The Effect of Osteopathic Manual Therapy on Vascular Supply
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Dec 2009
Shorter than P25 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
May 4, 2017
CompletedMay 4, 2017
March 1, 2017
3 months
November 24, 2009
February 12, 2012
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The Knee Flexion Active Range of Motion, Balance and Pain (VAS)
Jan 2010 to March 2010
Study Arms (2)
Osteopathic evaluation
ACTIVE COMPARATORosteopathic evaluation of motion and tissue mobility
Osteopathic evaluation with treatment
EXPERIMENTALosteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Interventions
osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
Eligibility Criteria
You may qualify if:
- Radiographic-confirmed knee osteoarthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital District Health Authority
Halifax, Nova Scotia, B3H 1V7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wendy Jardine
- Organization
- CDHA
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy M Jardine, MScPT
Nova Scotia Health Authority
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist osteopath
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 4, 2017
Results First Posted
May 4, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share