The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
NCT ID: NCT01854892
Last Updated: 2017-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
162 participants
INTERVENTIONAL
2013-06-30
2017-05-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
SINGLE
Study Groups
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Manipulation
Spinal manipulation
Manipulation
High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.
Mobilization
Spinal mobilization
Mobilization
Static isometric contractions of the lumbar spine to induce spinal mobilization
Laser Therapy
Cold laser therapy
Laser Therapy
Cold laser applied to the paravertebral muscles in the lumbar region
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
No
Sponsors
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Ohio University
OTHER
Responsible Party
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James Thomas
Professor
Principal Investigators
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James S Thomas, Ph.D., PT
Role: PRINCIPAL_INVESTIGATOR
Ohio University
Brian C Clark, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio University
Locations
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Ohio University
Athens, Ohio, United States
Countries
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References
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Stamenkovic A, Clark BC, Pidcoe PE, van der Veen SM, France CR, Russ DW, Kinser PA, Thomas JS. Distinguishing chronic low back pain in young adults with mild to moderate pain and disability using trunk compliance. Sci Rep. 2021 Apr 7;11(1):7592. doi: 10.1038/s41598-021-87138-6.
Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
Clark BC, Russ DW, Nakazawa M, France CR, Walkowski S, Law TD, Applegate M, Mahato N, Lietkam S, Odenthal J, Corcos D, Hain S, Sindelar B, Ploutz-Snyder RJ, Thomas JS. A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study. Contemp Clin Trials. 2018 Jul;70:41-52. doi: 10.1016/j.cct.2018.05.012. Epub 2018 May 21.
Other Identifiers
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AT006978
Identifier Type: -
Identifier Source: org_study_id
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