CClinicalTrials.gg
CompletedNCT02320500Updated Apr 6, 2018

Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis

A Phase 4 interventional study of Standard Physiotherapy and Myofascial-specific therapy in Osteoarthritis, Knee, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-06.

Sponsored by Queen's University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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?
02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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)

    Behavioral: Standard Physiotherapy

  • 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)

    Other: Myofascial-specific therapy

Interventions

  • BehavioralStandard Physiotherapy

    standard of care physiotherapy once every 2 weeks for 8 weeks

  • OtherMyofascial-specific therapy

    Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)

06

What researchers measure

Primary outcomes

  1. Pain scores on visual analogue scale (VAS)

    Time frame: 8 weeks

Secondary outcomes

  1. Brief pain inventory (BPI)

    Time frame: biweekly for 8 weeks, 3 months, 6 months

  2. Oxford knee score

    Time frame: biweekly for 8 weeks, 3 months, 6 months

  3. McGill short pain questionnaire

    Time frame: biweekly for 8 weeks, 3 months, 6 months

  4. timed up and go (TUG)

    Time frame: Baseline, 3 months

  5. 6 minute walk test

    Time frame: Baseline, 3 months

  6. Biodex functional tests

    Time frame: Baseline, 3 months

  7. total knee arthroplasty? If so, when

    Time frame: 6 month

  8. VAS pain scores

    Time frame: biweekly up to 8 weeks, then 3 months & 6 months

07

Study locations

1 site
  • Hotel Dieu Hospital
    Kingston, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02320500
Lead sponsor
Queen's University
Responsible party
Dr. Gavin Wood (Principal Investigator, Queen's University) — Principal investigator
First posted
Dec 19, 2014
Start date
Sep 2013
Primary completion
Jul 2016
Completion
Dec 2016
Last update
Apr 6, 2018

Study contacts

Richard Henry, MD, FRCPC
principal investigator · Queens University/Kingston General Hospital
Gavin Wood, MD, FRCSC
principal investigator · Queens University/Kingston General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion