Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions
Phase: NA
Conditions: Spinal Degenerative Disorder
Sponsor: Vanderbilt University Medical Center

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Postoperative Management for Degenerative Spinal Conditions 
 
Sponsored by: Patient-Centered Outcomes Research Institute (PCORI) 
 
Contract Number: CER-1306-01970 
ClinicalTrials.gov: NCT02184143 
 
Principal Investigator:  
Kristin R. Archer, PhD, DPT 
 
Medical Monitor: 
Joseph O’Brien, MD, MPH 
 
Version # 8.0 
DATE June 24, 2014 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Postoperative Management for Degenerative Spinal Conditions   
 
Protocol 
___________________________________________________________________________________ 
Design Synopsis  
1. Primary Hypothesis and Principal Objective  
2. Background and Significance  
2.1. Importance of the Problem   
2.2. Cognitive-Behavioral Predictors of Poor Outcomes  
2.3. Fear-Avoidance Model 
2.4. Cognitive-Behavioral Therapy and Self-Management 
2.5. Physical Therapy after Spine Surgery 
2.6. Multimodal Rehabilitation after Spine Surgery 
2.7. Study Innovation 
2.8. Study Significance 
3. Study Design  
3.1. Design Overview  
3.2. Comparators  
  
3.2.1. Treatment Group 1: CBPT 
  
3.2.2. Treatment Group 2: Education 
3.3. Standardization of Postoperative Treatments across Centers  
3.4. Therapist Training and Certification of Centers   
4. Patient Selection  
4.1. Overview and Clinical Centers   
4.2. Inclusion Criteria  
4.3. Exclusion Criteria  
5. Trial Protocol 
5.1. Overview  
5.2. Phase 1: Qualitative Data Collection 
5.3. Phase 2: Screening 
5.4. Phase 3: Consent and Enrollment  
5.5. Phase 4: Baseline Data Collection 
  
5.5.1. Accelerometer Data 
5.6. Phase 5: Randomization and Treatment          
  
5.6.1. Treatment 
5.7. Phase 6: Follow-up Visits 
  
5.7.1. Accelerometer Data 
5.8. Primary and Secondary Outcomes   
  
5.8.1. Primary Outcomes  
  
5.8.2. Secondary Outcomes 
  
5.8.3. Intermediary Outcomes 
5.9. Other Outcomes  
5.10. Safety Issues  

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5.10.1. Safety Concerns Related to the Treatment 
  
5.10.2. Safety Concerns Related to Patient Privacy  
5.11. Retention  
5.12. Management of Concomitant Conditions  
5.13. Adverse Event Reporting  
5.13.1. Definitions  
5.13.2. Monitoring and Reporting Adverse Events  
5.13.3. Reporting Serious Adverse Events  
6. Statistical Design and Analysis  
6.1. Study Aims and Hypotheses  
6.2. Outcome Measures  
6.3. Statistical Analysis  
  
6.3.1. Aim 1 
  
6.3.2. Aim 2 
  
6.3.3. Aim 3 
  
6.3.4. Aim 4 
6.4. Missing Data  
6.5. Justification of Sample Size 
6.6. Interim Analysis  
7. Human Subjects Issues  
 
     7.1. Overview 
 
     7.2. IRB Approval 
 
     7.3. Human Subjects Involvement, Characteristics, and Design   
 
     7.4. Sources of Materials 
 
     7.5. Potential Risks 
 
     7.6 Recruitment and Informed Consent 
 
     7.7. Protection against Risks 
 
     7.8. Potential Benefits of the Proposed Research to Human Subjects and Others 
 
     7.9. Importance of the Knowledge to be Gained 
 
     7.10. Patient Confidentiality 
8. References  
9. Appendices 
9.1. Participating Centers  
9.2. Summary of CBPT Treatment 
9.3. Summary of Education Treatment 
9.4. Data Collection Schedule  
 
 
 
 
 
 
 
 
 

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Design Synopsis 
 
Title: Comparative Effectiveness of Postoperative Management for Degenerative Spinal Conditions 
 
Sponsor: PCORI 
 
Type of study: Comparative Effectiveness  
 
Objective: The proposed study will conduct a two-group randomized control trial to compare which of 
two treatments provided by telephone – a cognitive-behavioral based physical therapy (CBPT) program 
focusing on self-management strategies or an education program about postoperative recovery - are 
more effective for improving patient-centered outcomes in older adults recovering from lumbar spine 
surgery for degenerative conditions.  
 
 
Specific Aim 1: To determine the most important treatment outcomes to older adults undergoing 
 
lumbar spine surgery for degenerative conditions. 
 
 Hypothesis 1: The most important outcomes to older adults undergoing lumbar spine surgery 
 will include pain, physical functioning, and general health. 
 
Specific Aim 2: To compare whether a CBPT program or an education program is more effective in 
reducing disability and pain and improving general health, physical activity, and physical function 
following lumbar spine surgery for degenerative conditions. 
 
 
Hypothesis 2: CBPT participants compared to education participants will demonstrate 
significantly greater improvement in disability (Oswestry Disability Index), pain (Brief Pain 
Inventory), general health (12-item Short Form) and physical activity (movement 
accelerometers) at 6 and 12 months following lumbar spine surgery and physical function as 
measured by standardized performance tests of strength, gait speed, and mobility (5-Chair 
Stand, Timed Up and Go, 10-Meter Walk) at 12 month follow-up. 
 
Specific Aim 3: To determine how CBPT improves outcomes in patients following lumbar spine 
surgery for degenerative conditions.  
 
Hypothesis 3: Participants reporting decreases in fear of movement and increases in pain self-
efficacy will demonstrate improvement in outcomes following the CBPT program at 6 and 12 
months following lumbar spine surgery. 
 
Specific Aim 4: To determine which sub-groups of adults are most likely to benefit from CBPT 
following lumbar spine surgery for degenerative conditions.  
 

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Hypothesis 4: CBPT participants that are 60 years or older, have a fusion procedure, and report 
clinically significant depressive symptoms will demonstrate greater improvement in outcomes at 
12 months following lumbar spine surgery. 
 
Study design: Multicenter, prospective randomized controlled trial.  
 
Comparators: 
Group 1:  CBPT   
Group 2:  Education 
 
Study duration: 4 years (2-month start-up, 4-month qualitative data collection, 24-month accrual, 12-
month follow-up, and 6 months analysis and writing). Participants will be followed for 1 year from the 
time of surgery. 
 
Sample size: 260 eligible patients are planned to be consented; 221 are expected to be retained at 12-
month follow-up. 
 
Number of study sites: 2 
 
Inclusion criteria  
1) Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes;  
2) Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without 
myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis 
procedures; 
3) English speaking due to feasibility of employing study personnel to deliver and assess the study 
intervention; and  
4) Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition) 
 
Exclusion criteria  
1) Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or 
microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less 
severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or 
laminectomy without arthrodesis); 
2) Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity 
as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion 
population);  
3) Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor; 
4) Presence of back and/or lower extremity pain < 3 months indicating no history of chronic pain;  
5) History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. 
Including but not limited to Parkinson’s disease, Multiple Sclerosis, Epilepsy, Brain tumors, 
Huntington’s disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System 
disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis; 
6) Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic 
disorder and Delusional disorder;  

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7) Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel 
limitation;  
8) Patients having surgery under a workman’s compensation claim; and  
9) Unable to provide a stable address and access to a telephone indicating the inability to participate in 
either the telephone-based CBPT or education program. 
 
Projected outcome measures  
Primary: The 10-item Oswestry Disability Index is a standard measure of condition specific disability 
that assesses the impact of lumbar spinal disorders on daily living, with questions about pain intensity, 
lifting, sitting, standing, walking, sleeping, hygiene, traveling, social life, and sex life. The MCID has 
been found to range from 11 to 12.8 points in patients following lumbar spine surgery. The Brief Pain 
Inventory is an assessment of pain. The minimum clinically important difference (MCID) for pain has 
been found to range from 1.2 to 2.1 points in patients following lumbar spine surgery. General physical 
and mental health will be measured with the physical and mental composite scales of the SF-12. The 
physical component scale (PCS) assesses the four subdomains of physical functioning, role-physical, 
bodily pain, and general health and the mental component scale (MCS) assesses the 4 subdomains of 
vitality, social functioning, role-emotional, and mental health. The minimal clinically significant change 
for the PCS and MCS has been estimated at 10%. 
 
Secondary: Physical activity will be objectively measured using movement accelerometers (Actigraph 
GT3X+). The 5 Chair Stand Test from the Short Physical Performance Battery from the Established 
Populations for the Epidemiologic Study of the Elderly studies will be used to assess strength. The 10-
Meter Walk and Timed Up and Go tests will also be used to assess self-selected walking speed and 
functional mobility, respectively. 
 
Intermediary: The 17-item Tampa Scale for Kinesiophobia will be used to measure fear of movement. 
The MCID for the TSK has been reported to be 4 points in patients with back pain. The 10-item Pain 
Self-Efficacy Questionnaire will measure the strength and generality of a person’s belief in his/her 
ability to accomplish a range of activities despite pain.  
 
Randomization: To ensure that the number of subjects is about the same in the two arms of the study 
for each clinical site, the randomization scheme will frequency-match patients in a 1:1 ratio in blocks of 
assignments stratified by age and type of surgery (i.e., fusion or no fusion). The 4 frequency-matched 
strata will be as follows: (1) Age 21-59 and fusion; (2) Age 60-90 and fusion; (3) Age 21-59 and no 
fusion; (4) Age 60-90 and no fusion. Block size will be determined randomly with the patient as the unit 
of randomization. Randomization will be administered centrally by the Coordinating Center (Vanderbilt) 
through the REDCap electronic database. 
 
Statistical analysis: All analyses will be both on an “intention-to-treat” and “as treated” basis.  
 
Safety monitoring: A medical monitor will be responsible for monitoring the accumulated interim data 
as the trial progresses to ensure patient safety, review efficacy, evaluate recruitment, and assess overall 
data quality. 

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 1.  Primary Hypothesis and Principal Objective  
 
The United States has the highest rate of lumbar spine surgery in the world, with rates increasing over 
200% in the last decade (1-3). Medicare spends over $1 billion annually on lumbar spine surgery (4). 
Despite surgical advances, up to 40% of older adults have persistent pain, disability and functional 
limitations (5-13). We have found that high fear of movement is a risk factor for increased pain and 
disability and decreased physical health in patients following lumbar spine surgery (14,15). This finding 
supports previous work in surgical and chronic low back pain populations (16-24). Brief cognitive-
behavioral therapy (CBT) and self-management treatments have proven effective for reducing 
psychosocial risk factors and improving pain and activity outcomes (25-33). However, these treatments 
are unavailable or insufficiently adapted for postoperative care. 
 
Preliminary evidence through a currently funded R21 project (R21AR062880) has demonstrated the 
preliminary efficacy of a CBT-based self-management program for pain and disability in a surgical 
spine population. Thus, we propose in the current application a large, rigorous evaluation of our 
cognitive-behavioral based physical therapy (CBPT) program with the goal of engaging adults in their 
own care and improving pain and functional outcomes. We hypothesize that the CBPT intervention 
focusing on self-management will decrease pain and disability and improve general health, physical 
activity and physical function in community-dwelling adults undergoing spine surgery, through 
reductions in fear of movement and increases in pain self-efficacy.  
 
 
 
 
 

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2.  Background and Significance  
 
2.1. Importance of the Problem. Degenerative lumbar spinal stenosis is a major public health burden 
in the United States (U.S.). The prevalence is 45% in individuals greater than 60 years of age (34,35). 
Lumbar spinal stenosis is a major cause of pain and physical impairment, which results in reduced 
quality of life (36). This condition is now the most common diagnosis associated with lumbar spine 
surgery in older adults (36-38). The U.S. has the highest rate of lumbar spine surgery in the world, with 
rates increasing over 200% since 1990 among adults over age 60 years with degenerative spinal disease 
(1-3). Medicare spends over $1 billion annually on lumbar spine surgery (4). Despite surgical advances, 
older adults undergoing lumbar spine surgery have poorer physical and mental health outcomes 
compared to the general population (39,40). More specifically, up to 40% report persistent pain, 
functional disability and poor quality of life and 20% to 24% undergo a reoperation (5-13).  
The estimated percentage of people over 60 years is expected to increase by 75% over the next 
20 to 30 years (41,42). Thus, an increased number of older adults will experience age-associated 
degenerative conditions and spine surgery rates and Medicare expenditure will continue to rise (43). 
Innovative and accessible postoperative treatments, such as the proposed study, are needed to address 
this variability in postoperative outcomes and prevent long-term physical disability and chronicity in 
older adults after spine surgery. This study will provide data to support the utilization of innovative and 
accessible rehabilitation interventions that can be used by older adults across a range of painful 
conditions. 
 
2.2. Cognitive-Behavioral Predictors of Poor Outcomes. Robust evidence indicates that patient 
demographic and psychosocial characteristics are strongly related to surgical spine outcomes (44). 
Furthermore, several studies have found that specific cognitive-behavioral factors of fear of movement 
and avoidance coping are associated with increased pain and disability after surgery for lumbar disc and 
various spinal disorders (16-20). We have demonstrated that high fear of movement is a risk factor for 
increased pain and disability and decreased physical function in patients following lumbar spine surgery 
for degenerative conditions (14,15). Fear of movement refers to an excessive fear of physical activity 
resulting from a dysfunctional belief that movement will cause harm or reinjury (45). The proposed 
study translates these recent observations into an interventional study which seeks to determine whether 
a multimodal rehabilitation intervention, targeting fear of movement and decreased physical activity, is 
effective for improving recovery in older adults following lumbar spine surgery.  
 
2.3.  Fear-Avoidance Model. The conceptual framework for the hypothesized effect of fear of 
movement on pain, disability, and function 
after lumbar surgery is based on the fear-
avoidance model of Vlaeyen et al. (46). The fear-
avoidance model has been successfully tested in 
adults with chronic low back pain (21-24). This 
model has also been tested across age groups. 
Studies suggest that age moderates the relationship 
between catastrophizing and pain outcomes and 
that fear of movement may play a stronger 
mediating role in older compared to younger 
patients (47-49). Our own work and that of other 
Figure 1. Theoretical Model for Lumbar Spine Surgery 

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investigators have demonstrated this model’s applicability to older adults following spinal surgery 
(19,20,50,51). This adaptation of Vlaeyen’s fear-avoidance model has been extended to include the key 
concept of low self-efficacy, which is related to avoidance of physical activity in community-dwelling 
older adults (52-55) and poor outcomes in patients with musculoskeletal pain (56-60). This model 
provides a theoretical rationale, supported by the literature, for identifying and intervening on specific 
cognitive-behavioral risk factors in older adults following lumbar spine surgery for degenerative 
conditions.  
 
The model suggests that after an acute insult, such as surgery, pain that is perceived as non-
threatening will lead to a return to normal activity and eventually functional recovery. In contrast, pain 
that is perceived as threatening will promote anxiety and give rise to pain catastrophizing (i.e., tendency 
to magnify pain sensations) and fear of movement. This fear persists beyond the expected healing time 
and leads to low self-efficacy and avoidance behaviors and a “disuse” syndrome. Subsequently, 
depressive symptoms and disability increase avoidance of physical activity and perpetuate the pain 
process. It is important to note that the conceptual framework does not suggest a direct causal flow 
among risk factors or that all factors are necessary for persistent disability. Instead, fear of movement or 
low self-efficacy, when present, can perpetuate the disability cycle, resulting in restrictions in physical 
function and productive social roles. Evidence on the fear-avoidance model in chronic low back and 
spine surgery populations support a biopsychosocial approach to postoperative rehabilitation and the 
need for identification of high risk subgroups based on demographic and cognitive-behavioral factors. 
 
2.4. Cognitive-Behavioral Therapy and Self-Management.  Cognitive-behavioral therapy (CBT) 
interventions have strong empirical support, with documented positive influence on fear of movement, 
pain catastrophizing, and self-efficacy in chronic pain populations (61-65). Moreover, studies have 
demonstrated that brief (4 to 6 sessions) and telephone-administered CBT-based programs are effective 
approaches for reducing pain and improving function in patients with chronic and surgical pain (25-33). 
CBT programs commonly include relaxation (i.e., deep breathing and progressive muscle relaxation), 
cognitive restructuring, and behavioral techniques for pain management (66-69). Well-accepted 
cognitive restructuring strategies involve identifying “automatic negative” thoughts, acquiring positive 
coping self-statements, and distraction techniques (70-72). Finally, common behavioral techniques 
consist of pacing, graded activity, and graded exposure in vivo (GEXP) (69,73). GEXP involves gradual 
increases in activity by systematically challenging beliefs about harmfulness of activities (73). CBT-
based self-management programs have also demonstrated improvement in patient outcomes and the 
adoption of a physically active lifestyle, as well as improvement in fear-avoidance beliefs and self-
efficacy, in various populations with chronic conditions (74,75). Patient-oriented self-management 
programs, consisting of goal-setting, problem-solving strategies, and action-plans, are particularly 
effective for community-dwelling older adults with chronic conditions (76,77). These evidence-based 
CBT and self-management strategies provide the basis for the proposed multimodal rehabilitation 
intervention. 
 
2.5. Physical Therapy after Spine Surgery.  Surgeons routinely offer physical therapy to older adults 
after spine surgery, without high-quality evidence that this postoperative approach reduces barriers to 
improved outcomes (78). Several randomized trials have found no significant difference between 
standard physical rehabilitation and either no treatment or an educational booklet (79-81). These results 
may be due to the inability of physical therapy to address the psychosocial factors, such as fear of 
movement, often associated with poor surgical spine outcomes. Participation and engagement in 

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physical activity and exercise is also closely related to self-efficacy in community-dwelling older adults 
(52-55). The literature suggests that behavioral components should be added to exercise programs in 
order to provide a multimodal approach to postoperative rehabilitation (82,83). This recommendation is 
based on the demonstrated effectiveness of combining CBT-based strategies and physical therapy into 
interdisciplinary rehabilitation programs for patients with chronic low back pain. Randomized controlled 
trials have found that rehabilitation delivered through a team approach (psychologists and physical 
therapists) are more effective than usual care in reducing fear of movement, pain and disability (84-87). 
Studies also suggest that physical therapists can implement the cognitive-behavioral skills necessary to 
reduce pain and disability (88-93). Overall, the literature recommends multimodal rehabilitation for 
older adults after spine surgery; however, CBT and self-management treatments are unavailable or 
insufficiently adapted for postoperative care. There are currently no accessible and effective treatments 
that clinicians can recommend, and older adults can do, after spine surgery to improve outcomes. 
 
 
2.6. Multimodal Rehabilitation after Spine Surgery.  The current knowledge base of multimodal 
therapeutic strategies after lumbar spine surgery is limited. To date, only two studies have investigated 
combining CBT strategies and physical therapy in patients following surgery for lumbar degenerative 
conditions (94,95). Single-site randomized controlled trials by Christensen et al. (94) and Abbott et al. 
(95) found significantly lower leg pain with an 8 week group behavioral physical therapy intervention 
and decreased disability with a 3 session psychomotor therapy program, respectively, at 2 years 
following lumbar fusion. However, limitations of both studies are that interventions excluded 
empirically-supported cognitive strategies and were not designed to increase self-efficacy and improve 
physical activity through self-management. An additional limitation is that interventions were not 
designed for older adults. Studies by Christensen and Abbott included participants that were less than 65 
years of age and had no history of prior spinal surgery or comorbidities, which is not representative of 
patients undergoing spine surgery for degenerative conditions. The proposed study will fill important 
knowledge gaps and generate critical information on the effectiveness of a CBT-based self-management 
approach to postoperative rehabilitation for community-dwelling adults. 
 
2.7. Study Innovation.  Our novel CBPT program is a patient-oriented self-management treatment for 
adults, which is characterized by active participation and personal responsibility (96), and is designed to 
maximize gains in functional outcomes that are relevant and meaningful to patients. CBT-based self-
management programs have demonstrated improvement in patient outcomes and the adoption of a 
physically active lifestyle in various adult patient populations (97-102). Our study is innovative from a 
clinic perspective, because rehabilitation in surgical populations has not traditionally focused on self-
management. Rather surgeons have focused on infection control and other factors that emphasized the 
clinician’s role.  
There is an evidence gap concerning how psychosocial factors and patient characteristics affect 
postoperative treatment response in adults recovering from surgery. Studies reporting physical therapy 
and education comparisons have not investigated the mechanisms through which rehabilitation affects 
long-term outcomes. Furthermore, studies demonstrate limited adjustment for confounding factors (103-
108). While little is known about the influence of patient-level factors on outcomes following specific 
therapies, there is an expansive observational literature documenting that patient characteristics affect 
long-term outcomes after lumbar spine surgery. The proposed study will be the first to examine potential 
mediators for improvement in postoperative outcomes as a result of a self-management approach and 

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whether sub-groups of patients based on age are more likely to benefit from the CBPT intervention. 
Results will further our understanding of tailored interventions based on age for pain management (49).  
The proposed study is innovative in its use of a telephone-delivery model. Qualitative research 
helped overcome accessibility barriers by adapting the CBPT program for delivery over the telephone 
(109). Our telephone-delivery model addresses the financial and transportation constraints and mobility 
issues that typically render clinic-based rehabilitation impractical for an aging population (110-113). We 
will be able to treat adults from “hard-to-reach” and underserved populations, such as older adults with 
multiple comorbidities and residents of rural areas. Home-based programs also appear to be superior to 
highly supervised center based programs in terms of adherence to exercise, especially in the long-term 
for older adults (50 years or older) (114). As centers of excellence are created in our evolving health 
care market, patients will travel longer distances to receive specialty care. There will be a critical need 
for easily accessible programs that support older adults in their home community. The implementation 
of our CBPT program over the telephone will help patients engage in purposeful, goal directed 
behaviors at home and at work and participate fully in family and community life. The long-term goal is 
to empower adults to return to a productive life both inside and outside the home and ultimately improve 
their quality of life and participation in society. The next step in our work is the current proposal which 
conducts a large, rigorous evaluation of our CBPT program in a racially/ ethnically diverse patient 
population, with the goal of engaging adults in their own care and improving pain and functional 
outcomes. These data will be useful in guiding the development of accessible interventions that can be 
used across a variety of painful conditions. 
 
2.8. Study Significance. This novel CBT-based self-management approach to postoperative 
rehabilitation seeks to redefine the transdisciplinary model of health care and increase access to well-
established pain management strategies. Our line of work is part of a current shift in the physical therapy 
treatment paradigm toward “psychologically informed” rehabilitation and compelling data is needed to 
support this expanded scope of practice. There is an urgent need for adults to have readily accessible 
treatments that allow them to take an active role in their care. Our long-term goal is to provide low-cost, 
evidence-based programs that clinicians can recommend, and adults can do, to improve pain and 
functional outcomes. Furthermore, the proposed study will examine how cognitive-behavioral factors 
and age play a role in the efficacy of treatment for pain and disability in community-dwelling adults. 
Results will further our understanding of tailored interventions based on age for pain management. Our 
interventional approach is designed to empower adults to return to a productive life both inside and 
outside the home and ultimately improve their quality of life and participation in society. 
 
3.  Study Design  
 
3.1. Design overview.  The CBPT study is a multi-center, prospective randomized controlled trial of 
CBPT versus education in adults following lumbar spine surgery for degenerative conditions.  The 
primary hypothesis for the study is that the CBPT intervention will decrease pain and disability and 
improve general health, physical activity, and physical function in this surgical population, through 
reductions in fear of movement and increases in pain self-efficacy.  
 
Eligible patients will be randomized to one of the 2 treatment groups after undergoing surgical treatment 
for a lumbar degenerative condition. Patients will be asked to complete a preoperative questionnaire and 
participate in a postoperative baseline assessment prior to the start of the intervention phase (6 weeks 

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after surgery). This baseline assessment will occur at a standard postoperative clinic visit. Patients will 
also be asked to participate in follow-up visits at 6 and 12 months after surgery. The primary outcomes 
are self-reported pain, disability, and general health. Secondary and tertiary outcomes include physical 
activity and physical function, respectively. Additionally, use of pain medication, re-hospitalization 
following initial spine surgery, and surgeries following initial spine surgery will also be ascertained and 
compared between the two treatment groups at 6 and 12 months after surgery. A schematic of the trial 
design is presented below in Figure 2. 
 
                        Figure 2: Trial Design 
 
 
 
  
 
 
 
 
 
 
3.2. Comparators.  Patients who meet the eligibility criteria and have signed an informed consent 
statement will be randomly assigned to one of two groups after surgery and completing the baseline 
assessment: 
 
Group 1:  CBPT 
Group 2:  Education 
 
Randomization will provide patients a 50/50 opportunity to be in either group. The stratified 
randomization scheme will assign patients in randomly permuted blocks of assignments stratified by age 
and type of surgery (i.e., fusion or no fusion).  The 4 frequency-matched strata will be as follows: (1) 
Age 21-59 and fusion; (2) Age 60-90 and fusion; (3) Age 21-59 and no fusion; (4) Age 60-90 and no 
fusion. This scheme will ensure that the two groups will be balanced by age (to minimize age effects of 
pain and disability) and by fusion (to minimize effects of differences in injury severity, procedural 
complexity, and recovery time).  
 
The randomization plan will be prepared and administered centrally by the Coordinating Center 
(Vanderbilt) but will not require real time interaction with Vanderbilt staff members. Requests for 
randomizations will be made by the study physical therapist using a secure web-based application. An 
assignment will be issued only if the database shows that the patient is eligible, the consent statement 
has been signed, and a baseline assessment completed. 
 
3.2.1. Treatment Group 1.  The CBPT program focuses on a patient-oriented self-management 
approach to reduce pain and disability and improve physical activity and function, through reductions in 
fear of movement and increases in self-efficacy. Brief CBT programs for pain developed by Woods and 
Asmundson (84), Williams and McCracken (69), and Turner et al. (115) and a self-management 
approach developed for older adults by Lorig (101,102,116,117) provide the basis for the CBPT 
Consent 
Education  
6 and 12 
months after 
surgery 
Preoperative 
Screening 
Randomization 
Follow up 
Assessment 
  CBPT  
6 weeks 
after 
surgery 
Baseline 
Assessment 
Questionnaire 
Preoperative 
Assessment 

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program. Sessions cover an introduction and rationale for treatment, deep breathing (118), progressive 
muscle relaxation (119), graded activity plan, goal-setting (120), distraction techniques (29), automatic 
thoughts (72), coping self-statements (72), pacing techniques (121), and relapse prevention and 
symptom management plans (122). Each session builds upon the content of the previous session and 
weekly action plans are personally tailored based on patient goals. The program consists of six weekly 
telephone sessions with a trained physical therapist. The first session is approximately 60 minutes and 
the remaining 5 sessions are approximately 30 minutes (see Appendix 9.2. for more detail). Each patient 
randomized into the CBPT program will receive a binder to follow along with the study therapist.   
 
Potential Adverse Effects.  There are no potential adverse effects specific to the cognitive-behavioral 
and self-management strategies. There may be distress related to discussing mood and beliefs about pain 
and functional activity.  
 
3.2.2. Treatment Group 2.  The education program focuses on postoperative recovery and is based on 
web-based modules that were developed and tested in Dr. Wegener’s NIH-funded project in patients 
with musculoskeletal injury (R01AR054009). Educational modules were adapted in collaboration with 
community-dwelling adults who completed preliminary testing of the CBPT program (109). Sessions 
address benefits of physical therapy, proper biomechanics after surgery, importance of daily exercise, 
and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, 
communication with health providers, and preventing future injury are also provided. The education 
program is matched to the CBPT treatment in terms of session frequency, length and contact with the 
study therapist. Each patient randomized into the education program will receive a binder to follow 
along with the study therapist (see Appendix 9.3 for more detail). 
 
Potential Adverse Effects.  There are no potential adverse effects specific to the educational treatment. 
There may be distress related to discussing their surgery and recovery.  
 
3.3. Standardization of Postoperative Treatments across Centers.  The clinical course of the patients 
in both arms of the study will follow the universal protocols for postoperative management of lumbar 
degenerative conditions at academic medical centers. All patients return for a standard postoperative 
clinic visit at 6 weeks to assess surgical recovery and usually receive a prescription for physical therapy 
(2x/week for 6 weeks). Minor variability in practices, such as need for physical therapy referral and 
duration of physical therapy, as well as type of oral analgesics will be at the discretion of the treating 
surgeon. This may impart some variation in care across the centers, but will realistically mimic the 
current state of the art for the best care possible in each of the treatment arms. Relevant details regarding 
postoperative treatment will be recorded and used in the analysis as necessary to balance comparisons 
between groups. 
 
3.4.  Therapist Training and Certification of Centers.  Two study physical therapists at Vanderbilt 
will be delivering both the CBPT and education treatments. The study therapists will complete a formal 
training course (sponsored by Vanderbilt) in both the CBPT and educational treatments. Formal training 
will occur during one 2-day session with the PI of the study (Dr. Archer) and a clinical psychologist (Dr. 
Wegener) specializing in CBT and self-management techniques. A written competency for both 
treatments and a skills test for the CBPT program will be completed at the end of training. After passing 
both tests (scores > 85), both treatments will be implemented with study staff and progression will be 

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discussed during weekly research meetings. Then, a pre-test of the CBPT and education treatments will 
occur with 2 patients from each center. All sessions during the pre-test are audiotaped and reviewed by 
the PI and Dr. Wegener to evaluate adherence to each of the treatment protocols and to specific CBT 
and self-management competencies. Prior to initiation of the study, completion of the therapist training 
course, competency and skills tests, practice sessions, and the pre-test will be documented. 
 
4. 
Patient Selection  
 
4.1. Overview and Clinical Centers.  Approximately, 260 community-dwelling adults will be recruited 
from the centers. The two centers are academic medical centers with large numbers of lumbar 
degenerative conditions and with a proven track record for prospective study of patients having lumbar 
spine surgery (5R01HS017990 and R21AR062880). Eligible patients will be identified and recruited at 
the participating clinical centers subject to the inclusion and exclusion criteria listed below. 
 
The Coordinating Center (Vanderbilt) will develop a master recruitment plan and work with the other 
center (Johns Hopkins) to customize this master plan.  Recruitment goals will be set for each individual 
center and monitored on an ongoing basis.  
 
4.2. Inclusion criteria.  In order to qualify for inclusion in the trial, patients must satisfy the following 
inclusion criteria: 
 
1) Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes;  
2) Surgical treatment of a lumbar degenerative condition (spinal stenosis, spondylosis with or without 
myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis 
procedures; 
3) English speaking due to feasibility of employing study personnel to deliver and assess the study 
intervention; and 
4) Age older than 21 years (younger individuals do not typically have a lumbar degenerative condition). 
 
4.3. Exclusion criteria.  Patients who satisfy any of the following exclusion criteria will be ineligible 
for enrollment in the trial: 
 
1) Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or 
microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less 
severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or 
laminectomy without arthrodesis); 
2) Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity 
as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion 
population);  
3) Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor; 
4) Presence of back and/or lower extremity pain < 3 months indicating no history of sub-acute or 
chronic pain;  
5) History of neurological disorder or disease, resulting in moderate to severe movement dysfunction. 
Including but not limited to Parkinson’s disease, Multiple Sclerosis, Epilepsy, Brain tumors, 

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Huntington’s disease, Alzheimer's disease, Muscular Dystrophy, Stroke, Autonomic Nervous System 
disorders, Traumatic Brain Injury, Cerebral Palsy, and Amyotrophic Lateral Sclerosis; 
6) Presence of schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic 
disorder and Delusional disorder;  
7) Patients not able to return to clinic for standard follow-up visits with surgeon due to time and travel 
limitation;  
8) Patients having surgery under a workman’s compensation claim; and  
9) Unable to provide a stable address and access to a telephone indicating the inability to participate in 
either the telephone-based CBPT or education program. 
 
5. 
Trial Protocol 
 
5.1. Overview.  The patient-related activities of the CBPT trial can be divided into the following phases: 
 
• Phase 1: Qualitative data collection (Vanderbilt site only) 
• Phase 2: Screening for eligibility;  
• Phase 3: Consent and enrollment into trial prior to surgery; 
• Phase 4: Baseline data collection (6 weeks after surgery);  
• Phase 5: Randomization and Treatment; 
• Phase 6: Post-treatment follow-up phase (6 and 12 months after surgery); 
 
The visit and data collection schedule described below is summarized in Appendix 9.4. 
 
5.2. Phase 1: Qualitative Data Collection (Vanderbilt only) 
 
5.2.1. Patient Interviews. Twenty interviews will be conducted at Vanderbilt to identify patient-
centered outcomes for the randomized controlled trial. However, data collection will occur until 
redundancy or saturation is reached (i.e., no additional information is obtained from the last informants). 
Interview participants will be recruited through a stratified purposeful sampling approach from a current 
cohort of 80 adults who have been enrolled into a NIH-funded pilot trial comparing the CBPT and 
education programs. This purposeful sample will be stratified by responders (i.e, reduction in disability 
of 12.8 points or greater as measured by the Oswestry Disability Index) or non-responders (i.e., 
reduction < 12.8 points) at 12 months following surgery. Research personnel will contact eligible 
individuals by mail and then phone to determine interest in participation and verbal and written consent 
will be obtained.  
 
5.2.2. Focus Groups. After the interviews, focus groups will be conducted to: 1) identify any outcomes 
that might have been missed by the interviews; 2) review existing measurement scales used to capture 
all identified outcomes; 3) generate discussion on how measurement scales might be improved to better 
capture patients’ actual experiences with these outcomes over time and across contexts (e.g., work, 
family, recreation); and 4) to review models of patient surgical outcomes developed from the interviews. 
Four focus groups are planned, with 6 to 8 participants in each. Groups will be comprised of patients 
that were not involved in the interview process and recruitment will occur through the stratified 
purposeful sampling approach described above. 2 hours will be allotted for each group. Groups will be 
led by Dr. Schlundt (co-investigator) and an experienced moderator from the Qualitative Research Core 

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at Vanderbilt University. Focus group participants will be asked to read and sign informed consent 
forms at the start of the session. Groups will include a spontaneous reporting of symptoms and health 
concerns and how patients managed symptoms. Then codes and categories (i.e., outcomes) will be 
presented that were identified through the interviews. Measures will also be presented that reflect these 
outcomes to answer the research question – “ Do outcome measures commonly used in surgical spine 
trials adequately reflect what is most important to patients?”  
 
5.2.3. Pilot Testing and Cognitive Interviews. The final outcome measures/items will be piloted via 
mail or email with 25 patients who have participated in the interviews or focus groups. Ten additional 
patients will be recruited for in-person cognitive interviews (i.e., talk out loud as they complete the 
measurement tool). The cognitive interviews will assess the following for the outcome scales/items: 1) 
comprehension; 2) process by which the respondent retrieves relevant information from memory; 3) 
decision process to answer each item; and 4) response process. 
 
5.3. Phase 2: Screening for Eligibility.  Patients will be screened for eligibility in each center by the 
local research coordinator in close coordination with the surgeon co-investigators. Screening through the 
medical record will occur prior to surgery and a scheduled preoperative clinic visit. Additional screening 
will occur either during the preoperative clinic visit or after by the study coordinator through a list of 
screening questions. All potentially eligible patients will be entered into REDCap, a study number 
assigned, and eligibility criteria confirmed. The Coordinating Center (Vanderbilt) will be available to 
adjudicate eligibility.   
 
5.4. Phase 3: Consent and Enrollment.  Eligibility will be confirmed with the treating surgeon and 
through a list of screening questions for the patient. Patients will then be approached for their consent to 
participate in the randomized controlled trial following their preoperative clinic visit. The study 
coordinator will perform the consent process using a scripted dialogue and materials developed for the 
CBPT study. A power point presentation will also be made available for use by the research team to 
describe the study and what it means to participate in the study.   
 
Once consented into the randomized trial, patients will complete a preoperative questionnaire. This 
assessment will gather data on patient demographic and injury characteristics, medical and social 
history, expectations of surgery, fear of movement, pain self-efficacy, affect, depressive symptoms, and 
preoperative levels of pain, disability, and general physical and mental health. Patients will also be asked 
to complete a battery of physical performance tests to assess strength, mobility, and gait speed.  
 
5.5. Phase 4: Baseline Data Collection.  The date of surgery is the 0 time for reckoning baseline visit 
and all follow-up visits (i.e., all follow-up visits are scheduled at specific times measured from the date 
of surgery). The surgery scheduler will schedule both the surgery and a standard 6-week postoperative 
clinic visit for the patient. The Research Coordinator at each site will contact patients to schedule a 
baseline study visit prior to their standard 6-week postoperative clinic visit with the surgeon. Patients at 
this study visit will complete questions on work status, medication, physical therapy, expectations, and 
satisfaction and a battery of questionnaires to measure fear of movement, pain self-efficacy, depressive 
symptoms, general physical and mental health, and pain and disability outcomes. Physical function will 
be assessed through performance-based tests that include the Chair Stand test, 10-Meter Walk test, and 

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Timed Up and Go. Patients will be provided with an accelerometer to wear for 7 days following the 
study visit. 
 
Study personnel conducting the baseline assessment will be unaware of the patient treatment condition. 
All data from the baseline self-reported assessment will be entered directly into the REDCap Data Entry 
System by the patient. Data from the performance based tests will be recorded on case report forms by 
study personnel and then transferred to the REDCap Data Entry System.  Details as to the information 
collected during the baseline assessment is included as Appendix 9.4.  
 
5.5.1. Accelerometer Data.  Each accelerometer will be initialized at the Coordinating Center 
(Vanderbilt) to record three-dimensional accelerations raw signal at 40 Hz. However, detailed 
instructions on how to wear and care for the accelerometer will be provided by the Study Coordinator at 
each local site during the baseline visit. Patients will be asked to wear the accelerometer secured at the 
right hip with a waist belt for seven consecutive days excluding night rest (sleep). All patients will also 
be given a stamped, self-addressed envelope to return the accelerometer to the Coordinating Center 
(Vanderbilt) after wearing for seven days. Research personnel at Vanderbilt will download the data 
using ActiLife v6.4 software. If wear interval data are not available for at least 4 days (with each day 
being at least 10 hours), the Research Coordinator at the Coordinating Center (Vanderbilt) will contact 
the patient by phone and ask them to wear the accelerometer for another 7 days. The accelerometer will 
then be mailed from the coordinating center (Vanderbilt) to the patient along with a self-addressed 
stamped envelope to return after wearing for seven days. 
 
5.6. Phase 5: Randomization and Treatment. Once the patient has been consented, undergone surgery 
for a lumbar degenerative condition, and completed the baseline assessment, the Research Coordinator 
at each site will update the REDCap Data Management System and the patient will be randomized 
electronically. To ensure that the number of subjects is about the same in the two arms of the study for 
each clinical site, the randomization scheme will assign patients in a 1:1 ratio in randomly permuted 
blocks of assignments stratified by age and type of surgery (i.e.; fusion or no fusion). Block size will be 
determined randomly with the patient as the unit of randomization.  
 
The randomization plan will be prepared by the study’s biostatistician and administered centrally by the 
Coordinating Center (Vanderbilt), but will not require real time interaction with Vanderbilt staff 
members. Requests for randomization will be made by the study therapist using a secure web-based 
application. An assignment will be issued only if the database shows that the patient is eligible, the 
consent statement has been signed, and a baseline postoperative assessment completed. Enrollment will 
be documented in the patient’s chart according to center protocol.   
 
5.6.1. Treatment.  Once patients have completed the baseline assessment with the Research 
Coordinator and received the movement accelerometer, the study physical therapist will call the patient 
to schedule the first treatment session. Patients will complete 6 sessions over the phone. Sessions will be 
scheduled on a weekly basis.   
 
5.7. Phase 6: Post-treatment Follow-up Phase (6 and 12 months after surgery).  The randomization 
computer program will generate a personalized appointment schedule for the patient; this schedule will 

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indicate the ideal date for each follow-up visit, as well as the time window around the ideal date during 
which the follow-up visit may be done.  
 
Patients will have follow-up visits at 6 and 12 months after surgery. Each visit will have an interval of 
time surrounding the ideal date for the visit during which the visit may be done and the data included in 
the trial database. The ideal date for a visit is the exact anniversary from surgery. Visit windows (+/- 2 
weeks for all visits) will be constructed to be contiguous, so that at any point in time, some visit window 
is open, subject to a check on the minimum separation required between consecutive visits. Patients at 
the study follow-up visits will complete the same questions and battery of questionnaires as the baseline 
assessment and wear an accelerometer for 7 days. Patients will also be asked questions on intervening 
events such as re-hospitalization and surgery. At the 12-month follow-up, patients will return for an on-
site visit and complete the performance-based tests. 
 
Study personnel conducting the follow-up assessment will be unaware of the patient treatment condition. 
All data from the follow-up self-reported assessment will be entered directly into the REDCap Data 
Entry System by the patient or on case-report forms. Data from the performance based tests will be 
recorded on case report forms by study personnel and then transferred to the REDCap Data Entry 
System.  The types of specific data to be collected at each of the follow-up visits are included as 
Appendix 9.4. 
 
5.7.1. Accelerometer Data.  See section 5.5.1 for procedures with regard to accelerometers.  
 
5.8. Outcomes.  All outcomes will be assessed using widely used, standardized measures.  They are 
described below. 
 
5.8.1. Primary Outcomes. The Brief Pain Inventory (BPI) (123) will assess pain intensity. The 4-item 
pain intensity subscale assesses current, worst, least, and average pain. The subscale uses a numerical 
rating scale with 0 representing ‘no pain or does not interfere’ and 10 representing ‘pain as bad as you 
can imagine or completely interferes.’ Scores greater than or equal to 5 indicate moderate to severe pain 
intensity and interference. The BPI has proven both reliable (Cronbach’s alpha > 0.80) and valid (highly 
correlated with well-validated generic measures of pain and general health and condition specific 
disability) in both surgical patients and patients with chronic low back pain (124-126). The minimum 
clinically important difference (MCID) for pain has been found to range from 1.2 to 2.1 points in 
patients following lumbar spine surgery (127). The 10-item Oswestry Disability Index (ODI) (128) is a 
standard measure of condition specific disability that assesses the impact of lumbar spinal disorders on 
daily living, with questions about pain intensity, lifting, sitting, standing, walking, sleeping, hygiene, 
traveling, social life, and sex life. Ratings for each item are from 0 (high functioning) to 5 (low 
functioning). Total scores are divided by the total possible score and multiplied by 100 to create a 
percentage of disability. The ODI has demonstrated strong test-retest reliability (Pearson’s r > 0.80) and 
validity, and good internal consistency (Cronbach’s alpha > 0.70) in both surgical spine patients and 
patients with chronic low back pain (129-130). The MCID has been found to range from 8.2 to 12.8 
points in patients following lumbar spine surgery (127,131). General physical and mental health will be 
measured with the physical and mental composite scales of the SF-12 (132). The physical component 
scale (PCS) assesses the four subdomains of physical functioning, role-physical, bodily pain, and 
general health and the mental component scale (MCS) assesses the 4 subdomains of vitality, social 

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functioning, role-emotional, and mental health. Total subscale scores range from 0 to 100, with 100 
indicating the highest level of health. The PCS and MCS of the SF-12 have demonstrated 
responsiveness, good test–retest reliability, good internal consistency, and validity with correlations 
greater than 0.90 with the SF-36 in generalized and various patient populations (132-134). The minimal 
clinically significant change for the PCS and MCS has been estimated at 10% (134). 
 
5.8.2. Secondary Outcome. Physical activity will be measured objectively using a commercially 
available movement accelerometer (ActiGraph GT3X+), a small triaxial accelerometer (46 mm × 33 mm 
× 15 mm) that weighs approximately 19 grams (135). The water resistant device assesses acceleration in 
three individual orthogonal planes using a vertical axis, horizontal axis and a perpendicular axis. 
Accelerometers are used in physical activity monitoring because of their small size, low cost, 
convenience, the ability to record data for several days (136), and ability to assess multiple dimensions 
of physical activity (e.g., total activity, time spent in different levels of intensity and predicted energy 
expenditure) (137-139). Accelerometers have proven valid with moderate correlations with the criterion 
method of doubly labeled water for total and active energy expenditure in young and older adults 
(140,141). For the purpose of this study, the monitor will be initialized to record three-dimensional 
accelerations raw signal at 40 Hz. Physical activity will be assessed using total volume of physical 
activity, expressed as the mean counts per minute over the duration of accelerometer monitoring. In 
addition, percentage of time spent in commonly used domains of physical activity intensity (sedentary, 
light, moderate, and vigorous) will be considered.  
 
Chair Stand test from the Short Physical Performance Battery (SPPB) from the Established 
Populations for the Epidemiologic Study of the Elderly studies will be used to assess strength (142). The 
Chair Stand test has demonstrated good to excellent test-retest reliability, good internal consistency 
(Cronbach’s alpha > 0.70), and predictive validity in analyses showing risk for mortality and disability 
(143,144). The 10-Meter Walk (146) test will measure self-selected walking speed. Ambulatory support 
devices may include canes, crutches, or walkers and will be recorded. The time it takes for subjects to 
complete the task is measured with a stop watch and recorded as meters per second (m/sec). Excellent 
inter-rater and intra-rater reliability (ICC > .90) and good test-retest reliability for self-paced timed 
walking speed tests using a stopwatch have been reported (146). Validity for walking speed tests has 
been determined by significant correlations with self-report measures of function and mortality in older 
adults (146,147). The MCID for the 10-meter walk test at a comfortable pace has been estimated to be 
0.16 meter/second and a meaningful change in older adults has been documented at 0.10 meter/second 
(148). The Timed Up and Go (TUG) test will be used to assess functional mobility (149). Time less than 
10 seconds indicates functional independence and more than 30 seconds demonstrates functional 
dependence. The TUG has been shown to have excellent test-retest reliability (149,150) and be a valid 
and responsive performance measure in older individuals (151). The MCID for the TUG has been 
reported as a reduction in time ranging from 1.2 to 2.3 seconds in older adults with pain (152). 
 
5.8.3. Intermediary Outcomes. The Tampa Scale for Kinesiophobia (TSK) (153) will be used to 
measure fear of movement. Participants are asked to rate each item on a 4-point Likert scale with 
scoring alternatives ranging from ‘strongly disagree’ to ‘strongly agree.’ The MCID for the TSK has 
been reported to be 4 points in patients with back pain (154). The TSK has been found to have good 
internal consistency (Cronbach’s alpha > 0.70) and test-retest reliability (Pearson’s r > 0.70) in surgical 
patients and patients with various musculoskeletal conditions (155,156). The 10-item Pain Self-Efficacy 
Questionnaire (PSEQ) (157) will measures the strength and generality of a person’s belief in his/her 

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ability to accomplish a range of activities despite pain. Participants rate how confident they are on a 7-
point scale from ‘not at all confident’ to ‘completely confident.’ Scores range from 0 to 60, with a score 
greater than 40 indicating high pain self-efficacy (158). The PSEQ has been found to have excellent 
internal consistency (Cronbach’s alpha > 0.90), good test-retest reliability (Pearson’s r > 0.70), and 
construct validity through correlations with depression, anxiety, coping strategies, pain ratings, and 
work-related tasks in patients with chronic pain (158).   
 
5.9 Other Outcomes. At each clinic and study visit, the treating surgeon and/or research personnel will 
record the type and frequency of pain medication use. Data on number of re-hospitalizations (including 
length of stay) and number and type of surgeries (e.g., revision spine surgery) following initial spine 
surgery will also be collected from medical and billing records at each site and through patient self-
report. 
 
5.10. Safety Issues.  Safety issues can be divided into (i) safety concerns related to the therapeutic 
interventions and (ii) concerns related to patient privacy.  
 
5.10.1. Safety Concerns Related to the Therapeutic Treatments. There are no potential adverse 
effects specific to the participation in cognitive and behavioral therapy and self-management 
interventions. There is the potential for physical discomfort (increased pain and reduced activity level) 
and falls due to participating in the physical performance tests. There may also be distress related to 
answering questions and discussing mood and pain beliefs. 
 
5.10.2. Safety Issues Related to Patient Privacy. It is the investigator’s responsibility to conduct the 
protocol under the current version of Declaration of Helsinki, Good Clinical Practice, and rules of local 
IRBs. The investigators must ensure that the patient’s anonymity be maintained in their data submission 
to the coordinating center (Vanderbilt). Patients will only be identified by an identification code and not 
by their name, SSN, or hospital medical record number. Study Site Investigators will maintain a separate 
confidential enrollment log which matches identifying codes with the patients’ names and addresses 
(i.e., available only to local clinic staff). All study material will be maintained in strict confidence. 
 
5.11. Retention.  The study participants will receive an honorarium in recognition of their time and 
effort. Twenty patients will be compensated $25 for participating in an interview and 32 patients will 
receive $50 for completing a focus group session and $100 (max) for travel reimbursement to 
Vanderbilt. 10 patients will be compensated $25 for participating in a cognitive interview and $100 
(max) for travel reimbursement to Vanderbilt. For the trial, a $25 payment will be given for completing 
the baseline assessments at a standard postoperative clinic visit (6 weeks following surgery) and a $25 
payment for each follow-up assessment (6 and12 month time points). A $50 payment will be given for 
each complete accelerometer assessment (i.e., 4 days of data). For the 12-month on-site visit, 
participants will be reimbursed $100 (max) for travel reimbursement. Treatment group participants will 
also be compensated $50 for the 6-session program to reimburse for phone expenses. We will also keep 
participants engaged through distribution of follow-up reminder letters and phone calls.  
  
5.12. Management of Concomitant Conditions.  Concomitant conditions will be managed with the 
standards of care at the local treatment facility and should not be affected by study participation. 
 

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5.13. Adverse Event Reporting.  The CBPT trial will monitor and report adverse events to ensure 
patient safety. Definitions and procedures for reporting adverse events are designed to satisfy 45 CFR 
Part 46, Subpart A; the “Common Rule”, shared by 17 Departments and Agencies  as well as 21 CFR 
312, the FDA regulation for adverse events.  The Common Rule requires written procedures and policies 
for ensuring reporting of “unanticipated problems” involving risks to participants to IRBs, appropriate 
institutional officials, and the Department or Agency Head.  
 
5.13.1. Definitions. We will use the following definitions in identifying adverse events.  
 
• Adverse event. An adverse event is any untoward medical occurrence that may present itself during 
treatment or administration with clinical procedure and which may or may not have a causal 
relationship with the treatment. Adverse events include any unanticipated problems involving risks 
to participants, or breaches of protocol which might entail risk to participants. The term 
"unanticipated problem" includes both new risks and increased rates of anticipated problems. 
 
• Serious adverse event. A serious adverse event (SAE) is an adverse event occurring at any time 
during the study that results in death, inpatient hospitalization or prolongation of existing 
hospitalization, or a persistent or significant disability/incapacity. Other events may also be 
considered an SAE if, based on medical judgment, the event jeopardized the patient to the point of 
requiring medical or surgical intervention to prevent the occurrence of any of the conditions for an 
SAE listed above. 
 
• Unexpected adverse event. An unexpected adverse event is any adverse event with specificity or 
severity that is not consistent with the risk information in the study protocol. 
 
• Associated with the use of the treatment means that there is a reasonable possibility that the 
adverse experience may have been caused by the treatment. 
 
5.13.2. Monitoring and Reporting Adverse Events. Adverse events will be recorded on study data 
forms whether or not they are thought to be associated with the study or with one of the study 
treatments. Adverse events may be discovered during regularly scheduled visits or through unscheduled 
patient contacts between visits. Adverse events will be monitored both as secondary outcomes of the 
study (i.e., falls during the physical function tests) as well as adverse events that are not outcomes per se 
of the study.   
 
At the first study team meeting, investigators will review definition of all outcomes, adverse events and 
serious adverse events and revisions to the protocol will be made as appropriate. Summary data on 
adverse events (together with study outcomes) will be monitored by the medical monitor at semiannual 
meetings or more frequently, as needed. These summaries will include analyses comparing rates of 
adverse events by blinded treatment group, by clinic, or in other subgroups requested by the medical 
monitor. Where applicable, signs and symptoms associated with the adverse event will be graded as to 
severity by the clinical site staff as mild, moderate, or severe using the Common Terminology Criteria 
for Adverse Events. 
 

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After each review, the medical monitor will issue a written summary of its review of the study data, 
including adverse events, for transmission to the IRBs at each of the study centers. Analyses or listings 
of adverse events will not be provided to the IRBs; however, adverse events involving unanticipated 
problems involving risks to participants, or breaches of protocol which might entail risk to participants 
must be reported to local IRBs as soon as possible after they are discovered. Each participating center is 
responsible for ensuring that all local IRB requirements for reporting adverse events are met. 
 
5.13.3. Reporting Serious Adverse Events. Serious adverse events (SAE) must be reported upon 
discovery at the clinical center. This will involve completing an SAE CRF describing the severity and 
details of the event. The SAE form, together with a memo summarizing the circumstances of the event 
and the current status of the patient, must be faxed to the coordinating center (Vanderbilt) within one 
working day of the discovery of the SAE. Also, within one day, the clinical center must notify the 
coordinating center (Vanderbilt) of the SAE by telephone or confirmed e-mail. The coordinating center 
(Vanderbilt) will transmit the SAE form to the medical monitor. If the SAE occurs at the coordinating 
center (Vanderbilt), the coordinating center will transmit the SAE form and memo to the other study 
center. The medical monitor will review each SAE report and provide comments to the PCORI project 
officer within one week of receipt of the report.  
 
6. 
Statistical Design and Analysis  
 
6.1. Study Aims and Hypotheses  
 
 
Specific Aim 1: To determine the most important treatment outcomes to older adults undergoing 
 
lumbar spine surgery for degenerative conditions. 
 
 Hypothesis 1: The most important outcomes to older adults undergoing lumbar spine surgery 
 will include pain, physical functioning, and general health. 
 
Specific Aim 2: To compare whether a CBPT program or an education program are more effective 
in reducing disability and pain and improving general health, physical activity, and physical 
function following lumbar spine surgery for degenerative conditions. 
 
 
Hypothesis 2: CBPT participants compared to education participants will demonstrate 
significantly greater improvement in disability (Oswestry Disability Index), pain (Brief Pain 
Inventory), general health (12-item Short Form) and physical activity (movement 
accelerometers) at 6 and 12 months following lumbar spine surgery and physical function as 
measured by standardized performance tests of strength, gait speed, and mobility (Chair Stand, 
10-Meter Walk, Timed Up and Go) at 12 month follow-up. 
 
Specific Aim 3: To determine how the CBPT treatment improves outcomes in patients following 
lumbar spine surgery for degenerative conditions.  
 
Hypothesis 3: Participants reporting decreases in fear-of movement and increases in pain self-
efficacy will demonstrate improvement in outcomes following the CBPT program at 6 and 12 
months following lumbar spine surgery. 

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Specific Aim 4: To determine which sub-groups of adults are most likely to benefit from the CBPT 
program following lumbar spine surgery for degenerative conditions.  
 
Hypothesis 4: CBPT participants that are 60 years or older, have a fusion procedure, and report 
clinically significant depressive symptoms preoperatively will demonstrate greater improvement 
in outcomes at 6 and 12 months following lumbar spine surgery. 
 
6.2. Outcome Measures.  The outcomes are defined above in Section 5.9.  They are summarized below: 
 
Primary Outcome Measure: 
• Self-reported disability (Oswestry Disability Index) 
• Self-reported pain (Brief Pain Inventory) 
• Self-reported general health (SF-12) 
 
Secondary Outcome Measure: 
• Physical Activity (Movement accelerometer: total daily amount of physical activity) 
• Physical Function (Chair Stand, 10-Meter Walk, Timed Up and Go) 
 
Other Outcomes:  
• Use of pain medication  
• Re-hospitalization following initial spine surgery (number and length of stay) 
• Surgeries following initial spine surgery (number and type) 
 
6.3. Statistical analysis  
 
6.3.1. Specific Aim 1. Patient Interviews. All patient interviews will be audio-recorded and transcribed 
by the Qualitative Research Core using a commercial transcription service (www.rev.com). Qualitative 
analysis will occur in three interrelated phases: 1) individual quotes will be isolated in the interview 
transcripts; 2) a hierarchical coding system will be developed to organize the quotations in relationship 
to the study questions and to capture the full range and depth of participant response; and 3) the 
structure, frequency, and interrelationships of the coded quotes will be used to develop an integrative 
model of how patients understand and value the outcomes of surgery. We will use a coding system from 
our preliminary focus groups with neurosurgical back pain patients as the starting point for this work. 
The analysis will begin by looking at simple frequencies of codes and proceed towards a theoretical 
framework. The process will include both inductive analysis (theory to fact) and deductive analysis (fact 
to theory). The resulting framework will be communicated using diagrammatic models supported by a 
narrative text. The text will incorporate direct quotations from patients to illustrate and communicate 
important constructs and relationships. Management of transcripts, quotations, and codes will be done 
using a local instance of open source qualitative data analysis software (http://cat.ucsur.pitt.edu/ 
default.aspx). The resulting models and narratives will be reviewed by investigators and stakeholders 
and revised based on their feedback.  
       Focus Groups. All focus groups will be audio-recorded and transcribed and qualitative analysis of 
the focus groups will concentrate on generating items that can be used to measure outcomes. The 
interviews will have identified the major categories of symptoms/outcomes that patient’s value and the 

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focus groups will allow us to better understand how these outcomes vary over time and as a function of 
context. Quotes will be used to generate a pool of measurement items, and an inductive/deductive 
approach similar to that employed for the interviews will be used to group the items into categories. 
Further analysis will be used to eliminate redundancies and improve item wording until an item pool has 
been generated. The generated list of items will be reviewed by the investigators and stakeholders by 
making adjustments to categories, placement of items within categories, and specific wording of items. 
If qualitative data identify additional patient-reported outcomes that were not projected, the investigators 
will make every effort to identify previously validated and reliable “off-the-shelf” scales to assess these 
domains. 
Pilot Testing and Cognitive Interviews. Pilot testing will be used to empirically reduce the number 
of items, eliminate items will little or no variance, and check on the internal consistency of item 
categories. In addition, this will provide a very preliminary check on construct validity. Items that lack 
face validity or are not well-understood will be changed or removed. Finally, if respondent burden is too 
great in the opinion of the pilot patients, the survey will be appropriately shortened, while not 
compromising our ability to achieve our specific aims. The cognitive interviews will be recorded and 
transcribed and used to further refine the outcome tool. We expect some items will be dropped and 
others reworded for greater clarity. Our goal is to create a tool kit that is short enough so that it will not 
create an undue burden on patients, yet detailed enough to capture a more nuanced view of outcomes as 
we understand them from the qualitative work. We will also assess reading level of items and edit 
accordingly to ensure they are accessible to older adults with lower levels of education. The final 
patient-centered outcomes and measures will be reviewed by the investigators and stakeholders prior to 
implementation during Phase 2 of the study. 
 
6.3.2. Specific Aim 2. The data will be explored numerically and graphically. Group means and 
corresponding confidence intervals will be calculated for baseline variables, to confirm balance between 
groups. The characteristics of the patients who are lost to follow-up will be compared to those who 
complete the follow-up assessments. For each outcome variable, we will fit a multivariable regression 
model, with site as a covariate. We will explore possible non-linear (quadratic, cubic) effects of the 
treatment over time. We plan on adjusting for the baseline measurement of the outcome variable, age, 
type of surgery, site, and depressive symptoms. A random slope over time may be included to allow a 
separate slope to be estimated for each patient. The primary analysis will be intent-to-treat; missing 
observations due to drop-out and other reasons not related to the treatments will be handled with 
multiple imputation methodology. Our use of Bayesian estimation procedures will allow us to easily 
impute missing data within our models. In most cases, this will allow us to use data with some missing 
values, and avoid the information loss that is inherent in complete case analysis. Where it is unlikely that 
values are missing at random, we will include an imputation sub-model that uses available covariates to 
account for plausible patterns of non-random missingness. Though it is not possible to demonstrate that 
data are missing at random, including as many predictor variables in the imputation model as possible 
generally increases the chances that the missing at random assumption (conditional on the covariate 
values) is reasonable (159). To quantify the effect of the number of sessions completed by study 
participants on outcomes of interest (i.e., dose-response), we intend to explicitly model the response 
following session j for subject i in the following linear model: 
 
where the function I is an indicator for j sessions completed, and yij - yi0 is the change in response after 
session j from baseline (session 0). This model can be generalized to account for a non-linear response 
to dose.  

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Accelerometer Analysis. Raw data form the accelerometer will be pre-processed using ActiLife 
v6.4 software, and integrated into 60-second and 10-second epochs for assessing wear/non-wear 
intervals and time spent in various physical activity intensities, respectively. Non-wear will be defined 
as at least 60-minute intervals of “zero” activity counts with 2-min incidental wear intervals allowed. 
Wear intervals lasting less than 30 minutes will be classified as non-wearing. Total daily wear time will 
be calculated by subtracting non-wear time from 24 hours. Primary analyses will use total volume of 
physical activity, expressed as the mean counts per minute over the duration of accelerometer 
monitoring. Secondary analyses will use percentage of time spent in commonly used domains of 
physical activity intensity (sedentary, light, moderate, and vigorous). 
 
6.3.3. Specific Aim 3. Separate regression models will be used to explore associations between changes 
in fear of movement and pain self-efficacy and changes in pain, disability, general health, and physical 
activity from baseline to 6 and 12 months after surgery for the entire sample. We will construct a 
mediation model that estimates the effect of the mediation by changes in fear of movement and in pain 
self-efficacy on outcomes as the result of surgery. This comprises 3 sub-models that relate (1) the 
treatment to health outcomes directly, (2) the treatment to fear of movement and pain self-efficacy and 
(3) both the treatment and fear of movement and pain self-efficacy to health outcomes simultaneously. 
This will demonstrate any mediation effect, if present, by seeing how the relationship between treatment 
and outcomes changes when the potential mediators are added or removed. 
 
6.3.4. Specific Aim 4. Regression models will be used to explore the interaction between patient 
characteristics and treatment for each outcome in the entire sample. Important sub-groups will be 
identified based on the strength of association between the response to treatment (change in outcomes) 
and each covariate included in the model (i.e., patient age, type of surgery, depressive symptoms). To 
illustrate, consider the simplified model with just one covariate:  
 
where xi is some covariate of interest from the list above. 
β1, β2 and β3 are parameters for the treatment, covariate and treatment-by-covariate interaction, 
respectively. Sub-groups that show a stronger response to treatment will have relatively large, negative 
interaction parameter values, indicating that they would reduce the outcome score beyond treatment in 
the absence of the covariate. 
 
6.4. Missing data.  Missing data are a serious concern that complicates the interpretation of the study 
results.  We will address this issue from both a trial conduct and analysis perspective.  Regarding trial 
conduct, we will 
 
1. Limit participant burden and inconvenience in data collection 
2. Provide compensation for participation and completion in the study 
3. Select high quality investigators 
4. Provide pre-study training of investigators as well as on-study reinforcement 
5. Monitor and report missing data rates during the trial 
6. Emphasize the importance of full participation in the trial during the consent process 
7. Collect information on the reasons for missing data 
8. Actively engage participants in the study and educate them about the importance of their 
engagement 

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9. Collect surrogate information on participants who miss clinic visits 
10. Hold regular CBPT meetings to discuss strategies for enrollment and engagement of 
participation 
11. Set targets for acceptable rates of missing data  
 
While these efforts will help to minimize missing data, we recognize that missing data are inevitable.  
 
Our use of Bayesian estimation procedures will allow us to easily impute missing data within our 
models. In most cases, this will allow us to use data with some missing values, and avoid the 
information loss that is inherent in complete case analysis. Where it is unlikely that values are missing at 
random, we will include an imputation sub-model that uses available covariates to account for plausible 
patterns of non-random missingness. Though it is not possible to demonstrate that data are missing at 
random, including as many predictor variables in the imputation model as possible generally increases 
the chances that the missing at random assumption (conditional on the covariate values) is reasonable. 
 
6.5. Justification of Sample Size in the Randomized Trial.  We estimated power for the study, based 
on a target of 110 patients per arm with complete follow-up data at 12 months. Power was estimated by 
generating simulated data, then using the simulated data to try to estimate the original model parameters. 
We are interested in determining whether the model can estimate the effects of the treatment with 
adequate precision. We used a simplified model of treatment effect, a fixed effect model that describes 
the difference between measurements at the baseline y(0) and after treatment y(1): 
 
where ϵi ~ N(0,σ2) is the residual for individual i, and I is the indicator function, here evaluating to 1 if 
the individual is in the treatment group and 0 otherwise. Thus, β describes the effect of the treatment, 
and µ the expected change in the absence of treatment. For Aim 4, power was measured with respect to 
the ability to distinguish a non-zero effect of the subgroup-treatment interaction effect (β3). 
We generated 200 simulated datasets by resampling available pilot data from a currently funded 
R21 project (1R21AR062880-01). Control subjects were resampled from control individuals in the pilot 
data, and treatment subjects were also resampled from control individuals, but with the target effect size 
added to the sampled values. Power was estimated by fitting Bayesian models to each of the simulated 
datasets for each response variable and recording the proportion of calculated 95% credible intervals 
(BCI) for β that excluded zero.  
 
6.6. Interim analysis.  A medical monitor is responsible for monitoring the accumulated interim data as 
the trial progresses to ensure patient safety and to review efficacy. During the first year of the study, 
involvement of the monitor will occur prior to randomizing the first patient. A conference call will be 
conducted to review study procedures and the monitoring of adverse events to ensure that a 
comprehensive safety monitoring plan is in place 
 
After the trial commences, the medical monitor will review data or other issues twice a year. The 
monitor may request more frequent meetings if necessary. He may also request additional safety reports 
on a more frequent basis. For example, all serious adverse events (SAE) are reported to the medical 
monitor for consideration and recommendations as they occur. The medical monitor will review semi-
annual reports by masked treatment groups of the primary and secondary outcomes as well as all adverse 
events that are not identified as outcomes per se. 

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The medical monitor also reviews the overall progress of the trial in terms of recruitment and data 
quality and makes a formal recommendation to the Primary Investigator at the end of each scheduled 
meeting as to whether the trial should continue unmodified, continue with protocol modifications, or be 
stopped.  
 
7. 
Human Subjects Issues  
 
7.1. Overview.  The study protocol, questionnaires, consent forms, and brochures will be submitted to 
each participating center’s IRB. Sites that recruit patients will submit their recruitment materials to their 
IRB prior to use. A site may not initiate any patient contact about the CBPT trial until the site has IRB 
approval for the trial. All study personnel must complete training in the Protection of Human Subjects. 
The proposed study anticipates recruiting a significant proportion of racial/ethnic minorities (African-
Americans, Asian-Americans and Hispanics) as well as non-Hispanic white subjects. 
 
7.2. Institutional Review board (IRB) Approval.  A site may not initiate patient activities in the CBPT 
trial until the site has IRB approval for the trial. Consent forms must have IRB approval. Sites must 
provide the coordinating center (Vanderbilt) with a copy of the initial IRB approval notice and 
subsequent renewals as well as copies of the IRB approved consent statements. 
 
7.3. Human Subjects Involvement, Characteristics, and Design.  The proposed study includes 
community-dwelling adults who are having surgical treatment of a lumbar degenerative condition 
(spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using 
laminectomy with or without arthrodesis (i.e., fusion) procedures. Eligible and consenting participants 
will return for a 6 week postoperative clinic baseline visit. At this postoperative visit, all participants 
will complete a baseline assessment and will then be randomized to one of the 2 study groups (CBPT vs. 
education). Based on preliminary data, the study population will be on average 59 years of age, 59% 
female, and 84% White. All human subjects training and assessment will require approval from the 
Vanderbilt and Johns Hopkins Institutional Review Board (IRB), and all human subjects’ involvement 
will utilize informed consent documentation.  
 
7.4. Sources of Materials.  All materials will be collected and recorded for research purposes. The 
socio-demographic, clinical, and outcomes information collected during this investigation will be 
obtained from multiple sources, including subjects directly, medical records, and hospital databases. 
These data will be entered directly into REDCap (a secure, web-based application) when possible or 
recorded on case report forms and then transferred to REDCap when necessary (e.g., performance-based 
physical function test results). All data will be secured by password-only access for the purpose of 
confidentiality. The surgery and clinic notes will also be used to collect data. Outcomes data will be 
derived from questionnaires completed both in the clinic and at home and activity monitors, and through 
interactions between the patient and research personnel during physical performance tests. Study 
personnel collecting the outcome data will be unaware of the patient treatment condition.  
 
7.5. Potential Risks.  The risk to human subjects of participation in this study is minimal due to the 
nature of this behavioral treatment. The possibility exists that a subject may experience a degree of 
emotional discomfort related to learning about and managing elevated fear of movement beliefs and 

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28 
depressive symptoms and completing questions on depressive symptoms and general physical and 
mental health. We will anticipate and respond by providing subjects with information about their 
questionnaire results and discuss with them any issues or concerns raised by the testing. Research 
personnel and study physical therapists will have a list of referral sources available for individuals who 
request or are in need of further counseling or support. In addition, research staff will review assessment 
forms immediately upon completion and if an individual reports severe depression, suicidal ideation or 
other medical/ psychological problem requiring attention the staff will contact the referring surgeon and 
arrange for appropriate referral. Physical risks encountered during participation in this study may occur 
during the performance-based tests, such as an increase in pain symptoms, a decrease in short-term 
activity level, or a fall. However, research personnel will closely monitor patients during these tests and 
stop testing if an excessive increase in symptoms or problems with balance is noted. There is a small 
risk of breach of confidentiality, but the data for this study will be secured in a password protected 
database. Access to this database will be limited to the investigators and study staff. Data will be 
deidentified for data analysis and interpretation.  
 
7.6. Recruitment and Informed Consent.  Prototype consent will be prepared for the CBPT trial. 
Individual sites may add material but may not delete material thought to be necessary for informed 
consent. Clinical sites may reformat and reword information to conform to their local requirements. 
Before approaching patients for enrollment prior to surgery, discussions will be conducted with patients’ 
surgeons to obtain permission. The surgeon and clinical staff will be fully informed of the nature of the 
study and any risks and benefits. The research coordinator will approach the patient after the 
preoperative clinic visit or a preoperative education class. The coordinator will meet with the patient, as 
well as family members, and will describe the proposed study protocol using a scripted dialogue and 
materials developed for the CBPT study. It will be emphasized to all study participants and family 
members that the data collected will be for research purposes and that refusal to participate in the 
investigation will have no effect on the patient’s routine treatment. The person obtaining consent will 
inform the patient that there is no obligation to participate in the study, and will provide her name and 
phone number where she can be reached if they have further questions or wish to withdraw from the 
study at any time. The person obtaining the consent will also provide the patient with a written copy of 
the consent forms and provide ample time for the patient and family to have questions answered prior to 
enrollment. Copies of the signed consent forms will be given to the patient, and this fact will be 
documented in the patient’s record. 
 
7.7. Protections Against Risk.  Under the auspices of the participating center’s Institutional Review 
Board, all participants will be protected by the project’s staff strict adherence to study protocols 
governing participant safety, data privacy, informed consent, withdrawal from the study without 
prejudice, and immediate reporting directly to the site PI and the IRB of any adverse events involving 
the participants. Data obtained with subject identifiers will be kept in locked file cabinets to ensure 
confidentiality, and all paper file contents will be shredded before disposal. All subjects will be assigned 
a unique study number for use in the REDcap database and all electronic data will be kept in password-
protected computer files to ensure confidentiality. Participants will continue to have access to their usual 
sources of medical care throughout the study. These measures will provide a very high level of 
protection against risk to the participants.   
 

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Time and patient inconvenience have been considered in the study design. We have worked over the 
past year to construct a streamlined testing battery to minimize respondent burden by selecting the least 
time-intensive and cumbersome measures available given our study aims and scientific standards and by 
adapting our battery in accordance with patient feedback and tolerability (e.g., eliminating or replacing 
measures proven to be cumbersome). Patients will also be reimbursed for their time and travel according 
to standard rates used in other studies. Although potential risk is minimal in the context of this study, we 
have carefully powered the study to include only the number of patients needed to adequately address 
our Aims, further minimizing unnecessary inconvenience and risk. 
 
7.8. Potential Benefits of the Proposed Research to Human Subjects and Others.  All participants 
will gain additional assistance in managing their pain and disability and we anticipate that patients in the 
CBPT group will report greater improvements in pain, disability, and function related to learning 
cognitive-behavioral and self-management strategies. There may also be a potential benefit derived from 
being enrolled in an investigation and having additional patient assessments. Such additional 
assessments may detect unrecognized clinical and health issues, which could be of benefit to patients’ 
outcomes. Finally, participants may derive a great deal of personal comfort in knowing that their 
psychological distress and negative pain-related beliefs are part of the surgical recovery process. Thus, a 
potential benefit may be a reduction in stress and anxiety over recovery. The potential for direct patient 
benefit outweighs any minimal risk of harm to the participants.  
 
7.9. Importance of the Knowledge to be Gained.  The proposed study is intended to provide new 
knowledge about the processes and outcomes of a novel approach to providing health care to a surgical 
population. Such knowledge is important because the population of surgical spine patients is growing 
rapidly, the current treatment regimen appears insufficient based on outcome variability, and there are 
few other promising therapeutics alternatives for dealing with postoperative recovery. There is also a 
very real possibility of advancing our knowledge of the utility and efficacy of cognitive-behavioral 
based physical therapy treatment and of telephone delivery of rehabilitation for persons at-risk for poor 
surgical outcomes as it relates to clinical outcomes with resultant improvements in persistent pain and 
disability, and daily functioning. The potential importance of this knowledge outweighs the minimal risk 
of harm to the participants. 
 
7.10. Patient Confidentiality.  All study forms, reports, and other records that are part of the study data 
collection materials will be identified by coded number to maintain patient confidentiality. All paper, 
records will be kept in locked file cabinets. All electronic records of study data will be identified by 
coded number. Clinical information will not be released without written permission of the patient, 
except as necessary for monitoring by the IRB, PCORI, or medical monitor. Consent procedures and 
forms, and the communication, transmission and storage of patient data will comply with individual site 
IRB and PCORI requirements for compliance with The Health Insurance Portability and Accountability 
Act (HIPPA). 
 

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91. Hay E, Lewis M, Vohara K, Main CJ, Watson P, Dziedzic KS, Sim J, Minns Lowe C, Croft PR. 
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103. Aalto TJ, Malmivaara A, Kovacs F, Herno A, Alen M, Salmi L, Kröger H, Andrade J, Jiménez R, 
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104. Mannion AF, Elfering A. Predictors of surgical outcome and their assessment. Eur Spine J. 
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105. DeBerard MS, Masters KS, Colledge AL, Schleusener RL, Schlegel JD. Outcomes of posterolateral 
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108. Block AR, Ohnmeiss DD, Guyer RD, Rashbaum RF, Hochschuler SH. The use of presurgical 
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110. Perednia DA, Allen A. Telemedicine technology and clinical applications. JAMA. 1995;273:483-5. 
 
111. Balas EA, Jaffrey F, Kuperman GJ, Boren SA, Brown GD, Pinciroli F, Mitchell JA. Electronic 
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114. Ashworth NL, Chad KE, Harrison EL, Reeder BA, Marshall SC. Home versus center based 
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115. Turner JA, Mancl L, Aaron LA. Brief cognitive-behavioral therapy for temporamandibular disorder 
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116. Lorig K. Action planning: a call to action. J Am Board Fam Med. 2006;19:324-5.  
 
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118. Syrjala KL. Relaxation and imagery techniques. In: Loeser JD, editor. Bonica’s management of 
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119. Bernstein DA, Borkovec TD, Hazlett-Stevens H. New directions in progressive relaxation training. 
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120.  Scobbie L, Wyke S. Identifying and applying psychological theory to setting and achieving 
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121. D’Zurilla TJ, Goldfried MR. Problem solving and behavior modification J Abnormal Psychol. 
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123. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med 
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124. Zalon ML. Comparison of pain measures in surgical patients. J Nurs Meas. 1999;7:135-52. 
 
125. Keller S, Bann C, Dodd S, Schein J, Mendoza TR, Cleeland C. Validity of the Brief Pain Inventory 
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126. Mendoza TR, Chen C, Brugger A, Hubbard R, Snabes M, Palmer SN, Zhang Q, Cleeland C. The 
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127. Parker SL, Adogwa O, Paul AR, Anderson WN, Aaronson O, Cheng JS, McGirt MJ. Utility of 
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128. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine. 2000;25:2940-52. 
 
129. Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and 
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130. Pratt RK, Fairbank JC, Virr A. The reliability of the Shuttle Walking Test, the Swiss Spinal 
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131. Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically 
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132. Ware JE, Jr., Kosinski M, Keller SD. A 12 Item Short Form Health Survey: Construction of scales 
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133. Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form 
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135. Chen K, Bassett D. The technology of accelerometry-based activity monitors: current and future. 
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137. Vanhelst J, Mikulovic J, Bui-Xuan G, Dieu O, Blondeau T, Fardy P. Comparison of two ActiGraph 
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138. Rothney M, Brychta  R, Chen K, and Buchowski M. Validation of the ActiGraph Two–Regression 
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140. Van Remoortel H, Giavedoni S, Raste Y, Burtin C, Louvaris Z, Gimeno-Santos E, Langer D, 
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141. Strath SJ, Pfeiffer KA, Whitt-Glover MC. Accelerometer use with children, older adults, and adults 
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145. Puthoff ML. Outcome measures in cardiopulmonary physical therapy: short physical performance 
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146. Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed 
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147.  Marks R. Reliability and validity of selfpaced walking time measures for knee osteoarthritis. 
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148. Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in 
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153. Kori SH, Miller RP, Todd DD. Kinesiophobia: A new region of chronic pain behavior. Pain 
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155.French DJ, France CR, Vigneau F, French JA, Evans RT. Fear of movement/(re)injury in chronic 
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159. Gelman A, Hill J. Data Analysis Using Regression and Multilevel/Hierarchical Models. 1st ed. 
Cambridge University Press; 2006. 
 
9. Appendices 
 
9.1. Participating Centers 
 
Vanderbilt University Medical Center (Coordinating Center) 
Johns Hopkins Medical Center 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9.2. Summary of the CBPT Intervention by Session 
 
  
Topics 
All Sessions include: Graded Exposure 
in Vivo; Goal-Setting; Problem-Solving 
Major Content and Activities 
Each session builds upon the content of the 
previous session. Format includes: 1) review of 
previous session personally-tailored activity and 
walking goals and skills homework, 2) problem-
solving barriers to completing goals, 3) introduction 
of new content through discussion and worksheets, 
and 4) review of homework assignment to be 
completed before next session. 
Session 1: Goal Setting 
Introduction; Establish a Graded Activity 
Plan and Fear Hierarchy; Deep 
Breathing 
Review purpose of the program, conduct semi-
structured patient interview, explore gate control 
theory of pain, complete a graded activity plan and 
fear hierarchy, set activity goals based on hierarchy, 
explore walking history and set walking goals, 
introduce deep breathing as pain management 
strategy. 
Session 2: Your Mind and Recovery 
Distraction Techniques; Progressive 
Muscle Relaxation 
Check graded activity practice and activity goals, set 
new activity goals, review walking goals and set 
new goals, problem-solve barriers to completing 
goals, introduce distraction as pain management 
strategy and complete worksheet, introduce 
progressive muscle relaxation CD. 
Session 3: Balance your Thinking 
Identify Negative Thoughts; Positive 
Self-Statements 
Review activity and walking progress and set new 
goals, problem-solve barriers to completing goals, 
introduce event-thoughts-feeling-action handout, 
identify negative thoughts that effect activity using 
worksheet, practice replacing negative thoughts with 
positive self-talk and complete worksheet.  
Session 4: Rest and Activity 
Activity Types; Pacing; Benefits of 
Program 
Review activity and walking progress and set new 
goals, problem-solve barriers to completing goals, 
review activity types handouts, explore pacing 
strategies for pain management and complete 
worksheet, identify benefits of program so far and 
complete worksheet. 
Session 5: Managing Setbacks 
Relapse Prevention Plan 
Review activity and walking progress and set new 
goals, problem-solve barriers to completing goals, 
review relapse cycle handout, complete managing 
setbacks worksheet. 
Session 6: Staying Healthy 
Pain Management Plan; Wrap-up 
Review activity and walking progress, problem-solve 
barriers to completing goals, complete pain 
management plan worksheet, identify benefits of 
program so far and complete worksheet, reinforce 
importance of regular exercise and follow-up visits 
with surgeon and other health care providers. 
 
 
 

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44 
 
9.3. Summary of the Education Intervention by Session 
 
  
Topics 
Major Content and Activities 
Session 1: Physical Therapy  
 
Review purpose of the program, conduct semi-
structured patient interview, describe physical 
therapy, introduce benefits of physical therapy, 
describe different physical therapy techniques, 
and introduce different exercise programs. 
Session 2: Promote Back Healing I 
 
Discuss importance of proper posture and 
transitions, describe proper sleeping positions, 
and introduce ways to promote healing. 
Session 3: Promote Back Healing II 
 
Discuss importance of proper body mechanics, 
describe proper lifting techniques, and describe 
proper ergonomics at home and at work.  
Session 4: Home Exercise 
 
Describe the importance of a home exercise 
program (HEP), discuss the goals of a HEP, 
introduce the components of a HEP, and discuss 
the benefits of a HEP. 
Session 5: Prevent Future Injury 
 
Discuss ways to prevent re-injury, describe 
mechanisms of low back strain, introduce ways to 
manage a low back strain. 
Session 6: Staying Healthy 
 
Describe ways to stay healthy, discuss specific 
benefits of exercise and not smoking, and discuss 
ways to reduce stress, improve sleep, eat 
healthier, and conserve energy. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9.4. Data Collection Schedule   
 
Assessment/Procedure 
Pre-op 
Baseline 
6 month 
12 month 
Patient Consent 
X 
 
 
 
Patient Characteristics  
 
 
 
 
     Age, Gender, Race/Ethnicity 
 
X 
 
 
 
     Marital Status 
X 
 
 
 
     Educational Level 
X 
 
 
 
     Insurance Status 
X 
 
 
 
     Height/Weight 
X 
 
 
 
     Smoking Status 
X 
X 
X 
X 
     Working status 
X 
X 
X 
X 
Medical History/Co-morbidities  
 
 
 
 
     Pain Duration 
X 
 
 
 
     Prior Spinal Surgery 
X 
 
 
 
     Co-morbidities  
X 
X 
X 
X 
     Current medications 
X 
X 
X 
X 
     Intervening Events 
 
X 
X 
X 
 Surgical Characteristics  
 
 
 
 
     Type (fusion/no fusion) 
X 
 
 
 
     Spinal levels 
X 
 
 
 
     Revision (yes/no) 
X 
 
 
 
Psychosocial Characteristics 
 
 
 
 
     Fear of Movement (TSK) 
X 
X 
X 
X 
     Pain Self-Efficacy (PSEQ) 
X 
X 
X 
X 
     Depressive Symptoms (PHQ-9) 
X 
X 
X 
X 
     Expectations of Recovery 
X 
 
 
 
     Satisfaction  
 
X 
X 
X 
 Primary and Secondary Outcomes    
 
 
 
 
     Pain (BPI) 
X 
X 
X 
X 
     Disability (ODI) 
X 
X 
X 
X 
     General Health (SF-12) 
X 
X 
X 
X 
     Chair Stand 
X 
X 
 
X 
     10 Meter Walk 
X 
X 
 
X 
     Functional Mobility (TUG) 
X 
X 
 
X 
     Physical Activity Counts (Accelerometer) 
 
X 
X 
X 
Health Services Utilization 
 
 
 
 
     Physical Therapy Services 
X 
X 
X 
X 
     Narcotic Use 
X 
X 
X 
X 
     Re-hospitalization 
 
X 
X 
X 
     Additional Surgery 
 
X 
X 
X