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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01854892
Enrollment
162
Registered
2013-05-16
Start date
2013-06-30
Completion date
2017-05-05
Last updated
2017-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

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

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.

Interventions

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

OTHERMobilization

Static isometric contractions of the lumbar spine to induce spinal mobilization

OTHERLaser Therapy

Cold laser applied to the paravertebral muscles in the lumbar region

Sponsors

Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in numerical pain rating score48 hours post 3 week intervention
Change in disability score48 hours post 3 week interventionRoland Morris disability questionnaire

Secondary

MeasureTime frameDescription
Change in score on PROMIS Pain Behavior Survey48 hours post 3 week interventionThis 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 survey48 hours post 3 week interventionsThis 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 survey48 hours post 3 week interventionThis 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 survey48 hours post 3 week interventionThis 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026