- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03556423
Neurophysiological Mechanisms Involved in Knee Osteoarthritis
26. maj 2022 opdateret af: Guillaume Léonard, Université de Sherbrooke
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
See outcome measures
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
28
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec
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Sherbrooke, Quebec, Canada, J1H 4C4
- Centre de recherche sur le vieillissement (CdRV)
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Sherbrooke, Quebec, Canada, J1H 5N4
- CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 79 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline - Integrity of the corticospinal system
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by transcranial magnetic stimulation (TMS)
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Descending pain inhibition circuits
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by a counter-irritation paradigm (conditioned pain modulation using a thermode and a bath of circulating cold water)
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Pain intensity
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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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.
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Pain, stiffness and physical function
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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Before surgery, 6 months and 1 year post-surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain catastrophizing
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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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.
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Before surgery, 6 months and 1 year post-surgery
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Kinesiophobia
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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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.
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Before surgery, 6 months and 1 year post-surgery
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Anxiety
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured with the Spielberger's State-Trait Anxiety Inventory
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Before surgery, 6 months and 1 year post-surgery
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Qualitative aspect of pain
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the McGill Pain Questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Impact of pain on physical function and quality of life
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Brief Pain Inventory (BPI)
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Before surgery, 6 months and 1 year post-surgery
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Functional autonomy, social autonomy
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the SMAF questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Level of physical activity
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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Physical Activity Scale for the Elderly (PASE)
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Before surgery, 6 months and 1 year post-surgery
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Hypersensitivity of central nervous system
Tidsramme: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Central Sensitization Inventory
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Before surgery, 6 months and 1 year post-surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Guillaume Leonard, Ph.D., pht., Centre de recherche sur le vieillissement (CdRV)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2018
Primær færdiggørelse (Faktiske)
1. maj 2020
Studieafslutning (Faktiske)
1. marts 2022
Datoer for studieregistrering
Først indsendt
16. maj 2018
Først indsendt, der opfyldte QC-kriterier
12. juni 2018
Først opslået (Faktiske)
14. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-454-IUGS
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