Neurophysiological Mechanisms Involved in Knee Osteoarthritis

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556423
• Other study ID #: 2015-454-IUGS
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See outcome measures

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 1, 2022
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Canada	Centre de recherche sur le vieillissement (CdRV)	Sherbrooke	Quebec
Canada	CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of physical activity	Physical Activity Scale for the Elderly (PASE)	Before surgery, 6 months and 1 year post-surgery
Other	Hypersensitivity of central nervous system	This outcome will be measured by the Central Sensitization Inventory	Before surgery, 6 months and 1 year post-surgery
Primary	Change from baseline - Integrity of the corticospinal system	This outcome will be measured by transcranial magnetic stimulation (TMS)	Before surgery, 6 months and 1 year post-surgery
Primary	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)	Before surgery, 6 months and 1 year post-surgery
Primary	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.	Before surgery, 6 months and 1 year post-surgery
Primary	Change from baseline - Pain, stiffness and physical function	This outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Before surgery, 6 months and 1 year post-surgery
Secondary	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.	Before surgery, 6 months and 1 year post-surgery
Secondary	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.	Before surgery, 6 months and 1 year post-surgery
Secondary	Anxiety	This outcome will be measured with the Spielberger's State-Trait Anxiety Inventory	Before surgery, 6 months and 1 year post-surgery
Secondary	Qualitative aspect of pain	This outcome will be measured by the McGill Pain Questionnaire	Before surgery, 6 months and 1 year post-surgery
Secondary	Impact of pain on physical function and quality of life	This outcome will be measured by the Brief Pain Inventory (BPI)	Before surgery, 6 months and 1 year post-surgery
Secondary	Functional autonomy, social autonomy	This outcome will be measured by the SMAF questionnaire	Before surgery, 6 months and 1 year post-surgery