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Die klinische Studie NCT07494591 für Ipsilateral Shoulder Pain, Videoassistierte thorakoskopische Chirurgie ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 Nicht-invasiv
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Die klinische Studie NCT07494591 ist eine interventionsstudie zur Untersuchung von Ipsilateral Shoulder Pain, Videoassistierte thorakoskopische Chirurgie und hat den Status noch nicht rekrutierend. Der Start ist für 1. April 2026 geplant, bis 216 Teilnehmer aufgenommen werden. Durchgeführt von Shanghai Pulmonary Hospital, Shanghai, China wird der Abschluss für 30. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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 ...Mehr anzeigen
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel
Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial
Erkrankungen
Ipsilateral Shoulder PainVideoassistierte thorakoskopische ChirurgieWeitere Studien-IDs
- L25-604
NCT-Nummer
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2026-12-30
Geplante Rekrutierung
216
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellTEAS 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...Mehr anzeigen |
Schein-VergleichspräparatSham 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...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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, ChinaVerantwortliche Partei
Shiyou Wei, Hauptprüfer, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
Zentrale Studienkontakte
Kontakt: Shiyou Wei, 15601680099, [email protected]
Kontakt: Xin Lv, 13661869919, [email protected]
3 Studienstandorte in 1 Ländern
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