The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
- Conditions
- Low Back Pain
- Interventions
- Other: Laser TherapyOther: ManipulationOther: Mobilization
- Registration Number
- NCT01854892
- Lead Sponsor
- Ohio University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Laser Therapy Laser Therapy Cold laser therapy Manipulation Manipulation Spinal manipulation Mobilization Mobilization Spinal mobilization
- Primary Outcome Measures
Name Time Method Change in disability score 48 hours post 3 week intervention Roland Morris disability questionnaire
Change in numerical pain rating score 48 hours post 3 week intervention
- Secondary Outcome Measures
Name Time Method Change in score on PROMIS Pain Behavior Survey 48 hours post 3 week intervention This survey was developed by the NIH to provide reliable and valid measures of pain behavior. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Change in scores on PROMIS pain interference survey 48 hours post 3 week interventions This survey was developed by the NIH to provide reliable and valid measures of pain interference. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Change in scores on PROMIS physical function survey 48 hours post 3 week intervention This survey was developed by the NIH to provide reliable and valid measures of physical function. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention).
Change in scores on PROMIS pain intensity survey 48 hours post 3 week intervention This survey was developed by the NIH to provide reliable and valid measures of pain intensity. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Trial Locations
- Locations (1)
Ohio University
🇺🇸Athens, Ohio, United States