NCT07494591

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 20, 2026

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Cumulative Opioid Consumption at 24 Hours Postoperatively

    24 Hours Postoperatively

  • Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours Postoperatively

    24 Hours Postoperatively

Other Outcomes (5)

  • Incidence of Ipsilateral Shoulder Pain (ISP)

    48 Hours and 72 Hours Postoperatively

  • Cumulative Opioid Consumption from 25 to 48 Hours Postoperatively

    48 Hours Postoperatively

  • Postoperative Recovery Quality

    24 Hours, 48 Hours, and 72 Hours Postoperatively

  • +2 more other outcomes

Study Arms (2)

TEAS Group

EXPERIMENTAL

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

Sham TEAS Group

SHAM COMPARATOR

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

Interventions

TEASDEVICE

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).

TEAS Group
Sham TEASDEVICE

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).

Sham TEAS Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Shanghai East Hospital,Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200120, China

Location

Fudan university Shanghai cancer center

Shanghai, Shanghai Municipality, China

Location

Study Officials

  • Shiyou Wei

    Tongji University Affiliated Shanghai Pulmonary Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations