Clinical trial NCT00410397: The Use of Manual Therapy to Treat Low-Back and Hip Pain
Official title: The Use of Myofascial Release in Lumbopelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Pain
Keywords: Low back pain
Hip pain
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Reduction in low back pain on a 1-10 scale.
timeFrame: Immediately following treatment.
Secondary outcomes:
measure: Reduction in low back pain on a 0-10 scale.
timeFrame: 6-8 hours after treatment.
measure: Reduction in low back pain on a 0-10 scale.
timeFrame: After four weeks of therapy.
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University College of Osteopathic Medicine
state: Oklahoma
Study officials:
affiliation: Oklahoma State University College of Osteopathic Medicine
name: Corey R Babb, B.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma State University College of Osteopathic Medicine
name: JoAnn G Ryan, D.O.
role: STUDY_DIRECTOR
References:
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. doi: 10.2106/JBJS.E.01273.
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. doi: 10.1186/1471-2474-6-43.
citation: 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.
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. doi: 10.1186/1471-2474-7-29.
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. doi: 10.1186/1471-2474-6-25.
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. doi: 10.1097/00007632-199707010-00017.