Clinical trial NCT02320500: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Pain scores on visual analogue scale (VAS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Brief pain inventory (BPI)
timeFrame: biweekly for 8 weeks, 3 months, 6 months
measure: Oxford knee score
timeFrame: biweekly for 8 weeks, 3 months, 6 months
measure: McGill short pain questionnaire
timeFrame: biweekly for 8 weeks, 3 months, 6 months
measure: timed up and go (TUG)
timeFrame: Baseline, 3 months
measure: 6 minute walk test
timeFrame: Baseline, 3 months
measure: Biodex functional tests
timeFrame: Baseline, 3 months
measure: total knee arthroplasty? If so, when
timeFrame: 6 month
measure: VAS pain scores
timeFrame: biweekly up to 8 weeks, then 3 months & 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queens University/Kingston General Hospital
name: Richard Henry, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Queens University/Kingston General Hospital
name: Gavin Wood, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: