- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03556423
Neurophysiological Mechanisms Involved in Knee Osteoarthritis
May 26, 2022 updated by: Guillaume Léonard, Université de Sherbrooke
Pain in Individuals With Knee Osteoarthritis : Beyond the Joint and the Musculoskeletal System
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.
Study Overview
Status
Completed
Conditions
Detailed Description
See outcome measures
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 4C4
- Centre de recherche sur le vieillissement (CdRV)
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Sherbrooke, Quebec, Canada, J1H 5N4
- CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
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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
50 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
Description
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
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 |
Measure Description |
Time Frame |
---|---|---|
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)
|
Before surgery, 6 months and 1 year post-surgery
|
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)
|
Before surgery, 6 months and 1 year post-surgery
|
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.
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Before surgery, 6 months and 1 year post-surgery
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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)
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Before surgery, 6 months and 1 year post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain catastrophizing
Time Frame: Before surgery, 6 months and 1 year post-surgery
|
This outcome will be measured with the Pain Catastrophizing Scale (PCS) .
The PCS inquire participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain.
Each item of the PCS is scored on a 5-point scale where 0 = not at all and 4 = all the time.
PCS yields three subscale scores assessing rumination, magnification and helplessness.
The PCS total score is computed by summing responses to all 13 items.
The PCS yields a total score ranging from 0 to 52.
Higher values on this scale represent a greater tendency of the subject to perceive pain negatively and to foresee the consequences of pain in a more catastrophic way.
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Before surgery, 6 months and 1 year post-surgery
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Kinesiophobia
Time Frame: Before surgery, 6 months and 1 year post-surgery
|
This outcome will be measured with the Tampa Scale of Kinesiophobia (TSK) .
The TSK is a 17-item self-report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
The total score ranges between 17 and 68.
A high value on the TSK indicates a high degree of kinesiophobia, and a cutoff score was developed by Vlaeyen (1995), where a score of 37 or over is considered as a high score, while scores below that are considered as low scores.
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Before surgery, 6 months and 1 year post-surgery
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Anxiety
Time Frame: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured with the Spielberger's State-Trait Anxiety Inventory
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Before surgery, 6 months and 1 year post-surgery
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Qualitative aspect of pain
Time Frame: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the McGill Pain Questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Impact of pain on physical function and quality of life
Time Frame: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Brief Pain Inventory (BPI)
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Before surgery, 6 months and 1 year post-surgery
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Functional autonomy, social autonomy
Time Frame: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the SMAF questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of physical activity
Time Frame: Before surgery, 6 months and 1 year post-surgery
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Physical Activity Scale for the Elderly (PASE)
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Before surgery, 6 months and 1 year post-surgery
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Hypersensitivity of central nervous system
Time Frame: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Central Sensitization Inventory
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Before surgery, 6 months and 1 year post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guillaume Leonard, Ph.D., pht., Centre de recherche sur le vieillissement (CdRV)
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)
July 1, 2018
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
June 12, 2018
First Posted (Actual)
June 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 26, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-454-IUGS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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