Trial Radar IA | ||
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Lo studio clinico NCT07494591 per Ipsilateral Shoulder Pain, Chirurgia toracoscopica video-assistita è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 Non invasivo
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La sperimentazione clinica NCT07494591 è uno studio interventistico per Ipsilateral Shoulder Pain, Chirurgia toracoscopica video-assistita, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 aprile 2026, con l'obiettivo di raggiungere 216 partecipanti. Sotto la guida di Shanghai Pulmonary Hospital, Shanghai, China, dovrebbe concludersi entro il 30 dicembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 27 marzo 2026.
Sommario breve
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 ...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale
Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial
Patologie
Ipsilateral Shoulder PainChirurgia toracoscopica video-assistitaAltri ID dello studio
- L25-604
Numero NCT
Data di inizio (effettiva)
2026-04-01
Ultimo aggiornamento pubblicato
2026-03-27
Data di completamento (stimata)
2026-12-30
Arruolamento (previsto)
216
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleTEAS 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...Mostra di più |
Comparatore simulatoSham 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...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- 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, ChinaParte responsabile dello studio
Shiyou Wei, Investigatore principale, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
Contatti principali dello studio
Contatto: Shiyou Wei, 15601680099, [email protected]
Contatto: Xin Lv, 13661869919, [email protected]
3 Centri dello studio in 1 paesi
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