NCT03556423 - Neurophysiological Mechanisms Involved in Knee Osteoarthritis | Crick | Crick

Neurophysiological Mechanisms Involved in Knee Osteoarthritis

N/ACompletedNCT03556423

Université de Sherbrooke28 enrolled

Overview

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.

See outcome measures

Study Type

OBSERVATIONAL

Enrollment

28

Conditions

Knee Osteoarthritis Chronic Pain

Outcomes

Primary Outcomes

Change from baseline - Integrity of the corticospinal system

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

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

Change from baseline - Descending pain inhibition circuits

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

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

Change from baseline - Pain intensity

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.

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

Change from baseline - Pain, stiffness and physical function

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

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

Secondary Outcomes

Pain catastrophizing

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.

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

Kinesiophobia

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.

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

Anxiety

This outcome will be measured with the Spielberger's State-Trait Anxiety Inventory

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

Qualitative aspect of pain

This outcome will be measured by the McGill Pain Questionnaire

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

Impact of pain on physical function and quality of life

This outcome will be measured by the Brief Pain Inventory (BPI)

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

Functional autonomy, social autonomy

This outcome will be measured by the SMAF questionnaire

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