Condition: Chronic Low Back Pain · Sponsor: VA Office of Research and Development
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…
This description comes directly from the study's public registry record.
Brandon J Stevenson, MSW BS · (319) 388-0581 · Brandon.Stevenson@va.gov
Always discuss trial participation with your own doctor first.
| 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 | 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| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora, Colorado, United States | Withdrawn |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 |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04142177