Preoperative Transcutaneous Electrical Acupoint Stimulation for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery: A Multi-Center, Single-Blind, Randomized Controlled Trial
| Registry | NCT07494591 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 216 (Estimated) |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China (Other) |
| Conditions | Ipsilateral Shoulder Pain, Video-Assisted Thoracoscopic Surgery |
| Interventions | TEAS, Sham TEAS (Device) |
| Dates | start 2026-04-01 (estimated), primary completion 2026-12-20 (estimated), completion 2026-12-30 (estimated), first posted 2026-03-27, last updated 2026-03-27 |
| Locations | 3 sites in China |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TEAS Group | Experimental | Device: TEAS | 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. |
| Sham TEAS Group | Sham comparator | Device: Sham TEAS | 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. |
Sex: All, ages: 18 Years to 99 Years
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai, Shanghai Municipality | China | |
| Shanghai East Hospital,Affiliated to Tongji University | Shanghai, Shanghai Municipality | China | |
| Fudan university Shanghai cancer center | Shanghai, Shanghai Municipality | China |