Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Standard Physiotherapy
Myofascial-specific therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Hotel Dieu Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard physiotherapy
Myofascial-specific therapy
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Pain scores on visual analogue scale (VAS)
Secondary Outcome Measures
Brief pain inventory (BPI)
Oxford knee score
McGill short pain questionnaire
timed up and go (TUG)
6 minute walk test
Biodex functional tests
total knee arthroplasty? If so, when
VAS pain scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02320500
Brief Title
Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Official Title
Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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. Based on the investigators pilot investigation, the investigators expect those who receive myofascial-specific therapy to experience reduced pain (compared to the standard therapy group) and increased flexibility compared to baseline levels. This simple conservative therapy could postpone (or in some cases, eliminate) the need for a knee replacement since pain is the major indication for surgery. If successful, this treatment could improve the quality of life and increase productivity for thousands suffering from knee osteoarthritis and preserve valuable health care resources.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard physiotherapy
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Myofascial-specific therapy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Standard Physiotherapy
Intervention Description
standard of care physiotherapy once every 2 weeks for 8 weeks
Intervention Type
Other
Intervention Name(s)
Myofascial-specific therapy
Intervention Description
Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
Primary Outcome Measure Information:
Title
Pain scores on visual analogue scale (VAS)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Brief pain inventory (BPI)
Time Frame
biweekly for 8 weeks, 3 months, 6 months
Title
Oxford knee score
Time Frame
biweekly for 8 weeks, 3 months, 6 months
Title
McGill short pain questionnaire
Time Frame
biweekly for 8 weeks, 3 months, 6 months
Title
timed up and go (TUG)
Time Frame
Baseline, 3 months
Title
6 minute walk test
Time Frame
Baseline, 3 months
Title
Biodex functional tests
Time Frame
Baseline, 3 months
Title
total knee arthroplasty? If so, when
Time Frame
6 month
Title
VAS pain scores
Time Frame
biweekly up to 8 weeks, then 3 months & 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Henry, MD, FRCPC
Organizational Affiliation
Queens University/Kingston General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gavin Wood, MD, FRCSC
Organizational Affiliation
Queens University/Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
We'll reach out to this number within 24 hrs