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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Osteopathic evaluation; Other: Osteopathic evaluation with treatment

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Capital District Health Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Wendy M Jardine, MScPT, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 24, 2009
• First Submitted That Met QC Criteria: November 24, 2009
• First Posted (Estimate): November 25, 2009

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: knee osteoarthritis; manual therapy; osteopathy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CDHA-RS/2010-227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No