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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• Device 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

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 3 centers

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

Identifiers

NCT: NCT07494591 · L25-604

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗