Pain Phenotyping in Knee OA: a Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2025-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Osteo Arthritis Knee Chronic Post-operative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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n/a, observational

n/a, observational study

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dinesh Kumbhare, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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OA pain research coordinator

Role: CONTACT

Phone: 416-597-3422

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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CTO3624

Identifier Type: -

Identifier Source: org_study_id