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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

December 11, 2006
January 8, 2008
December 2006
February 2007   (final data collection date for primary outcome measure)
Reduction in low back pain on a 1-10 scale. [ Time Frame: Immediately following treatment. ] [ Designated as safety issue: No ]
  • Reduction in low back pain on a 1-10 scale immediately following treatment.
  • Reduction in low back pain on a 1-10 scale six to eight hours after treatment.
  • Overall reduction in low back on over a four-week period.
Complete list of historical versions of study NCT00410397 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
The Use of Manual Therapy to Treat Low-Back and Hip Pain
The Use of Myofascial Release in Lumbopelvic Pain

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Low Back Pain
  • Pain
  • Procedure: Osteopathic Manipulative Medicine
    Pelvic balancing, myofascial release of the anterior pelvis.
  • Procedure: Sham Manipulation
    Neutral positional, gentle palpation
  • Experimental: A
    Osteopathic Manipulative Medicine
    Intervention: Procedure: Osteopathic Manipulative Medicine
  • Placebo Comparator: B
    Intervention: Procedure: Sham Manipulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00410397
2006028
No
Corey Babb/ MS4, Oklahoma State University Center for Health Sciences
Oklahoma State University Center for Health Sciences
Not Provided
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
Oklahoma State University Center for Health Sciences
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP