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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Manipulation

Mobilization

Laser Therapy

About this trial

This is an interventional other trial for Low Back Pain focused on measuring low back pain, manipulation, laser therapy, osteopathic, chiropractic, mobilization, muscle energy, physical therapy, muscle, spine, adjustment, rehabilitation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Ohio University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Manipulation

Mobilization

Laser Therapy

Arm Description

Spinal manipulation

Spinal mobilization

Cold laser therapy

Outcomes

Primary Outcome Measures

Change in numerical pain rating score

Change in disability score

Roland Morris disability questionnaire

Secondary Outcome Measures

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)

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)

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)

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).

Full Information

NCT ID

NCT01854892

First Posted

May 3, 2013

Last Updated

May 11, 2017

Sponsor

Ohio University

1. Study Identification

Unique Protocol Identification Number

NCT01854892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

May 5, 2017 (Actual)

Study Completion Date

May 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manipulation

Arm Type

Experimental

Arm Description

Spinal manipulation

Arm Title

Mobilization

Arm Type

Experimental

Arm Description

Spinal mobilization

Arm Title

Laser Therapy

Arm Type

Experimental

Arm Description

Cold laser therapy

Intervention Type

Other

Intervention Name(s)

Manipulation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Mobilization

Intervention Description

Static isometric contractions of the lumbar spine to induce spinal mobilization

Intervention Type

Other

Intervention Name(s)

Laser Therapy

Intervention Description

Cold laser applied to the paravertebral muscles in the lumbar region

Primary Outcome Measure Information:

Title

Change in numerical pain rating score

Time Frame

48 hours post 3 week intervention

Title

Change in disability score

Description

Roland Morris disability questionnaire

Time Frame

48 hours post 3 week intervention

Secondary Outcome Measure Information:

Title

Change in score on PROMIS Pain Behavior Survey

Description

Time Frame

48 hours post 3 week intervention

Title

Change in scores on PROMIS pain interference survey

Description

Time Frame

48 hours post 3 week interventions

Title

Change in scores on PROMIS pain intensity survey

Description

Time Frame

48 hours post 3 week intervention

Title

Change in scores on PROMIS physical function survey

Description

Time Frame

48 hours post 3 week intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James S Thomas, Ph.D., PT

Organizational Affiliation

Ohio University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brian C Clark, Ph.D.

Organizational Affiliation

Ohio University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio University

City

Athens

State/Province

Ohio

ZIP/Postal Code

45701

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33828171

Citation

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. Erratum In: Sci Rep. 2021 Aug 3;11(1):16114.

Results Reference

derived

PubMed Identifier

32756930

Citation

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.

Results Reference

derived

PubMed Identifier

29792940

Citation

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.

Results Reference

derived

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

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