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NCT Number: NCT03556423

Neurophysiological Mechanisms Involved in Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

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About this study

See outcome measures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. Anxiety

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

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

  4. Qualitative aspect of pain

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

    This outcome will be measured by the McGill Pain Questionnaire

  5. Impact of pain on physical function and quality of life

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

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

  6. Functional autonomy, social autonomy

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

    This outcome will be measured by the SMAF questionnaire

Other outcomes

  1. Level of physical activity

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

    Physical Activity Scale for the Elderly (PASE)

  2. Hypersensitivity of central nervous system

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

    This outcome will be measured by the Central Sensitization Inventory

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jun 14, 2018
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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