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

Ohio University

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Laser Therapy; Other: Manipulation; Other: Mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01854892

AT006978

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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162 participants in 3 patient groups

Manipulation

Experimental group

Description:

Spinal manipulation

Treatment:

Other: Manipulation

Mobilization

Experimental group

Description:

Spinal mobilization

Treatment:

Other: Mobilization

Laser Therapy

Experimental group

Description:

Cold laser therapy

Treatment:

Other: Laser Therapy