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

NCT01854892 | Completed DMC

• 1 other identifier: AT006978
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; manipulation; laser therapy; osteopathic; chiropractic; mobilization; muscle energy; physical therapy; muscle; spine; adjustment; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in score on PROMIS Pain Behavior Survey

  48 hours post 3 week intervention

• Change in scores on PROMIS pain interference survey

  48 hours post 3 week interventions

• Change in scores on PROMIS pain intensity survey

  48 hours post 3 week intervention

• Change in scores on PROMIS physical function survey

  48 hours post 3 week intervention

Study Arms (3)

Manipulation

EXPERIMENTAL

Spinal manipulation

Other: Manipulation

Mobilization

EXPERIMENTAL

Spinal mobilization

Other: Mobilization

Laser Therapy

EXPERIMENTAL

Cold laser therapy

Other: Laser Therapy

Interventions

Manipulation OTHER

High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.

Manipulation

Mobilization OTHER

Static isometric contractions of the lumbar spine to induce spinal mobilization

Mobilization

Laser Therapy OTHER

Cold laser applied to the paravertebral muscles in the lumbar region

Laser Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

Related Publications (3)

• 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.

  PMID: 33828171 DERIVED

• 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.

  PMID: 32756930 DERIVED

• 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.

  PMID: 29792940 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• James S Thomas, Ph.D., PT

  Ohio University

  PRINCIPAL INVESTIGATOR

• Brian C Clark, Ph.D.

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 16, 2013
• Study Start: June 1, 2013
• Primary Completion: May 5, 2017
• Study Completion: May 5, 2017
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

US (1)