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Study for Chronic Low Back Pain in Veterans

This study is for U.S. Veterans experiencing chronic low back pain (pain lasting at least 6 months, most days, and interfering with activities). It aims to find the best non-surgical and non-medication treatments. You might receive internet-based pain self-management (Pain EASE), tailored exercise, continued care, cognitive behavioral therapy (CBT), or spinal manipulation therapy (SMT). The study will compare these treatments to see which one best reduces how much pain interferes with your daily life, as measured three months after treatment. This study is currently enrolling 2529 participants.

Study design
This is an interventional study with a sequential randomized, pragmatic, 2-step comparative effectiveness design, planning to enroll 2529 participants.
What's involved
You may receive up to 8 tailored exercise sessions with ongoing home exercise, or 10 sessions of Cognitive Behavioral Therapy (CBT) over 3 months, or up to 10 sessions of Spinal Manipulation Therapy (SMT) over 3 months.
Compensation
Not stated in the trial record.
Follow-up
Your pain interference will be measured at 3 months post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04142177

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~2,529 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Pain EASETailored exerciseContinued Care and Active MonitoringCognitive Behavioral Therapy (CBT)Spinal Manipulation Therapy (SMT)Yoga

At a glance

Recruiting sites
13 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief Pain Inventory (BPI) Interference scale
Measured over 3 months post-treatment

Conditions

Chronic Low Back Pain

Explore related trials

Chronic low back pain

Where it's being run

19 sites across 15 states
California3
Florida2
Virginia2
Arizona1
Colorado1
Georgia1
Indiana1
Maryland1

Study leadership

  • David J Clark, PhD MD · STUDY_CHAIR · VA Palo Alto Health Care System, Palo Alto, CA
  • Matthew J. Bair, MD MS · STUDY_CHAIR · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Who to contact

Brandon J Stevenson, MSW BS
[email protected]
(319) 388-0581 · ext. 3870
Email the study team

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What this trial measures

  • Brief Pain Inventory (BPI) Interference scale3 months post-treatment

    Pain interference will be assessed with the Brief Pain Inventory (BPI) Interference subscale, a validated measure that rates pain interference of pain on 7 items (mood, physical activity, work, social activity, relations, sleep, and life enjoyment). BPI scores range 0 to 10, with higher scores representing worse pain interference, and a 1-point change considered clinically important. Linear mixed effects models will be used to compare the primary outcome (change in pain interference score from pre-treatment to 3 months after treatment) between Step 1 treatments in all participants and between Step 2 treatments in Step 1 non-responders. The mixed effects model will include treatment and study site as fixed effects, and therapist as random effects. For the comparison of Step 1 treatments, the model will also include a fixed effect for opioid use at study entry.