Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression
Study Overview
Brief Summary
Osteoarthritis (OA) is disease in which the joint breaks down, causing pain. The decision to surgically replace the knee, a procedure called total knee arthroplasty (TKA), depends on x-ray results as well as pain and dysfunction. Despite TKA resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'TKA non-responders'. Two pain conditions - myofascial pain syndrome (MPS) and central sensitization - frequently coexist with signs of OA and may contribute to a TKA non-responder profile. MPS, caused by knots within skeletal muscle, can contribute to an OA patient's pain and dysfunction. In central sensitization, faulty pain sensing leads to increased pain sensitivity. However, there is currently no established process to identify these sources of pain and potential associated TKA non-responder risk. Our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential TKA nonresponders. This new approach may increase healthcare efficiency (reduce TKA waitlist and length of hospital stay), and help patients receive the right care at the right time.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients aged 18 or older
- •on the waitlist for TKA (unilateral) for knee osteoarthritis
Exclusion Criteria
- •undergoing revision or non-elective surgery
- •unable to provide informed consent and follow study procedures
Outcomes
Primary Outcomes
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression
Time Frame: 21 months
Secondary Outcomes
- Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire(21 months)
- Physical function, as assessed by the Aggregate Locomotor Function test(21 months)
- Pain regions and pain pattern, as assessed by Pain Body Diagram(21 months)
- Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire(21 months)
- Prevalence of myofascial trigger points(21 months)
- Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)(21 months)
- Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold(21 months)