Pain Phenotyping in Knee OA: a Pilot Trial

NCT06066684 | Unknown

• 1 other identifier: CTO3624
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteo Arthritis Knee; Chronic Post-operative Pain

Outcome Measures

Primary Outcomes (1)

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

  21 months

Secondary Outcomes (7)

• Pain regions and pain pattern, as assessed by Pain Body Diagram

  21 months

• Likelihood of neuropathic pain component, as assessed by the painDETECT questionnaire

  21 months

• Symptoms of central sensitisation, as assessed by the Central Sensitization Inventory questionnaire

  21 months

• Physical function, as assessed by the Aggregate Locomotor Function test

  21 months

• Prevalence of myofascial trigger points

  21 months

Interventions

n/a, observational OTHER

n/a, observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult knee osteoarthritis patients

You may qualify if:

• adult patients aged 18 or older
• on the waitlist for TKA (unilateral) for knee osteoarthritis

You may not qualify if:

• undergoing revision or non-elective surgery
• unable to provide informed consent and follow study procedures

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

NOT YET RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dinesh Kumbhare, MD, PhD

  UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

OA pain research coordinator

CONTACT

416-597-3422; TRI-SPARC@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: September 18, 2023
• Primary Completion: June 18, 2025
• Study Completion: September 18, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-09

Locations

CA (2)