TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
TEAS
DeviceTEAS 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 TEAS
Devicehe 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).
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: TEAS GroupExperimental treatment 1 intervention
Group B: Sham TEAS GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
24 Hours PostoperativelySecondary outcomes
1
Cumulative Opioid Consumption at 24 Hours Postoperatively
Total opioid use within 24 hours postoperatively will be recorded and converted to intravenous morphine equivalents.
Time frame
24 Hours Postoperatively2
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.
Time frame
24 Hours PostoperativelyOther outcomes
1
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.
Time frame
48 Hours and 72 Hours Postoperatively2
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.
Time frame
48 Hours Postoperatively3
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.
Time frame
24 Hours, 48 Hours, and 72 Hours Postoperatively4
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.
Time frame
48 Hours PostoperativelySponsors and contacts
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Source ClinicalTrials.gov
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