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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00410397
Other study ID # 2006028
Secondary ID
Status Completed
Phase N/A
First received December 11, 2006
Last updated January 8, 2008
Start date December 2006
Est. completion date February 2007

Study information

Verified date January 2008
Source Oklahoma State University Center for Health Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Osteopathic Manipulative Medicine
Pelvic balancing, myofascial release of the anterior pelvis.
Sham Manipulation
Neutral positional, gentle palpation

Locations

Country Name City State
United States Oklahoma State University College of Osteopathic Medicine Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in low back pain on a 1-10 scale. Immediately following treatment. No
Secondary Reduction in low back pain on a 0-10 scale. 6-8 hours after treatment. No
Secondary Reduction in low back pain on a 0-10 scale. After four weeks of therapy. No
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