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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854892
• Other study ID #: AT006978
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: May 11, 2017
• Start date: June 2013
• Est. completion date: May 5, 2017

Study information

• Verified date: May 2017
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Manipulation
High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.
• Mobilization
Static isometric contractions of the lumbar spine to induce spinal mobilization
• Laser Therapy
Cold laser applied to the paravertebral muscles in the lumbar region

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in numerical pain rating score		48 hours post 3 week intervention
Primary	Change in disability score	Roland Morris disability questionnaire	48 hours post 3 week intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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