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Completed

NCT Number: NCT02320500

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu Hospital

Kingston, Ontario, Canada

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Physiotherapy

Behavioral

standard of care physiotherapy once every 2 weeks for 8 weeks

Myofascial-specific therapy

Other

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

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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2014
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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