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Neurophysiological Mechanisms Involved in Knee Osteoarthritis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03556423
Enrollment
28
Registered
2018-06-14
Start date
2018-07-01
Completion date
2022-03-01
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Knee Osteoarthritis

Keywords

Arthritis, Chronic pain, Transcranial magnetic stimulation (TMS), Magnetic resonance imaging (MRI), Conditioned pain modulation (CPM), Clinical measures, Knee osteoarthritis

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

Interventions

None listed

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline - Pain intensityBefore surgery, 6 months and 1 year post-surgeryThis 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 functionBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Change from baseline - Integrity of the corticospinal systemBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by transcranial magnetic stimulation (TMS)
Change from baseline - Descending pain inhibition circuitsBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by a counter-irritation paradigm (conditioned pain modulation using a thermode and a bath of circulating cold water)

Secondary

MeasureTime frameDescription
Qualitative aspect of painBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by the McGill Pain Questionnaire
Functional autonomy, social autonomyBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by the SMAF questionnaire
Impact of pain on physical function and quality of lifeBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by the Brief Pain Inventory (BPI)
Pain catastrophizingBefore surgery, 6 months and 1 year post-surgeryThis 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.
KinesiophobiaBefore surgery, 6 months and 1 year post-surgeryThis 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.
AnxietyBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured with the Spielberger's State-Trait Anxiety Inventory

Other

MeasureTime frameDescription
Level of physical activityBefore surgery, 6 months and 1 year post-surgeryPhysical Activity Scale for the Elderly (PASE)
Hypersensitivity of central nervous systemBefore surgery, 6 months and 1 year post-surgeryThis outcome will be measured by the Central Sensitization Inventory

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026