The Use of Manual Therapy to Treat Low-Back and Hip Pain

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00410397
First received: December 11, 2006
Last updated: January 8, 2008
Last verified: January 2008
  Purpose

Low back pain (LBP) is a common problem in the adult population with many approaches to treatment, but no clear answer. One of the causes of LBP, musculoskeletal pain, can be triggered by spasm of the deep muscles of the back and pelvis. This study, therefore, focuses on treating pelvic muscle pain as a way of lessening LBP.


Condition Intervention
Low Back Pain
Pain
Procedure: Osteopathic Manipulative Medicine
Procedure: Sham Manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Myofascial Release in Lumbopelvic Pain

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Reduction in low back pain on a 1-10 scale. [ Time Frame: Immediately following treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in low back pain on a 0-10 scale. [ Time Frame: 6-8 hours after treatment. ] [ Designated as safety issue: No ]
  • Reduction in low back pain on a 0-10 scale. [ Time Frame: After four weeks of therapy. ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: December 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Osteopathic Manipulative Medicine
Procedure: Osteopathic Manipulative Medicine
Pelvic balancing, myofascial release of the anterior pelvis.
Placebo Comparator: B Procedure: Sham Manipulation
Neutral positional, gentle palpation

Detailed Description:

Osteopathic manipulative medicine (OMM) is a well-researched standard of care in the treatment of low back pain (LBP). Under the heading of OMM, many different modalities exist to decrease a patient's somatic dysfunction. Among the most commonly used are high velocity (thrusting through an immobilized joint) and muscle energy (engaging a restrictive barrier using the patient's own strength).

Although a very common complaint, there is no exact etiology for LBP. Many different theories exist, including postural disturbances, leg length discrepancies, and even genetic predispositions. A study in Spine finds that among those with chronic LBP there is a subgroup of people with reduced hip flexion, and concludes that hip motion should be considered in treatment of patients with LBP. Currently, there exists no research on the manipulation of hip flexors in the treatment of LBP. This study, therefore, will test the efficacy of OMM on the deep pelvic musculature as a way of decreasing LBP.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age-older than 18 years and younger than 65 years
  • Lumbopelvic pain

Exclusion Criteria:

  • Cardiovascular disease (heart-failure, myocardial infarction, hypertension)
  • Diabetes
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Chronic Illness
  • Pregnancy-self reported
  • Neurodegenerative Disease
  • Osteopenia
  • Osteoporosis
  • Metastatic Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410397

Locations
United States, Oklahoma
Oklahoma State University College of Osteopathic Medicine
Tulsa, Oklahoma, United States, 74107
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Corey R Babb, B.A. Oklahoma State University College of Osteopathic Medicine
Study Director: JoAnn G Ryan, D.O. Oklahoma State University College of Osteopathic Medicine
  More Information

Publications:
Responsible Party: Corey Babb/ MS4, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00410397     History of Changes
Other Study ID Numbers: 2006028
Study First Received: December 11, 2006
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
Low back pain
Hip pain

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

ClinicalTrials.gov processed this record on September 18, 2014