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O estudo clínico NCT07380087 (SHINE) para Capsulite adesiva, Adhesive Capsulitis of Unspecified Shoulder, Adhesive Capsulitis, Shoulder, Ombro congelado, Dor no ombro, Shoulder Stiffness está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade do PortoSuprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis (SHINE) 50 Randomizado
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O estudo clínico NCT07380087 (SHINE) é um estudo intervencionista para Capsulite adesiva, Adhesive Capsulitis of Unspecified Shoulder, Adhesive Capsulitis, Shoulder, Ombro congelado, Dor no ombro, Shoulder Stiffness. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de março de 2026, com o objetivo de incluir 50 participantes. Coordenado por Universidade do Porto e deve ser concluído em 31 de julho de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 2 de fevereiro de 2026.
Resumo
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...
Mostrar maisDescrição detalhada
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...
Título oficial
Efficacy of Suprascapular Nerve Block on the Tolerability and Effectiveness of Shoulder Hydrodistension in Patients With Adhesive Capsulitis: A Randomized Clinical Trial
Condições médicas
Capsulite adesivaAdhesive Capsulitis of Unspecified ShoulderAdhesive Capsulitis, ShoulderOmbro congeladoDor no ombroShoulder StiffnessPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- SHINE
- FMUP/ULSSJ - 01/2026
Número NCT
Data de início (real)
2026-03-01
Última atualização postada
2026-02-02
Data de conclusão (estimada)
2028-07-31
Inscrição (estimada)
50
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Shoulder Hydrodistension
Suprascapular Nerve Block
Shoulder Pain
Shoulder Mobility
Randomized Clinical Trial
Pain Management
Rehabilitation
Suprascapular Nerve Block
Shoulder Pain
Shoulder Mobility
Randomized Clinical Trial
Pain Management
Rehabilitation
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador ativoHydrodistension 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 mais | 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. Bloqueio do nervo 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. |
Desfecho primário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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 Porto54 estudos clínicos ativos para explorarResponsável pelo estudo
João Rocha Neves, Investigador principal, MD, MSc, MPH, PhD, MBA, FEBVS, Universidade do Porto
Contato central do estudo
Contato: Joao Manuel Rocha-Neves,, MD, MSc, MPH, PhD, MBA, FEBVS, 910486230, [email protected]
Contato: Joao Paulo Castro,, MD, MSc, +351914278223, [email protected]
1 Locais do estudo em 1 países
Porto District
Unidade Local de Saude São João, EPE, Porto, Porto District, 4200-319, Portugal
Joao Ferreira Castro, MD, MSc, Contato, 914278223, [email protected]
Joao Manuel Rocha-Neves, MD, MSc, MPH, PhD, MBA, FEBVS, Contato, 910486230, [email protected]