TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery

Официальное название

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

Обзор

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 to either receive TEAS before surgery or standard care. Researchers will measure how much shoulder pain patients experience and compare the two groups.The goal is to see if TEAS can help patients feel less pain and recover better after this type of lung surgery.

Подробное описание

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 potential in various pain conditions.

This study is a multi-center, single-blind, randomized controlled trial designed to investigate the efficacy and safety of preoperative TEAS in reducing the incidence and severity of ipsilateral shoulder pain following VATS for lung surgery.

Approximately 216 participants who are scheduled to undergo VATS for lung surgery will be recruited from multiple centers. Participants meeting the inclusion criteria will be randomly assigned in a 1:1 ratio to either the TEAS group or the sham stimulation control group using a stratified block randomization method to ensure balanced group distribution. The study design employs single-blinding, meaning participants will be unaware of their group assignment.

Participants in the TEAS group will receive preoperative transcutaneous electrical acupoint stimulation at specific acupoints with a pre-set current intensity. The sham stimulation control group will receive an identical procedure with the device set to deliver no active electrical stimulation. The intervention will be administered prior to the surgical procedure.

The primary outcome of this study is the incidence and severity of ipsilateral shoulder pain within the first 24-48 hours post-surgery, measured using Verbal Response Scale (VAS) .

Secondary and other outcomes include opioid consumption, pain scores at different time points, quality of recovery, patient satisfaction with pain management, and the occurrence of adverse events related to the intervention.

Data will be collected at various time points throughout the perioperative period and analyzed to determine the potential benefits of preoperative TEAS. This study aims to provide high-quality evidence for the clinical application of TEAS as a safe, effective, and easily implementable strategy for preventing or alleviating ISP after VATS, thereby improving patient outcomes.

Вмешательства

• Устройство 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 the day before surgery and before anesthesia induction on the day of surgery. Elec
• Устройство 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 the operation interface. Sham stimulation is administered twice: in the evening th

Первичные конечные точки

• Incidence of Ipsilateral Shoulder Pain (ISP) with Shoulder Movement at 24 Hours Postoperatively [Срок оценки: 24 Hours Postoperatively]

Вторичные конечные точки (2)

• Cumulative Opioid Consumption at 24 Hours Postoperatively [Срок оценки: 24 Hours Postoperatively]
• Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours Postoperatively [Срок оценки: 24 Hours Postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Shanghai Pulmonary Hospital — Шанхай
• Shanghai East Hospital,Affiliated to Tongji University — Шанхай
• Fudan university Shanghai cancer center — Шанхай

Идентификаторы

NCT: NCT07494591 · L25-604

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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