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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ipsilateral Shoulder Pain; Video-Assisted Thoracoscopic Surgery
• Intervention / Treatment: Device: TEAS; Device: Sham TEAS

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.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyou Wei; Phone Number: 15601680099; Email: lovewishyou@tongji.edu.cn
• Study Contact Backup: Name: Xin Lv; Phone Number: 13661869919; Email: xinlvg@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200120
      • Shanghai East Hospital,Affiliated to Tongji University
    • Shanghai, Shanghai Municipality, China, 200082
      • Shanghai Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAS 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.	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. Electrodes will be applied at LI4 (Hegu), PC6 (Neiguan), SJ14 (Jianliao), and LI15 (Jianyu).
Sham Comparator: Sham 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.	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 the day before surgery and before anesthesia induction on the day of surgery, for 30 minutes each time. Electrode placement is identical to the TEAS arm at LI4 (Hegu), PC6 (Neiguan), SJ14 (Jianliao), and LI15 (Jianyu).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ipsilateral Shoulder Pain (ISP)	Pain intensity during movement (maximal shoulder circumduction) and at rest will be assessed at 48 and 72 hours postoperatively using the same VRS method as the primary outcome, and the number of participants with VRS ≥1 will be recorded.	48 Hours and 72 Hours Postoperatively
Cumulative Opioid Consumption from 25 to 48 Hours Postoperatively	Total opioid use from 25 to 48 hours postoperatively will be recorded and converted to intravenous morphine equivalents.	48 Hours Postoperatively
Postoperative Recovery Quality	Recovery quality will be assessed using the 15-item Quality of Recovery (QoR-15) scale, which includes 5 dimensions (emotional state, physical comfort, psychological support, physical independence, pain) with 15 items total (score range 0-150, higher scores indicate better recovery). The minimal clinically important difference (MCID) is 6 points.	24 Hours, 48 Hours, and 72 Hours Postoperatively
Time to First Postoperative Flatus Passage	The time (in hours) from the end of surgery to the participant's first flatus passage per rectum will be recorded.	48 Hours Postoperatively
Incidence of Postoperative Nausea and Vomiting postoperatively	The number of participants experiencing nausea or vomiting from 25 to 48 hours and 49 to 72 hours postoperatively will be recorded.	48 Hours and 72 Hours Postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Shiyou Wei, Tongji University Affiliated Shanghai Pulmonary Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: L25-604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No