Efectos de la Estimulación Magnética Periférica Repetitiva en Individuos con Dolor Crónico de Codo o Muñeca (rPMS)
Efectos de la Estimulación Magnética Periférica Repetitiva Periférica en Individuos con Dolor Crónico de Codo o Muñeca, Un Ensayo Controlado Aleatorizado Piloto
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mari Garcia, M.Sc.
- Número de teléfono: (204) 478-6352
- Correo electrónico: MARITERE.GARCIACAMPUZANO@umanitoba.ca
Copia de seguridad de contactos de estudio
- Nombre: Zahra Moussavi, Ph.D.
- Número de teléfono: 204-474-7023
- Correo electrónico: Zahra.Moussavi@umanitoba.ca
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3L 2P4
- Reclutamiento
- Riverview Health Center
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Contacto:
- Cassandra Aldaba, M.Sc.
- Número de teléfono: 204-478-6163
- Correo electrónico: umaldabc@myumanitoba.ca
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
|
Comparador falso: 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. |
|
Experimental: 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. |
|
Comparador falso: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain pressure threshold (PPT)
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in visual subjective pain scale
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zahra Moussavi, University of Manitoba
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Lesiones de codo
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades del Sistema Nervioso
- Enfermedades Musculares
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Lesiones de tendones
- Lesiones en el brazo
- Tendinopatía
- Neuropatía mediana
- Mononeuropatías
- Síndromes de compresión nerviosa
- Trastornos Traumáticos Acumulativos
- Torceduras y esguinces
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Tendinopatía de codo
- Dolor crónico
- Síndrome del túnel carpiano
Otros números de identificación del estudio
- Rithim Harmony - 5266
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
This is a small pilot study. Once there is enough data with good quality, the investigators will consider data sharing.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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