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Pain Phenotyping in Knee OA: a Pilot Trial

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06066684
Enrollment
55
Registered
2023-10-04
Start date
2023-09-18
Completion date
2025-09-18
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post-operative Pain, Osteo Arthritis Knee

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.

Interventions

OTHERn/a, observational

n/a, observational study

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression21 months

Secondary

MeasureTime frame
Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire21 months
Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire21 months
Physical function, as assessed by the Aggregate Locomotor Function test21 months
Pain regions and pain pattern, as assessed by Pain Body Diagram21 months
Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)21 months
Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold21 months
Prevalence of myofascial trigger points21 months

Countries

Canada

Contacts

Primary ContactOA pain research coordinator
TRI-SPARC@uhn.ca416-597-3422

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026