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L'essai clinique NCT07494591 pour Ipsilateral Shoulder Pain, Chirurgie thoracoscopique assistée par vidéo est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 Non invasif
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L'essai clinique NCT07494591 est une étude interventionnel pour Ipsilateral Shoulder Pain, Chirurgie thoracoscopique assistée par vidéo. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 avril 2026, avec un objectif de 216 participants. Dirigée par Shanghai Pulmonary Hospital, Shanghai, China, l'étude devrait être terminée d'ici le 30 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
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 ...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel
Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial
Pathologies
Ipsilateral Shoulder PainChirurgie thoracoscopique assistée par vidéoAutres identifiants de l'étude
- L25-604
Numéro NCT
Date de début (réel)
2026-04-01
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2026-12-30
Inscription (estimée)
216
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Double aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalTEAS 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...Afficher plus |
Comparateur facticeSham 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...Afficher plus |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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)
Partie responsable de l'étude
Shiyou Wei, Investigateur principal, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
Contact central de l'étude
Contact: Shiyou Wei, 15601680099, [email protected]
Contact: Xin Lv, 13661869919, [email protected]
3 Centres de l'étude dans 1 pays
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