- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00410397
The Use of Manual Therapy to Treat Low-Back and Hip Pain
The Use of Myofascial Release in Lumbopelvic Pain
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74107
- Oklahoma State University College of Osteopathic Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: B
|
Neutral positional, gentle palpation
|
|
Experimental: A
Osteopathic Manipulative Medicine
|
Pelvic balancing, myofascial release of the anterior pelvis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in low back pain on a 1-10 scale.
Time Frame: Immediately following treatment.
|
Immediately following treatment.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction in low back pain on a 0-10 scale.
Time Frame: 6-8 hours after treatment.
|
6-8 hours after treatment.
|
|
Reduction in low back pain on a 0-10 scale.
Time Frame: After four weeks of therapy.
|
After four weeks of therapy.
|
Collaborators and Investigators
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
Publications and helpful links
General Publications
- Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
- Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
- Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol. 2001 Mar;13(2):128-34. doi: 10.1097/00002281-200103000-00006.
- Hestbaek L, Leboeuf-Yde C, Kyvik KO. Is comorbidity in adolescence a predictor for adult low back pain? A prospective study of a young population. BMC Musculoskelet Disord. 2006 Mar 16;7:29. doi: 10.1186/1471-2474-7-29.
- Hestbaek L, Larsen K, Weidick F, Leboeuf-Yde C. Low back pain in military recruits in relation to social background and previous low back pain. A cross-sectional and prospective observational survey. BMC Musculoskelet Disord. 2005 May 26;6:25. doi: 10.1186/1471-2474-6-25.
- Porter JL, Wilkinson A. Lumbar-hip flexion motion. A comparative study between asymptomatic and chronic low back pain in 18- to 36-year-old men. Spine (Phila Pa 1976). 1997 Jul 1;22(13):1508-13; discussion 1513-4. doi: 10.1097/00007632-199707010-00017.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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