Pain Phenotyping in Knee OA: a Pilot Trial

Recruiting

• Conditions: Osteo Arthritis Knee; Chronic Post-operative Pain

• Registration Number: NCT06066684
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-18
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-04
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-06-18
• Study Completion: 2025-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• adult patients aged 18 or older
• on the waitlist for TKA (unilateral) for knee osteoarthritis

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Exclusion Criteria

• undergoing revision or non-elective surgery
• unable to provide informed consent and follow study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression	21 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada