Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response
Recruiting now · Not applicable
Conditions studied: Chronic Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT04142177
- Run by
- VA Office of Research and Development
- People needed
- 2529
- Starts
- 2022-06-13
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Low back pain
- present for at least 6 months,
- present most days or everyday,
- interferes the most with activities considering all of the places where the patient experiences pain;
- Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
- Veteran age 18 years or older, either sex, any racial or ethnic background;
- Able to comprehend and willing to sign the study informed consent form;
- Able and willing to attend in-person treatment sessions;
- Anticipate continuing care at the enrolling VA for the period of the study;
- Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Currently enrolled in any other interventional study unless exempted by CSP;
- Acute or chronic illness that would prevent the Veteran from receiving study treatments offered (e.g., uncontrolled hypertension, recent myocardial infarction within the last 6 months, unstable angina, acute congestive heart failure);
- Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
- Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
- Current severe alcohol or substance abuse use disorder;
- Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
- Back surgery within the last 6 months, or undergoing evaluation for back surgery or planned back surgery;
- Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;
- Pregnancy
Where it is running
- Asheville VA Medical Center, Asheville, NC — Asheville, North Carolina, United States (enrolling)
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (enrolling)
- South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States (enrolling)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
- Orlando VA Healthcare System, Orlando, FL — Orlando, Florida, United States (enrolling)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (enrolling)
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis, Indiana, United States (enrolling)
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (enrolling)
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States (enrolling)
- VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda, California, United States (enrolling)
- Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
- Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States
- VA Southern Nevada Healthcare System, North Las Vegas, NV — North Las Vegas, Nevada, United States
- Hampton VA Medical Center, Hampton, VA — Hampton, Virginia, United States
Full record on ClinicalTrials.gov
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