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Knee OsteoarthritisNCT03556423

Neurophysiological Mechanisms Involved in Knee Osteoarthritis

An observational study of Knee Osteoarthritis and Chronic Pain, run by Université de Sherbrooke at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 79 years
Conditions the study is for
Knee Osteoarthritis, Chronic Pain
How many people
28 participants
Where
2 sitesCanada
Study dates
1 Jul 2018to 1 Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Centre de recherche sur le vieillissement (CdRV)

    Sherbrooke, Quebec, J1H 4C4

  • CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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

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.

Read the detailed description

See outcome measures

Keywords
Arthritis, Chronic pain, Transcranial magnetic stimulation (TMS), Magnetic resonance imaging (MRI), Conditioned pain modulation (CPM), Clinical measures, Knee osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Chronic Pain, Arthritis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline - Integrity of the corticospinal system

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

    Measured: Before surgery, 6 months and 1 year post-surgery

  2. 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)

    Measured: Before surgery, 6 months and 1 year post-surgery

  3. 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.

    Measured: Before surgery, 6 months and 1 year post-surgery

  4. Change from baseline - Pain, stiffness and physical function

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

    Measured: Before surgery, 6 months and 1 year post-surgery

Secondary outcomes (6)

  1. 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.

    Measured: Before surgery, 6 months and 1 year post-surgery

  2. 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.

    Measured: Before surgery, 6 months and 1 year post-surgery

  3. Anxiety

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

    Measured: Before surgery, 6 months and 1 year post-surgery

  4. Qualitative aspect of pain

    This outcome will be measured by the McGill Pain Questionnaire

    Measured: Before surgery, 6 months and 1 year post-surgery

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

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

    Measured: Before surgery, 6 months and 1 year post-surgery

  6. Functional autonomy, social autonomy

    This outcome will be measured by the SMAF questionnaire

    Measured: Before surgery, 6 months and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start1 Jul 2018
  3. Primary completion1 May 2020
  4. Study completion1 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556423
Sponsor's protocol ID
2015-454-IUGS
Status last verified
May 2022
First submitted
16 May 2018
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis and Chronic Pain, run by Université de Sherbrooke at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline - Integrity of the corticospinal system (time frame: Before surgery, 6 months and 1 year post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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