- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07926789
Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
Randomized Clinical Trial to Evaluate the Efficacy of Neuromuscular Taping on Muscle Pain in Patients With Degenerative Osteoarticular Disease of the Spine
The goal of this clinical trial is to learn if neuromuscular taping (kinesio taping), added to a standard exercise program, reduces muscle pain in adults with chronic neck pain or chronic low back pain caused by degenerative disease of the spine (such as facet joint osteoarthritis, spondylosis, or degenerative disc disease). The main questions it aims to answer are:
Does neuromuscular taping, applied once a week for 3 weeks in addition to standard exercise therapy, reduce muscle pain more than placebo taping?
Researchers will compare neuromuscular taping applied with a muscle and fascial technique to placebo taping (the same tape placed on the same area without tension or therapeutic technique) to see if the active taping provides greater pain relief.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Noemí Casaponsa
- Número de teléfono: 43197 0034938960025
- Correo electrónico: recerca@csapg.cat
Ubicaciones de estudio
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Barcelona, España
- Consorci Sanitari Alt Penedès Garraf
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Contacto:
- Sandra Herrero
- Número de teléfono: 0034938960025
- Correo electrónico: aherrerol@csapg.cat
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men and women aged 18 years or older
- Persistent pain (duration of more than 3 months) with a diagnosis of chronic -neck pain or chronic low back pain due to degenerative joint disease
- Stable pain treatment, with no changes expected during the following 3 weeks
- Willingness to participate and signed informed consent
Exclusion Criteria:
- Cervicobrachialgia (neck pain radiating to the arm)
- Lumbosciatica (low back pain radiating to the leg)
- Pregnancy in the second or third trimester
- Skin conditions that contraindicate the application of neuromuscular tape
- Allergy to adhesive materials
- Thrombosis or risk of thrombosis
- Severe trauma that has not been previously examined and diagnosed by a physician
- Participation in another clinical trial involving an experimental intervention during the period of this trial and/or with a visit schedule incompatible with this trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Participants will have neuromuscular tape applied to the neck or lower back after the first exercise session of each week, and remove it on the fourth day |
The muscle technique consists of applying the tape without stretching it. Either the muscle or the skin is placed under stretch, but the tape itself is applied with no tension along its entire length. The base anchor is applied with the body segment in a neutral position; the target muscle is then stretched and the tape is laid over it. Finally, the segment is returned to the neutral position and the end anchor is applied. This technique is used to inhibit muscle tone. Once the tape has been applied, patients will be instructed to remove it on the fourth day. They may carry on with their normal daily activities and may get the tape wet when washing or showering. If the tape causes significant discomfort, patients may remove it early and must record this in their pain diary. If the tape comes off before the fourth day, patients must also record this in the diary. |
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Comparador falso: Control
These patients will have the same tape placed on the same area without tension or therapeutic technique |
The same tape placed on the same area without tension or therapeutic technique |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
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Pain intensity, measured using a Visual Analog Scale (VAS). Pain will be recorded before the first treatment session of each week. Since treatment consists of two physiotherapy sessions per week for four weeks, the VAS will be recorded at the start of sessions 1, 3, 5, and 8, the last of which corresponds to the final day of treatment. In addition, patients will complete a pain diary every day between treatment sessions. |
From enrollment to the end of treatment at 4 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSAPG-31
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Marco de tiempo para compartir IPD
After publication of main results of the study
Criterios de acceso compartido de IPD
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .