The BEST Trial: Biomarkers for Evaluating Spine Treatments
Official Title
The BEST Trial: Biomarkers for Evaluating Spine Treatments
Acronym
BEST
Organization
University of North Carolina, Chapel HillOTHER
Status Module
Record Verification Date
Aug 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 12, 2022Actual
Primary Completion Date
Jul 30, 2024Actual
Completion Date
Oct 22, 2024Actual
First Submitted Date
May 24, 2022
First Submission Date that Met QC Criteria
May 24, 2022
First Posted Date
May 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
May 30, 2025
Results First Submitted that Met QC Criteria
Jul 2, 2025
Results First Posted Date
Jul 23, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 2, 2025
Last Update Posted Date
Jul 23, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of North Carolina, Chapel HillOTHER
Collaborators
Name
Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating the optimal treatment or combination of treatments based on patient features and response to the initial treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.
Detailed Description
Each participant will complete an initial screening call and enrollment visit, followed by a 2-week run-in period, two consecutive 12-week treatment periods, and a 12-week post-treatment follow-up period. Upon completion of the run-in period, participant eligibility will be reassessed based on adherence to study protocol. Participants who no longer meet eligibility criteria will be considered screen failures and discontinued from the study.
All participants will undergo phenotyping assessments at Visit 0, 1 and 2 corresponding to baseline, the end of the first 12-week intervention period, and the end of the second 12-week intervention period, respectively. A subset of participants will undergo additional phenotyping, consisting of a more comprehensive set of phenotyping assessments, at the same visits.
Pain, Enjoyment of Life, and General Activity (PEG) and Patient Global Impressions Scale (PGIC) will be assessed at 6 weeks (midpoint of intervention period one), 12 weeks (Visit 1), 18 weeks (midpoint of intervention period two), 24 weeks (Visit 2), and 36 weeks post-baseline (12 weeks after intervention period two). Basic safety assessments will also be performed at these time points to assess participant tolerability to their current study intervention(s). Patients who are unable to tolerate their assigned study treatment will be educated on how to safely discontinue their current treatment plan but will otherwise remain in the study.
Conditions Module
Conditions
Chronic Low-back Pain
Keywords
Pain
Back Pain
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,014Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment Period 1: Enhanced Self-Care (ESC)
Active Comparator
This arm includes participants who are randomized to ESC in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ESC or be randomized to augment ESC with an additional treatment during Treatment Period 2.
Behavioral: Enhanced Self-Care (ESC)
Treatment Period 1: Acceptance and Commitment Therapy (ACT)
Active Comparator
This arm includes participants who are randomized to ACT in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on ACT, augment ACT with an additional treatment, or switch to a new treatment during Treatment Period 2.
Behavioral: Acceptance and Commitment Therapy (ACT)
Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
Active Comparator
This arm includes participants who are randomized to EBEM in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on EBEM, augment EBEM with an additional treatment, or switch to a new treatment during Treatment Period 2.
Behavioral: Evidence-Based Exercise and Manual Therapy (EBEM)
Treatment Period 1: Duloxetine
Active Comparator
This arm includes participants who are randomized to Duloxetine in Treatment Period 1.
Depending on their response to Treatment 1 measured at 12 Weeks post-initial randomization, participants in this arm will stay on Duloxetine, augment Duloxetine with an additional treatment, or switch to a new treatment during Treatment Period 2.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Enhanced Self-Care (ESC)
Behavioral
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Patient-Reported Pain Intensity and Interference Score
Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.
Baseline, 24 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Patient-Reported Outcomes Measurement Information System-Pain Interference
Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
To be eligible, an individual must meet all of the following inclusion criteria:
Ability to read and understand English
Provision of signed and dated informed consent form(s)
Willing and able to receive study-related messages and survey links via email
Willing and able to receive study-related phone calls
Age 18 years old or older
Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months
Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s)
Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible
A PEG score 4 or higher prior to the Run-in period
Willing and able to undergo required phenotyping
Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer
Meet Run-in period engagement eligibility criteria:
o Completion of two Run-in study information modules prior to period 1 randomization (Visit 0)
Low-back pain more severe than pain in other parts of the body
Available to complete the full study protocol (approximately 9 months)
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnant at the time of Visit 0 (Baseline)
Affirmative participant response to any of the following conditions:
Progressive neurodegenerative disease
History of discitis osteomyelitis (spine infection) or spine tumor
History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing)
Diagnosis of any vertebral fracture in the last 6 months
Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates.
History of any bone-related cancer or cancer that metastasized to the bone
Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months
History of any non-skin cancer treatment in the last 24 months
Visual or hearing difficulties that would preclude participation
Uncontrolled drug/alcohol addiction
Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation
Currently participating in another interventional pain study
Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial
All relevant study data will be shared through NIH portals as required.
Types
Not provided
Time Frame
Data will be made publicly available on the NIH HEAL Platform or other NIH repositories after acceptance of publication for the primary results per NIH HEAL Data Sharing Policy and will remain available for a minimum of 10 years.
While 1014 participants in total were enrolled in the trial, 805 were randomized. This was due to participant withdrawal or participant ineligibility during the run-in period between the enrollment visit and randomization.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Acceptance and Commitment Therapy (ACT) Alone
This arm included both participants who had a strong response to Acceptance and Commitment Therapy (ACT) in Period 1 and participants who were not assessed for response at the end of Period 1. In Period 1, participants randomized to ACT took part in 12 therapy sessions over the course of 12 weeks. Each participant was scheduled for a combination of 4 remote face-to-face visits and 8 therapist-supported online sessions, which included a self-directed module combined with personalized provider coaching delivered via an online messaging system. In Period 2, strong responders were encouraged to continue to practice ACT skills at home without therapist supervision and were given access to an additional 11 ACT audio modules.
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Treatment Period 1: Acceptance and Commitment Therapy (ACT)
Evidence-Based Exercise and Manual Therapy (EBEM)
Behavioral
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
Treatment Period 1: Evidence-Based Exercise and Manual Therapy (EBEM)
Duloxetine
Drug
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
Treatment Period 1: Duloxetine
Cymbalta
Baseline, 24 Weeks
Number of Participants Self-Reporting Taking Opioids
The number of participants self-reporting taking opioids ("Yes" response) is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?".
24 Weeks
Patient-Reported Outcomes Measurement Information System- Physical Function
Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Baseline, 24 Weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score
Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Baseline, 24 Weeks
Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety
Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
Baseline, 24 Weeks
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.
Baseline, 24 Weeks
Sleep Duration
Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.
Baseline, 24 Weeks
San Diego
California
92037
United States
University of California, San Francisco
San Francisco
California
94158
United States
University of Kansas Health System
Kansas City
Kansas
66160
United States
Massachusetts General Hospital/Brigham Women's Hospital, Harvard Medical School
Boston
Massachusetts
02114
United States
University of Michigan
Ann Arbor
Michigan
48189
United States
University of North Carolina Hospital Pain Management Clinic
Chapel Hill
North Carolina
27599
United States
Atrium Health Wake Forest Baptist
Winston-Salem
North Carolina
27517
United States
The Ohio State University Wexner Medical Center
Columbus
Ohio
43203
United States
University of Pittsburgh
Pittsburgh
Pennsylvania
15219
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
University of Washington
Seattle
Washington
98104
United States
Derived
Jones Berkeley S, Wedin S, Patidar SM, Margolies SO, Goetzinger AM, Mauck MC, Wasan AD, McCracken LM. Design and implementation of online acceptance and commitment therapy with enhanced therapist support for chronic low back pain (ACT for PAIN). Pain Med. 2025 Aug 1;26(8):451-458. doi: 10.1093/pm/pnaf026.
Mauck MC, Barth KS, Bell KM, Brooks AK, Chadwick AL, Gunn CA, Hurley RW, Ivanova A, Piva SR, Schneider MJ, Bailey JF, Bagaason S, Batorsky A, Borckardt JJ, Bowden AE, Carey TS, Castellanos J, Chen L, Chidgey B, Dalton D, Dufour JS, Fields AJ, Fritz JM, Goolsby RW, Greco CM, Harris RE, Harte S, Hassett AL, Hoffmeyer A, Jones Berkeley S, Kaplan C, Kidwell KM, Knapik GG, Kosorok MR, Kurillo G, Lobo R, Lotz JC, Mackey S, Mageswaran P, Majumdar S, Mao J, Marras WS, McCumber M, McLean SA, Mehling W, Mitchell UH, Napadow VJ, O'Neill C, Patel KV, Peltier S, Psioda M, Rowland B, Rundell SD, Schrepf A, Sperger J, Vo N, Wallace MS, Wasan AD, Weaver TE, Weber KA 2nd, Williams DA, Wilson L, Zeidan F, Zhao B, Anstrom KJ, Clauw DJ, Sowa GA. The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial. Pain Med. 2025 Sep 1;26(9):538-553. doi: 10.1093/pm/pnaf032.
FG001
ACT Plus Duloxetine, Moderate Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Duloxetine in Period 2 while continuing ACT treatment.
FG002
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Evidence Based Exercise and Manual Therapy (EBEM) treatment in Period 2 while continuing ACT.
FG003
ACT Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to ACT in Period 1 and started Enhanced Self-Care Therapy (ESC) treatment in Period 2 while continuing ACT.
FG004
ACT Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2 while continuing ACT.
FG005
ACT Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2 while continuing ACT.
FG006
ACT Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2 while continuing ACT.
FG007
ACT Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
FG008
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
FG009
ACT Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
FG010
ACT Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started Duloxetine treatment in Period 2. ACT treatment was discontinued.
FG011
ACT Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started EBEM treatment in Period 2. ACT treatment was discontinued.
FG012
ACT Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to ACT in Period 1 and started ESC treatment in Period 2. ACT treatment was discontinued.
FG013
Duloxetine Alone
This arm included both participants who had a strong response to Duloxetine in Period 1 and participants who were not assessed for response at the end of Period 1.
FG014
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
FG015
Duloxetine Plus Evidence Based Exercise & Manual Therapy(EBEM), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
FG016
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
FG017
Duloxetine Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2 while continuing Duloxetine.
FG018
Duloxetine Plus Evidence Based Exercise and Manual Therapy (EBEM), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2 while continuing Duloxetine.
FG019
Duloxetine Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2 while continuing Duloxetine.
FG020
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
FG021
Duloxetine Followed by Evidence Based Exercise and Manual Therapy(EBEM), Low Period 1 Trt Response
This arm included participants who had a low response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
FG022
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
FG023
Duloxetine Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ACT treatment in Period 2. Duloxetine treatment was discontinued.
FG024
Duloxetine Followed by Evidence Based Exercise and Manual Therapy (EBEM), Poor Period 1 Trt Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started EBEM treatment in Period 2. Duloxetine treatment was discontinued.
FG025
Duloxetine Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to Duloxetine in Period 1 and started ESC treatment in Period 2. Duloxetine treatment was discontinued.
FG026
Evidence Based Exercise and Manual Therapy (EBEM) Alone
This arm included both participants who had a strong response to EBEM in Period 1 and participants who were not assessed for response at the end of Period 1.
FG027
EBEM Plus Duloxetine, Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
FG028
EBEM Plus Acceptance and Commitment Therapy (ACT), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
FG029
EBEM Plus Enhanced Self-Care Therapy (ESC), Moderate Period 1 Treatment Response
This arm included participants who had a moderate response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
FG030
EBEM Plus Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2 while continuing EBEM.
FG031
EBEM Plus Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2 while continuing EBEM.
FG032
EBEM Plus Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ESC treatment in Period 2 while continuing EBEM.
FG033
EBEM Followed by Duloxetine, Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
FG034
EBEM Followed by Acceptance and Commitment Therapy (ACT), Low Period 1 Treatment Response
This arm included participants who had a low response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
FG035
EBEM Followed by Enhanced Self-Care Therapy (ESC), Low Period 1 Treatment Response
This arm included participants who had a low response to ESC in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
FG036
EBEM Followed by Duloxetine, Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started Duloxetine treatment in Period 2. EBEM treatment was discontinued.
FG037
EBEM Followed by Acceptance and Commitment Therapy (ACT), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ACT treatment in Period 2. EBEM treatment was discontinued.
FG038
EBEM Followed by Enhanced Self-Care Therapy (ESC), Poor Period 1 Treatment Response
This arm included participants who had a poor response to EBEM in Period 1 and started ESC treatment in Period 2. EBEM treatment was discontinued.
FG039
Enhanced Self-Care Therapy (ESC) Alone
This arm included both participants who had a strong response to ESC in Period 1 and participants who were not assessed for response at the end of Period 1.
FG040
ESC Plus Duloxetine, Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started Duloxetine treatment in Period 2. ESC treatment was discontinued.
FG041
ESC Plus Acceptance and Commitment Therapy (ACT), Moderate to Low Period 1 Treatment Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started ACT treatment in Period 2. ESC treatment was discontinued.
FG042
ESC Plus Evidence Based Exercise and Manual Therapy (EBEM), Moderate to Low Period 1 Trt Response
This arm included participants who had a moderate to poor response to ESC in Period 1 and started EBEM treatment in Period 2. ESC treatment was discontinued.
FG00063 subjects
FG0018 subjects
FG0028 subjects
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COMPLETED
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NOT COMPLETED
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Type
Comment
Reasons
Withdrawal by Subject
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Lost to Follow-up
FG00015 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage 2 Screening (Week 12 Pre-Rand.)
Type
Comment
Milestone Data
STARTED
FG00028 subjects
FG0018 subjects
FG0028 subjects
FG0035 subjects
FG00412 subjects
FG00521 subjects
FG00620 subjects
FG00712 subjects
FG00822 subjects
FG00928 subjects
FG0102 subjects
FG0111 subjects
FG0121 subjects
FG01348 subjects
FG0149 subjects
FG0154 subjects
FG0164 subjects
FG0174 subjects
FG0188 subjects
FG0199 subjects
FG02025 subjects
FG02126 subjects
FG02226 subjects
FG0234 subjects
FG0243 subjects
FG0255 subjects
FG02671 subjects
FG0275 subjects
FG02815 subjects
FG02912 subjects
FG0306 subjects
FG0319 subjects
FG03214 subjects
FG03313 subjects
FG03412 subjects
FG0357 subjects
FG0364 subjects
FG0371 subjects
FG0384 subjects
FG03916 subjects
FG04041 subjects
FG04159 subjects
FG04259 subjects
COMPLETED
FG00026 subjects
FG0018 subjects
FG0028 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage 2 Intervention (Weeks 12-24)
Type
Comment
Milestone Data
STARTED
FG00026 subjects
FG0018 subjects
FG0028 subjects
FG0035 subjects
FG00412 subjects
FG00521 subjects
FG00620 subjects
FG00712 subjects
FG00822 subjects
FG00928 subjects
FG0102 subjects
FG0111 subjects
FG0121 subjects
FG01345 subjects
FG0149 subjects
FG0154 subjects
FG0164 subjects
FG0174 subjects
FG0188 subjects
FG0199 subjects
FG02025 subjects
FG02126 subjects
FG02226 subjects
FG0234 subjects
FG0243 subjects
FG0255 subjects
FG02670 subjects
FG0275 subjects
FG02815 subjects
FG02912 subjects
FG0306 subjects
FG0319 subjects
FG03214 subjects
FG03313 subjects
FG03412 subjects
FG0357 subjects
FG0364 subjects
FG0371 subjects
FG0384 subjects
FG03914 subjects
FG04041 subjects
FG04159 subjects
FG04259 subjects
COMPLETED
FG00026 subjects
FG0018 subjects
FG0028 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
BG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
BG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
BG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000203
BG001198
BG002199
BG003205
BG004805
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002199
ParticipantsBG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Highest Level of Education Completed
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Current Employment Status
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Current Relationship Status
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Number of People Living in Household
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Annual household income from all sources
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Pain, Enjoyment of Life, General Activity (PEG) score
The PEG scale, a subset of the Brief Pain Inventory (BPI), evaluates pain intensity and its impact on enjoyment of life and general activity (i.e., pain interference) using a ranked scale (score 0 = "No Pain" or "Does not Interfere" to 10 = "Pain as bad as you can imagine" or "Completely Interferes"). Each component (Pain, Enjoyment of Life, and General Activity) is on a 0-10 scale, with an average score taken of the three, and with a higher average score reflecting greater disruption in daily functioning.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Pain, Enjoyment of Life, General Activity (PEG) score, median (range)
The PEG scale, a subset of the Brief Pain Inventory (BPI), evaluates pain intensity and its impact on enjoyment of life and general activity (i.e., pain interference) using a ranked scale (score 0 = "No Pain" or "Does not Interfere" to 10 = "Pain as bad as you can imagine" or "Completely Interferes"). Each component (Pain, Enjoyment of Life, and General Activity) is on a 0-10 scale, with an average score taken of the three, and with a higher average score reflecting greater disruption in daily functioning.
Median
Full Range
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Self-reported low back pain duration (months)
Mean
Standard Deviation
months
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Self-reported low back pain duration
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Low Back Pain Frequency in the past 6 months
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Low Back Pain Specific Pain Intensity
Low-Back Pain Specific Pain Intensity measures pain intensity using a single, 10-point ranked scale (score 0 = "No Pain" to 10 = "Worst Imaginable Pain") where a higher score reflects greater pain intensity.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Low Back Pain Specific Pain Intensity, median (range)
Low-Back Pain Specific Pain Intensity measures pain intensity using a single, 10-point ranked scale (score 0 = "No Pain" to 10 = "Worst Imaginable Pain") where a higher score reflects greater pain intensity.
Median
Full Range
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ever had low back operation
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
When was last back operation
The number of participants analyzed are participants who had a low back operation.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00124
ParticipantsBG002
Any back operations involve a spinal fusion
The number of participants analyzed are those who had a low back operation.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00025
ParticipantsBG00124
ParticipantsBG002
Ever unemployed for 1 or more months due to low back pain
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ever filed or awarded worker's compensation claim related to back problem
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Involved in a lawsuit or legal claim related to back problem
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ever applied for, or received, disability insurance for pain condition
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
BMI
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Systolic Blood Pressure (mmHg)
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Diastolic Blood Pressure (mmHg)
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Heart Rate (bpm)
Mean
Standard Deviation
bpm
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ever Hip Replacement Surgery
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Ever Knee Replacement Surgery
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Observed Gait
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
TAPS Tobacco Use
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 1 is a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year (i.e., previous 12 months). Each of the four multiple-choice items has five possible responses to choose from (0=Daily or Almost Daily to 4=Never). For each item, higher scores indicate better outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
Participants
TAPS Alcohol Use
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 1 is a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year (i.e., previous 12 months). Each of the four multiple-choice items has five possible responses to choose from (0=Daily or Almost Daily to 4=Never). For each item, higher scores indicate better outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
Participants
TAPS Drug Use
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 1 is a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year (i.e., previous 12 months). Each of the four multiple-choice items has five possible responses to choose from (0=Daily or Almost Daily to 4=Never). For each item, higher scores indicate better outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
Participants
TAPS Prescription Drug Used Not as Intended
The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Tool Part 1 is a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year (i.e., previous 12 months). Each of the four multiple-choice items has five possible responses to choose from (0=Daily or Almost Daily to 4=Never). For each item, higher scores indicate better outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
Currently Taking Opioid Medication (daily)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Previously Diagnosed with Coronavirus Disease 2019 (COVID-19)
The Fear-Avoidance Beliefs - Physical Activity (FABQ-PA) questionnaire consists of 4 items measuring fear-avoidance of physical activity. A patient rates their agreement with each statement on a 7-point Likert scale where 0= completely disagree and 6=completely agree. The total score is the sum of individual questions with a total score range of 0-24. Higher scores indicate a greater tendency to avoid physical activity due to fear (i.e., higher fear-avoidance).
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Generalized Anxiety Disorder (GAD-2) Raw Score
GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total score is the sum of individual questions with a total score range of 0-6; the higher the score, the more frequent one is bothered by anxiety.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Keele STarT Back Screening Tool Risk
A 9-item questionnaire assessing physical and psychosocial factors that can contribute to persistent low back pain. The psychosocial subscale (5-items) helps differentiate between medium and high-risk groups. The first eight questions are disagree (0) or agree (1). The last question is a scale of 0 (Not at all) to 4 (Extremely). The total score ranges from 0-9 with higher scores indicating higher risk. The total raw score and subscore categorize low risk (total = 3 or less), medium risk (total = 4+ and subscore = 3 or less), and high risk (total = 4+ and subscore = 4+) groups.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Oswestry Disability Index (ODI) Percentage
A 10-item questionnaire used to measure disability related to low back pain. Each question is scored from 0-5 (minimum to maximum). The percentage of disability is the sum all the responses, divided by the total number of questions answered multiplied by 5, then multiplied by 100 (i.e., total scored / total possible score x 100). The score ranges from 0% (no disability) to 100% (most severe disability). Scores from 0% to 20% indicate minimal disability; 20% to 40%, moderate disability; 40% to 60%, severe disability; 60% to 80%, crippled; and 80% to 100%, bedbound or exaggerating.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Oswestry Disability Index (ODI) Percentage, median (range)
A 10-item questionnaire used to measure disability related to low back pain. Each question is scored from 0-5 (minimum to maximum). The percentage of disability is the sum all the responses, divided by the total number of questions answered multiplied by 5, then multiplied by 100 (i.e., total scored / total possible score x 100). The score ranges from 0% (no disability) to 100% (most severe disability). Scores from 0% to 20% indicate minimal disability; 20% to 40%, moderate disability; 40% to 60%, severe disability; 60% to 80%, crippled; and 80% to 100%, bedbound or exaggerating.
Median
Full Range
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Pain Catastrophizing Scale - Short Form 6 (PCS-SF6)
A 6-item questionnaire used to assess pain-specific psychosocial construct comprising cognitive and emotional processes such as helplessness, pessimism, rumination about pain-related symptoms. The 5-point Likert scale responses are ranging from 0 (not at all) to 4 (all the time). Scores range from 0 to 24 with higher scores indicating greater pain catastrophizing.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
Participants
Pain Detect Neuropathic Pain Questionnaire (painDETECT) Raw Score
Measures the presence of neuropathic pain by summing the Likert scale responses of 'never' (0) to 'very strongly' (5) for 7-items. The total raw score ranges from 0 to 35 with higher scores indicating a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Patient Health Questionnaire-2 (PHQ-2): Raw Score
The PHQ-2 is a 2-item Likert-scale (0=Not at all to 3=Nearly every day) screening tool to assess depression. The score has a range of 0 to 6. A score of 3 is the optimal cut point when using the PHQ-2 to screen for depression. A higher score indicates more likely depression.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Healing Encounters and Attitudes Lists (HEAL) Positive Outlook: Raw Score
HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. HEAL measures patient-reported aspects of healing encounters and attitudes. This includes evaluating factors like the patient's perception of the communication with their provider, the overall quality of care, and their feelings about the treatment process. Range for raw score was 6 to 30 and a T-score range of 21.3 to 69.3. A T-score of 50 is equal to the mean and is considered normal. Higher scores indicate more positive perception.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
PROMIS Cognitive Function and Abilities - Short Form 2a Raw Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function and Abilities Short Form 2a assesses cognitive function and abilities. Raw scores (range 2 to 10) on the survey are converted to T scores (range 29.5 to 61.2), which are standardized scores based on the average in the population; a score of 50 would indicate meeting the average (mean) physical function T score in the reference general population, with a standard deviation of 10. Higher scores reflect greater cognitive function and abilities.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
General Sensory Sensitivity Score (GSS) - External
The GSS assesses sensory sensitivity across the five external senses, as well as interoception, based on Yes (1) or No (0) responses. The GSS external score is the sum of five items with scores ranging from 0 to 5 with a higher score indicating a worse outcome.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
General Sensory Sensitivity (GSS) Score - Interoception
The GSS assesses sensory sensitivity across the five external senses, as well as interoception, based on Yes (1) or No (0) responses. The GSS interoception score is the sum of three items with scores ranging from 0 to 3 with a higher score indicating a worse outcome.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
General Sensory Sensitivity (GSS) Score - Total
The GSS assesses sensory sensitivity across the five external senses, as well as interoception, based on Yes (1) or No (0) responses. The total score is the sum of all 8 items with scores ranging from 0 to 8 with a higher score indicating a worse outcome.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Self-reported Sleep Duration in the Past Month (hours)
Mean
Standard Deviation
hours
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Symptom Severity Index
The Symptom Severity Index indicates severity of symptoms in the past week and past 6 months. The score ranges from 0 to 13 with a higher score indicating a worse outcome.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Widespread Pain Inventory: Raw Score
The Widespread Pain Inventory (WPI) measures chronic pain. The WPI score has a range 0-19. A higher score indicates more pain.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Stomach Pain in the Past 4 Weeks
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Headaches in the Past 4 Weeks
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Radiating Pain to Buttock/Thigh, Past 2 Weeks
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Radiating Pain to Below Knee, Past 2 Weeks
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Transportation Needs
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for transportation ranges from 0 (no) to 1 (yes) with 1 being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Healthcare Needs
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for healthcare needs ranges from 0 (no) to 1 (yes) with 1 being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health: Food Insecurity
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for food insecurity ranges from 0 (never true) to 2 (often true) with a higher score being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Food Money
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for food money ranges from 0 (never true) to 2 (often true) with a higher score being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Utilities
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for health utilities ranges from 0 (no) to 1 (yes) with 1 being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Stable Housing
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for stable housing ranges from 0 (no) to 1 (yes) with 1 being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Emotional Support
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for emotional support ranges from 0 (no) to 1 (yes) with 1 being a worse outcome.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Social Determinants of Health (SDOH): Number of Close Friends
The SDOH screening tool is a questionnaire used to assess an individual's social needs, which can impact their health. The score for number of close friends ranges from 0-10 with a higher number indicating more friends.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Perceived Discrimination: Race/Ethnicity
Participants indicate how many times they have been treated unfairly over the course of their lives related to race/ethnicity. To score this scale, researchers add the number of events that happened at least once for the respondent. Higher scores on this scale mean more experiences of lifetime discrimination.
Participants indicate how many times they have been treated unfairly over the course of their lives related to orientation/gender identity. To score this scale, researchers add the number of events that happened at least once for the respondent. Higher scores on this scale mean more experiences of lifetime discrimination.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001198
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Patient-Reported Pain Intensity and Interference Score
Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.16(3.74 to 4.58)
OG0013.86(3.43 to 4.28)
OG0023.57(3.15 to 3.99)
OG003
Secondary
Patient-Reported Outcomes Measurement Information System-Pain Interference
Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
t-scores
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Secondary
Number of Participants Self-Reporting Taking Opioids
The number of participants self-reporting taking opioids ("Yes" response) is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?".
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Count of Participants
Participants
24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
Secondary
Patient-Reported Outcomes Measurement Information System- Physical Function
Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
t-scores
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score
Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
t-scores
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Secondary
Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety
Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
t-scores
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Secondary
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
t-scores
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Secondary
Sleep Duration
Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.
The analysis population is the all-randomized population to Stage 1 interventions.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline, 24 Weeks
ID
Title
Description
OG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
Time Frame
All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1: Acceptance and Commitment Therapy (ACT)
ACT is a form of cognitive behavioral therapy that is well established for the treatment of chronic pain. The goal of ACT is to build psychological flexibility thereby interrupting pain avoidance behavior patterns. Participants randomized to ACT will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Online sessions will focus on helping participants accept pain, connect with negative thoughts and emotions, develop mindfulness and identify and commit to values and goals that are important to them. During face-to-face sessions with the therapist, participants will be encouraged to share their experience of skills practice and mastery, provide examples of skill use at home, and describe what barriers they encountered.
0
191
4
191
2
191
EG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
0
172
1
172
92
172
EG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
0
184
6
184
7
184
EG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
0
205
2
205
4
205
EG004
Stage 2: Acceptance and Commitment Therapy (ACT)
Participants newly randomized to ACT in Stage 2 will take part in 12 sessions over the course of 12 weeks. Sessions will be delivered as a combination of 4 remote face-to-face visits with a therapist and 8 therapist-supported online sessions (self-directed online modules supported by provider coaching). Participants assigned to maintain ACT will be encouraged to continue at-home skills and will have access to all previously viewed online content. In addition, participants will have access to 11 additional online ACT audio modules, but without the communications with the therapist.
0
65
4
65
1
65
EG005
Stage 2: Duloxetine
Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. All participants will be assessed at the midpoint of the intervention treatment period (Week 18) for tolerance, adverse events, and response. At the midpoint phone call:
Participants tolerating the medication with no side effects will be instructed to increase to 60mg/day (if currently taking 30mg/day) or remain on their current dosage (if currently taking 60mg/day).
0
71
0
71
29
71
EG006
Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)
Participants newly randomized to EBEM in stage 2 will take part in a total of 10 sessions over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each. Participants assigned to maintain EBEM will receive 4 additional in-person EBEM sessions during weeks 1-4 of this period. If visits are missed and/or need to be rescheduled, visits may be scheduled up to 5 weeks from the date of the first augmenting/maintenance visit.
0
110
3
110
3
110
EG007
Stage 2: Enhanced Self-Care Therapy (ESC)
Participants newly randomized to ESC in stage 2 will be provided modules digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress. Participants assigned to maintain ESC in the second period intervention will receive personalized recommendations based on the most recently completed PROMIS 29+2.
0
85
2
85
0
85
EG008
Stage 2: ACT and Duloxetine
Participants received both ACT and duloxetine in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
33
1
33
12
33
EG009
Stage 2: ACT and EBEM
Participants received both ACT and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
52
0
52
3
52
EG010
Stage 2: ACT and ESC
Participants received both ACT and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
84
4
84
2
84
EG011
Stage 2: Duloxetine and EBEM
Participants received both duloxetine and EBEM in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
22
0
22
4
22
EG012
Stage 2: Duloxetine and ESC
Participants received both duloxetine and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
54
1
54
18
54
EG013
Stage 2: EBEM and ESC
Participants received both EBEM and ESC in Stage 2. Participants who received augmented Stage 2 treatments always continued their stage 1 treatment. The continued intervention matches the dose of those maintaining Stage 1 treatment alone, and the added intervention is as if they were newly randomized.
0
85
4
85
5
85
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial Fibrillation
Cardiac disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG0030 events0 affected205 at risk
EG0040 events0 affected65 at risk
EG0050 events0 affected71 at risk
EG0060 events0 affected110 at risk
EG0070 events0 affected85 at risk
EG0080 events0 affected33 at risk
EG0090 events0 affected52 at risk
EG0100 events0 affected84 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected54 at risk
EG0131 events1 affected85 at risk
Chest pain
Cardiac disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Appendicitis
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Incisional hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Intestinal mass
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Ulcer
General disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Cat scratch disease
Infections and infestations
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Accident
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Magnetic resonance imaging abnormal
Investigations
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Ketoacidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Uterine polyp
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 events1 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0011 events1 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Urinary tract infection
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Prostate cancer
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Testis cancer
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Physical assault
Social circumstances
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Metabolic surgery
Surgical and medical procedures
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Psychiatric care
Surgical and medical procedures
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Angina pectoris
Vascular disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00118 events17 affected172 at risk
EG0020 events0 affected184 at risk
EG0030 events0 affected205 at risk
EG0040 events0 affected65 at risk
EG0052 events2 affected71 at risk
EG0060 events0 affected110 at risk
EG0070 events0 affected85 at risk
EG0080 events0 affected33 at risk
EG0090 events0 affected52 at risk
EG0100 events0 affected84 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected54 at risk
EG0130 events0 affected85 at risk
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0018 events8 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00134 events33 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00121 events21 affected172 at risk
EG0022 events2 affected184 at risk
EG003
Irritability
General disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG0010 events0 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 events2 affected191 at risk
EG0011 events1 affected172 at risk
EG0024 events4 affected184 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00112 events12 affected172 at risk
EG0021 events1 affected184 at risk
EG003
Insomnia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00111 events11 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00117 events16 affected172 at risk
EG0020 events0 affected184 at risk
EG003
Dizziness
Vascular disorders
Systematic Assessment
EG0000 events0 affected191 at risk
EG00112 events12 affected172 at risk
EG0020 events0 affected184 at risk
EG003
The BEST Trial is a sequential, multiple-assignment randomized trial designed to estimate the optimal treatment (or sequence) for chronic low back pain based on unique biomarkers and response to treatment. As this precision-medicine focus dictates individualized rather than arm-level contrasts, no between-arm comparative-effectiveness analyses are planned as primary analyses. The primary goal of this study was to identify predictive biomarkers for each treatment not comparative effectiveness.
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG00059.03(57.67 to 60.39)
OG00158.48(57.12 to 59.84)
OG00257.61(56.25 to 58.97)
OG00360.13(58.77 to 61.49)
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG0008
OG0016
OG0028
OG0039
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG00042.14(40.81 to 43.46)
OG00143.32(41.99 to 44.64)
OG00243.11(41.78 to 44.43)
OG00341.18(39.86 to 42.5)
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG00049.22(47.71 to 50.74)
OG00147.83(46.32 to 49.35)
OG00249.03(47.51 to 50.54)
OG00350.19(48.68 to 51.71)
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG00049.73(48.1 to 51.35)
OG00148.15(46.52 to 49.77)
OG00249.14(47.52 to 50.77)
OG00350.43(48.8 to 52.05)
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.
Units
Counts
Participants
OG000203
OG001198
OG002199
OG003205
Title
Denominators
Categories
Title
Measurements
OG00052.61(50.98 to 54.25)
OG00151.45(49.82 to 53.09)
OG00251.91(50.28 to 53.54)
OG00353.21(51.58 to 54.84)
OG001
Stage 1: Duloxetine
Duloxetine is a serotonin norepinephrine reuptake inhibitor (SNRI) that is FDA-approved for use in Chronic Low-Back Pain, and, as such, is included as a recommended therapy in nearly all current treatment guidelines for low back pain. Study participants will be treated with duloxetine for 12 weeks during the active treatment phase. At the time of randomization, the approved drug pharmacy at each study site will dispense between 185 and 192 duloxetine 30 mg capsules and provide to participants. This will ensure enough capsules to maintain up to a 60 mg dosage through the 12-week intervention phase and to taper the dose in the 13th week if needed.
OG002
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)
Licensed physical therapists (PTs) or Doctors of Chiropractic (DCs) will rely on evidence-based guidance to direct decision-making on the particular type of manual and exercise therapy that may be best suited to an individual study participant. Special attention will be paid to the clinician's choice of language in regard to the purpose and expected outcomes of manual therapy in order to avoid enhancing catastrophizing ideations or preference for passive interventions. A total of 10 sessions will be provided over an 8-week treatment period. Two sessions per week are provided in the first two weeks followed by weekly sessions over the next 6 weeks. Treatment sessions will last approximately 60 minutes each.
OG003
Stage 1: Enhanced Self-Care Therapy (ESC)
The Enhanced Self-Care intervention will be comprised of educational modules on evidence-based cognitive-behavioral self-management skills for pain. These modules will be provided digitally for self-administration over a period of 12 weeks. There will be no therapist associated with the delivery of these educational materials; however, after the first four modules, email or text messages will be used to make personalized recommendations for accessing additional modules based upon identified problems from the baseline assessment. Additionally, the walking program module will utilize Fitbit step tracking to allow participants to monitor their walking progress.