educational materials; and the brief CBT treatment (TBSCE) will involve one 1-hour telephone session 
with a psychologist and the provision of educational materials, with one follow-up phone call by the 
psychologists approximately 1-2 months after the 1st session of TBSCE, and focused troubleshooting 
with any problems that might arise. Both treatments will involve the patient needing to wear a Fitbit 
activity tracker daily for 3 months. However, the AcTIVE-CBT treatment will involve specific therapy-
related interactions surrounding the Fitbit unit. Participants in the AcTIVE-CBT group will be given a 
‘pledge’ form which indicates their intent to try to upload their information to the Fitbit website regularly 
and consult their Fitbit regularly during the study, to the extent that they are able (Attachment O – 
Pledge Visit 2 Extended). Participants in the TBSCE group will be given a ‘pledge’ form which 
indicates their intent to try to upload their information to the Fitbit website regularly, but will not include 
prompts for participants to consult their Fitbit during the study, and will ask them not to spend time 
reviewing their information on the Fitbit website or using the Group or Friend functions, to the extent 
that they are able, during the first 3 months of the study (Attachment N – Pledge Visit 2 Brief). At the 
conclusion of the study, unless participants elect not to do so, participants will be provided with an 
official report containing their study data, including their activity tracker data. Participants may keep the 
Fitbit unit/s that they use during the study, after study conclusion, irrespective of their group 
assignment.  
 
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In addition, patient consent will include that the study will follow participants for 3 months and collect 
information on back specific functional status, pain, Fitbit data, health-related quality of life, and other 
study measures. Potential participants will consent either to data collection for 3 months only, or to 
also include an ongoing data collection on a monthly basis after the 3-month assessment, for up to 9 
additional months, or until the funding period ends (whichever date comes first). Participants may 
change their mind about the duration of time they wish to participate in data collection at any time 
during the study.   
 
Potential participants will be informed that, if they choose to participate in the study, they will remain 
blinded to which study interventional procedure they received (LRFA vs. simulated LRFA) until 3 
months. Pledge forms will ask participants to not actively seek out to find answers for which procedural 
group they are in. At 3 months they will have the opportunity to become unblinded if they wish, and 
make any usual health care decisions related to CLBP that they wish at that time, with or without the 
input of their treating physician. This might include having LRFA, irrespective of whether they had 
already received LRFA or simulated LRFA as part of this study. They will also be informed that if they 
wish to become unblinded at any time during the study (to seek treatment off protocol for example) or 
discontinue enrollment in the trial, they can do so. Potential participants will also be told that at 3 
months they can be informed about which of the 2 behavioral interventions (AcTIVE-CBT and TBSCE) 
constituted the official study ‘control’. At 3 months they will have the opportunity to become unblinded 
to this information if they wish, and make any usual health care decisions related to CLBP that they 
wish at that time, with or without the input of their treating physician. This might include other 
behavioral treatments including conventional in-person CBT, typical video-based telehealth as offered 
by the VAPSHCS TREWI program, or others, irrespective of whether they received the AcTIVE-CBT 
or TBSCE treatment as part of this study. They will also be informed that if they wish to become 
unblinded at any time (and to pursue usual care outside of the study protocol) or discontinue 
enrollment in the trial, they will be allowed to do so at their discretion. 
 
The consent process will occur at a time deemed mutually feasible for the Veteran patient and staff 
member and coordinated on a case-by-case basis. The consent process will take place in a private 
location (e.g., a medical exam room or private conference room). In most instances, this will take place 
in the Building 100 Room 7C-130A (in the Pain Clinic clinical area). However, if Room 7C-130A is 
occupied, this will take place in another unoccupied patient room in the Pain Clinic clinical area, or in 
Room 7C-14.  
A research staff member (see Study Staff Form) will review each section of the IRB-approved ICF, 
inviting discussion to ensure comprehension. Potential participants will be asked to repeat back 
understanding of this material as necessary. Individuals will not be permitted to participate if there is 
any question as to whether a person is able to provide informed consent. Study staff will be trained to 
ensure competency to discuss informed consent and strategies to ensure there is no coercion. 
Potential participants will be provided with as much time as needed to review the ICF and ask the 
research staff member questions about the ICF, their rights as human participants, and participation in 
the study. Potential participants will be fully informed of all risks and benefits prior to giving their written 
informed consent and prior to enrollment in the study. To minimize the possibility of coercion or undue 
influence prospective subjects will be informed that their decision regarding involvement will in no way 
influence their clinical care and they will be asked if they need some time to consider their involvement 
before providing consent. All study personnel will have completed the necessary human subjects 
protections training per VA policy. Informed consent will be conducted in English. Prospective subjects 
will be asked if they are able to understand English and whether they feel comfortable speaking it.  
If during the course of this contact the potential participant has questions that cannot be addressed by 
research staff, one of the study investigators or the research manager (depending on the nature of the 
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questions) will follow up with the potential participant to answer the questions. Potential participants 
may take time to think about participating and render a decision in a subsequent visit.  
Research staff will also review a HIPAA authorization form with the potential participant that permits 
research staff to review CPRS encounters to extract data collected during treatment. The potential 
participant will then be asked to sign and date the ICF. Research staff will also date and sign the ICF. 
All participants will be offered a copy of the signed ICF for their personal records. A note of enrollment 
will be made in CPRS. 
Research staff will file original copies of both the consent and HIPAA forms in the Seattle ERIC offices, 
kept separate from data collected during screening and subsequent data collected during participation 
in the study. Research staff will provide participants with staff contact information after the consent 
process. Participants will also be provided the VAPSHCS research brochure. 
 
 
 
 
5.4 Inclusion/Exclusion Criteria 
Table 4: Study Inclusion/Exclusion Criteria and Justification 
Initial Screening Criteria (pre-screening) 
Inclusion Criteria 
Exclusion Criteria 
Rationale/ Indications for 
Exclusion Criteria 
Chronic low back pain of duration ≥ 3 months, 
defined by: “How long has back pain has 
been an ongoing problem for you. Response 
of “> 3 months” defines CLBP.63  
 
Clinical suspicion that the current low back pain 
symptoms have a significant and sustained 
component that is attributed to lumbar spine-
related syndromes including lumbosacral radicular 
syndrome (radiculopathy), symptomatic lumbar 
spinal stenosis (neurogenic claudication), with 
confirmatory imaging findings, spinal instability 
requiring surgery, or other ‘red flag’ conditions 
(infection/ malignancy/ fracture) 
 
Primarily due to 
appropriateness for the 
LRFA intervention vs. 
simulated LRFA  
 
Low back pain intensity numerical rating scale 
(NRS) ≥ 4 (must be 4 or higher)  
 
Has failed at 1st line rehabilitative treatments, 
including physical therapy, yoga, tai chi, 
chiropractic or osteopathic manipulation, 
and/or massage. 
Pregnant females, prisoners, or the cognitively 
impaired (see also below) 
Primarily due to 
appropriateness for the 
LRFA intervention vs. 
simulated LRFA  
Patient is considered as a candidate for 
unilateral or bilateral LRFA at 2-4 spinal levels 
(between L1 and S1)   
‘Positive responses’ to 1st set of lumbar 
MBBs, including 1) ≥50% pain improvement 
Prior lumbar RFA  
Primarily due to 
appropriateness for the 
LRFA intervention vs. 
simulated LRFA  
Prior lumbar spine surgery involving the levels 
where LRFA is to be performed, within the past 2 
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of typical low back pain, and 2) onset of 
typical lumbar back pain relief within 30 mins 
and relief lasting at least 30 mins after the 
onset of initial pain relief  
Depending on the distribution of recruited 
participants’ MBB responses (50-79% vs. 
≥80%) after the initial period of recruitment, 
we may restrict study participation in the 
participant selection phase in order to 
oversample participants who have ≥80% relief 
with MBBs.    
 
years 
Lumbar fusion or instrumentation involving the 
levels where LRFA is to be performed 
Onset of the current low back pain symptoms prior 
to a laminectomy/discectomy/foraminotomy 
involving the levels where LRFA is to be 
performed, or within 2 years of a prior 
laminectomy/discectomy/foraminotomy involving 
the levels where LRFA is to be performed 
Must have access to a computer, tablet, or 
smartphone with internet access at home or 
at work (not via a public resource such as the 
public library) 
Prior CBT for chronic pain (a full course focused 
on pain, ≥4 sessions) 
Primarily due to 
appropriateness for the 
AcTIVE-CBT vs. TBSCE  
Must be able to read English, provide 
informed consent and complete the 
assessment instruments accurately  
 
Primary psychotic or major thought disorder 
(lifetime), any active suicidal/homicidal ideation 
(past 6 months), unstable or severe 
psychiatric/behavioral conditions (e.g. delirium, 
mania, psychosis) 
 
Primarily due to 
appropriateness for the 
AcTIVE-CBT vs. TBSCE  
Hospitalization for psychiatric reasons involving 
psychosis other than suicidal ideation, homicidal 
ideation, and/or PTSD, in the past 5 years 
Primarily due to 
appropriateness for the 
AcTIVE-CBT vs. TBSCE  
 
 
Cognitive limitations that would prevent 
participation in AcTIVE-CBT or the control 
behavioral intervention (score of 5/10 or less on 
the Short Portable Mental Status Questionnaire) 
Primarily due to 
appropriateness for the 
AcTIVE-CBT vs. TBSCE  
Severe medical comorbidities posing major 
functional limitations in ambulation and function or 
medical prognosis, including vascular, pulmonary 
or coronary artery disease, metastatic cancer. 
Exclude patients with MD-diagnosed fibromyalgia 
or chronic widespread pain   
 
Primarily due to general 
study participation 
Primarily due to general 
study participation 
Final Screening Criteria 
Must meet all of the above Initial Screening 
Inclusion Criteria 
Must continue to meet all of the above Initial 
Screening Exclusion Criteria 
 
‘Positive responses’ to 2st set of lumbar 
MBBs, including 1) ≥50% pain improvement 
 
 
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5.5 Study Evaluations 
 
Screening 
Pre-screening and screening procedures have been described above in pp. 27-33. See the Screening 
Checklists (Attachments L, RR, SS). 
 
Study Measures 
The primary study outcome is the Roland-Morris Disability Questionnaire (RMDQ). We will also 
collect several secondary outcomes as described below. All the main study outcomes as described 
below are patient-reported outcomes (PROs), except for Fitbit Zip-assessed daily step counts. A 
schedule of when each study measure will be administered is provided below in Table 5. The Study 
Measures are contained in the study assessments (Attachments, P, Q, R, and S). 
• 
Roland-Morris Disability Questionnaire (RMDQ): The RMDQ is a back pain specific functional 
status questionnaire adapted from the Sickness Impact Profile (SIP).3 The RMDQ consists of 24 
yes/no items, which represent common dysfunctions in daily activities experienced by 
participants with low back pain. A single unweighted score is derived by summing the 24 items, 
with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). The 
RMDQ was designed for paper administration, and is also well-suited for telephone use. 
 
• 
Fitbit Zip-Assessed Daily Step Counts: Multiple recent studies have demonstrated the reliability 
and validity of the Fitbit Zip units as compared to actual observed step counts or legacy 
reference standard activity monitors such as the Modus Health StepWatch.4-6 
 
• 
Pain Numerical Rating Scale (NRS): We will measure back pain using a 0-10 pain NRS (0=no 
pain and 10=worst pain imaginable) assessing average pain over the past week and pain “right 
now”. Numerical rating scales of pain intensity are valid, reliable, and sensitive to detecting 
change in pain intensity after treatment.7,8 We will also ask participants to make a second report 
of typical low back pain, and 2) onset of 
typical lumbar back pain relief within 30 mins, 
and relief lasting at least 30 mins after the 
onset of initial pain relief  
Depending on the distribution of recruited 
participants’ MBB responses (50-79% vs. 
≥80%) after the initial period of recruitment, 
we may restrict study participation in the 
participant selection phase in order to 
oversample participants who have ≥80% relief 
with MBBs.    
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of what they expect their NRS rating for back pain would be if they were not currently or recently 
taking medications for pain (analgesics). 
 
• 
PROMIS Short Form 10: The NIH Task Force on Research Standards for Chronic Low Back 
Pain62 recommended using PROMIS Short Form items to assess the constructs of depression, 
anxiety, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with 
participation in social roles. We will use the PROMIS Short Form 10, as recently recommended 
by an expert panel on the optimal core outcome measurement instruments for clinical trials in 
nonspecific low back pain (Chiarotto et al. Core outcome measurement instruments for clinical 
trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495.) 
 
• 
Physical Activity: Self-reported moderate and vigorous physical activities from the Behavioral 
Risk Factor and Surveillance System studies.  
 
• 
Global Perceived Effect: This is a 7-point Likert scale describing change in disability since 
baseline and ranges from “much worse” to “much better”.63-65 Participants will also assess their 
satisfaction with treatments received for LRFA, simulated LRFA, AcTIVE-CBT and TBSCE 
control.  
 
• 
Medications: Patients will report medications they have taken for pain in the past 3 days.  
 
• 
Adverse Events: Patients will report any adverse events they have experienced since the day of 
randomization/day of LRFA vs. simulated LRFA procedure.  
 
• 
Ad hoc AE reporting: Participants will be given instructions at the time of informed consent to 
contact research staff by phone for AE reporting at any time, after the day of randomization/day 
of LRFA vs. simulated LRFA procedure.  
 
• 
Bang Blinding Index: To assess success of participant blinding.  
 
A schedule of study assessments is provided in Table 5. Over the follow-up period lasting at least 3 
months, the following study assessments will be performed at VA Puget Sound, or conducted by 
telephone, as described below: 
VISIT 1 (taking place at the time of the second MBBs) (60-70 mins duration) 
Study assessments for Visit 1 will be conducted in person, coordinated to coincide with the timing of 
the participant’s 2nd set of MBBs, after the 2nd set of MBBs. Where this is infeasible, some or all of 
the Visit 1 study assessment will be conducted over the phone, after the 2nd set of MBBs. Either in 
person or over the telephone, participants will answer questions (Attachment P – Survey Visit 1) 
including sociodemographic factors, the RMDQ, low back pain NRS, and medication use.  
If Visit 1 is conducted in-person after the 2nd set of MBBs, research staff will also make a brief follow-
up phone call at least 2-5 days after the 2nd set of MBBs, to ascertain the duration of low back pain 
relief after the 2nd set of MBBs (Attachment L – Screening Checklist, question 21). This brief phone 
call will last <5 minutes.  
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VISIT 2 (taking place on the same day as the LRFA or simulated LRFA with targeted steroid 
injections procedure, before the procedure) (20-30 mins duration) 
Study assessments for Visit 2 will be conducted in person. Participants will answer questions 
(Attachment Q - Survey Visit 2) including the RMDQ, low back pain NRS, other pain questions, 
PROMIS SF-10, and medication use.  
VISITS 3-4 (taking place 1 month and 2 months after your procedure (10-15 mins duration) 
Study assessments for Visit 3-4 will be conducted by telephone, unless a participant prefers to have 
these conducted in person at the Seattle campus. Participants will answer questions (Attachment R 
– Survey Visit 3_4) including the RMDQ, low back pain NRS, Global Perceived Effect and 
Satisfaction, medication use, and adverse event reporting. 
VISIT 5 (taking place 3 months after your procedure (20-30 mins) 
Study assessments for Visit 5 will be conducted by telephone, unless a participant prefers to have 
these conducted in person at the Seattle campus. Participants will answer questions (Attachment U 
– Survey Visit 5) including the RMDQ, low back pain NRS, other pain questions, PROMIS SF-10, 
Global Perceived Effect and Satisfaction, medication use, and adverse event reporting. 
Table 5*     
Study Phase 
Screening & Baseline 
Treatment 
Optional 
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Interim Study Visit  
If a participant elects a major change to their procedural or behavioral treatments for low back pain in 
the first 3 months after their procedure, we will offer an additional study visit that could be conducted 
over the phone, unless a participant prefers to have this assessment conducted in person at the 
Seattle campus. Participants will complete a questionnaire with several different sections, including 
the RMDQ, low back pain NRS, Global Perceived Effect and Satisfaction, medication use, and 
adverse event reporting. 
 
Optional Study Assessments  
After completing Visit 5, we will offer patients two choices about continued study participation and 
the manner of continued participation (blinded vs. unblinded). Participants may decide ‘yes’ or ‘no’ to 
either, neither, or both of these two choices listed: 
1) Participants can decide to be told which two of the 4 possible treatments they received 
(LRFA or targeted steroid injections to the facet nerves, and extended CBT or brief CBT) i.e. 
‘unblinding’, or they may continue on without finding out which treatments they received 
(remaining blinded). If a participant decides to continue on in the study blinded, but wishes to 
Visit Number/Name 
1/Final 
Screen and 
Consent 
2/ Baseline 
3/ Month 1 
4/ Month 2 
5/ 
Month 3  
(1o outcome) 
Interim 
6-14 
Visit Timeline** 
-1 to -4 wks. 
0 
1 mo. 
2 mo. 
3 mo. 
3-6 mo. 
Monthly 
Length of Visit (min.) 
60-70 
20-30 
10-15 
10-15 
15-20 
10-15 
10-15 
Informed Consent 
 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
LRFA vs. Simulated LRFA 
Procedure 
 
 
 
 
 
 
 
Sociodemographics 
 
 
 
 
 
 
Roland-Morris Disability 
Questionnaire and 
Physical Activity 
 
 
 
 
 
 
 
Low Back Pain NRS 
Average Opioid Use 
Other Pain Questions 
 
 
 
 
 
PROMIS SF 10 
 
 
 
 
 
Global Perceived Effect 
and Satisfaction 
 
 
 
 
 
 
 
Self-reported Medications 
 
Adverse Event Reporting 
 
Compensation 
$35 
$25 
$10 
$10 
$25 
$10 
$10 
* Fitbit activity tracking is not listed, since it occurs continuously during the study period.  
**Dates of initial and final screen are approximate, contingent on the dates of potential participant’s clinical visits. 
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learn this information at a later date, research staff will provide that participant with their 
treatment allocation information at any time until the conclusion of this study. 
2) Participants may decide to continue on as part of this study (which would involve completing 
monthly telephone questionnaire by phone, for a period of 3-9 months longer after Visit 5), or 
decide to end participation in this study. If a participant were to continue as part of this study, 
the monthly questionnaires would be the same as what the participant completed by 
telephone during phone Visits 3-4, and would take between 10-15 minutes to complete. 
These optional assessments (Attachment S – Survey Visits 6-14) are completely voluntary. If 
a participant initially decides to complete the optional assessments, but later opts to stop 
completing them, we will not offer the optional assessments again. Participants will be 
compensated for completing each optional assessment.  
3) If a participant spontaneously offers expresses that they are ambivalent about the options 
discussed in #1 and #2 immediately above (unprompted by study staff), and requests more 
information, study staff will inform participants that remaining blinded to the treatments 
received for a longer period of time is more beneficial to meeting the study’s goals, as is 
participants’ continuing to complete the optional monthly assessments. Therefore, if a 
participant is truly ambivalent about the options discussed in #1 and #2 immediately above, 
remaining blinded and continuing with monthly assessments for as long as participants wish 
is the most useful course in terms of meeting the study’s goals.  
4) We will clarify that optional study visits will not take place after the formal end of the study, so 
some participants recruited late during the study will have fewer “optional” study visits that 
they can complete. 
 
Participants will be informed that in this study, research staff will need to periodically look up 
participants’ information in the electronic health record. This will be so for the duration of this study, a 
period that may last up to several years. This includes looking up such information from participants’ 
health records after the 3-month follow-up period, irrespective of whether participants have decided 
to complete the optional telephone questionnaires. If a participant decides to withdraw from this 
study, however, and informs the research team not to access his/her health record after that time, 
we will not access that participant’s health record after that time. 
  
5.6 Data Analysis 
This is a pilot study, and is not powered to detect specific magnitude effects at the level of statistical 
significance. Instead, the purpose of this study is to ascertain the magnitude of effects and relevant 
variability, so that a definitive large-scale future RCT can be conducted.  
Since the vast majority of CLBP patients at VAPSHCS have not received prior CBT, the number of 
patients receiving LRFA will be the limiting factor in recruitment. We intend to pre-screen all MBB 
procedures that are performed in the VAPSHCS Pain Clinic during the study period, to identify potential 
LRFA candidates in advance. Based on current procedural volume, we estimate that the VAPSHCS pain 
clinic will perform 800 LRFA procedures in 2019 and annually during the study period, and ≥40% of these 
procedures done annually (n~320) will be for individuals with ≥50% pain relief concordant with the 
expected duration of anesthetic effect from 2 sets of (comparative) MBBs. Based on past experience in 
the LESS RCT of epidural injections, we estimate that at least 18% of eligible participants (n=58) will 
meet other study criteria and be willing to be randomized annually during the study period. Of these, we 
aim to recruit up to for 30 Veterans for this study, and expect to lose up to 10 Veterans during the run-in 
period prior to randomization, or during follow-up; our target goal is to have n=20 Veterans who will 
complete the run-in period, be randomized, and contribute 3-month follow-up data for the primary 
outcome (the RMDQ), with a minimum of 4 Veterans within each of the 4 cells of the 4x4 table (see 
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Figure 2). If the number of Veterans failing the run-in period, or lost to follow-up, is lower than expected, 
we may recruit fewer than 30 Veterans total during the course of this study. If the number of Veterans 
failing the run-in period, or lost to follow-up, is higher than expected, we will request permission from the 
VAPSHCS IRB to recruit more than 30 Veterans total during the course of this study.  
 
The analysis will examine treatment groups for baseline imbalances in covariates, understanding that our 
small sample size will limit the ability to adjust analyses in subsequent steps. We will then conduct an 
intent-to-treat analysis. Given that this is a preliminary study, the analysis will focus on effect sizes rather 
than statistical significance. Analyses will be conducted by research staff members biostatistician Dr. 
Ania Korpak and biostatistician Andrew Timmons at the Seattle ERIC. We will examine for ‘interactions’ 
between the effect of LRFA (vs. control) and that of AcTIVE-CBT (vs. TBSCE control) on 3-month RMDQ 
scores, using a 2-way ANOVA. We will contrast the size of this estimate with that of the individual (‘main 
effects’) of LRFA vs. simulated LRFA (Figure 2; groups A+C vs. B+D) and AcTIVE-CBT vs. TBSCE 
control (groups A+B vs. C+D). If the size of interaction effect is small relative to the main effects, the main 
effects will inform estimation of the sample sizes needed for a future adequately powered RCT of LRFA 
vs. simulated LRFA or AcTIVE-CBT vs. control. Secondary comparisons of cell D vs. cell C, and cell D 
vs. cell B, would inform sample size estimation for a future RCT of combined treatment with LRFA + 
AcTIVE-CBT, compared to each of these treatments alone. If the size of interaction effect is large relative 
to the size of the main effects (making it inappropriate to study ‘main effects’), power calculations for the 
future RCT will be based on the effect sizes yielded from comparisons of cell D vs. cell C, cell D vs. cell 
B, and cell D vs. cell A. We will follow the same approach for other study outcomes.  
 
5.7 Withdrawal of Subjects 
Participant withdrawals 
We will record termination/withdrawal information for participants who decide to leave the study prior to 
completing the 3-month follow-up. Participants may leave the study at their own discretion, by 
contacting the research team and notifying them of the decision to leave the study. If participants wish 
to become unblinded, research staff will inform them of their treatment allocations at the time 
participants give notification of their decision to leave the study. Withdrawal from the study will not 
affect care participants receive at VA facilities. Participants will continue to receive any VA care for back 
pain that they elect to pursue, in coordination with their providers and VA clinical care processes.   
Participants may be withdrawn from the study without their consent if they become incarcerated during 
the study, or if the researchers feel that the study is in some way negatively affecting the participant’s 
health or wellbeing.  Participants may also be withdrawn from the study if they demonstrate threatening 
behaviors or potentially harmful behaviors towards research study staff. Participants will be withdrawn 
from the study if they are unable to be contacted and/or unable to complete study assessments for 3 
consecutive monthly study assessments.  In this case, it is assumed that they do not wish to continue in 
the study, and further contacts would be intrusive.  
Although not considered ‘withdrawal’ per se, participants who are consented may be subsequently 
excluded prior to randomization, if they 1) are found to not meet inclusion/exclusion criteria, or 2) fail 
the run-in period between Visits 1 and 2 (i.e. they cannot be reached by researchers during the run-in 
period. These exclusions cannot take place after randomization. For the purposes of the Informed 
Consent form, to simplify understanding for potential participants, we do not distinguish between 
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withdrawals and these pre-randomization exclusions.  
5.0 
Reporting 
 
Collection of safety information (monitoring) will be performed by the research staff that administer the 
assessment questionnaires and facilitate data collection, during data collection. Collection of safety 
information will also include any ad hoc participant-initiated contacts with the study team, and follow-
ups by study staff if tracking the course of any potential complications. We will establish a Data 
Monitoring Committee (DMC) to oversee study safety data. The DMC is described further below. 
 
We will record any potential complications as adverse events (AEs), defined as any untoward medical 
occurrence that may present during treatment, but which does not necessarily have a causal 
relationship with this treatment. We will also record serious adverse events (SAEs). We will complete 
an AE adverse events form for any AEs that occur during the course of this trial. We will record each 
event as it happens (or as soon as it becomes known to study research team) and we will follow the AE 
in subsequent scheduled/completed monthly assessments until resolution, the end of the patient’s 
participation or study completion (whichever occurs first). Study staff will report all AEs to the study PI 
within 1 business day of learning of the AE. Study staff will also report AEs to the appropriate clinical 
treating provider (the interventional spine physician for AEs possibly related to medical issues or 
procedural issues, and the treating psychologist for AEs possibly related to mental health). Study staff 
will complete and send the AE CRF to the Study PI within 5 business days of learning of the AE. The 
study staff will be responsible for entering the AE data into the study database within 5 business days 
of learning of the AE. Study staff will review the completeness of the entered data and will report the AE 
to the IRB. AEs will be reported to the IRB at the time of continuing reviews. If appropriate, AEs will be 
reported to the DMC (as described further below).   
 
• 
The study team will notify the study PI about any SAEs that occur within 1 business day of learning of 
the SAE. The study PI will notify the IRB within 5 business days of learning about the SAE. The DMC 
will review SAEs at their scheduled meetings. All SAEs will be reviewed and clinically evaluated by the 
treating physician. Subsequent clinical evaluation and any further assessment, that may include 
laboratory or imaging testing as well as treatment, will be done per clinical standards of care. 
• 
Any death that occurs to a subject during their participation in the study is reportable to the IRB and the 
DMC. The notification to the DMC and the IRB will include a determination from the study PI as to the 
likelihood of a relationship to the study procedure. 
A. Definition of an Adverse Event, Anticipated Adverse Event and Serious Adverse Event 
 
An adverse event (AE) is any untoward medical occurrence that may present during treatment, but 
which does not necessarily have a causal relationship with this treatment. It can therefore be any 
unfavorable and unintended event (such as an abnormal laboratory finding), symptom, or disease 
temporally associated with research participation, whether or not related to research participation. 
Anticipated AEs/potential AEs are those which might reasonably be expected to occur from LRFA or 
simulated LRFA with targeted steroid injections. These might include, but are not necessarily limited to: 
• 
Pain treatment-related: pain at the procedure site, increased pain in low back pain or nerve pain 
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• 
Neurological: paralysis, temporary weakness or numbness in legs, dysesthesias or allodynia 
• 
Hypersensitivity reactions to the medications used during the procedure (e.g. anesthetic, or 
sedative): respiratory or cardiac reactions, seizures, allergic reaction, serious and occasional 
fatal hypersensitivity (anaphylactic) reactions 
• 
Endocrine: short-term increases in blood glucose levels may occur with one-time administration 
of corticosteroid, in patients with diabetes  
• 
Infection 
• 
Cardiovascular: bleeding at the incision site, injury to blood vessels, clotting of veins 
• 
Vasovagal reaction, hypotension (low blood pressure) (these occur only intra-procedure or 
immediately after the procedure) 
• 
Miscellaneous: Swelling and bruising at the incision site 
Anticipated AEs following prolonged fluoroscopy (X-ray) might include: hair loss, skin redness, 
and skin damage. 
A serious adverse event (SAE) is defined as any untoward medical occurrence that:   
• 
Results in death 
• 
Is life-threatening (Note: the term life-threatening in the definition of “serious” refers to an event in 
which the patient was at risk of death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe). 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization. 
• 
Results in persistent or significant disability/incapacity. 
• 
Results in congenital anomaly/birth defect (if exposure to a medical product prior to conception 
or during pregnancy may have resulted in an adverse outcome in the child). 
• 
Requires intervention to prevent permanent impairment or damage. 
• 
Important medical events that may not result in death, be life-threatening or require 
hospitalization may be considered a SAE when, based on appropriate medical judgment, they 
may jeopardize the patient and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
In the proposed trial, the following events are considered SAEs: 
• 
Neurologic: paralysis, stroke, central nervous system infection 
• 
Serious hypersensitivity: anaphylactic reactions 
• 
Death 
• 
An event that is life threatening, is permanently disabling, or requires inpatient hospitalization 
 
Severity of adverse event grading scale: 
• 
Mild: an experience that is usually transient, and requires no special treatment or intervention 
• 
Moderate: an experience that is alleviated with simple therapeutic treatments 
• 
Severe: an experience that requires more than simple therapeutic interventions 
Relationship to research participation AEs: 
• 
Unrelated - This causal relationship is assigned when the AE is definitely not associated with the 
research participation/treatment 
• 
Unlikely - This causal relationship is assigned when there is no temporal relationship to the 
administration of the investigational material or other factors are more likely to have caused the 
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event. 
• 
Possibly related - This causal relationship is assigned when the AE starts at a reasonable time 
after study participation but could have been produced by the subject’s clinical state or other 
modes of therapy administered to the subject. 
• 
Probably related - This causal relationship is assigned when the adverse event starts at a 
reasonable time after study participation, stops/improves when study participation/treatment has 
been stopped, and cannot be reasonably explained by known characteristics of the clinical state. 
• 
Definitely related - This causal relationship is assigned when the adverse event starts at a 
reasonable time after study participation/treatment, stops/improves when study 
participation/treatment has been stopped, can reasonably be explained by known characteristics 
of the study participation/treatment. 
 
B. Determination of an Adverse Event 
 
AE identification 
We will monitor for adverse events during the entire duration of each patient’s participation, including all 
scheduled/completed monthly assessments and reporting offered by participants during unplanned 
contacts. In the proposed trial, there are two methods for AE identification: active and passive. 
 Active identification 
Patient Reported: At scheduled study assessments, research staff will inquire about medical/adverse 
events including surgery, ED visits, hospitalizations and ICU admissions, and allergic reactions. When 
a patient reports any of the medical events listed above, study research staff will complete an Adverse 
Event form (Attachment V – Adverse Event Form) and ask the patient details about the event. Such 
information will include, at a minimum, the date of the event, event seriousness, event treatment and 
event outcome. Assessments of AEs will include an open-ended question: “Did you experience any 
other complications?” We will treat any response to these questions as if it is an AE until the study PI 
can further review and discuss it with the study team if needed. 
Passive identification 
Medical records review: We will monitor medical records for SAEs at the time of scheduled 
assessments (monthly) until the end of the 3-month data collection, or longer if a participant elects to 
continue with optional study assessments after 3 months. If we identify an SAE, the study coordinator 
will complete an AE CRF and inform the study PI. The list of SAEs to be checked for monthly include: a 
major neurologic event (paralysis, stroke, central nervous system infection), serious hypersensitivity/ 
anaphylactic reactions, death, a life-threatening or permanently disabling event, or one that requires 
inpatient hospitalization.  
AE attribution and outcome 
The study PI will review all AEs to determine study relatedness and outcome of the event. If the PI is 
not available, AEs that are more pertinent to medical issues or procedures will be reviewed by Dr. 
Nishio or Soares, and AEs that are more pertinent to mental health will be reviewed by Dr. Williams. 
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C. Other reporting 
We will complete an AE CRF for any AEs that occur during the main 3-month follow-up period of data 
collection. We will record each event as it happens (or as soon as it becomes known to study research 
team) and we will follow the AE at subsequent scheduled/completed monthly assessments, the end of 
the patient’s participation in the study or study completion, or until directed by the participant’s treating 
provider (treating interventional spine provider or treating psychologist) that the AE has resolved or 
further tracking is not needed (whichever of these occurrences happens first). Study staff will report all 
AEs to the study PI within 24 hours of learning of the AE. Study staff will complete and send the AE 
CRF to the Study PI within 5 business days of learning of the AE. The study staff will be responsible for 
entering the AE data into the study database within 5 business days of learning of the AE. Study staff 
will review the completeness of the entered data and based on the type of AE and requirements for the 
reporting AE (see below including UAPs), will report the AE to the DMC and/or IRB. 
Unanticipated problems (UAPs) are any problem that is 1) unexpected given the research procedures 
and subject population, 2) related or possible related to participation in the research, and 3) that may 
have placed participants at a greater risk of harm than was previously recognized. Harm can be further 
classified as potential harm or actual harm. The study team and/or PI will report any UAPs to the IRB 
within 5 business days of learning about the AE that was later classified as a UAP. If serious, we will 
report this using the form " Report of Unanticipated AND Related Serious Adverse Event (SAE), 
Unanticipated AND Related Adverse Device Effect (ADE), and/or Unanticipated AND Related Problem 
Involving Risk to Subjects or Others (UPIRTSO)" (Attachment W – Serious Adverse Event Form). UAPs 
encompass 'unexpected AEs' and are reported similarly. The DMC will review UAPs that are serious at 
their meetings. 
All AEs, UAPs, and SAEs will be clinically reviewed by a study physician (Drs. Suri, Nishio, Soares, or 
Williams as described above) and clinically evaluated and treated as needed, depending on the 
problem at hand.  
The study team will notify the study PI about any expected or unexpected SAEs that occur within 24 
hours of learning of the SAE. The study PI will notify the IRB within 5 business days of learning about 
the SAE. The DMC will review SAEs at their meetings. All SAEs will be reviewed and clinically 
evaluated by the treating physician.   
Any death that occurs to a subject during their participation in the study is reportable to the IRB. The 
study PI will report the event to DMC, and to the study sponsor RR&D according to the timeframes of 
required reporting. The notification to the DMC and IRB will include a determination from the study PI 
as to the likelihood of a relationship to the study procedure. 
D. Safety monitoring 
The DMC will review the accruing data to: 1) ensure that study conduct, enrollment, and patient follow-
up is adequate; 2) ensure that there are no serious safety concerns; and 3) assess evidence related to 
the study outcomes. The DMC will convene every 4 months during active recruitment, and in ad hoc 
meetings as needed. A report will be compiled for each DMC meeting that will outline study progress 
including recruitment, retention, protocol violations, AEs, SAEs, and unanticipated problems. In 
addition, the DMC members will be notified of individual SAEs on an on-going, real-time basis. DMC 
members will also be sent a “complete” safety and efficacy data report after the first 10 subjects have 
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completed 3-month follow-up, and at the end of data collection for the full expected sample size of 20 
participants completing the main 3-month follow-up outcomes. In these “complete” safety and efficacy 
data reports, we will use a Fisher’s exact test to formally compare the event rates between ITT 
treatment groups and will qualitatively compare to established normative rates. Due to the number of 
statistical comparisons expected to be made, we do expect to see some differences of p<0.05 for some 
types of events, so we stress the qualitative nature of these comparisons. Based on the currently 
published data, we anticipate that AEs in the LRFA arm may be more common than in the simulated 
RFA arm. If there is a qualitative difference in the proportion of SAEs occurring between the study 
groups and there are concerns regarding the negative effects of the intervention, then the research 
team in consultation with both the study statistician and the DMC may recommend protocol changes or 
discontinue the study.   
E. Withdrawal of subjects due to adverse effects 
We will maintain in the study participants who develop SAEs that are study-related or not, as well as 
with severe or moderate study-related events (intention-to-treat), unless participants elect to withdraw 
from the study.  
6.0 
Privacy and Confidentiality 
The study will use participants’ Protected Health Information (PHI) for the purposes of 
participant payment by mailed checks to the participant’s current address. Also, PHI will be 
used to contact participants via telephone (as outlined above). PHI will be contained in the 
crosswalk file that links participant identifiers with the study-specific StudyID. No PHI will be 
disclosed as part of this study. 
We will take multiple steps to protect participants’ privacy, confidentiality, and inappropriate 
disclosure of data, under strict VA security guidelines. All study staff will maintain current on required 
VA trainings for privacy and confidentiality. Data will be stored in Participant Data Files that will be 
de-identified, labeled with a code number that is unique to each patient in the study (‘study-specific 
StudyID’). The study-specific StudyID will be a unique numerical code consecutively numbered in 
order of approach/screening. We will NOT include any protected health information (PHI) in the 
Participant Data Files. The Participant Data Files will be stored in a secure password-protected 
electronic location on the VA servers (expected to be the in the J: drive on the Health Services 
Research & Development (HSR&D) server), accessible only to study staff members and authorized 
personnel. Staff will maintain a Master List key code that links participants with the study-specific 
StudyID. This Master List key code will be stored in a secure password-protected electronic location 
on the VA servers, separately from all other study data. All hard copy participant data will be stored 
in locked filing cabinets in the locked/secured offices of the Seattle ERIC, while all electronic data will 
be stored in password-protected files in a limited access folder (to research staff) on a secure VA 
network drive. Only IRB-approved study personnel will have access to Participant Data Files or 
Informed Consent Forms. We will only analyze data that does NOT contain PHI, and will report 
participant data in aggregate form only- no PHI will be entered into analyses or reports. 
 
7.0 
Communication Plan 
This section is not applicable since this is a single-site study. 
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8.0 
Information Security and Data Storage/Movement 
• 
Data would only remain within the VA, and would not be moved outside the VA.  
• 
Any hard-copy documents involved will be stored in locked file cabinets in the locked/secured 
offices of the Seattle ERIC. These will be retained for six years after study closure, until 
destroyed in accordance with VA procedures, and will not be moved from the ERIC, since 
there is no need for movement of the documents.  
• 
Similarly, the electronic databases described above in section 7.0 will not be moved. These 
will be retained for six years after study closure, at which time they will be destroyed in 
accordance with VA procedures. We will update the above plan as needed if VA procedures 
and requirements change in the future. 
 
 
 
 
 
 
 
 
 
 
 
 
9.0 
References 
 
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