The Effect of Osteopathic Manual Therapy on Vascular Supply

Study Overview
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Brief Summary
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The purpose of this study is to determine if the use of osteopathic manual therapy can influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a group of subjects with knee osteoarthritis. It is also the objective of this study to determine if there is a difference between the osteopathic evaluation and the combination of an osteopathic evaluation and treatment.

Official Title
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The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Osteopathic evaluation
* Other: Osteopathic evaluation with treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiographic-confirmed knee osteoarthritis Exclusion Criteria: Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma)) Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis) Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees Subjects who have knee OA in only one knee and that knee has had previous knee surgery Subjects who have previous vascular surgery to either leg

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osteopathic evaluation<br>osteopathic evaluation of motion and tissue mobility | Other: Osteopathic evaluation<br>* evaluation of movement and tissue mobility<br>|
| Experimental: Osteopathic evaluation with treatment<br>osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues | Other: Osteopathic evaluation with treatment<br>* osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistive Index (RI) | Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels. | Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Knee Flexion Active Range of Motion, Balance and Pain (VAS) |  | Jan 2010 to March 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, manual therapy, osteopathy