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NCT Number: NCT01020591

The Effect of Osteopathic Manual Therapy on Vascular Supply

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic evaluation

Other

evaluation of movement and tissue mobility

Osteopathic evaluation with treatment

Other

osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted

Primary outcomes

  1. 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 outcomes

  1. The Knee Flexion Active Range of Motion, Balance and Pain (VAS)

    Time frame: Jan 2010 to March 2010

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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