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El ensayo clínico NCT07494591 para Ipsilateral Shoulder Pain, Cirugía toracoscópica asistida por video 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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TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 No invasivo

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El ensayo clínico NCT07494591 es un estudio intervencionista para Ipsilateral Shoulder Pain, Cirugía toracoscópica asistida por video. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de abril de 2026 hasta completar 216 participantes. Dirigido por Shanghai Pulmonary Hospital, Shanghai, China, se espera que finalice el 30 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
Shoulder pain is a common problem after certain types of lung surgery called video-assisted thoracoscopic surgery (VATS). This study examines whether a treatment called transcutaneous electrical acupoint stimulation (TEAS) can help reduce this pain. TEAS is a non-invasive technique that uses mild electrical stimulation at specific points on the body.Patients who are having VATS lung surgery will be randomly assigned ...Mostrar más
Descripción detallada
Ipsilateral shoulder pain (ISP) is a common and often debilitating complication following video-assisted thoracoscopic surgery (VATS) for lung surgery, significantly impacting patient recovery and quality of life. Current pain management strategies are not always fully effective in preventing or alleviating ISP. Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-pharmacological intervention that has shown...Mostrar más
Título oficial

Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial

Condiciones médicas
Ipsilateral Shoulder PainCirugía toracoscópica asistida por video
Otros ID del estudio
  • L25-604
Número del NCT
NCT07494591
Inicio del estudio (real)
2026-04-01
Última actualización
2026-03-27
Fecha de finalización (estimada)
2026-12-30
Inscripción (prevista)
216
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalTEAS Group
Participants will receive preoperative transcutaneous electrical acupoint stimulation (TEAS) . TEAS will be administered for 30 minutes twice: (1) the evening before surgery and (2) before anesthesia induction on the day of surgery.
TEAS
TEAS is a non-invasive transcutaneous electrical stimulation procedure. The TEAS device delivers a sparse-dense waveform. The current intensity is set within a range of 2-20 mA. The intervention administrator adjusts the current intensity within the pre-defined safety limits according to patient tolerance to maintain a mild soreness/"deqi" sensation. TEAS will be delivered twice for 30 minutes each: in the evening th...Mostrar más
Comparador simuladoSham TEAS Group
The control group receives a sham stimulation procedure with sensory matching. Sham TEAS will be administered for 30 minutes twice: (1) the evening before surgery and (2) before anesthesia induction on the day of surgery.
Sham TEAS
he sham procedure is a sensory-matched inactive stimulation. During the first 30 seconds, identical stimulation parameters to the active TEAS group are delivered using a sparse-dense waveform with instantaneous stimulation (5-10 mA) to produce a mild tingling sensation matched to the active arm. After 30 seconds, the device stops delivering effective electrical current while maintaining normal indicator lights and th...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Incidence of Ipsilateral Shoulder Pain (ISP) with Shoulder Movement at 24 Hours Postoperatively
Pain intensity will be assessed using the Verbal Rating Scale (VRS, 0-10, with 10 indicating worst pain). Participants will perform maximal shoulder circumduction (anterior, superior, posterior, inferior) in sitting/standing position with elbow extended, and the maximum VRS score will be recorded. ISP is defined as a VRS score ≥1.
24 Hours Postoperatively
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Cumulative Opioid Consumption at 24 Hours Postoperatively
Total opioid use within 24 hours postoperatively will be recorded and converted to intravenous morphine equivalents.
24 Hours Postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours Postoperatively
The number of participants experiencing nausea or vomiting within 24 hours postoperatively will be recorded.
24 Hours Postoperatively
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Patients scheduled for unilateral thoracic surgery
  • Age ≥ 18 years, regardless of gender
  • ASA physical status classification I-III
  • No severe cardiopulmonary insufficiency or other major comorbidities

  • Pre-existing shoulder pain or functional impairment
  • Severe mental illness or cognitive impairment
  • Bilateral thoracic surgery
  • Any other conditions deemed inappropriate by the investigators (with reasons to be documented)
Shanghai Pulmonary Hospital, Shanghai, China logoShanghai Pulmonary Hospital, Shanghai, China
Parte responsable del estudio
Shiyou Wei, Investigador principal, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
Contactos centrales del estudio
Contacto: Shiyou Wei, 15601680099, [email protected]
Contacto: Xin Lv, 13661869919, [email protected]
3 Centros del estudio en 1 países

Shanghai Municipality

Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, 200082, China
Shanghai East Hospital,Affiliated to Tongji University, Shanghai, Shanghai Municipality, 200120, China
Fudan university Shanghai cancer center, Shanghai, Shanghai Municipality, China