The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function

Study Overview
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Brief Summary
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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.

Official Title
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The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Manipulation
* Other: Mobilization
* Other: Laser Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulation<br>Spinal manipulation | Other: Manipulation<br>* High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.<br>|
| Experimental: Mobilization<br>Spinal mobilization | Other: Mobilization<br>* Static isometric contractions of the lumbar spine to induce spinal mobilization<br>|
| Experimental: Laser Therapy<br>Cold laser therapy | Other: Laser Therapy<br>* Cold laser applied to the paravertebral muscles in the lumbar region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in numerical pain rating score |  | 48 hours post 3 week intervention | 
| Change in disability score | Roland Morris disability questionnaire | 48 hours post 3 week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on PROMIS Pain Behavior Survey | 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) | 48 hours post 3 week intervention | 
| Change in scores on PROMIS pain interference survey | 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) | 48 hours post 3 week interventions | 
| Change in scores on PROMIS pain intensity survey | 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) | 48 hours post 3 week intervention | 
| Change in scores on PROMIS physical function survey | 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). | 48 hours post 3 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, manipulation, laser therapy, osteopathic, chiropractic, mobilization, muscle energy, physical therapy, muscle, spine, adjustment, rehabilitation