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Clinical Trial NCT07494591 for Ipsilateral Shoulder Pain, Video-Assisted Thoracoscopic Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery 216 Non-Invasive
Clinical Trial NCT07494591 is an interventional study for Ipsilateral Shoulder Pain, Video-Assisted Thoracoscopic Surgery and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2026 and continue until the study accrues 216 participants. Led by Shanghai Pulmonary Hospital, Shanghai, China, this study is expected to complete by December 30, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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 ...Show More
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...Show More
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
Conditions
Ipsilateral Shoulder PainVideo-Assisted Thoracoscopic SurgeryOther Study IDs
- L25-604
NCT ID Number
Start Date (Actual)
2026-04-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-12-30
Enrollment (Estimated)
216
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTEAS 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. | 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 th...Show More |
Sham ComparatorSham 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. | 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 th...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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 Responsible Party
Shiyou Wei, Principal Investigator, Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China
Study Central Contact
Contact: Shiyou Wei, 15601680099, [email protected]
Contact: Xin Lv, 13661869919, [email protected]
3 Study Locations in 1 Countries
Shanghai Municipality
Shanghai Pulmonary Hospital, Shanghai, Shanghai Municipality, 200082, China
Shanghai East Hospital,Affiliated to Tongji University, Shanghai, Shanghai Municipality, 200120, China
Fudan university Shanghai cancer center, Shanghai, Shanghai Municipality, China