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Clinical trialNCT04142177RecruitingInterventional

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

SponsorVA Office of Research and DevelopmentEnrollment2,529Chronic Low Back Pain
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Phoenix Va Health Care System, Phoenix, Az

    Phoenix, Arizona, United States

    Recruiting
  • Va Loma Linda Healthcare System, Loma Linda, Ca

    Loma Linda, California, United States

    Recruiting
  • Va Long Beach Healthcare System, Long Beach, Ca

    Long Beach, California, United States

    Recruiting
  • Va Palo Alto Health Care System, Palo Alto, Ca

    Palo Alto, California, United States

    David J Clark, PhD MD
    Recruiting
  • Rocky Mountain Regional Va Medical Center, Aurora, Co

    Aurora, Colorado, United States

    Withdrawn
  • Bay Pines Va Healthcare System, Pay Pines, Fl

    Bay Pines, Florida, United States

    Terminated
  • Orlando Va Healthcare System, Orlando, Fl

    Orlando, Florida, United States

    Recruiting
  • Atlanta Va Medical and Rehab Center, Decatur, Ga

    Decatur, Georgia, United States

    Recruiting
  • Richard L. Roudebush Va Medical Center, Indianapolis, in

    Indianapolis, Indiana, United States

    Recruiting
  • Baltimore Va Medical Center Va Maryland Health Care System, Baltimore, Md

    Baltimore, Maryland, United States

    Terminated
  • Va Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, Ma

    Boston, Massachusetts, United States

    Recruiting
  • St. Louis Va Medical Center John Cochran Division, St. Louis, Mo

    St Louis, Missouri, United States

    Recruiting
  • Va Southern Nevada Healthcare System, North Las Vegas, Nv

    North Las Vegas, Nevada, United States

    Terminated
  • Asheville Va Medical Center, Asheville, Nc

    Asheville, North Carolina, United States

    Recruiting
  • Va Portland Health Care System, Portland, Or

    Portland, Oregon, United States

    Recruiting
  • South Texas Health Care System, San Antonio, Tx

    San Antonio, Texas, United States

    Recruiting
  • Va Salt Lake City Health Care System, Salt Lake City, Ut

    Salt Lake City, Utah, United States

    Recruiting
  • Hampton Va Medical Center, Hampton, Va

    Hampton, Virginia, United States

    Terminated
  • Hunter Holmes Mcguire Va Medical Center, Richmond, Va

    Richmond, Virginia, United States

    Terminated

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
13 Jun 2022
Primary completion
30 Jun 2027
Completion
30 Jun 2027
Last update posted
4 May 2026
Registered enrollment
2,529
Registry id
NCT04142177

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.