Pain Phenotyping in Knee OA: a Pilot Trial

Osteo Arthritis Knee Clinical Trial

Official title:

Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066684
• Other study ID #: CTO3624
• Status: Recruiting
• Start date: September 18, 2023
• Est. completion date: September 18, 2025

Study information

• Verified date: September 2023
• Source: University Health Network, Toronto
• Contact: OA pain research coordinator
• Phone: 416-597-3422
• Email: TRI-SPARC[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 18, 2025
• Est. primary completion date: June 18, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Post-operative Pain
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Other:
• n/a, observational
n/a, observational study

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression		21 months
Secondary	Pain regions and pain pattern, as assessed by Pain Body Diagram		21 months
Secondary	Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire		21 months
Secondary	Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire		21 months
Secondary	Physical function, as assessed by the Aggregate Locomotor Function test		21 months
Secondary	Prevalence of myofascial trigger points		21 months
Secondary	Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)		21 months
Secondary	Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold		21 months