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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01854892
First Posted: May 16, 2013
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Thomas, Ohio University
  Purpose

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.


Condition Intervention
Low Back Pain Other: Manipulation Other: Mobilization Other: Laser Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function

Resource links provided by NLM:


Further study details as provided by James Thomas, Ohio University:

Primary Outcome Measures:
  • Change in numerical pain rating score [ Time Frame: 48 hours post 3 week intervention ]
  • Change in disability score [ Time Frame: 48 hours post 3 week intervention ]
    Roland Morris disability questionnaire


Secondary Outcome Measures:
  • Change in score on PROMIS Pain Behavior Survey [ Time Frame: 48 hours post 3 week intervention ]
    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 [ Time Frame: 48 hours post 3 week interventions ]
    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 [ Time Frame: 48 hours post 3 week intervention ]
    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 [ Time Frame: 48 hours post 3 week intervention ]
    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).


Enrollment: 162
Study Start Date: June 2013
Study Completion Date: May 5, 2017
Primary Completion Date: May 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manipulation
Spinal manipulation
Other: Manipulation
High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.
Experimental: Mobilization
Spinal mobilization
Other: Mobilization
Static isometric contractions of the lumbar spine to induce spinal mobilization
Experimental: Laser Therapy
Cold laser therapy
Other: Laser Therapy
Cold laser applied to the paravertebral muscles in the lumbar region

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854892


Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Investigators
Principal Investigator: James S Thomas, Ph.D., PT Ohio University
Principal Investigator: Brian C Clark, Ph.D. Ohio University
  More Information

Responsible Party: James Thomas, Professor, Ohio University
ClinicalTrials.gov Identifier: NCT01854892     History of Changes
Other Study ID Numbers: AT006978
First Submitted: May 3, 2013
First Posted: May 16, 2013
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by James Thomas, Ohio University:
low back pain
manipulation
laser therapy
osteopathic
chiropractic
mobilization
muscle energy
physical therapy
muscle
spine
adjustment
rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms