Skip to main content
OpenTrials
Completed

NCT Number: NCT01854892

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

manipulation

Other

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

Mobilization

Other

Static isometric contractions of the lumbar spine to induce spinal mobilization

LASER Therapy

Other

Cold laser applied to the paravertebral muscles in the lumbar region

Primary outcomes

  1. Change in numerical pain rating score

    Time frame: 48 hours post 3 week intervention

  2. Change in disability score

    Time frame: 48 hours post 3 week intervention

    Roland Morris disability questionnaire

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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).

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 16, 2013
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.