Effets de la stimulation magnétique périphérique répétitive sur les personnes souffrant de douleur chronique au coude ou au poignet (rPMS)
<p>Effets de la stimulation magnétique périphérique répétitive périphérique sur les personnes souffrant de douleur chronique du coude ou du poignet, un essai pilote randomisé contrôlé</p>
This pilot, randomized, sham-controlled, single-blind study will evaluate the effectiveness of repetitive peripheral magnetic stimulation (rPMS) in reducing pain in adults with tennis/golfer's elbow or carpal tunnel syndrome. Approximately 40 participants will be randomly assigned to active or sham stimulation delivered over two consecutive days. Outcomes, including pressure pain threshold, subjective pain ratings, and local tissue oxygenation (fNIRS), will be assessed at baseline, immediately post-intervention, and during follow-up up to 6 months to evaluate both clinical effects and underlying physiological mechanisms.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Objectives - The primary objective is to investigate the effect of active repetitive peripheral magnetic stimulation (rPMS) in reducing pain in individuals with either tennis/golfer elbow syndrome (either medial or lateral epicondylitis) or carpal tunnel syndrome in a pilot randomized placebo-controlled clinical trial. The secondary objective is to investigate the duration of the rPMS effects up to 6 months.
Study Population - The study population will consist of two groups of individuals: one group including 10 with tennis/golfer elbow syndrome and second group including 10 with carpal tunnel syndrome. Participants will be recruited from volunteers by advertising and/or doctors' referral.
Research Design and Study Procedure - This study design is a parallel-cohort exploratory single-blind, randomized, sham-controlled study investigating the effect of rPMS in pain reduction in individuals with either elbow or wrist chronic pain. Eligible participants in each group will be stratified by condition (elbow vs carpal tunnel) and randomized within each stratum to active or sham rPMS. The sham group participants will have the option to receive the active treatment after a month of receiving the sham treatment.
The rPMS protocol is two consecutive days of therapy. In each day, the participants will receive 400 pulses at 10 HZ in 1.5 sec trains with 10-second intertrain intervals. All participants will be assessed for their pain levels at baseline, immediately post-intervention, one week after the intervention and then every month up to 6 months follow-up sessions.
The assessments include subjective Visual Analogue Scale (VAS) score for pain on a scale of 0 to 10, the minimum pressure pain threshold (PPT) and near-infrared spectroscopy (NIRS) over the target area.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mari Garcia, M.Sc.
- Numéro de téléphone: (204) 478-6352
- E-mail: MARITERE.GARCIACAMPUZANO@umanitoba.ca
Sauvegarde des contacts de l'étude
- Nom: Zahra Moussavi, Ph.D.
- Numéro de téléphone: 204-474-7023
- E-mail: Zahra.Moussavi@umanitoba.ca
Lieux d'étude
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Manitoba
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Winnipeg, Manitoba, Canada, R3L 2P4
- Recrutement
- Riverview Health Center
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Contact:
- Cassandra Aldaba, M.Sc.
- Numéro de téléphone: 204-478-6163
- E-mail: umaldabc@myumanitoba.ca
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Clinical diagnosis or self-reported history consistent with either medial or lateral epicondylitis or carpal tunnel syndromes.
- Presence of chronic pain in the target area (mentioned above) at the time of enrollment.
- Ability to understand the study procedures and provide informed consent.
Exclusion Criteria:
- Contraindications to peripheral magnetic stimulation, including implanted electronic medical devices or metallic implants in locations deemed unsafe for stimulation.
- Open wounds, active skin conditions, or other local conditions at the stimulation site.
- Current neurological, musculoskeletal, or systemic medical conditions that, in the opinion of the investigators, would interfere with safe participation or interpretation of study outcomes.
- Current upper-limb injury or condition other than tennis/golfer elbow or carpal tunnel syndromes that could confound pain or perfusion measurements.
- Pregnancy.
- Inability to tolerate the stimulation or measurement procedures.
- Inability to adequately understand study instructions or provide informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Two days active rPMS - Tennis/golfer syndrome
Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive real rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
Comparateur factice: Two days sham rPM - Tennis/golfer syndrome
Participants of this arm, suffer from chronic pain at elbow either medial or lateral epicondylitis (tennis/golder syndromes) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
|
Expérimental: Two days Active rPMS - Carpal Tunnel Syndrome
Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive REAL rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
It is a magnetic coil with a device that creates electromagnetic pulses. The Real one gives pulses with 100% intensity. |
|
Comparateur factice: Two days Sham rPMS - Carpal Tunnel syndrome
Participants of this arm, suffer from chronic pain at wrist (carpal tunnel syndrome) and receive SHAM rPMS pulses as treatment for two days successively, each day 300 pulses at 10 Hz. |
Sham coil gives very weak pulses off target that does not penetrate to the skin. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in pain pressure threshold (PPT)
Délai: from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.
|
PPT is measured by a pressure altimeter and identifies the minimum pressure that the subject feels pain. |
from baseline to post-treatment assessments on day 3 and week2 up to 6 months follow-up.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in visual subjective pain scale
Délai: from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.
|
the visual subjective pain scale is a score using 0 to 10 on the pain level. |
from Pre-intervention to post on day 3, week 1 and other post assessments up to 6 months.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zahra Moussavi, University of Manitoba
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Blessures au coude
- La douleur
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies du système nerveux
- Maladies musculaires
- Blessures et Blessures
- Maladies neuromusculaires
- Maladies du système nerveux périphérique
- Blessures aux tendons
- Blessures au bras
- Tendinopathie
- Neuropathie médiane
- Mononeuropathies
- Syndromes de compression nerveuse
- Troubles traumatiques cumulatifs
- Entorses et foulures
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Tendinopathie du coude
- La douleur chronique
- Syndrome du canal carpien
Autres numéros d'identification d'étude
- Rithim Harmony - 5266
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
Informations sur les médicaments et les dispositifs, documents d'étude
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