Ipsilateral Shoulder PainNCT07494591
TEAS for Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Lung Surgery
A study testing TEAS in people with Ipsilateral Shoulder Pain and Video-Assisted Thoracoscopic Surgery, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ipsilateral Shoulder Pain, Video-Assisted Thoracoscopic Surgery
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200082
Shanghai East Hospital,Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200120
Fudan university Shanghai cancer center
Shanghai, Shanghai Municipality
About this study
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
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.
Read the 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.
- Being tested
- TEAS, Sham TEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Hours Postoperatively
Secondary outcomes (2)
Cumulative Opioid Consumption at 24 Hours Postoperatively
Total opioid use within 24 hours postoperatively will be recorded and converted to intravenous morphine equivalents.
Measured: 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.
Measured: 24 Hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ipsilateral Shoulder PainStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Shiyou Wei, Principal investigator, Tongji University Affiliated Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494591
- Sponsor's protocol ID
- L25-604
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei S, Huang J, Xin P, Wang L, Yu J, Liu Y, Huang W, Ling D, Lv X. Transcutaneous Electrical Acupoint Stimulation to Prevent Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Surgery: A Multicenter Randomized Controlled Trial Protocol. J Pain Res. 2026 Sep 30;19:627058. doi: 10.2147/JPR.S627058. eCollection 2026.
PubMed 42830958
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07494591
- Acronym / sponsor ID
- L25-604
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS Group | Experimental | Device: TEASParticipants 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 TEASThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEASTEAS 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). | Device | TEAS Group |
| Sham TEAShe 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). | Device | Sham TEAS Group |
Primary outcome
Incidence of Ipsilateral Shoulder Pain (ISP) with Shoulder Movement at 24 Hours Postoperatively
Time frame: 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.
2 secondary outcomes
Cumulative Opioid Consumption at 24 Hours Postoperatively
Time frame: 24 Hours Postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours Postoperatively
Time frame: 24 Hours Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 42830958Wei S, Huang J, Xin P, Wang L, Yu J, Liu Y, Huang W, Ling D, Lv X. Transcutaneous Electrical Acupoint Stimulation to Prevent Ipsilateral Shoulder Pain After Video-Assisted Thoracoscopic Surgery: A Multicenter Randomized Controlled Trial Protocol. J Pain Res. 2026 Sep 30;19:627058. doi: 10.2147/JPR.S627058. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiyou Wei principal investigator
Tongji University Affiliated Shanghai Pulmonary Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Ipsilateral Shoulder Pain and Video-Assisted Thoracoscopic Surgery, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyou Wei (15601680099, lovewishyou@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ipsilateral Shoulder Pain (ISP) with Shoulder Movement at 24 Hours Postoperatively (time frame: 24 Hours Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.