Clinical trial NCT03556423: Neurophysiological Mechanisms Involved in Knee Osteoarthritis
Official title: Pain in Individuals With Knee Osteoarthritis : Beyond the Joint and the Musculoskeletal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Chronic Pain
Keywords: Arthritis
Chronic pain
Transcranial magnetic stimulation (TMS)
Magnetic resonance imaging (MRI)
Conditioned pain modulation (CPM)
Clinical measures
Knee osteoarthritis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Change from baseline - Integrity of the corticospinal system
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Change from baseline - Descending pain inhibition circuits
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Change from baseline - Pain intensity
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Change from baseline - Pain, stiffness and physical function
timeFrame: Before surgery, 6 months and 1 year post-surgery
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Kinesiophobia
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Anxiety
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Qualitative aspect of pain
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Impact of pain on physical function and quality of life
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Functional autonomy, social autonomy
timeFrame: Before surgery, 6 months and 1 year post-surgery
Other outcomes:
measure: Level of physical activity
timeFrame: Before surgery, 6 months and 1 year post-surgery
measure: Hypersensitivity of central nervous system
timeFrame: Before surgery, 6 months and 1 year post-surgery
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement (CdRV)
state: Quebec
city: Sherbrooke
country: Canada
facility: CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de Recherche sur le Vieillissement (CdRV)
name: Guillaume Leonard, Ph.D., pht.
role: PRINCIPAL_INVESTIGATOR
References: