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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
November 24, 2009
November 25, 2009
February 12, 2012
May 4, 2017
May 4, 2017
December 2009
March 2010   (Final data collection date for primary outcome measure)
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.
The superficial femoral artery blood flow parameters (systolic peak velocity, end diastolic velocity, pulsatility index (PI) and resistance index (RI), and the arterial diameter) [ Time Frame: 10 minutes ]
Complete list of historical versions of study NCT01020591 on ClinicalTrials.gov Archive Site
The Knee Flexion Active Range of Motion, Balance and Pain (VAS) [ Time Frame: Jan 2010 to March 2010 ]
The Knee Flexion Active Range of Motion, Balance and Pain (VAS) [ Time Frame: 10 minutes ]
Not Provided
Not Provided
 
The Effect of Osteopathic Manual Therapy on Vascular Supply
The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Other: Osteopathic evaluation
    evaluation of movement and tissue mobility
  • Other: Osteopathic evaluation with treatment
    osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
  • Active Comparator: Osteopathic evaluation
    osteopathic evaluation of motion and tissue mobility
    Intervention: Other: Osteopathic evaluation
  • Experimental: Osteopathic evaluation with treatment
    osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
    Intervention: Other: Osteopathic evaluation with treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01020591
CDHA-RS/2010-227
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Wendy Jardine, Nova Scotia Health Authority
Nova Scotia Health Authority
Not Provided
Principal Investigator: Wendy M Jardine, MScPT Nova Scotia Health Authority
Nova Scotia Health Authority
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP