Pain Phenotyping in Knee OA: a Pilot Trial

November 29, 2023 updated by: University Health Network, Toronto

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: OA pain research coordinator
  • Phone Number: 3115 416-597-3422
  • Email: TRI-SPARC@uhn.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Not yet recruiting
        • St. Joseph's Healthcare Hamilton
        • Contact:
      • Toronto, Ontario, Canada, M5T 2S8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

adult knee osteoarthritis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain regions and pain pattern, as assessed by Pain Body Diagram
Time Frame: 21 months
21 months
Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire
Time Frame: 21 months
21 months
Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire
Time Frame: 21 months
21 months
Physical function, as assessed by the Aggregate Locomotor Function test
Time Frame: 21 months
21 months
Prevalence of myofascial trigger points
Time Frame: 21 months
21 months
Pain facilitation, as assessed by Temporal Summation of Pain (wind-up)
Time Frame: 21 months
21 months
Deep tissue pain sensitivity, as assessed by Pain Pressure Threshold
Time Frame: 21 months
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dinesh Kumbhare, MD, PhD, UHN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

June 18, 2025

Study Completion (Estimated)

September 18, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO3624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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