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El ensayo clínico NCT07380087 (SHINE) para Capsulitis adhesiva, Adhesive Capsulitis of Unspecified Shoulder, Adhesive Capsulitis, Shoulder, Hombro congelado, Dolor de hombro, Shoulder Stiffness está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Suprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis (SHINE) 50 Aleatorizado

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07380087 (SHINE) es un estudio intervencionista para Capsulitis adhesiva, Adhesive Capsulitis of Unspecified Shoulder, Adhesive Capsulitis, Shoulder, Hombro congelado, Dolor de hombro, Shoulder Stiffness. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de marzo de 2026 hasta completar 50 participantes. Dirigido por la Universidad de Oporto, se espera que finalice el 31 de julio de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 2 de febrero de 2026.
Resumen
Adhesive capsulitis ("frozen shoulder") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate.

This randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrod...

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Descripción detallada

1 Efficacy of suprascapular nerve block on the tolerability and efficacy of shoulder hydrodistension in patients with adhesive capsulitis: randomized clinical trial

  • Principal Investigator Name: João Paulo Castro Contact: [email protected]

    Under the supervision of:

    Professor José Paulo Andrade Full Professor at the Faculty of Medicine of the University of Porto Professor Iva Brito Senior Consultant in Rheuma...

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Título oficial

Efficacy of Suprascapular Nerve Block on the Tolerability and Effectiveness of Shoulder Hydrodistension in Patients With Adhesive Capsulitis: A Randomized Clinical Trial

Condiciones médicas
Capsulitis adhesivaAdhesive Capsulitis of Unspecified ShoulderAdhesive Capsulitis, ShoulderHombro congeladoDolor de hombroShoulder Stiffness
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • SHINE
  • FMUP/ULSSJ - 01/2026
Número del NCT
NCT07380087
Inicio del estudio (real)
2026-03-01
Última actualización
2026-02-02
Fecha de finalización (estimada)
2028-07-31
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
Shoulder Hydrodistension
Suprascapular Nerve Block
Shoulder Pain
Shoulder Mobility
Randomized Clinical Trial
Pain Management
Rehabilitation
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Comparador activoHydrodistension Alone
Participants assigned to this arm will undergo standard ultrasound-guided shoulder hydrodistension without any prior nerve block. The procedure consists of an anterior intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This intervention represents the current standard treatment for adhesive capsulitis.
Shoulder Hydrodistention
Shoulder hydrodistension is performed using an anterior intra-articular approach. The procedure consists of an injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone into the glenohumeral joint, with the aim of capsular distension, pain reduction, and improvement of shoulder mobility.
ExperimentalSuprascapular Nerve Block Followed by Shoulder Hydrodistension
Participants in this arm will receive an ultrasound-guided suprascapular nerve block immediately before the hydrodistension procedure. The nerve block is performed at the suprascapular notch using 2 mL of ropivacaine. After the block, participants undergo standard anterior shoulder hydrodistension consisting of an intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolon...Mostrar más
Shoulder Hydrodistention
Shoulder hydrodistension is performed using an anterior intra-articular approach. The procedure consists of an injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone into the glenohumeral joint, with the aim of capsular distension, pain reduction, and improvement of shoulder mobility.
Bloqueo del nervio supraescapular
The suprascapular nerve block is performed under ultrasound guidance at the suprascapular notch using an injection of 2 mL of ropivacaine. The block is administered immediately before shoulder hydrodistension with the aim of reducing procedural pain and improving patient tolerance.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in Shoulder Pain - Numeric Rating Scale for Pain (NRS 0-10)
Shoulder pain intensity at rest and/or with movement will be measured using the Numerical Rating
"From enrollment to the end of follow up at 3 years
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Adults aged 18 years or older
  • Clinical diagnosis of adhesive capsulitis of the shoulder
  • Persistent pain and functional limitation despite initial conservative treatment
  • Ability to understand study procedures
  • Ability to provide written informed consent

  • Known allergy or hypersensitivity to ropivacaine or methylprednisolone
  • Active infection (local or systemic)
  • Uncontrolled coagulopathy or ongoing therapeutic anticoagulation
  • Recent surgery of the affected shoulder
  • Neurological disease affecting the upper limb
  • Pregnancy
Universidade do Porto logoUniversidad de Oporto54 estudios activos para explorar
Parte responsable del estudio
João Rocha Neves, Investigador principal, MD, MSc, MPH, PhD, MBA, FEBVS, Universidade do Porto
Contactos centrales del estudio
Contacto: Joao Manuel Rocha-Neves,, MD, MSc, MPH, PhD, MBA, FEBVS, 910486230, [email protected]
Contacto: Joao Paulo Castro,, MD, MSc, +351914278223, [email protected]
1 Centros del estudio en 1 países

Porto District

Unidade Local de Saude São João, EPE, Porto, Porto District, 4200-319, Portugal
Joao Ferreira Castro, MD, MSc, Contacto, 914278223, [email protected]
Joao Manuel Rocha-Neves, MD, MSc, MPH, PhD, MBA, FEBVS, Contacto, 910486230, [email protected]