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Clinical Trials/NCT03556423
NCT03556423
Completed
Not Applicable

Pain in Individuals With Knee Osteoarthritis : Beyond the Joint and the Musculoskeletal System

Université de Sherbrooke2 sites in 1 country28 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Université de Sherbrooke
Enrollment
28
Locations
2
Primary Endpoint
Change from baseline - Integrity of the corticospinal system
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Introduction: Total knee arthroplasty (TKA) is an effective intervention to relieve people with osteoarthritis (OA). Nevertheless, 15 to 30% of patients continue to experience severe pain following surgery. Recent data suggest that central nervous system (CNS) changes may play a role in OA pain and possibly explain why some patients have poorer clinical outcomes following TKA. Objectives: Our main objectives are to explore the relationship between OA pain and (1) the integrity of corticospinal system, (2) the efficacy of descending pain inhibition circuits. Methods: Fifty-two patients waiting for TKA will be recruited. The integrity of the corticospinal projections will be measured using transcranial magnetic stimulation (recruitment curve of the affected quadriceps femoris muscle) and the descending pain inhibition circuits (bulbospinal projections) will be assessed by a counter-irritation paradigm (i.e., conditioned pain modulation with immersion of the arm in painfully cold water). Diffuse tension imaging (DTI) will also be used to quantify the strength of these corticospinal and bulbospinal projections. Clinical outcomes will be evaluated before and after arthroplasty with a series of validated questionnaires such as the WOMAC Scale, the McGill Pain Questionnaire and the Brief Pain Inventory. These different neurophysiological and clinical measures will be taken before surgery, 6 months after surgery and 1 year post-surgery. Anticipated results: The investigators expect a moderate association between pain and the strength of the corticospinal and bulbospinal projections. Moreover, it is expected that there will be a moderate association between the strength of the corticospinal/bulbospinal projections and the clinical evolution of patients.

Detailed Description

See outcome measures

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guillaume Léonard

Professor

Université de Sherbrooke

Eligibility Criteria

Inclusion Criteria

  • Being an adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
  • Refrain from consuming cigarettes and caffeine 2 hours and 6 hours before testing, respectively
  • Refrain from taking short-acting analgesics (e.g., acetaminophen) 6 hours before testing

Exclusion Criteria

  • Having difficulty understanding french language
  • Having a diagnosis of neurological disorder or diagnosis of chronic pain (other knee OA)
  • Having metal implants in the skull
  • Having pacemaker or neurostimulator
  • Being pregnant
  • Being epileptic

Outcomes

Primary Outcomes

Change from baseline - Integrity of the corticospinal system

Time Frame: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by transcranial magnetic stimulation (TMS)

Change from baseline - Descending pain inhibition circuits

Time Frame: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by a counter-irritation paradigm (conditioned pain modulation using a thermode and a bath of circulating cold water)

Change from baseline - Pain intensity

Time Frame: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by a visual analogue scale (VAS). The VAS is a straight horizontal line of fixed length, usually 10 cm. The ends are defined as the extreme limits of the parameter to be measured; 0 = "no pain", 10 = "the worst imaginable pain". Using a ruler, the score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

Change from baseline - Pain, stiffness and physical function

Time Frame: Before surgery, 6 months and 1 year post-surgery

This outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Secondary Outcomes

  • Kinesiophobia(Before surgery, 6 months and 1 year post-surgery)
  • Anxiety(Before surgery, 6 months and 1 year post-surgery)
  • Pain catastrophizing(Before surgery, 6 months and 1 year post-surgery)
  • Qualitative aspect of pain(Before surgery, 6 months and 1 year post-surgery)
  • Impact of pain on physical function and quality of life(Before surgery, 6 months and 1 year post-surgery)
  • Functional autonomy, social autonomy(Before surgery, 6 months and 1 year post-surgery)

Study Sites (2)

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