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

Sponsored by:	Oklahoma State University Center for Health Sciences
Information provided by:	Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:	NCT00410397

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

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Use of Myofascial Release in Lumbopelvic Pain

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
A: Experimental Osteopathic Manipulative Medicine	Procedure: Osteopathic Manipulative Medicine Pelvic balancing, myofascial release of the anterior pelvis.
B: Placebo Comparator	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

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:

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. Review.

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. Review.

Borenstein DG. Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol. 2001 Mar;13(2):128-34. Review.

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.

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.

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. 1997 Jul 1;22(13):1508-13; discussion 1513-4.

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

Keywords provided by Oklahoma State University Center for Health Sciences:

Low back pain
Hip pain

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain

ClinicalTrials.gov processed this record on May 06, 2009