The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ohio University
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- Change in disability score
Study Overview
Brief Summary
Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.
While there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Report history consistent with chronic low back pain
- •Average pain intensity at least mild when assessed with a numerical pain scale
- •At least mild disability when assessed with a questionnaire
- •Meets criteria for clinical prediction rule
Exclusion Criteria
- •A history of certain neurological, cardiorespiratory, and musculoskeletal disorders
- •Have active cancer or be blind
- •Report recent use of certain medications and treatments
- •Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months
- •Have too high body mass or unexplained weight loss
- •Have clinical depression
- •Have pending litigation related to the low back pain or are receiving any type of disability services
- •Current drug or alcohol use that would interfere with adherence to study requirements
Outcomes
Primary Outcomes
Change in disability score
Time Frame: 48 hours post 3 week intervention
Roland Morris disability questionnaire
Change in numerical pain rating score
Time Frame: 48 hours post 3 week intervention
Secondary Outcomes
- Change in score on PROMIS Pain Behavior Survey(48 hours post 3 week intervention)
- Change in scores on PROMIS pain interference survey(48 hours post 3 week interventions)
- Change in scores on PROMIS physical function survey(48 hours post 3 week intervention)
- Change in scores on PROMIS pain intensity survey(48 hours post 3 week intervention)
Investigators
James Thomas
Professor
Ohio University