Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain
Conditions: Low Back Pain
Sponsor: VA Office of Research and Development

Human Subjects Protocol
VA Puget Sound IRB
VA Puget Sound IRB 2
Effective Date:
Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain 
Funding Agency: VA RR&D
Principal Investigator: Pradeep Suri MD MS 
V8.2
6.11.2025
 
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Abstract
Objective:
Low back pain (LBP) is second only to hearing problems as a reason for Veteran disability, and it is the most 
common cause of disability globally. Although general activity is encouraged in the treatment of LBP, there is 
no empirical information available on the specific types of activities that are beneficial or harmful for patients 
seen in primary care for LBP. This study will identify those physical activities with short-term (transient) effects 
on LBP exacerbations (or “flares” of LBP), as well as identifying the long-term (cumulative) effects of such 
activities on functional recovery.
Research Design and Methodology:
The proposed research will use a novel approach to distinguish the short-term effects on LBP of physical 
activities from the long-term effects of such activities, by conducting a longitudinal case-crossover study nested 
within a cohort study. This design accounts for measured and unmeasured confounds by using each case as 
his/her own control- an entirely observational study that is analogous to a crossover experiment- capitalizing on 
modern mobile health and actigraphy technology. The primary exposures of interest are 10 self-reported 
physical activities commonly performed during work and activities of daily living, and actigraphy-assessed 
physical activity. The primary outcomes are participant-reported “flares” of low back pain (Aim 1) and 
participant-reported back-related functional limitations (mobility and activities of daily living [ADLs]) at 1-year 
follow-up, as measured by the Roland-Morris Disability Questionnaire. This observational study will include up 
to 730 Veterans with LBP aged 18 and older recruited from the VA Puget Sound Health Care System 
(VAPSHCS). The study will not affect Veterans’ medical care in any way. After verbal informed consent, 
recruitment, and baseline data collection, study participants will complete frequent, serial electronic “e- 
Questionnaires” using their own personal electronic devices (personal computer [PC], tablet, or smartphone) 
over the 1-year period of follow-up. Participants may also wear ActiGraph units for the 1st 4 weeks of follow-up. 
Long-term outcomes will be assessed by extended e-Questionnaires completed at 1-year follow-up. Aim 1 
analyses will examine the short-term effects of 10 specific activity categories on participant-reported flares 
across all study assessments over 1-year follow-up. Aim 2 analyses will examine associations between the 
frequency of exposure to 10 specific activity categories over weeks 1-4 of follow-up, and long-term functional 
recovery at 12 months as defined by the RMDQ. All analyses will use a biopsychosocial framework accounting 
for potential confounders (sociodemographics, psychological factors, etc.) and effect modifiers, and will include 
sensitivity analyses to examine the robustness of findings and important study assumptions.
Relevance to VA Mission:
This work will provide completely new, foundational information that will support Veterans with LBP in 
navigating the complex process of recovery. It will also help VA clinicians to make recommendations 
regarding return to work and activities for those with LBP. These findings will also inform the development of 
future activity-based educational treatments for optimizing functional recovery for Veterans with LBP.
 
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List of Abbreviations
AE
Adverse Event
CDW
Corporate Data Warehouse
CPRS
Computerized Patient Record System
CSQ
Coping Strategies Questionnaire
DMAP 
EHR
Data Management and Access Plan 
Electronic Health Record
EMR 
ERIC
Electronic Medical Record
Epidemiologic Research and Information Center
FLAReS
Flares of Low Back Pain with Activity Research Study
HIPAA
Health Insurance Portability and Accountability Act
HR 
HSR&D
Human Resources
Health Services Research & Development
ICD
International Classification of Diseases
IRB
Institutional Review Board
IRQ 
JIT
LBP
Initial Review 
Questionnaire Just-In-Time
Low Back Pain
LSRS
NIH
Lumbosacral Radicular Syndrome
National Institutes of Health
NRS
Numerical Rating Scale
OASC 
OR 
PACT
PC
Organizational Assessment Sub-Committee 
Odds Ratio
Patient-Aligned Care Team 
Personal Computer
PCL-C
Post-traumatic Stress disorder Checklist
PCP
Primary Care Provider
PHI
Protected Health Information
PHQ-8
PI
8-Item Patient Health Questionnaire
Principal Investigator
PRAF
PROMIS
Project Revision/Amendment Form
Patient-Reported Outcomes Measurement Information System
PTSD
RMDQ
Post-Traumatic Stress Disorder
Roland-Morris Disability Questionnaire
RR&D
RTW
Rehabilitation Research & Development
Return to Work
SAE
Serious Adverse Event
SISQ
Single Item Stress Questionnaire
SLSS
TSK
Symptomatic Lumbar Spinal Stenosis
Tampa Scale of Kinesiophobia
UAP
Unanticipated Problem
UW
University of Washington
VA
Veterans Affairs
VAPS
VA Puget Sound
VAPSHCS
VA Puget Sound Health Care System
VISTA
Veterans Information Systems and Technology Architecture
 
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Contents
Protocol Title......................................................................................................................................................5
Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain..................................5
1.0
Study Personnel....................................................................................................................................5
2.0
Introduction............................................................................................................................................8
3.0
Objectives............................................................................................................................................10
4.0
Resources and Personnel..................................................................................................................12
5.1 Study Design.............................................................................................................................................12
5.2 Recruitment Methods...........................................................................................................................15
5.3 Informed Consent Procedures............................................................................................................20
5.4 Inclusion/Exclusion Criteria.................................................................................................................22
5.5 Study Evaluations.................................................................................................................................23
5.6 Data Analysis........................................................................................................................................27
5.7 Withdrawal of Subjects........................................................................................................................31
6.0
Reporting..............................................................................................................................................32
7.0
Privacy and Confidentiality.................................................................................................................32
8.0
Communication Plan..........................................................................................................................33
9.0
Information Security and Data Storage/Movement.........................................................................34
10.0
References...........................................................................................................................................35
 
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Protocol Title:
Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain
Lay Title: F  lares
 
  of Low Back Pain with Activities Research Study (‘FLAReS’)
1.0
Study Personnel
Principal
 
  Investigator:
 
  Pradeep
 
  Suri,
 
  MD,
 
  MS
 
  
Staff Physician, VA Puget Sound Health Care System
Rehabilitation Care Services/Seattle Epidemiologic Research and Information Center (ERIC), VA 
Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Professor, Department of Rehabilitation Medicine, University of Washington
Collaborators:
Janna Friedly, MD (at UW, no affiliation with VA Puget Sound Health Care System, no contact with 
participants or study data other than in aggregate form such as published in medical journals, not 
covered under the VA IRB approval. Due to this lack of engagement from a VA human subjects 
perspective, Dr. Friedly is not listed on IRB or R&D documents other than the protocol).
Associate Professor, Department of Rehabilitation Medicine, University of Washington
Mark Jensen, PhD (at UW, no affiliation with VA Puget Sound Health Care System, no contact 
with participants or study data other than in aggregate form such as published in medical journals, 
not covered under the VA IRB approval. Due to this lack of engagement from a VA human subjects 
perspective, Dr. Jensen is not listed on IRB or R&D documents other than the protocol).
Professor, Department of Rehabilitation Medicine, University of Washington
Patrick Heagerty, PhD (at UW, no affiliation with VA Puget Sound Health Care System, no contact 
with participants or study data other than in aggregate form such as published in medical journals, 
not covered under the VA IRB approval. Due to this lack of engagement from a VA human subjects 
perspective, Dr. Heagerty is not listed on IRB or R&D documents other than the protocol).
Professor, Department of Biostatistics, University of Washington
Study
 
  Staff:
 
 
 
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Anna Korpak, PhD
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Andrew Timmons, MS
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Aaron Baraff, MS
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Daniel Morelli, BA
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Chris Forsberg, MS
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Alexandra Fox, MSIS
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Alexander Peterson
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Elaine Hu
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Hazel Scott
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Hannah Brubeck
VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 91808
 
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Clinton Daniels
VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Jason Silver
VA Puget Sound Health Care System, 1660 S. Columbian Way, Seattle, WA, 91808
Mario Trejo
Seattle Epidemiologic Research and Information Center (ERIC), VA Puget Sound Health 
Care System, 1660 S. Columbian Way, Seattle, WA, 91808
 
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2.0
Introduction
Low back pain (LBP) is the #1 cause of disability worldwide and a leading cause among Veterans. The general 
advice to remain active when experiencing acute or chronic LBP is a key part of clinical practice guidelines.
However, existing guidelines provide no specific recommendations about the types of activity (e.g., lifting, 
bending, etc.) that should be engaged in or avoided (“Which?”) or the duration/intensity of such activities 
should they be performed (“How?”). The guidelines therefore do not address a major concern of patients with 
LBP, which is that certain activities may have short-term effects on pain exacerbations or “flares”, or cause 
sustained detrimental effects on pain or function. The distinctions between healthy, benign, and detrimental 
activities are also important to clinicians, who are often called upon to complete “work restriction forms” as part 
of the process of making return-to-work (RTW) decisions. An ideal set of work restrictions for persons with 
LBP would limit only those activities that are likely to cause flares of pain (transient effects) or poor overall 
functional recovery in the longer term (cumulative effects). However, there exist no empirically derived data 
concerning the transient vs. cumulative effects of specific activities during LBP, with which to guide work 
restrictions.
A typical “work restriction form” excerpt from California 
state is shown in Figure 1, listing 10 categories of activities 
relevant to LBP. These activities can occur commonly in 
the workplace, or in other aspects of everyday life. In the 
absence of empirical data, primary care providers’ work 
restrictions mirror their general practice style1,2 or personal 
beliefs1, which may conflict with evidence-based care,3 and 
may limit functional recovery if overly restrictive. Primary 
care providers (PCPs) may feel compelled to choose 
restrictions that avoid conflict with patients.2,4,5 These 
factors combine to create a situation where most PCPs feel 
ill-prepared or conflicted when making work restrictions.6 
Our proposed work will yield objective data regarding 
the risks associated with specific types of activities
during LBP, meeting an important need of both Veteran patients and PCPs.
The expected age range of study participants is 18 years of age and older. We expect the general health 
status of the subject population to be about average for Veterans’ ages. We will not include patients from 
special classes of subjects or vulnerable populations such as pregnant women, children, cognitively impaired 
persons, or prisoners due to possible coercion. We will not otherwise make any exclusions based on gender, 
sex, race, ethnicity, or any minority group designation. VA employees may be enrolled in the study; however, 
if enrolled, they cannot complete assessments on their VA paid time. “Questionnaires” or “e-Questionnaires” 
as
 
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referred to in this Protocol do not fall under the definition of “surveys” as used in the VA Survey Guidance 
document. As such, OASC and local VAPS HR will not be notified if a VA employee enrolls in this study. The 
term “e-Questionnaires” is used in materials related to human subjects approvals, but the term “e-Surveys” is 
used in participant-facing materials, due to the simplicity and brevity of the term “e-Survey”.
3.0
Objectives
Aim
 
  1:
   Estimate the short-term effects (24 hours) of specific physical activities on pain flares in 
Veterans with LBP.
Research question #1: What are the short-term (transient) effects (<24 hours) of specific types of 
physical activities on pain flares in Veterans with LBP?
We will conduct a longitudinal case-crossover study with 1-year follow-up to identify activities that trigger 
flares among up to 730 Veterans of working age (18-65 yrs) seen in VA primary care for LBP. The 
predictors of interest are 10 activity categories relevant to LBP that are commonly included in work 
restriction forms used for RTW determinations. The primary outcome is a validated flare definition 
characterized by pain and functional impact. Analyses will use a biopsychosocial framework accounting 
for key potential confounders and moderators, such as pain characteristics, work-related factors, 
catastrophizing, fear of movement, depression, stress, post-traumatic stress, and analgesic use.
Aim
 
  2:
   Estimate the long-term effects of specific physical activities among Veterans with LBP.
Research question # 2: What are the long-term (cumulative) effects of specific types of physical activities 
on functional recovery at 1-year follow-up?
In analyses of the longitudinal cohort within which the Aim 1 case-crossover study is nested, we will 
examine associations between the frequency of activities for 10 specific activity categories over the first 4 
weeks of follow-up, and long-term LBP-related functional recovery as defined by the Roland-Morris 
Disability Questionnaire (RMDQ) at 1-year follow-up (primary outcome). Analyses will account for a range 
of important potential confounders and moderators, using a biopsychosocial framework, as in Aim 1.
Secondary outcomes will include average pain intensity, lost work productivity, and quality of life, and 
analgesic use at 12 months.
These study aims will produce tables of evidence-based estimates contrasting the short-term risks of 
specific physical activities on LBP flares with the long-term effects on functional recovery. These data will 
then be used to design educational interventions to optimize physical activity, considering both the short- 
and long-term effects of physical activities.
Recruitment
 
  in   additional
 
  populations
 
  (project
 
  modification,
 
  January
 
  2023)
 
 
 
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In December 2022, we obtained sponsor approval from ORD RR&D to expand the target population of 
recruitment (beyond Veterans who have recently been seen in for back pain in VAPSHCS primary care, 
the “original target population”), in order to achieve the original recruitment goal of 440 Veterans who 
complete 1-year follow-up. In the current project modification, we expand recruitment to other Veterans 
with low back pain who have been seen in VAPSHCS (the “expanded target population”), but may not 
have had recent visits for back pain in VAPSHCS primary care. We will not contact individuals who have 
already been contacted once as part of recruitment efforts using the Information Statement (targeted to 
the original target population). The approach and analyses for the main study aims as stated above will 
not change; these main study aims will involve only the study sample recruited from the original target 
population (Veterans seen for low back pain in primary care). However, we will also conduct separate, 
analogous analyses, among Veterans recruited from the expanded target population. For certain 
analyses where exposure-outcome relationships do not differ between samples recruited from the 
original target population vs. the expanded target population, we will conduct secondary analyses 
pooling the two samples.
Overview of the Overall Study Approach
The content of subsequent sections warrants an introduction to the overall approach to the research 
involved. The research as a whole involves two separate but related components: (1) a VA component 
involving all VA recruitment, VA data collection, and all processes involving VA data (addressed by the 
current VA IRB application and referred to as the “VA component”), and (2) a non-VA component 
involving non-VA data collection that occurs entirely outside the VA and does not involve any VA data. 
This means that the current human subjects application and the VA informed consent processes 
described in this application pertain only to the VA component of the research (the VA research 
processes). Separate from the VA component of the research is the non-VA component, which will be 
carried out by researchers at the University of Washington (UW). Participants in the VA component of this 
research will be provided information that they can use to initiate contact, screening, and possible 
enrolment in the non-VA component conducted by UW researchers. The non-VA component of the 
research will run in parallel with the VA research processes, yet involves non-VA
 
  data
 
  collection
 
  only. The 
UW research processes will undergo a separate process of IRB approval at UW, including a separate 
process of informed consent. This non-VA data collection will include all e-Questionnaires described 
above, administered by a private (non-VA) data collection company specializing in secure HIPAA- 
compliant and 21 CFR 11-compliant electronic questionnaire administration (DatStat). DatStat has a 
successful track record for conducting secure electronic questionnaire administration for another current 
UW research study. Acquisition of e-Questionnaire data in this proposed manner- in partnership with UW 
researchers- permits the ability to conduct frequent serial assessments with quasi-randomized timings via 
e-Questionnaires, since at the current time there exist no feasible processes to collect such data as VA 
data using VA devices. At interim time points during the VA component of this study, e-Questionnaire 
data being collected by UW researchers as part of the non-VA component of this study will be 
downloaded by VA research study staff involved with this VA research study, at which time such data will 
become VA data and will not subsequently be shared outside the VA during the study. In summary, no 
VA data produced as part of this VA research study will be shared outside of the VA at any point 
during the conduct of this VA research. However, non-VA data collected by researchers at the UW 
will be shared with this VA research team. Thus, the flow of research data in this VA research study is 
only into the VA, and never out of the VA.
Most aspects of the proposed research as described in this human subjects research application 
pertain to the “VA component” of the study (VA data collection and VA research processes).
However, in order to provide a complete picture of what the study entails for reviewers of this
 
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protocol/application, the protocol also provides information about aspects of data collection occurring as 
part of the non-VA (UW) component of the study. From this point on in the protocol, data collection or 
study processes relevant only to the non-VA (UW) component of the study are provided in blue font such 
as this, to emphasize aspects that are not covered by the VA human subjects review processes (i.e. by 
the VAPSHCS IRB), but will be covered by the UW human subjects review processes (i.e. by the UW 
IRB). In addition, communications with the IRB Director, Information Systems Security Officer, and 
Privacy Officer resulted in the recommendation during the initial IRB approval process that we provide to 
potential VA participants a “Summary of UW Research” processes (Attachment S) to ensure that 
participants are fully aware from the outset about all aspects of being a study participant, including both 
VA and non-VA components of the research. Attachment S was previously approved with the original 
IRB submission, and a revised version is submitted with PRAF 1. As appropriate in the future, we will 
submit to the VAPSHCS IRB any documentation pertinent to study processes at UW and relevant 
documentation from the UW IRB.
4.0
Resources and Personnel
•
This research will be led by Dr. Pradeep Suri at VA Puget Sound Health Care System 
(VAPSHCS). Dr. Suri is the PI and will be responsible for study planning and broad oversight; 
supervising study procedures; integrity of data collection; interpretation of findings; and all 
subsequent steps including manuscript preparation and submission. He will have access to 
protected health information (PHI).
•
Ms. Tanus is the research coordinator. She will supervise research assistants and other 
study staff. She will be involved in recruiting subjects; obtaining informed consent; mailings to 
participants and from participants; coordinating provision of or receiving the ActiGraph units; 
tracking participants; and all other study procedures involving recruitment, data collection, 
and data management. She will have access to protected health information.
•
Dr. Korpak, Mr. Timmons, Mr. Baraff, and Mr. Forsberg are study biostatisticians. They will 
be involved in data analysis; and in manuscript preparation and submission. They will not have 
access to PHI.
•
Ms. Fox, Mr. Morelli, Ms. Wicks, Ms. Scott and Mr. Peterson will function as data managers. They will 
obtain data from the Corporate Data Warehouse and/or assemble that data into a format ready for 
analyses. They may have access to PHI at one stage in the study, when VA administrative data is obtained 
from the Corporate Data Warehouse (CDW) or from any future repository that replaces the CDW after the 
Cerner electronic health record (EHR) transition. Subsequently, any use of data will not involve interaction 
with PHI.
•
Ms. Irimia, Ms. Brubeck, and Ms. Dhillon are research assistants. They will be involved in 
recruiting subjects; obtaining informed consent; mailings to participants and from participants; 
coordinating provision of or receiving the ActiGraph units; tracking participants; and all other 
study procedures involving recruitment, data collection, and data management. They will have 
access to protected health information.
5.1 Study Design
 
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This will be an observational, longitudinal case-crossover study nested within a cohort study, 
following up to 730 Veterans seen for LBP in VA primary care prospectively for 12 months. Study 
procedures will not make changes to nor in any way affect the typical medical care for LBP provided at 
VAPSHCS. All study assessments following recruitment will be “e-Questionnaires” that participants 
complete using their own personal electronic devices (smartphones, tablets, or PCs, not provided by the 
study). There are two types of e-Questionnaires that participants will complete: “scheduled e- 
Questionnaires” and “flare window e-Questionnaires. Scheduled e-Questionnaires are quasi-random, 
‘cue-elicited’ frequent assessments that will be repeated numerous times throughout the 1-year follow-
up period. Cues to complete scheduled e-Questionnaires are automated “e-Alert” notifications sent by 
text
message and email at the start of each “scheduled assessment window”, the 3-hour period during which 
a scheduled e-Questionnaire may be completed. Scheduled e-Questionnaires will occur three times 
each week during weeks 1-4 of follow-up, once a week during weeks 5-8, and twice a month during 
months 2-12. Participants will also complete unscheduled “flare window e-Questionnaires” on an ad hoc 
basis, if they experience new flares of LBP at any time during the 1-year follow-up period. At study entry, 
participants will receive training on how to complete flare window e-Questionnaires, if they experience 
flares of pain, by logging on to a secure Participant Portal (the Flares of LBP with Activity Research Study 
or “FLAReS” website) within 3 hours after the onset of a new pain flare. In addition, all scheduled e- 
Questionnaires will remind participants to complete a flare window e-Questionnaire if they have a new 
pain flare. Scheduled e-Questionnaires and flare window e-Questionnaires generally contain the same 
question items, however, scheduled e-Questionnaires inquire about activity exposures preceding the start 
of the scheduled assessment window (when e-Alert notifications are sent), and flare window e- 
Questionnaires inquire about activity exposures over the time period preceding the flare onset. Each e- 
Questionnaire will begin by prompting the participant with the definition of a LBP flare. Participants will 
then report whether or not they are experiencing a flare, the primary outcome for Aim 1 of this study. E- 
Questionnaires will also inquire about activity exposures that have occurred over the 24-hour period prior 
to the assessment window start and - if an activity is reported – ask for further clarification of whether the 
activity was performed in the 2-hour period prior to the assessment window start. Further questions 
included in every e-Questionnaire are time-varying pain and psychological covariates (pain intensity, 
depression, catastrophizing, stress, etc.) assessed using brief, validated measures. All e-Questionnaires 
are inherently time lagged for activity-flare relationships, since they capture current flare status at time=t, 
and activities in the 24-hour period before the start of the assessment window/flare onset (t-1).
Participants may also be offered to wear the optional ActiGraph wGT3X-BT unit continuously for weeks 1-
4 of the study. Due to the participant burden involved with frequent serial e-Questionnaire assessments, a 
run-in period during weeks 1 and 2 of follow-up will exclude those individuals unable to maintain 
compliance with these assessments. Aim 1 analyses will examine the short-term effects of 10 specific 
activity categories on participant-reported flares across all study assessments over 1-year follow-up. Aim 
2 analyses will examine associations between the frequency of exposure to 10 specific activity categories 
over weeks 1-4 of follow-up, and long-term functional recovery at 12 months as defined by the RMDQ. All 
analyses will use a biopsychosocial framework accounting for potential confounders (sociodemographics, 
psychological factors, etc.) and effect modifiers, and will include sensitivity analyses to examine the 
robustness of findings and important study assumptions.
Please see “Overview of the Overall Study Approach” subsection in 3.0 above. As mentioned, the study 
as a whole involves two separate components: (1) a VA component involving all VA recruitment, VA data 
collection, and all processes involving VA data (addressed by the current VA IRB application and referred
 
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to as the “VA component”), and (2) a non-VA component involving non-VA data collection that occurs 
entirely outside the VA and does not involve any VA data. Non-VA data collection involves e- 
Questionnaires (referred to as “e-Surveys” in participant-facing materials). e-Questionnaires are to be 
administered as part of the non-VA (UW) research processes and are therefore provided to the VA IRB for 
completeness, but not for VA review. E-questionnaires are labelled as Attachments Q1-Q3.
ActiGraph units will not be available for participant use by the time when recruitment could otherwise be 
started. ActiGraph-related research questions are separate from the primary study aims which rely on 
participant-reported data, and are therefore non-essential and optional for participant use. Participants 
may or may not be offered to wear an ActiGraph and use of this device is optional. Due to the expected 
unavailability of ActiGraph units at the time when recruitment is started, potential participants approached 
at times when Actigraphs are not available will be offered the opportunity to participate without wearing the 
ActiGraph. With the current version of the protocol, we provide a revised Information Statement document 
that describes participation in the study either with or without participation in that component of the study 
that involves the ActiGraph. In other words, the revised Information Statement is now applicable whether 
or not the participant wears the ActiGraph as part of their study participation.
Description
 
  of
   Potential
 
  Risks
 
  and
 
  Risk
 
  vs.
 
  Benefit
 
 
Both VA and non-VA components of this study are entirely observational. Risks pertaining to the 
VA component of this research study involve those related to the obtaining, storage, and analysis of 
VA research data, and any possible inadvertent disclosures.
Physical risks: Participants who wear ActiGraphs may find it uncomfortable or inconvenient in general to 
wear the ActiGraph during the day or while sleeping. There is no risk of electrical shock while wearing 
the activity monitor. The Actigraph will not be able to track where participants are physically located.
Participants may experience sweating or skin irritation while wearing the activity monitor if they have 
sensitive skin. We will provide participants with tips on how to mitigate any discomfort or inconvenience 
due to the positioning/wear of the unit, such as shifting the unit positioning when feasible.
Psychological
 
  risks:
 
  Participants may experience fatigue and/or boredom while completing the research 
assessments. Some participants may also experience mild anxiety, frustration, and/or stress while 
reporting on their pain and mood during the research assessments.
Social, Legal, Privacy, and Other Risks: There are research risks to participants’ privacy associated with 
inappropriate disclosure of data. Specifically, there is a risk that a participant’s identity and participation in 
the study may be discovered by an outside party. However, we will take steps as described elsewhere in 
this document to ensure that the likelihood of such risk is negligible.
Risks pertaining to the non-VA component of this research study also involve those related to the 
obtaining, storage, and analysis of non-VA research data, and any possible inadvertent disclosures. Such 
risks relevant to the non-VA component of the research are covered in the separate human subjects 
approvals processes at UW, and also in the “Summary of UW Research” (Attachment S) provided as part 
of the VA research processes so that VA participants are aware from the start of both VA and non-VA 
components of the overall research. Following any future substantive modifications to the UW IRB 
application (for example, study staff modifications at UW would not be considered substantive), we will 
provide the relevant updated UW IRB documentation (including participant-facing materials) and 
approvals back to the VAPSHCS IRB.
 
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Description
 
  of
   Study
 
  Population/Expected
 
  Enrollment/Vulnerable
 
  Populations:
 
 
We expect to recruit up to 730 Veterans in the proposed study in order to obtain at least 440 Veterans 
who complete 1-year follow-up. Further details of inclusion/exclusion criteria are provided below in Table 
1 (see Section 5.4). All participants recruited will be Veterans. We will recruit Veterans from primary care 
clinics and other clinic encounters (including telephone visits) occurring at VAPSHCS. The anticipated 
age range of participants is between 18 years and 65 years of age. In expanded recruitment as part of a 
project
 
  modification
 
  (January
 
  2023),
 
  recruitment
 
  was
 
  also
 
  expanded
 
  to
   other
 
  Veterans
 
  with
 
  low
 
  back
 
  pain
 
  
who have been seen at VAPSHCS or through VA-associated community care, but not necessarily in 
VAPSHCS primary care specifically. Patients with severe and major active medical and psychiatric 
comorbidities will be excluded since they will likely be unable to complete the study procedures, 
particularly the requirements for frequent serial assessments in the first 4 weeks of follow-up. Otherwise, 
we expect the general health status of the subject population to be about average, for Veterans’ ages.
We will exclude Veterans from special classes of subjects or vulnerable populations such as pregnant 
women, children, cognitively impaired persons, or prisoners, to avoid possible coercion of vulnerable 
populations. We will not otherwise make any exclusions based on gender, sex, race, ethnicity, or any 
minority group designation. The study inclusion and exclusion criteria are specifically defined to capture 
the broadly-defined target population of Veterans seen for LBP seen in primary care, who are of working 
age (18-65 years), irrespective of whether participants are actually currently employed. We will re-contact 
any participants who were interested in the study and screened, but failed criteria from a prior version of 
the Screening Checklist, provided that they meet all criteria on the currently approved version of the 
Checklist.
5.2 Recruitment Methods
We will recruit up to 730 participants from among Veterans seeking care at VAPSHCS. The eligibility and 
exclusion criteria are defined to capture the medically eligible target population of Veterans seeking care for 
LBP.
Where not stated or indicated otherwise in blue font (signifying UW [non-VA] research processes), all aspects 
of the descriptions below pertain to the VA component of the proposed research.
5.2.1
 
  Recruitment
 
  and
 
  Informed
 
  Consent
 
 
We will conduct in-person recruitment at the time of primary care clinic visits for LBP (Mode 1), and by 
identifying potential participants using ICD-10 codes, with subsequent screening and recruitment conducted 
by telephone (Mode 2); both modes can be combined if some aspects of in-person recruitment (Mode 1) 
cannot be completed at the time of the visit for LBP. In Mode 1 (in-person recruitment), research staff will 
only have an initial contact with the patient if the patient is first introduced by non-study personnel (primary 
care staff), or if the participant approaches research staff on their own initiative. Research staff will not 
interact with potential participants while they are waiting for an appointment or while they are in an 
appointment, unless a participant has approached research staff on their own initiative. No designated 
vulnerable populations are included in this research. In Mode 2 (telephone-based recruitment), participants 
will receive an information packet by mail, and research staff would only speak with potential participants if 
the potential participant subsequently initiates a contact with research staff. Recruitment will begin with Mode 
2 only. As restrictions due to COVID-19 change, we may shift over time to incorporate Mode 1 recruitment. 
We will notify
 
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the IRB prior to shifting to Mode 1 recruitment. If any concerns arise due to restrictions related to COVID-19, 
recruitment may shift back to only Mode 2 recruitment, and we will notify the IRB in this case as well. Up to 
100,000 Veterans will be pre-screened using VA administrative data, and those potentially eligible will be 
contacted via Mode 1 or Mode 2 recruitment. An Information Statement will be used in lieu of a written and 
signed Informed Consent document. Veterans who were previously sent an invitation letter at a time when our 
consent processes required written informed consent (i.e., prior to 9/10/2021) may be recontacted with 1 
additional mailing packet (Mode 2 Recruitment). Additionally, if a potentially eligible Veteran initiates contact 
with our staff with the interest of possibly joining the study, we would begin screening and enrollment 
processes as indicated in this document. We will not recontact anyone who has previously informed us they 
were not interested in participation, or who was previously enrolled in the study.
The consent process will occur at a time deemed mutually feasible for the Veteran patient and staff member 
and coordinated on a case-by-case basis. If the consent process is conducted by Mode 1 (in-person) it will 
take place in a private location at VAPSHCS where possible (e.g., a medical exam room or private 
conference room). We will work with the primary care clinics, other outpatient clinics, and the Rehabilitation 
Care Services (RCS) service line to create a list of private spaces within a short distance of the primary care 
clinics that can be used for this purpose. These locations will vary depending on the half-day of the week and 
week of the month, and a list of these locations/times will be compiled into a “private space schedule”. 
Research staff will consult the private space schedule when potential participants are identified by Mode 1 (in-
person) recruitment. If no private space is available at a given time when a potential participant is identified by 
Mode 1, but there is space within the primary care waiting room (at the time of) where no other individuals 
are seated within a distance where conversations can realistically be overheard, we will offer potential 
participants the option of talking about the study, and undergoing informed consent (if appropriate), in the 
primary care waiting room itself. The large size of the primary care waiting room, its typically low occupancy 
at any given time, and the fact that there is a second area of the primary care waiting room on the western 
edge of the clinic space that is often entirely unoccupied by patients, makes the option of such staff-patient 
interactions possible while still permitting private discussions. If the primary care waiting room occupancy at a 
given time does not permit such staff-patient interactions, or any other barrier to private discussion presents, 
participants will be provided written materials and can opt to initiate Mode 2 recruitment (telephone-based) 
should they be interested in participation. If the consent process is conducted by Mode 2 (telephone), the 
VAPSHCS research staff member will make the telephone call from a VAPSHCS telephone in a private 
room.
5.2.2. Recruitment Mode 1 (in-person recruitment): Although labeled “Mode 1”, due to COVID-19-related 
precautions, in-person recruitment will serve as the secondary mode of recruitment, with telephone-based 
recruitment as the primary recruitment mode. Mode 1 recruitment will involve research staff members situated 
in the primary care clinics at VAPSHCS Seattle campus where the patient-aligned care teams (PACTs) are 
collected. Research staff will maintain a physical presence and intermittent contacts with PACT clinicians 
(physicians, nurse practitioners, physician assistants) as well as support staff. Flyers (Attachment A – 
Recruitment Flyer) will be posted in clinical areas of outpatient clinics. If a PACT clinician or clinical staff 
identifies a Veteran with LBP who is a potential candidate for the study, they will inquire with the Veteran 
regarding whether the Veteran would be interested and willing to discuss the study with a research staff 
member. If the Veteran expresses interest, clinical staff will then notify a research staff member (“handoff from 
a clinician”) to approach a Veteran after their clinic appointment is completed. If there is a handoff from a 
clinician, or if a Veteran initiates contact with a research staff member on their own, research staff will explain 
the study to the Veteran at the initial patient contact (on the day of the index LBP visit). Research staff will 
describe the study; its observational nature; the high volume of study assessments; use of electronic 
questionnaires (e-Questionnaires) via personal computer (PC), tablet, or smartphone; the system of e-Alert 
notifications or “cues” to complete e-Questionnaires via email and text messages; answer participant 
questions; confirm eligibility with screening criteria; and involve the study-associated clinician or PI where
 
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eligibility criteria determinations warrant a physician determination or evaluation. Specific instructions will be 
provided to potential participants about the two separate components involved in the research: (1) the VA 
component involving data collection within the VA, and that is part of this VA research; and (2) the UW 
component of electronic data collection (e-Questionnaires) that occurs outside the VA, and would be covered 
under a separate human subjects approval process for UW. Research staff will explain that participants’ VA 
medical care for LBP will not be affected in any way by participation in this study. Where potential participants 
wish to do so, informed consent will be offered and completed at the time of the index LBP visit for those 
study procedures involved in this VA research, using the Information Statement. This informed consent 
process is described in further detail below in section 5.3. If potential participants wish to have time to 
consider their involvement in the VA component of this study further before completing informed consent, or if 
some component of the study screening or education cannot be completed in-person, the remainder of 
recruitment procedures that are not yet completed can be done using recruitment Mode 2 methods as below. 
Following informed consent, participants will be provided with other study materials, including the “Key 
Points” document (Attachment K) which consists of the main points contained in the Information Statement 
and serves as a quick reference for participants; the instructions for completing e-Questionnaires document 
(Attachment I); and an activation code that allows access to the Participant Portal.
5.2.3
 
  Recruitment
 
  Mode
 
  2   (remote
 
  recruitment
 
  by
   telephone):
 
  Although labeled “Mode 2”, due to COVID-19- 
related precautions, remote recruitment will serve as the primary mode of recruitment, with in-person 
recruitment taking place only if/when determined to be safe and feasible by the study team, consistent with 
VA and local restrictions in place at that time. On a recurring basis during the recruitment phase, research 
study staff will identify potentially eligible patients seen in primary care using ICD-10 codes indicating LBP or 
related spinal disorders. Data collection is expected to span the start time of the transition of the electronic 
health record (EHR) from the Computerized Patient Record System (CPRS) to Cerner. Prior to the Cerner 
transition, we will identify participants with ICD-10 codes indicating LBP by one of several possible 
mechanisms, such as Veterans Information Systems and Technology Architecture (VISTA) queries, or using 
Corporate Data Warehouse (CDW) data. After the Cerner transition, we will identify participants with ICD-10 
codes indicating LBP using methods that have yet be determined; however, VAPSHCS research staff have 
been informed in seminars related to the Cerner transition that methods to identify potential research 
subjects in this way will be available after the Cerner transition. Potentially eligible Veterans with new ICD- 
10 codes indicating a recent LBP visit will be mailed information packets. Information packets will include a 
cover letter (Attachment L), the Information Statement document, and the summary of UW research 
processes (Attachment S). Information packets will describe study eligibility, the study assessments, and 
what study participation would entail. Packets will prompt interested Veterans to contact research staff by 
telephone. Once research staff are contacted by telephone, staff will administer the same procedures for 
providing study information, answering questions, screening, and training as described above for in-person 
recruitment (Mode 1), but such procedures will instead be completed by telephone. Veterans who complete 
all screening procedures and meet study criteria will be offered the chance to have any questions about the 
study answered by study staff. Those interested in participating will be offered informed consent for VA 
research processes, completed over the telephone, while referring to the Information Statement hardcopy 
included with the mailed information packet. Participants will be considered enrolled in the VA component of 
the study once the Information Statement content has been reviewed, questions have been answered, and 
the Veteran verbally agrees to participate in the study. Following this, participants will be mailed other study 
materials, including the “Key Points” document (Attachment K) which consists of the main points contained 
in the Informed Consent and serves as a quick reference for participants; the instructions for completing e- 
Questionnaires document (Attachment I); and an activation code that allows access to the Participant Portal; 
participants will also be called by phone to provide the activation code.
5.2.3.1
 
       
 
  Email notifications:
 
  To supplement mailed recruitment, we will email potential research 
subjects using Veterans’ email addresses (see HIPAA waiver) after the date when physical mailings are 
sent. The email content (Attachment LE) does not contain any identifying information about individual 
Veterans other
 
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than the email address; it does not contain any information that could identify Veterans’ health conditions, 
but it does describe what study participation would entail in general terms. Emails of this type will be sent 
via Microsoft Outlook, using bcc, using an email address that cannot be replied to and is not monitored.
Individuals who receive the email are prompted to call the study phone numbers for more information. Prior 
to this IRB submission, we have had discussions regarding these processes with IRB administrators Gage 
Doehlert and Amy Marsh (see correspondence).
Because email
 
  notifications may
 
  result in a greater burden of
 
  phone calls received by
 
  study staff, if
 
  study
 
  
staff
 
  numbers
 
  are
 
  diminished
 
  due
 
  to
   staff
 
  attrition
 
  or
   leave,
 
  email
 
  notifications
 
  may
 
  need
 
  to
   be
   stopped
 
  
for periods of time or permanently.
5.2.3.2
 
  Recruitment
 
  from
 
  an
   expanded target
 
  population: Through
 
  a   modification
 
  submitted
 
  to
   the
 
  VAPS
 
  IRB
 
  
in January 2023, recruitment is to be expanded to other Veterans with a history of back pain-related 
conditions who have been seen in VAPSHCS (the “expanded target population”) but may not have had 
recent visits for back pain in VAPSHCS primary care specifically. Within the expanded target population of 
Veterans with back-related conditions are subgroups of individuals with certain “specific” spine conditions, 
such as (1) “lumbosacral facet-mediated” back pain, (2) “sacroiliac joint-mediated back pain”, and (3) 
spondylolytic spondylolistheses. We will use CDW data (or other approved VA processes involved the 
electronic health record should these change, such as following the transition to Cerner) to identify Veterans 
enrolled at VAPSHCS on 10/1/2015 or anytime thereafter who have had ICD-10 or CPT codes indicating 
back pain-related conditions, to be approached as potential study participants. These individuals in the 
expanded target population will then be contacted using the same processes as described above in sections
5.2.3 and 5.2.3.1, with the exception that potential participants will not be identified on a recurring basis 
dependent on recent primary care visits associated with ICD-10 codes indicating LBP or related spinal 
disorders. Instead, they will be identified based on past diagnostic codes or procedure codes indicating past 
LBP or spinal disorders since 10/1/2015 and approached in separate batches of mailings and emails. No 
individuals who have previously been contacted as part of the original target population and been sent a 
mailing containing the Information Statement will be contacted as part of the expanded target population.
5.2.4 Informed
 
  Consent
 
  for
   research
 
  processes
 
  involving
 
  UW
 
  
As mentioned above, separate from the processes for VA research described in this application to 
conduct VA human subjects research, participants will undergo a separate UW informed consent 
process as part of UW human subjects approval processes. These processes are not part of the 
current VA human subjects research application. Following any future substantive modifications to the 
UW IRB application (for example, study staff modifications at UW would not be considered substantive), 
we will provide the relevant updated UW IRB documentation (including participant-facing materials) and 
approvals back to the VAPSHCS IRB.
5.2.5 Run-in
 
  period
 
 
Participants who join the study may subsequently fail requirements of the 2-week run-in period and be 
withdrawn from the study. A run-in period is needed for a study of this type to ensure that participants 
are able to complete the frequency of data collection that is necessary for the study to be valid. Criteria 
for failing the run-in period include (1) not completing the baseline e-Questionnaire, (2) not completing at 
least 4 of 6 e-Questionnaires in the 2-week run-in period, with an adequate proportion of e-Questionnaire 
items completed within surveys, as the definition for completion, or (3) not completing the UW informed 
consent for the (non-VA) UW component of the study; although listed separately to be explicit, 
completing the UW informed consent (3) is necessary before a participant is able to complete (1) and 
(2). These criteria could be waived or more time allotted if participants report a major life event 
(unexpected illness, injury, etc.) preventing a criterion from being met or are otherwise determined to be 
eligible by research staff on a case-by-case basis.
 
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5.2.6 Materials
 
  used
 
  to
   Recruit
 
  Subjects
 
 
Recruitment materials that we have submitted include the Recruitment Flyer (Attachment A), the introduction 
(cover) letter document that will be included with the mailing sent to potential participants identified by Mode 2 
recruitment (Attachment L), an introduction email letter document that will be sent to potential participants 
identified by Mode 2 (Attachment LE), a study Key Points document (Attachment K), instructions for 
completing e-Questionnaires (Attachment I), and the Information Statement. Of note, after IRB review of the 
PRAF submitted at the same time as this version of the Protocol, we request that the cover letter (Attachment 
L) and instructions for completing e-Questionnaires (Attachment I) be provided back to the research team in 
an editable format to permit mail merges. Any content to be included in future recruitment materials to be 
developed will be modeled after and be consistent with the content of the Information Statement.
5.2.7 Payment
 
  to
   Participants
 
 
Participants will be compensated for the time taken to complete the informed consent process, and for 
completion of each e-Questionnaire. Compensation will be paid by check or by direct deposit (EFT). The 
amounts of compensation will include the following: $20 for completion of informed consent procedures, $12 
for the baseline e-Questionnaire, $7 each for scheduled e-Questionnaires (up to 36 for each participant), $7 
for the first 10 flare-period e-Questionnaires, $4 for the 2nd set of 10 flare-period e-Questionnaires completed 
(that is, #11-20 completed), and $2 for the 3rd set of 10 flare-period e-Questionnaires completed (that is,
#21-30 completed). Participants will have the option to complete more than 30 flare-period e-Questionnaires if 
they wish, but the study will not compensate them for flare-period e-Questionnaires beyond the first 30. The 
decreasing payment for higher numbers of completed elective flare-period e-Questionnaires was specifically 
introduced to address a prior scientific reviewer suggestion (in the 1st round of formal peer review by RR&D) 
that the research processes employed reduce incentives for spurious flare over-reporting. There is also a $15 
compensation for the exit e-Questionnaire, and a $30 incentive for return of the ActiGraph unit. A larger ($50) 
incentive for ActiGraph return may be offered if an ActiGraph unit is not initially returned. This contingency 
plan for a higher compensation amount if the ActiGraph unit is not initially returned will not be disclosed to 
participants in the informed consent documents, since it would incentivize participants to delay returning the 
ActiGraph. This means that the amount listed for total possible compensation in the Information Statement 
document ($459) is $20 less than the amount listed for total possible compensation in the IRQ ($479) and 
other documents in this human subject application. For participants not wearing ActiGraphs, the total study 
compensation will be up to $429.
Payments will be bundled together to minimize inconvenience to participants and for reasons of feasibility, 
into 3 payment periods after the end of month 2, month 7, and months 12 (completion of study). If a 
participant withdraws from the study at another time that is not close in time to these 3 payment periods, a 
payment will be initiated at the time of withdrawal. The time points for payments and spacing between 
payments are motivated by our experience with current and recent VAPSHCS studies, including that it 
sometimes takes approximately 5 months after a payment is sent before we can confirm with the participant 
that the payment has been received. Tracking of non-VA (e-Questionnaire) data collection completion by VA 
staff for the purposes of participant payments is feasible because a researcher-facing portal for participant 
tracking will be accessible to VA research staff as part of the non-VA study processes. This portal can be 
accessed when needed to determine the applicable payment amounts at the time of each payment period.
5.2.8 Periodic
 
  contacts
 
  by
   phone,
 
  when
 
  needed
 
  Participants may be contacted by study staff via telephone in 
certain instances where data indicates participant misunderstanding about aspects of data collection or the 
study in general, or to respond to participant-initiated questions left on the study voicemail. During these 
conversations, research staff will be guided by the content provided in the Reminder Call Script (Attachment 
R). Participants may be contacted if they attempt to complete a Flare-window e-Questionnaire while also 
reporting that they are not having a flare (indicating misunderstanding about the flare definitions being used, 
or the expectations for reporting); for repeated missed Scheduled e-Questionnaires; for not completing any
 
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flare-window e-Questionnaires; for reporting non-wear of the ActiGraph during 2 or more assessments during 
the 1st 4 weeks; for problems related to the ActiGraph or returning the ActiGraph, or other questions prompting 
an a direct telephone contact; or similar occurrences reflecting a misunderstanding of or lack of compliance 
with study processes. Some telephone contacts with participants are advantageous to allow participant-staff 
interactions and maintain connectedness with the study, beyond what can be achieved electronically. These 
contacts thus ensure validity of the study findings.
5.3 Informed Consent Procedures
A Waiver of Informed Consent has been obtained to cover screening/recruitment procedures, that will allow 
research study staff to approach patients. Informed consent for study participation is as described below.
Informed consent will be offered following screening/completion of a Screening Checklist. The Screening 
Checklist is provided (Attachment AA). The Screening Checklist consists of the Inclusion/Exclusion criteria 
stated below in Table 1. A Waiver of Documentation of Informed Consent has been approved to use an 
Information Statement in lieu of requiring a signed consent form.
A. Informed Consent:
In the section below, all uses of the words ‘patients’ or ‘participants’ prior to completion of the 
informed consent process using the Information Statement refers to  potential candidates for study 
participation. Please see the Information Statement document.
Informed consent gives patients the opportunity to choose whether or not they want to participate in a 
study. Informed consent will be administered by research study staff (research assistants, research 
coordinator, or research specialist) who are or will be named as part of this study protocol and human 
subjects documentation. Research staff will have completed the necessary human subjects 
protections training per VA policy to engage in human subjects research and will remain current with 
such trainings during the study period. Any new study personnel added to the study in the future will 
also have been trained on VA consent procedures, and will be trained on informed consent for this 
study by existing research staff for this study. Adequate informed consent requires the disclosure of 
relevant information about the research, assurance of patient understanding of the information, and 
the patient’s voluntary agreement to participate. Research staff will explain the study to potential 
participants and answer questions. If questions cannot be answered by research staff, the PI (Dr. 
Suri) will be consulted to answer additional questions.
Participants will be informed that their decision whether or not to participate in the study would not 
affect the medical care they receive at the VA in any way. Participants will be informed that 
participation will involve completing frequent, serial e-Questionnaires using their own personal 
electronic devices (PC, tablet, or smartphone) over a 1-year period of follow-up. All data collection 
after the time of recruitment will involve these electronically administered e-Questionnaires. E- 
Questionnaires will include questions on sociodemographics, back specific functional status, pain, 
physical activities, health-related quality of life, mood, stress, and other study measures. Participants 
will be informed that joining the study is entirely optional.
Potential candidates will also:
i. Receive detailed information concerning the overall study goals from a research staff member. It 
will be explained that participants’ involvement in this observational study will not affect their medical 
care at the VA in any way.
ii. Receive adequate time to raise questions and voice concerns.
 
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iii. Be questioned to assure that they understand all information provided. Potential participants will be 
asked to repeat back understanding of this material, as necessary. Individuals will not be permitted to 
participate if there is any question as to whether a person is able to provide informed consent.
iv. Potential participants will be provided with as much time as needed to review the Information 
Statement and ask the research staff member questions about the Information Statement, their rights 
as participants, and participation in the study. Potential participants will be fully informed of all risks and 
benefits prior to giving their verbal informed consent and prior to enrollment in the study. Participants 
will be asked if they need some time to consider their involvement before providing consent. If so, a 
time will be scheduled to continue the discussion at a later date using Recruitment Mode 2 (telephone), 
or participants will be asked to call research staff using the study telephone number, if they wish to 
complete informed consent and participate in the study in the future.
iv. Following the above, potential participants will provide verbal consent to participate in the 
study procedures.
v. If informed consent procedures are being performed remotely by telephone interactions with 
research study staff (as in Mode 2 described above), the information packet sent to Veterans 
recruited in this manner will contain 1 copy of the Information Statement. The Information Statement 
can be retained by the participant for their records.
vi. Be informed about the run-in period requirements (see above in section 5).
During the informed consent process, study staff will explain to potential participants that participation in the 
VA component of this study will (1) involve data collection within the VA, which will produce VA data that will 
not subsequently leave the VA; and (2) data collection outside the VA. Data collected outside the VA will later 
be downloaded to the VA, at which point it becomes VA data and will not subsequently leave the VA during 
the study. The informed consent process (and the Information Statement submitted with this application) will 
briefly describe study processes involved with the non-VA component of this study, while clarifying that the 
VA informed consent process potential participants are completing at the time does not cover or apply to the 
non- VA component of the study.
During informed consent study staff will clarify the following
(1)Data
 
  collection
 
  within
 
  the
 
  VA
   will include several parts:
a. Information needed for participant screening, including the initial conversation between Veteran 
and research study staff, and subsequent interactions until and including informed consent.
b. Obtaining participants VA electronic medical record data from existing administrative data sources 
(e.g. CPRS, Vista, the Corporate Data Warehouse [CDW], Cerner, etc.). This data will be used for 
analyses at VA, and will not leave the VA.
c.
Any data obtained from sources outside the VA (as described immediately below) that enters the 
VA. Once such data enters the VA, it becomes VA data and subsequently will not leave the VA.
(2)Data
 
  collection
 
  outside
 
  the
 
  VA
   will include the following:
a. Electronic survey data collection conducted by a non-VA private company (DatStat, Inc.) 
specializing in secure HIPPA-compliant electronic data collection using participants’ own personal 
electronic devices (smartphone, tablet, and/or PC). e-Questionnaires will not include sensitive 
medical information. e-Questionnaires will involve self-reports of pain, physical limitations, 
physical activities, mood, and recent treatments for low back pain.
b. This component of electronic data collection will be led by researchers at the University of 
Washington (UW). The involvement of UW will entail a separate informed consent process for 
UW.
The consent process for VA research processes will occur at a time deemed mutually feasible for the 
Veteran patient and staff member and coordinated on a case-by-case basis. If the consent process is 
conducted by Mode 1 (in-person), we will follow the processes described above in section 5.2.1 to 
ensure that the staff-patient discussions take place in a private location at VAPSHCS (e.g., a medical
 
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exam room or private conference room) or another location where a private discussion can be 
ensured. If the consent process is conducted by Mode 2 (telephone), the VAPSHCS research staff 
member will make the telephone call from a VAPSHCS telephone in a private room to minimize the 
possibility of coercion or undue influence. Prospective subjects will be informed that all study 
personnel will have completed the necessary human subjects protections training per VA policy.
Informed consent will be conducted in English. Prospective subjects will be asked if they are able to 
understand English and whether they feel comfortable speaking it.
If during the course of this contact the potential participant has questions that cannot be addressed by 
research staff, another research staff member, the PI, or another study investigator will follow up with 
the potential participant to answer the questions. Potential participants may take time to think about 
participating and render a decision at a future time.
A waiver of HIPAA authorization has been approved for all study procedures, which allows the 
research team to view and analyze participant administrative data (CPRS, Cerner, or other data 
sources maintained by the VA) for the purposes of recruitment. In addition, the waiver of HIPAA 
authorization allows for analyses of VA administrative data for those individuals who do not respond to 
mailing packets, for the purpose of weighting the study sample of participants back to represent the 
target population of Veterans who were participants and those who did not respond to the mailing.
The waiver of HIPAA authorization does NOT apply to individuals who contact the study to opt out of 
the study, or to participants who contact the study but decide not to participate in the study.
The same general study-related information content provided by study staff at the screening 
visit/informed consent will also be made available to participants throughout the study period on the 
participant-facing website Participant Portal (the ‘FLAReS’ website, or flares.datstat.com/portal/), 
which will be run by the non-VA (UW) component of this research study. The FLAReS website was 
set up by the private (non-VA) data collection company mentioned earlier (DatStat/R1) specializing 
in secure HIPAA-compliant electronic questionnaire administration, and processes related to the 
website will be covered through the UW component of the proposed research and the related UW 
human subjects processes.
5.4 Inclusion/Exclusion Criteria
Low back pain is defined as pain occurring between the lower posterior margin of the rib cage and the 
horizontal gluteal fold. Low back pain intensity will be measured using the numerical rating scale (NRS) See 
Table 1 below for a complete and detailed list of inclusion and exclusion criteria, and justification/rationale for 
exclusion.
Table 1: Study Inclusion/Exclusion Criteria
Inclusion
 
  Criteria
 
 
Exclusion
 
  Criteria
 
 
• Veterans age 18-65 years seen in VA primary care for 
LBP (the original target population); or (as part of 
expanded recruitment): Veterans age 18-65 years who 
otherwise have had health care for LBP since 
10/1/2015, and report current back pain (Justification: 
adults of working age)
• ‘Red flag’ spine conditions (spinal cord injury, 
infection, malignancy, fracture) or spondyloarthropathy 
(Justification: red flag conditions are a distinct medical 
condition)*
• Pregnancy (Justification: exclusion of potentially
 
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• Must have regular access (every day, during most 
hours of the day) to a computer, tablet, or smartphone 
with internet access at home or at work (not via a 
public resource such as the public library). 
(Justification: needed for e-Questionnaire component 
of data collection occurring as part of UW research 
processes)
• Basic computer literacy, including the ability to navigate 
simple websites (Justification: needed for e- 
Questionnaire component of data collection occurring 
as part of UW research processes)
• Having a mobile phone capable of receiving alerts 
using text messages (Justification: needed for e- 
Questionnaire component of data collection occurring 
as part of UW research processes)
• Must be able to understand and read English, 
sufficient to provide informed consent and validly 
complete the study assessments. (Justification: 
needed for informed consent and validity of study 
assessments)
• Participants must enroll in the parallel study conducted 
at UW prior to the 2-week run-in period, and complete 
run-in period requirements for e-Questionnaire 
completion. Run-in period requirements including (1) 
completing the baseline e-Questionnaire, (2) 
completing at least 4 of 6 e-Questionnaires in the 2- 
week run-in period with an adequate proportion of e- 
Questionnaire items completed within surveys, and (3) 
completing the UW informed consent requirements for 
the (non-VA) UW component of the study. (Justification: 
run-in period is needed to identify participants capable 
of completing study procedures, including frequent and 
repeated data collection)
vulnerable populations)
• Prisoners or incarcerated (Justification: exclusion of 
potentially vulnerable populations)
• Severe active medical comorbidities or psychiatric illness 
likely to be a barrier to study participation including 
completing frequent, serial assessments (e.g., 
metastatic cancer). (Justification: exclusion due to likely 
being unable to complete study procedures)*
• Prior diagnoses for psychotic or major thought disorder 
or unstable or severe psychiatric/behavioral conditions 
(e.g. delirium, mania, psychosis) as identified in EHR 
data (CDW, Cerner, etc.)* (Justification: exclusion due 
to likely being unable to complete study procedures)*
• Diagnoses indicating cognitive limitations that might limit 
study participation (such as dementia)*
• Thoracolumbar spine surgery in the past 1 year
• Other major orthopedic surgery potentially impeding 
normal physical activities in a material way (such as 
surgeries involving the hip, knee, ankle, shoulder, elbow, 
wrist joints) within the past 6 months, or major abdominal 
or chest surgery within the past 6 months.*
• Planned major orthopedic, abdominal, or chest surgery 
in the next 2 months.
*Evaluated partially or primarily by review of EHR data (CDW or other administrative data) to identify potential participants with 
back pain and without red flags or other exclusions (prior to contacting potential participants)
5.5 Study Evaluations
Screening
At the time of Mode 1 and/or Mode 2 recruitment as described above, research study staff will administer 
the Screening Checklist (Attachment AA). The Screening Checklist is comprised of the 
Inclusion/Exclusion criteria stated below in Table 1. The screening checklist will also questions specific to 
two of the subgroups included in the expanded target population. The Screening Checklist may be 
completed as a paper version or entered directly into a database. Screening and informed consent will 
typically be conducted during the same session, for potential participants that meet study criteria and 
proceed on to informed consent.
EHR data collection
 
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Prior EHR and administrative data for study participants will be obtained from the CDW or other VA data 
repositories that are established after the VA’s transition to the Cerner system. Participants will be 
informed that in this study, research staff will need to periodically look up participants’ information in the 
electronic health record. This will be so for the duration of this study, a period that may last up to 2 years 
after a participant begins the study. This includes looking up such information from participants’ health 
records after the 1-year follow-up period. If a participant decides to withdraw from this study, however, 
and informs the research team not to access his/her health record after that time, we will not access that 
participant’s health record after that time. EHR reviews will be conducted to ascertain participants’ status 
with regards to the subgroups in the expanded target population as described above (facet-mediated 
pain, SIJ-mediated pain, spondylolysis) and the other subgroups described below in 5.6.2.a (LSRS and 
LSS).
ActiGraph data collection
Study participants may be provided with an ActiGraph wGT3X-BT unit at or after the time of recruitment, 
depending on whether an ActiGraph unit is available for use at the time of recruitment. Potential 
participants who do not want to wear the ActiGraph or express hesitancy about their ability to use the 
ActiGraph will be offered study participation without the component of wearing the ActiGraph. Thus, this 
paragraph pertains to those participants who wear the ActiGraph. Participants recruited by Mode 1 (in- 
person) recruitment will be provided an ActiGraph and a thigh strap at the time of recruitment.
Otherwise, ActiGraphs will be mailed to study participants. The ActiGraph wGT3X-BT is a triaxial 
accelerometer that has been validated as a measure of walking in LBP7 and for the measurement of 
other types of activity when worn on the thigh (sitting, standing, lying supine, and running).8-10 The 
ActiGraph does not display step counts or activity levels, limiting participants’ capacity to be influenced 
by this data. Participants who receive the device will wear the ActiGraph on the thigh all day except when 
in water. After wearing the ActiGraph for the 1st 4 weeks of follow-up, participants will mail back the unit 
in a prepaid delivery box that will be sent to participants in advance of the 4-week follow-up time point.
Once ActiGraph units are received back, data will be downloaded from the ActiGraph using VA-
approved software, and all data erased before subsequent use. According to the plan previously agreed 
to by the VA ISSO Sharon LePage-Erwin, data is downloaded first to a VA-approved external hard drive, 
and then transferred to the VA network. We will use existing ActiGraph algorithms for distinguishing 
types of activities (sitting, standing, lying supine, and running).10 No wireless or remote data sharing will 
be enabled on the ActiGraph, so no data can be transmitted in this way, safeguarding data and 
participants’ privacy. ActiGraphs will be periodically tested for proper functioning by being worn by 
participant staff and the ActiGraph output examined.
All other study evaluations as described immediately below will be conducted as part of the e- 
Questionnaires that are non-VA data collection. These are presented here for the sake of 
completeness, although their initial conduct/acquisition are not a part of the VA component of the 
research. After acquisition as part of the non-VA component of this research, the data will be shared 
with the VA study team, and henceforth will become VA data. The baseline e-Questionnaire will be 
administered within 2 days of a participant completing informed consent. Scheduled e-questionnaires will 
be administered 3 times weekly during weeks 1-4, once a week during weeks 5-8, and twice a month 
from months 2-12. The exit e-Questionnaire will be administered at 1-year follow-up. Flare window e- 
Questionnaires are completed on an ad hoc basis during the 1-year follow-up period, and are participant- 
initiated (not on a set schedule)
Baseline e-Questionnaire
The baseline e-Questionnaire to be administered as part of the UW (non-VA) study is provided
 
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(Attachment Q1). Of note, only the content of the e-Questionnaires can be provided, not the actual 
e-Questionnaires, since they are administered electronically. Below we list some of the study 
measures that are included in the baseline e-Questionnaires. Other measures may be added to 
this list in future PRAFs. The citations provided for these measures provide detailed descriptions 
of the measures, including validity and reliability.
•
Roland-Morris Disability Questionnaire (RMDQ): The RMDQ is a back pain specific functional 
status questionnaire adapted from the Sickness Impact.11 The RMDQ consists of 24 yes/no 
items, which represent common dysfunctions in daily activities experienced by participants 
with low back pain. A single unweighted score is derived by summing the 24 items, with higher 
scores indicating worse function with 0 (no disability) to 24 (maximum disability). The RMDQ 
was designed for paper administration, and is also well-suited for electronic device-based 
administration or telephone use.
•
Pain Numerical Rating Scale (NRS): We will measure back pain using a 0-10 pain NRS (0=no 
pain and 10=worst pain imaginable) assessing average pain over the past week and pain “right 
now”. Numerical rating scales of pain intensity are valid, reliable, and sensitive to detecting 
change in pain intensity after treatment.12,13 We will also ask participants to make a second 
report of what they expect their NRS rating for back pain would be if they were not currently or 
recently taking medications for pain (analgesics).
•
PROMIS Short Form 10: The NIH Task Force on Research Standards for Chronic Low Back 
Pain62 recommended using PROMIS Short Form items to assess the constructs of depression, 
anxiety, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with 
participation in social roles.
•
Tampa Scale of Kinesiophobia (TSK): The TSK is a 17-item scale developed to measure the 
fear of movement related to chronic lower back pain.14
•
UW Concerns about Pain Scale 8-item SF (previously called the UW Pain Appraisal Scale). Ths 
is a validated 8-item scale, described further at: https://uwcorr.washington.edu/measures/uw- 
cap/ 
•
PROMIS depression short-form (PHQ-8): The PROMIS depression short-forms have been 
previously validated
•
The Single-item Global Measure of Depression This single-item self-report measure of 
depression has been validated as compared to the Clinically Useful Depression Outcome scale, 
which involves 16 items assessing the DSM-IV inclusion criteria for major depressive disorder.17
•
Post-traumatic stress disorder (PTSD) Checklist, civilian version (PCL-C): The PCL is a 
standardized self-report rating scale for PTSD comprising 17 items that correspond to the 
key symptoms of PTSD.18
 
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•
Single-item stress question (SISQ) The SISQ has been shown to have content, criterion, and 
construct validity in comparison to comprehensive measures of stress, well-being, 
psychological symptoms, and sleep disturbances.19,20
•
Chronic Pain Acceptance Questionnaire: This 20-item scale was designed to measure 
acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts 
to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful 
goals.21
•
UW Pain Self-efficacy Questionnaire: This questionnaire was developed to assess the 
confidence people with ongoing pain have in performing activities while in pain 
(https://uwcorr.washington.edu/measures/uw-prse/).
•
Medications: Patients will report medications they have taken for pain in the past 24 hours.
Other variables to be included in the baseline e-Questionnaire include: low back pain history 
characteristics, work-related factors (receiving disability or compensation, or planned 
applications, hours/days off work at baseline, job satisfaction ratings, physical demands at work), 
smoking and vaping history, and questions with regards to current typical number of alcoholic 
beverages consumed per week and cannabinoid use.
Scheduled e-Questionnaires
We have now provided an updated version of the Scheduled e-Questionnaire content (Attachment 
Q2-Scheduled e-Questionnaire). As mentioned above, this e-Questionnaire is part of the UW 
(non-VA) study processes. Only the content of the e-Questionnaire can be provided, not the actual 
e-Questionnaire, since it is an electronic questionnaire. Variables included in both Scheduled and 
Flare Window e-Questionnaires include several of the measures listed immediately above under 
“Baseline e-Questionnaire”, such as: numerical rating scales of low back pain intensity23,24, 
analgesic use25, the 2-item version of the Coping Strategies Questionnaire15, the 2-item version of 
the TSK26, the 1-item global measure severity of depression17, the 2-item version of the PCL-C 
scale18, the single-item stress question (SISQ)19,20, hours of lost work27, other variables related to 
work quality/quantity,28 recent cigarette smoking, vaping history, number of alcoholic beverages 
consumed and cannabinoid use.
Flare Window e-Questionnaires
The flare window e-Questionnaire material includes the same content as the Scheduled e- 
Questionnaire content (Attachment B-Scheduled e-Questionnaire), but the wording of items are 
slightly different, to indicate the reference time period occurring prior to flare onset (instead of prior 
to the expected Scheduled e-Questionnaire start time). This e-Questionnaire (to be administered 
as part of the non-VA study processes) is submitted to the VAPSHCS IRB currently (see 
Attachment Q3). Only the content of the e-Questionnaire can be provided, not the actual e- 
Questionnaire, since it is administered electronically.
Exit e-Questionnaire
 
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The exit e-Questionnaire to be administered as part of the non-VA study processes will be provided 
to the VAPSHCS IRB at a future PRAF. The exit e-Questionnaire materials include many of the 
same measures as contained in the baseline e-Questionnaire, but omit some measures that need 
only be assessed at baseline (and not at final follow-up). The exit e-Questionnaire will also include 
measures of global perceived improvement and satisfaction, which were not included on the 
baseline e-Questionnaire.
Brief Telephone-based Exit Survey
For participants who have been unable to compete the Exit e-Questionnaire, we will offer
a brief telephone-based Exit Survey. The brief telephone-based Exit Survey is limited to 25 questions, 24 
of which are yes/no questions, and 1 of which is a 10-point scale. Participants will already be familiar 
with these items from prior surveys they have completed in the study, and the telephone-based Exit 
Survey should take between 5-10 minutes to complete. We will make up to 2 phone contacts in which a 
voicemail can be left, or if a participant declines the brief telephone-based Exit Survey (whichever comes 
first).We provide the questions for the new telephone-based Exit Survey in Attachment ZZ. Participants 
completing the brief telephone-based Exit Survey will be compensated the same amount as if they had 
completed the full electronic Exit e-Questionnaire.
VA data storage.
See Section 7.0 for further information relevant to data storage.
Part of the VA research records will be stored in paper form in a locked file cabinet (in the locked 
office space of the Seattle ERIC at VA Puget Sound) and part will be stored electronically. The file 
cabinets and computers will be locked and are housed in rooms that are locked when unoccupied. 
Other information will be stored electronically. All electronic data will be stored in encrypted, 
password-protected files on the VA secure research server with access restricted to VA research 
staff on this study team. Data will not be stored on any laptops or computers outside VA Puget 
Sound.
5.6 Data Analysis
5.6.1
 
  Sample
 
  Size
 
  Calculations:
 
  Of the recruitment goal of 730 Veterans, we expect that 290 
Veterans (40%) will have limited data available
(i.e. they will fail the run-in period, be non- 
compliant with e-Questionnaire data collection, be 
lost to follow-up, or withdraw). All data analysis 
will be conducted using VA data (including e- 
Questionnaire data that has been downloaded to 
the VA and has become VA data) by the 
biostatistical team from the Seattle ERIC listed in 
this human subjects application (Korpak, 
Timmons, Baraff, Forsberg). Key determinants of 
statistical power for the Aim 1 case-crossover 
analysis include the (1) activity exposure effect 
size, (2) activity frequencies (expected to be 5-
 
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25% based on a previously conducted pilot study29), (3) number of case/control periods, and (4) 
proportion of participants who are statistically informative (with both case and control periods). Given 
the transient nature of flares, in our view, only activity exposures with moderate magnitude effects 
(ORs of 1.5-2.0) will have a meaningful impact on the population level. Informed by the 
characteristics of activities, flares, and missing data from our pilot29, we estimated power using 
simulated data with 1000 replications, assuming =0.005 (Bonferroni-corrected for 10 activity 
groups), comparing different assumptions for sample size determinants, including activity 
frequencies as low as 3%. A sample size of n=440 yielded 90% power to detect ORs of 1.5 for 
activity frequencies 10%, 80% power to detect OR=1.6 at activity frequency=5%, and 80% power 
for OR= 1.81 given activity frequencies as low as 3% (Figure 2.). Allowing for 40% of participants 
not being analyzed due to having limited data available (loss to follow-up, fail run-in period, etc.), this 
yielded a planned sample size of n=730 for Aim 1. These power estimates are highly 
conservative, since (1) they use data from scheduled e-Questionnaires only and assume no data 
from ad hoc flare-window e-Questionnaires, and (2) they assume no information at all from the 
n=290 with limited data. Moreover, they are based on binary activity exposures, and analyses using 
continuous exposures (incorporating duration and frequency) will have greater power. As a point of 
comparison, the previously conducted pilot study was able to detect ORs ≥2.5 and p-values< 0.001 
despite having ~9x fewer participants than the currently proposed study.29 For Aim 2, using the same 
data simulated for Aim 1, and assuming an expected mean (standard deviation) 1-year RMDQ 
scores of 8.8 (6.4) from a prior study,30 Bonferroni-corrected =0.005, activity frequencies 20%, 
and n=440 without missing data (from n=730 initially recruited), we estimated power over a range of 
scenarios where we varied the strength of the association between the change in activity frequency 
over the 1st 4 weeks of follow-up (for each of the 10 activity categories) and a minimum clinically 
important change in 1-year RMDQ of 2.5 points.31 We found ≥80% power to detect a 2.5-RMDQ- 
point difference at 12 months in scenarios where a 65% change in activity frequency over the 1st 4 
weeks produced a 2.5-RMDQ-point difference at 12 months, and in all scenarios where the activity 
frequency-RMDQ relationships was more extreme (e.g., if a smaller % change in activity frequency 
produced a 2.5-RMDQ-point difference at 12 months. This confirms adequate power with a planned 
sample size of n=730 for Aim 2.
5.6.2. Analytic approach: All analyses will be conducted at VA by members of the Seattle ERIC 
biostatistical team, by research staff member biostatisticians named on this protocol as above. It is 
expected that Dr. Anna Korpak and Mr. Andrew Timmons of the Seattle ERIC will conduct all analyses 
involved. If needed, other members of the Seattle ERIC biostatistical team named above as study 
personnel may be called upon for analyses, such as Mr. Baraff and Mr. Forsberg. Senior biostatistical 
oversight will be provided by Dr. Patrick Heagerty at UW; however, Dr. Heagerty will not interact directly 
with study data and/or PHI, and will only see results in aggregate format such as would be presented for 
publication to a scientific journal.
We will conduct analyses to identify patterns of missing data that may indicate whether they are 
ignorable.10 Approaches to deal with missingness will vary depending on patterns of missingness and 
may change completely from the initial approach specified here. If >5% of outcome data are missing, 
the sample will be divided into two groups (missing vs. not missing) and fully observed variables will 
be examined to determine if they predict missingness on the affected outcome. Depending on this 
analysis, the missingness may be considered “observed at random” thus meeting some criteria for
 
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“missing at random” assumptions. Multiple imputation procedures will then be implemented. If data 
missingness is not ignorable, we will use Heckman’s selectivity models or pattern-mixture models 
with multiple imputation to model the missingness.10 These methods for dealing with missing data 
may change based on the actual nature of the data and missingness.
We will characterize the study sample using descriptive statistics and graphical techniques such as 
frequencies, means, medians, histograms and box plots. Quantitative variables (e.g., ActiGraph data) 
will be transformed as needed (e.g., log transformations for positively skewed long-tailed distributions, 
or conversion to categorical variables based on clinical rationale or distribution). All analytic 
approaches as stated below are preliminary plans,
and may change depending on developments in the 
field, new statistical innovations, and the nature of 
the data at hand.
5.6.2
 
    
  a. Aim 1 analyses
 
 : We 
will examine associations 
between activity group 
exposures and the participant-
reported flares outcome in 
conditional logistic regression 
models, using data from all 
scheduled and flare window
 
  e-
  
Questionnaires
 
  over
 
  1-
   year. 
There will be one model for each 
of the 10 primary activity 
categories. Models will include 
activity categories as time- 
varying predictors as in equation 
1, where Y is the outcome (flare 
vs. no flare), x is the activity
exposure (yes vs. no), and C represents potential time-varying confounders (psychological factors,
other activities). The letter i indicates the ith individual (i =1,2,. . . n), j indicates the jth time of follow-up 
(j =1,2,. . . ,ni) and xi(j-1) indicates an activity that was performed in the exposure window prior to the jth 
time (either the start of the control window [scheduled e-Questionnaire] or time of flare onset [flare 
window e-Questionnaire]). As previously noted, the survey methods are such that activity exposure 
and flare outcome are inherently time-lagged, with exposure preceding outcome. βw represents the 
association of activity x with flare outcome Y within individuals (the ‘within-individual effect’), or the 
expected odds of a flare with change in the activity exposure for a given individual. These analyses 
will yield odds ratios (OR) and 95% confidence intervals for within-individual ‘effects’ of activity 
triggers on an LBP flare. The initial analytic approach (Figure 3) will examine the association 
between binary activity exposure and binary flare outcome, with explicit adjustment for pain NRS and 
number of prior flares measured at time=j-1, and time-variant confounders selected based on 
conceptual importance; by design, the case-crossover method uses each person as their own 
control, accounting for known and unknown confounds that are fixed or relatively stable over time 
(i.e., age, sex, sociodemographics, medical and LBP history, work-related factors, and underlying 
psychological predispositions). We will use a Bonferroni-corrected threshold of p=0.005 for each 
Figure 3. Aim 1 Overview
 
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primary activity-
 
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flare comparison to account for 10 statistical comparisons (one for each of the 10 activity 
categories). We will further examine for activity-flare associations after accounting for important 
relationships based on theory and clinical knowledge, including the following: dose-response 
relationships; work- specific activity-flare associations; multivariate analyses including other potential 
confounders (other time-varying activities, depression, PTSD, stress, catastrophizing); potential 
moderators; different effect-periods of activity exposures (i.e., 24 vs. 2 hours); possible biases (e.g., 
conscious activity avoidance and carry-over effects); and clinical subgroup analyses (lumbosacral 
radicular syndrome [LSRS] symptomatic lumbar spinal stenosis [SLSS] diagnosed by a specialist, 
ascertained by chart review). We will also conduct similar subgroup analyses as secondary 
analyses, targeting the expanded target population subgroups described above (facet-mediated 
pain, SIJ-mediated pain, spondylolysis, ascertained by EHR review). We will analyze the reliability 
and accuracy of these subgroups. Of note, the primary analysis of walking, standing, and sitting will 
use the ActiGraph data (which are only obtained for the 1st 4 weeks of follow-up); secondary 
analyses will use the self- reported data for these 3 groups over the entire 1-year follow-up, and will 
also examine the association between ActiGraph and self-reported data. After these analyses using 
the binary flare outcome, we will use an analogous approach to examine relationships between 
activity categories and the secondary (continuous) outcome of NRS LBP intensity, with linear mixed-
effects regression. These analyses account for potential biases that might be introduced by 
participant self-identification of flare status; if no such bias exists, we would expect the direction of 
effects to be similar to those obtained in the initial analysis of flares.8,9
5.6.2b. Aim 2 analyses: We will examine associations between the frequency of activity during 
scheduled e-Questionnaires (% of periods during which each of the 10 primary activity categories 
were reported over the 1st 4 weeks of follow-up), and the outcome of long-term LBP-related functional 
limitations at 12 months as reflected by the RMDQ,31 using a Bonferroni-corrected threshold of 
p=0.005 (Figure 4). Activity over the 1st 4 weeks is the exposure of interest for the Aim 2 analysis 
because activity restriction is most expected early in an episode of LBP, and because of our 
previously-stated reasoning that early changes in activity may be particularly important in determining 
long-term/overall activity-function relationships. The percentage of periods with each activity category 
over the 1st 4 weeks will be calculated from self-reported activity information and ActiGraph output.
The main multivariate model for each activity category will explicitly adjust for a range of potential 
confounders based on prior knowledge and conceptual rationale, including baseline RMDQ score, 
and all psychological predictors and other baseline covariates. We will then conduct secondary 
analyses analogous to that done for Aim 1 to examine activity-1-year-RMDQ associations after 
accounting for important relationships based on theory and prior knowledge: potential moderation by 
baseline employment status,
compensation status, or job
satisfaction; potential 
moderation by analgesic use 
over the first 4 weeks of 
follow-up; sensitivity analyses 
contrasting associations with 
cumulative activity exposure 
early (weeks 1-2) vs. late 
(weeks 3-4 or weeks 5-8)
Figure 4. Aim 2 Overview
 
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during follow-up; and clinical subgroup analyses (LSRS and SLSS subgroups). We will use the same 
approach for the secondary outcomes of LBP intensity, lost work productivity, quality of life, and 
analgesic use at 1-years.
Analyses for Aims 1 and 2 will use VA administrative data to weight the sample of participants back 
to represent the target population of Veterans with back pain (including those who did not respond to 
the study).
5.6.3.
 
  Interpretation
 
 : Aims 1 and 2 will yield tables of risk estimates for (1) the short-term effects of 
the 10 specific activity categories on flares and (2) the long-term effects of such activities on 
functional recovery as reflected by the 1-year RMDQ score. We expect that different activities will 
have different patterns of short-term vs. long-term effects. In instances where short-term and long-
term effects are in the same direction, potential implications for activity recommendations may be 
straightforward. For example, if heavy lifting confers both greater short-term risk of pain flares and 
greater long-term risk of functional limitations at 1-year follow-up, the clinical implication may be that 
that lifting should be avoided for those with LBP. In some instances where the short-term vs. long-
term effects of activities differ, however, implications may depend on personal priorities and 
preferences. For example, if walking increases the short-term risk of a flare but has no effect on 
functional recovery at 1 year, the decision of whether or not to walk during a new LBP episode might 
be guided by a patient’s preferences. In other instances where the short-term vs. long-term effects of 
activities differ in direction, the latter may take priority (i.e., if walking improves functional recovery at 
1 year, but causes a small magnitude increase in pain flares, walking should likely be encouraged).
5.7 Withdrawal of Subjects
Participant
 
  withdrawals
 
 
We will record termination/withdrawal information for participants who decide to leave the study. 
Participants may leave the study at their own discretion, by contacting the research team and notifying 
them of the decision to leave the study. Participants may be withdrawn from the study without their 
consent if they become incarcerated during the study, or if the researchers feel that the study is in 
some way negatively affecting the participant’s health or wellbeing. Participants may be withdrawn 
from the study without their consent if their responses to surveys are consistent with systematic non- 
compliance such as consistent non-completion or non-response to surveys not explained by other 
factors; findings indicating false data such as e-Questionnaire completion times that are too fast to be 
possible; or inappropriate and repeated completion of ad hoc flare window surveys even after 
explanation/clarification. Participants may also not be offered participation, or be withdrawn from the 
study, if they demonstrate threatening behaviors or potentially harmful behaviors towards research 
study staff.
Although not considered ‘withdrawal’ per se, participants who are consented may be subsequently 
excluded, if they fail the 2-week run-in period requirements as described above. For the purposes of the 
Information Statement, to simplify understanding for potential participants, we do not distinguish 
between withdrawals and these pre-randomization exclusions.
 
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6.0
Reporting
There are no study-related processes in this purely observational study that would be expected to 
cause serious adverse events. E-Questionnaires inquire about musculoskeletal pain conditions and 
treatments, other diagnoses, sociodemographic factors, and factors related to healthy living and 
lifestyle. We do not anticipate these to pose any significant effect on a participant’s health or well- 
being, although it is theoretically possible (although highly improbable) that some questions may 
cause emotional distress or discomfort due to participants paying more attention to areas where 
musculoskeletal pain may or may not be present. Any possible discomfort or distress is expected to 
be negligible, and of note e-Questionnaires do not include question items pertinent to sensitive 
issues such as suicide risk, stigmatized behaviors, sexual trauma, etc. We will take the steps 
outlined in the IRQ to mitigate any possible discomfort or distress for participants when answering 
questions in the e-Questionnaires.
We will collect safety information regarding problems that are reported in an ad hoc basis to study 
staff by participants who complete informed consent for the VA component of this study as described 
in this human subjects application. Safety information will be collected via any applicable means 
(verbal and/or written communication) at the time of occurrence, but we will suggest that participants 
contact research staff by telephone. Safety information, including unexpected serious adverse 
events or problems, will be reported in accordance with VHA Handbook 1058.01. Collection of safety 
information will begin at study initiation. Collection of safety information will end at study closeout.
Study staff will report safety information to the PI Dr. Pradeep Suri at the time of occurrence. Events 
will be communicated via any applicable means (verbal and/or written communication). An adverse 
event or problem will be communicated to the IRB in writing using forms such as the 1) 
Unanticipated Serious Adverse Event or Problem Report, or 2) Continuing Review Questionnaire or 
Research Project Termination Report. An adverse event or problem will be communicated to the 
IRB in writing 1) within 5 business days of becoming aware of any serious unanticipated problem 
involving risks to subjects or others in VA research, or 2) at the time of study renewal or closure, 
whichever comes first, if the event is not serious or unexpected. Unauthorized research-related 
access, use, disclosure, transmission, removal, theft, or loss of VA sensitive information, including 
but not limited to PHI, individually-identifiable private information, confidential information, and 
Privacy Act-protected information will be reported within 1 hour of becoming aware of the event.
Data for reporting will be compiled at the time of study renewal or closure.
7.0
Privacy and Confidentiality
The study will use participants’ Protected Health Information (PHI) for the purposes of participant 
payment by mailed checks to the participant’s current address. Also, PHI will be used to contact 
participants via telephone (as outlined above). PHI will be contained in the crosswalk file that links 
participant identifiers with the study-specific StudyID. No PHI will be disclosed at any point in the 
study.
We will take multiple steps to protect participants’ privacy, confidentiality, and inappropriate 
disclosure of data, under strict VA security guidelines. All study staff will maintain current on required
 
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VA trainings for privacy and confidentiality. Data will be stored in Participant Data Files that will be 
de-identified, labeled with a code number that is unique to each patient in the study (‘study-specific 
StudyID’). The study-specific StudyID will be a unique numerical code consecutively numbered in 
order of approach/screening. We will NOT include any protected health information (PHI) in the 
Participant Data Files. The Participant Data Files will be stored in a secure password-protected 
electronic location on the VA servers (expected to be the in the J: drive on the Health Services 
Research & Development (HSR&D) server), accessible only to study staff members and authorized 
personnel. Staff will maintain a Master List key code that links participants with the study-specific 
StudyID. This Master List key code will be stored in a secure password-protected electronic 
location on the VA servers, separately from all other study data. All hard copy files such as signed 
informed consent forms (from prior to the time when these were replaced by Information 
Statements) .will be stored in locked filing cabinets in the locked/secured offices of the Seattle 
ERIC, while all electronic data will be stored in password-protected files in a limited access folder 
(to research staff) on a secure VA network drive. Only IRB-approved study personnel will have 
access to Participant Data Files or Informed Consent Forms. We will only analyze data that does 
NOT contain PHI, and will report participant data in aggregate form only- no PHI will be entered into 
analyses or reports.
If improper use or disclosure of research data occurs, the ISSO and Privacy Officer will be notified 
within one hour of the improper use or disclosure, and we will also adhere to any other local policies 
regarding improper use or disclosure.
Of note, no wireless or remote data sharing will be enabled on the ActiGraph, so no data can be 
transmitted in this way, safeguarding data and participants’ privacy.
8.0
Communication Plan
This study involves VAPSHCS as the coordinating center and UW as a participating site. When the initial 
application to conduct human subjects research (related to the non-VA component of this study) was 
submitted to the UW IRB by UW researchers, we provided a letter notifying the UW IRB of the existing 
VAPSHCS IRB approval and a copy of the VAPSHCS IRB approval letter. For any future modifications to 
the UW IRB-approved research processes, we will coordinate with UW researchers who will submit 
documentation to the UW IRB if appropriate; due to the study’s minimal risk, the UW IRB has indicated 
that they only want to receive updated documentation if major, substantiative changes are made to the 
study processes. If such changes occur, we will provide the appropriate documents to the UW IRB.. If we 
are told a particular document cannot be shared with the UW IRB and UW researchers, we will share a 
summary of the document’s contents instead.
At the time of any PRAF or modification submitted to the VAPSHCS IRB, we will submit relevant human 
subjects approvals from UW and documents approved by the UW IRB that have changed since the last 
PRAF or modification. Conversely, at the time of any modification submitted to the UW IRB, we will 
share the most recent VAPSHCS IRB approval letter unless previously shared, and either pertinent 
VAPSHCS IRB-approved documents, or summaries of such documents, according to the guidance 
provided by the VAPSHCS IRB or IRB administrators. In instances where we are told that VAPSHCS
 
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IRB-approved documents or summaries are not required with UW IRB modifications, we will not submit 
such documents.
There are no expected AEs or serious AEs involved with this purely observational research. We will 
work with UW researchers to ensure that UW researchers report SAEs or unanticipated problems 
(UAPs) to our VAPSHCS research team within 5 days of becoming aware of the SAEs or UAPs. The 
study design does not permit the sharing of individual-level VA data outside of the VA during the study. 
Therefore, if SAEs or UAPs are reported to or otherwise learned of by VA research staff, we will advise 
participants to contact UW research staff and report this information. Where applicable, information on 
SAEs or UAPs can also be shared with UW researchers in aggregate form.
9.0
Information Security and Data Storage/Movement
Research data pertaining to this application are VA data. These data would only remain within the 
VA, and would not be moved or shared outside the VA. Non-VA data produced by e-Questionnaires 
will be shared by UW researchers with VA researchers on the VA study team, at which time this data 
will become VA data and will not be moved or shared outside the VA.
Hard-copy (print) documents include completed screening checklists and signed informed consent 
forms. Electronic data include databases of parameters obtained during screening/recruitment, 
ActiGraph data, and VA administrative data obtained from the CDW or any such proxy that comes 
into use after the Cerner EHR transition. Additional electronic databases include non-VA data that 
are shared to the VA research team, at which time that non-VA data will become VA data. These 
non-VA data will be downloaded by VA researchers. This is one-way sharing, since once this 
becomes VA data it will not be shared outside VAPSHCS except as mandated by provisions for 
potential sharing of anonymized datasets once enterprise-level resources for this are available 
(described below). Of note, data from participants who completed informed consent using an 
Information Statement (without written documentation of informed consent) cannot be shared outside 
the federal government even after enterprise-level resources are available.
Any hard-copy documents involved will be stored in locked file cabinets in the locked/secured 
offices of the Seattle ERIC. These will be retained for six years after study closure, until destroyed 
in accordance with VA procedures, and will not be moved from the ERIC, since there is no need for 
movement of the documents (unless they need to be locally archived according to local R&D 
processes).
Similarly, the electronic databases/files described above will be maintained locally in a secure 
manner until enterprise-level resources become available for long-term storage and access. Once 
enterprise-level resources become available for long-term secure electronic storage, we will use 
those resources. Electronic databases will be retained for six years after study closure, at which time 
they will be destroyed in accordance with VA procedures. We will update the above plan as needed 
if VA procedures and requirements change in the future. We will ensure that data is 
destroyed/sanitized in accordance with VA Directive 6500.
Current VA requirements mandate provisions for making the final data sets resulting from VA funded 
research available outside the VA. As stated in the submitted DMAP document, once enterprise-
 
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level resources become available for electronic access, we will use those resources to make de- 
identified, anonymized datasets available to approved applicants under a formal written agreement. 
Only completely deidentified and anonymized versions of datasets would be shared. Sharing will 
only take place under a written agreement prohibiting the recipient from identifying or re-identifying 
(or taking steps to identify or re-identify) any individual whose data are included in the dataset. Of 
note, data from participants who completed informed consent using an Information Statement 
(without written documentation of informed consent) cannot be shared outside the federal 
government even after enterprise-level resources are available. We will update the above plan as 
needed if VA procedures and requirements change in the future.
Participants’ involvement in the UW (non-VA) research processes will result in deidentified and 
anonymized UW datasets containing participants’ e-Questionnaire responses that UW researchers 
will retain. Those datasets will not include several components of data that are part of the VA 
datasets, such as ActiGraph data, EMR data, and data collected during initial screening.
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