- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320500
Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks.
The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.
The Secondary outcomes will include:
(Comparisons between and/or within groups where appropriate):
- Pain score biweekly up to 8 weeks, at 3 months and 6 months
- Decision to proceed with surgery (yes/no)-to assess the alteration in the need for TKA
- Decision to continue treatment-(yes/no) is treatment beneficial?
- Function -Biodex, 6 min.walk test, Timed up and go- Measured at baseline and 3 months following last therapy session for standard vs. myofascial -is myofascial therapy better for function?
- Brief Pain Interference (BPI) short form- Baseline, 2 weeks and 8 weeks- to assess pain interference
- Oxford knee scores-Baseline, 2 and 8 weeks- reported functional disability (compare groups and to objective measures)
- McGill SF pain questionnaire at Baseline, 2 weeks and 8 weeks-to assess pain quality
- SF-12 at Baseline, 2 weeks and 8 weeks-to assess quality of life
- Analgesics consumed at Baseline, 2 weeks, 8 weeks, 6 months-to assess pain levels
- Compare the X-ray osteoarthritis (OA) grade with initial assessment of MTPs-Does presence of myofascial trigger points (MTPs) explain discordance between OA grade and pain?
- Pain scores on a 10 cm visual analogue scale at Baseline, 2 weeks, 6 months- assess change in pain intensity
- Surgery by 6 month follow-up? Yes/No, If so, when? - postponed or eliminated need for TKA?
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada
- Hotel Dieu Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of bi or unilateral knee OA
- knee pain attributed to knee OA
- referral to orthopedics as a potential candidate for knee total knee arthroplasty
- ability to comprehend/sign consent, independent mobility without assistive devices
Exclusion Criteria:
- allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
- infections of clinical abnormalities other than knee OA that could cause the knee pain
- other diagnosed chronic pain syndrome for which they are taking regular pain medications
- pregnancy or breast-feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard physiotherapy
Standard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA)
|
standard of care physiotherapy once every 2 weeks for 8 weeks
|
Experimental: Myofascial-specific therapy
Patient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks)
|
Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores on visual analogue scale (VAS)
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brief pain inventory (BPI)
Time Frame: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
Oxford knee score
Time Frame: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
McGill short pain questionnaire
Time Frame: biweekly for 8 weeks, 3 months, 6 months
|
biweekly for 8 weeks, 3 months, 6 months
|
timed up and go (TUG)
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
6 minute walk test
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
Biodex functional tests
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
total knee arthroplasty? If so, when
Time Frame: 6 month
|
6 month
|
VAS pain scores
Time Frame: biweekly up to 8 weeks, then 3 months & 6 months
|
biweekly up to 8 weeks, then 3 months & 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Henry, MD, FRCPC, Queens University/Kingston General Hospital
- Principal Investigator: Gavin Wood, MD, FRCSC, Queens University/Kingston General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANAE-217-12
- NOL 158909 (Other Identifier: Health Canada)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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