- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07633340
Routine Rehabilitation Versus Shock Wave Therapy for Scapular Dyskinesis
Routine Rehabilitation Versus Shock Wave Therapy for Patients With Scapular Dyskinesis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aliaa Mamdouh Abdelaziz Farag, MD
- Número de teléfono: 01069468486
- Correo electrónico: aliaa.mamdouh@med.tanta.edu.eg
Ubicaciones de estudio
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-
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Tanta, Egipto
- Reclutamiento
- Tanta University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- This study included 100 patients with scapular dyskinesis. The patients were divided into 2 groups: one group was treated with ESWT and routine rehabilitation, and the second group was treated with routine rehabilitation only. Adult patients with scapular dyskinesia who exhibited signs of dyskinesia for at least 6 months before enrolment in the study will be selected.
Exclusion Criteria:
- History of shoulder or thorax trauma or surgery.
- The back pain involved the cervical spine and thoracic spine.
- Participants with neurologic deficits
- history of inflammatory conditions such as ankylosing spondylitis
4- Certain situations where shockwave therapy is not recommended. These include:
Absolute contraindications:
- Active infection (i.e., osteomyelitis)
- Malignant tumors, particularly at the treatment site (focused shockwave)
- Pregnancy
Relative Contraindications:
- The brain or nerve in the treatment focus
- Treatment focused on the lungs or pleura
- Significant coagulopathy (increased risk of bleeding, such as haemophilia)
- Epiphyseal plate in treatment focus
Important considerations:
- Cardiac pacemakers or other implantable devices
- Current nonsteroidal anti-inflammatory drug use
- Current anticoagulation use
- Recent corticosteroid injections (receiving a steroid injection into the area to be treated within the previous 12 weeks).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Radial extracorporeal shock wave therapy/ Intervention group
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
|
Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (DornierMedTech GmbH, Wessling, Germany) under ultrasound guidance, at periscapular muscles .
1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.
The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month for the treatment group and without operating the machine for the sham group .
No anesthetic oranalgesic drugs will be administered to patients during the therapy session.
Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist.
|
|
Comparador falso: Sham rESWT/ Control group
Sham rESWT once weekly for one month.
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
|
The Dornier AR2 machine (Dornier MedTechGmbH, Wessling, Germany) used under ultrasound guidance, at affested periscapular muscles .
1.500 pulses will be applied by anR20 probe with intensity of 0.10 mJ to0.3mJ/mm2 (2.5 bar) & frequency 4 Hz every week for one month without operating the machine.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Improvement by Scapular Assistance Test and/or Scapular Dyskinesis Test
Periodo de tiempo: 1 month after intervention
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1 month after intervention
|
Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 36264PR768/7/24
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Results will be published by the investigators in academic journal.
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
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.
producto fabricado y exportado desde los EE. UU.
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