Pain Phenotyping in Knee OA: a Pilot Trial

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06066684
• Collaborator: (none)
• Enrollment: 55
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 27.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Observational Study; Association of Patient Pain Characteristics and Total Knee Arthroplasty Response	Other: n/a, observational

Study Design

• Study Type: Observational
• Anticipated Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prediction Modelling of TKA Non-responders Using Clinical and Pain Sensitization Measures
• Actual Study Start Date: Sep 18, 2023
• Anticipated Primary Completion Date: Jun 18, 2025
• Anticipated Study Completion Date: Sep 18, 2025

Outcome Measures

Primary Outcome Measures

1. clinical prediction model feasibility [21 months]

Secondary Outcome Measures

1. pain body diagram [21 months]

2. painDetect [21 months]

3. central sensitization inventory [21 months]

4. aggregate locomotor function test [21 months]

5. myofascial trigger points [21 months]

6. temporal summation of pain [21 months]

7. pain pressure threshold [21 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N 4A6
2	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT06066684
• Other Study ID Numbers: CTO3624
• First Posted: Oct 4, 2023
• Last Update Posted: Oct 4, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 4, 2023