Evaluating pain treatment effectiveness for veterans with chronic low back pain
CSP #2009 - Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response: The SCEPTER Trial
This study is testing different non-surgical treatments for chronic low back pain in veterans to see which ones help them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2529 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT04142177 on ClinicalTrials.gov |
What this trial studies
This study focuses on veterans suffering from chronic low back pain (cLBP) and aims to identify the most effective non-surgical and non-pharmacological treatment options. It employs a sequential randomized, pragmatic, 2-step comparative effectiveness design, where the first step compares continued care and active monitoring to internet-based pain self-management and an enhanced physical therapy intervention. Those who do not experience significant pain relief in the first step will be randomized in the second step to receive either yoga, spinal manipulation therapy, or cognitive behavioral therapy. The study is designed to address the high prevalence and impact of cLBP among veterans, particularly in light of the opioid crisis.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 and older who have experienced chronic low back pain for at least six months.
Not a fit: Patients with acute low back pain or those currently enrolled in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide veterans with effective, non-pharmacological treatment options for managing chronic low back pain.
How similar studies have performed: Other studies have shown promise in using non-pharmacological approaches for chronic pain management, making this study a continuation of exploring effective alternatives.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Low back pain 1. present for at least 6 months, 2. present most days or everyday, 3. interferes the most with activities considering all of the places where the patient experiences pain; 2. Pain, Enjoyment, General Activity (PEG) score of 4 or greater; 3. Veteran age 18 years or older, either sex, any racial or ethnic background; 4. Able to comprehend and willing to sign the study informed consent form; 5. Able and willing to attend in-person treatment sessions; 6. Anticipate continuing care at the enrolling VA for the period of the study; 7. Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Currently enrolled in any other interventional study unless exempted by CSP; 2. 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); 3. Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study; 4. Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga; 5. Current severe alcohol or substance abuse use disorder; 6. Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months); 7. Back surgery within the last 6 months, or undergoing evaluation for back surgery or planned back surgery; 8. Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments; 9. Pregnancy
Where this trial is running
Phoenix, Arizona and 18 other locations
- 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)
- 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)
Study contacts
- Study coordinator: Brandon J Stevenson, MSW BS
- Email: Brandon.Stevenson@va.gov
- Phone: (319) 388-0581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.