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The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity, Function and Symptoms of Subjects With Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Capital District Health Authority, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01020591
First received: November 24, 2009
Last updated: December 15, 2009
Last verified: December 2009
History of Changes
  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 Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The knee flexion active range of motion, balance and pain (VAS) [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Osteopathic evaluation 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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020591

Contacts
Contact: Wendy M Jardine, MScPT 902 429 6218 wendymjardine@gmail.com

Locations
Canada, Nova Scotia
Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Wendy Jardine         wendymjardine@gmail.com    
Principal Investigator: Wendy M Jardine, MScPT            
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Wendy M Jardine, MScPT Capital District Health Authority, Canada
  More Information

No publications provided

Responsible Party: Wendy Jardine, Capital District Health Authority
ClinicalTrials.gov Identifier: NCT01020591     History of Changes
Other Study ID Numbers: CDHA-RS/2010-227
Study First Received: November 24, 2009
Last Updated: December 15, 2009
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
knee osteoarthritis
manual therapy
osteopathy

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

ClinicalTrials.gov processed this record on June 18, 2013