Clinical trial NCT06066684: Pain Phenotyping in Knee OA: a Pilot Trial
Official title: Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteo Arthritis Knee
Chronic Post-operative Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult knee osteoarthritis patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical prediction model feasibility as determined by: Recruitment rate, follow-up at 12 months post-op, multivariable logistic regression
timeFrame: 21 months
Secondary outcomes:
measure: Pain regions and pain pattern, as assessed by Pain Body Diagram
timeFrame: 21 months
measure: Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire
timeFrame: 21 months
measure: Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire
timeFrame: 21 months
measure: Physical function, as assessed by the Aggregate Locomotor Function test
timeFrame: 21 months
measure: Prevalence of myofascial trigger points
timeFrame: 21 months
measure: Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)
timeFrame: 21 months
measure: Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold
timeFrame: 21 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: UHN
name: Dinesh Kumbhare, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: