Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

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?
    

Intervention name(s): Standard Physiotherapy; Myofascial-specific therapy
Intervention type(s): Behavioral; Other
Intervention description(s): standard of care physiotherapy once every 2 weeks for 8 weeks; Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment