NCT01020591

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

May 4, 2017

Completed
Last Updated

May 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

November 24, 2009

Results QC Date

February 12, 2012

Last Update Submit

March 24, 2017

Conditions

Keywords

knee osteoarthritismanual therapyosteopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Jan 2010 to March 2010

Study Arms (2)

Osteopathic evaluation

ACTIVE COMPARATOR

osteopathic evaluation of motion and tissue mobility

Other: Osteopathic evaluation

Osteopathic evaluation with treatment

EXPERIMENTAL

osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues

Other: Osteopathic evaluation with treatment

Interventions

evaluation of movement and tissue mobility

Osteopathic evaluation

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

Osteopathic evaluation with treatment

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographic-confirmed knee osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Wendy Jardine
Organization
CDHA

Study Officials

  • Wendy M Jardine, MScPT

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist osteopath

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 4, 2017

Results First Posted

May 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations