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

April 4, 2018 updated by: Dr. Gavin Wood, Queen's University

Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis

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.

Study Overview

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

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Kingston, Ontario, Canada
        • Hotel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 15, 2014

First Posted (Estimate)

December 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

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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