Knee OsteoarthritisNCT01020591
The Effect of Osteopathic Manual Therapy on Vascular Supply
A study testing Osteopathic evaluation and Osteopathic evaluation with treatment in people with Knee Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Osteopathic evaluation and Osteopathic evaluation with treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiographic-confirmed knee osteoarthritis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Osteopathic evaluation, Osteopathic evaluation with treatment
- Keywords
- knee osteoarthritis, manual therapy, osteopathy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic evaluationOther
evaluation of movement and tissue mobility
Osteopathic evaluation with treatmentOther
osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic evaluation | Active comparator | osteopathic evaluation of motion and tissue mobility Receives: 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 Receives: Other: Osteopathic evaluation with treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Jan 2010 to March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Jardine, Nova Scotia Health Authority
- Investigators
- Wendy M Jardine, MScPT, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020591
- Sponsor's protocol ID
- CDHA-RS/2010-227
- Status last verified
- Mar 2017
- First submitted
- 24 Nov 2009
- Last updated
- 4 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manual Therapy on the Vascular Supply to the Lower Extremity in Individuals With Knee Osteoarthritis, a Randomized Trial
- ClinicalTrials.gov ID
- NCT01020591
- Acronym / sponsor ID
- CDHA-RS/2010-227
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, manual therapy, osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 4 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic evaluation | Active comparator | Other: Osteopathic evaluationosteopathic evaluation of motion and tissue mobility |
| Osteopathic evaluation with treatment | Experimental | Other: Osteopathic evaluation with treatmentosteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Radiographic-confirmed knee osteoarthritis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic evaluationevaluation of movement and tissue mobility | Other | Osteopathic evaluation |
| Osteopathic evaluation with treatmentosteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted | Other | Osteopathic evaluation with treatment |
Primary outcome
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.
1 secondary outcome
The Knee Flexion Active Range of Motion, Balance and Pain (VAS)
Time frame: Jan 2010 to March 2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy M Jardine, MScPT principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic evaluation and Osteopathic evaluation with treatment in people with Knee Osteoarthritis, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.