The Use of Manual Therapy to Treat Low-Back and Hip Pain
Primary Purpose
Low Back Pain, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Medicine
Sham Manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Hip pain
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
Sites / Locations
- Oklahoma State University College of Osteopathic Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Osteopathic Manipulative Medicine
Outcomes
Primary Outcome Measures
Reduction in low back pain on a 1-10 scale.
Secondary Outcome Measures
Reduction in low back pain on a 0-10 scale.
Reduction in low back pain on a 0-10 scale.
Full Information
NCT ID
NCT00410397
First Posted
December 11, 2006
Last Updated
January 8, 2008
Sponsor
Oklahoma State University Center for Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00410397
Brief Title
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
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oklahoma State University Center for Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pain
Keywords
Low back pain, Hip pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Osteopathic Manipulative Medicine
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Medicine
Intervention Description
Pelvic balancing, myofascial release of the anterior pelvis.
Intervention Type
Procedure
Intervention Name(s)
Sham Manipulation
Intervention Description
Neutral positional, gentle palpation
Primary Outcome Measure Information:
Title
Reduction in low back pain on a 1-10 scale.
Time Frame
Immediately following treatment.
Secondary Outcome Measure Information:
Title
Reduction in low back pain on a 0-10 scale.
Time Frame
6-8 hours after treatment.
Title
Reduction in low back pain on a 0-10 scale.
Time Frame
After four weeks of therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey R Babb, B.A.
Organizational Affiliation
Oklahoma State University College of Osteopathic Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JoAnn G Ryan, D.O.
Organizational Affiliation
Oklahoma State University College of Osteopathic Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Oklahoma State University College of Osteopathic Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74107
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16595438
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.
Results Reference
background
PubMed Identifier
16080794
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.
Results Reference
background
PubMed Identifier
11224737
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.
Results Reference
background
PubMed Identifier
16539740
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.
Results Reference
background
PubMed Identifier
15918894
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.
Results Reference
background
PubMed Identifier
9231971
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.
Results Reference
background
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The Use of Manual Therapy to Treat Low-Back and Hip Pain
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