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The Effect of Osteopathic Manual Therapy on Vascular Supply

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020591
First Posted: November 25, 2009
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wendy Jardine, Nova Scotia Health Authority
  Purpose
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.

Condition Intervention
Knee Osteoarthritis Other: Osteopathic evaluation Other: Osteopathic evaluation with treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Wendy Jardine, Nova Scotia Health Authority:

Primary Outcome Measures:
  • Resistive Index (RI) [ Time Frame: 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 ]
    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.


Secondary Outcome Measures:
  • The Knee Flexion Active Range of Motion, Balance and Pain (VAS) [ Time Frame: Jan 2010 to March 2010 ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Osteopathic evaluation
osteopathic evaluation of motion and tissue mobility
Other: Osteopathic evaluation
evaluation of movement and tissue mobility
Experimental: Osteopathic evaluation with treatment
osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
Other: Osteopathic evaluation with treatment
osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020591


Locations
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Wendy M Jardine, MScPT Nova Scotia Health Authority
  More Information

Responsible Party: Wendy Jardine, Physiotherapist osteopath, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01020591     History of Changes
Other Study ID Numbers: CDHA-RS/2010-227
First Submitted: November 24, 2009
First Posted: November 25, 2009
Results First Submitted: February 12, 2012
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wendy Jardine, Nova Scotia Health Authority:
knee osteoarthritis
manual therapy
osteopathy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases