Postoperative CoughNCT06548711
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
A study testing Transcutaneous Acupoint Electrical Stimulation (TAES) in people with Postoperative Cough and Lung Cancer, run by Kong Fanming at 1 site in China.
Trial summary
Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Cough, Lung Cancer
- What is being tested?
- Transcutaneous Acupoint Electrical Stimulation (TAES)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2024to 17 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years old - Surgery performed under general anesthesia for radical resection of lung cancer or lung cancer resection combined with lymph node dissection.
- Pathological confirmation of primary lung cancer after surgery.
- Duration of persistent dry cough after lung surgery ≥2 weeks.
- Consciousness, ability to express opinions clearly, and voluntary signing of informed consent.
Who cannot join
- Patients diagnosed with acute respiratory system diseases within 1 month.
- Patients diagnosed with pneumonia based on chest X-ray.
- Patients with a history of asthma or tuberculosis.
- Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, coagulation disorders (hypercoagulable state or bleeding tendency), or other severe systemic diseases.
- Patients who have used steroid drugs within the past 3 months.
- Patients who have taken angiotensin-converting enzyme inhibitors (ACEIs) within the past 6 months.
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- Patients with surgical incisions, skin allergies, wounds, or infections in the treatment area.
- Patients who cannot tolerate transcutaneous acupoint electrical stimulation or withdraw during the procedure.
- Patients with contraindications to transcutaneous electrical stimulation or implanted electrophysiological devices.
- Patients who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Fanming Kong, PhD, + 86 22 27986525, kongfanming08@163.com
About this study
Official title: Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the change in total score of Leicester Cough Questionnaire-Mandarin Chinese version (LCQ-MC) compared to baseline, and overall evaluation of treatment effectiveness by patients. A total of 84 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. Clinical observation forms were completed and clinical data were recorded in the database. Statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.
Read the detailed description
To obtain sufficient evidence from evidence-based medicine, prospective, random, blind, and controlled clinical trials are adopted to evaluate the effectiveness and safety of TEAS in treating postoperative cough in lung cancer patients. This study aims to provide a potential non-pharmacological treatment option for postoperative cough patients with lung cancer, improve the quality of life of postoperative lung cancer patients, identify the population that is more likely to benefit from TEAS treatment and provide a solid scientific basis and guidance for personalized acupuncture treatment for postoperative cough in lung cancer patients.
- Conditions
- Postoperative Cough, Lung Cancer
- Being tested
- Transcutaneous Acupoint Electrical Stimulation (TAES)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Acupoint Electrical Stimulation (TAES)Other
Transcutaneous acupoint electrical stimulation (TAES) is a non-invasive treatment method that delivers gentle electrical pulses through the skin to specific acupuncture points on the body. This technique aims to mimic the effects of traditional acupuncture, providing a convenient and painless method of treatment.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | The patient takes a sitting position, uses alcohol to wipe the skin at the selected acupoint, waits for it to dry, and then applies the electrode patch. Connect the percutaneous acupoint electric stimulator and provide transcutaneous acupoint electric stimulation, selecting a continuous wave at 2 Hz. Receives: Other: Transcutaneous Acupoint Electrical Stimulation (TAES) |
| Sham TEAS group | Sham comparator | The electrode patch is placed on the acupoint, similar to the TEAS group patients, but without starting the electric stimulation, and indicates to the patient that there will be no special sensation during the treatment process. The electrode is well protected during the operation and will not come off. Receives: Other: Transcutaneous Acupoint Electrical Stimulation (TAES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCQ-MC
The questionnaire consists of 19 items, each of which is divided into 7 levels according to the severity, including the impact of chronic cough on the physiological domain (chest pain, cough, sputum, fatigue, sleep, hoarseness, etc.), psychological domain (feeling embarrassed, anxious, depressed, annoyed, etc.), and social domain (work, daily life, leisure activities, conversation, phone calls, interference with friends or family members). The score for each domain is the total score of each item in that domain divided by the number of questions (scored from 1 to 7), and the total score is the sum of the scores for the three domains (scored from 3 to 21). A higher score represents a better patient's health condition.
Measured: Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start17 Apr 2024
- Primary completion17 Apr 2026 (estimated)
- Study completion17 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CoughStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kong Fanming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kong Fanming, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548711
- Sponsor's protocol ID
- TYLL2024[Z]026
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT06548711
- Acronym / sponsor ID
- TYLL2024[Z]026
- Conditions
- Postoperative Cough, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Kong FanmingUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 Apr 2026 (estimated)
- Study completion
- 17 Jun 2026 (estimated)
- First posted
- 12 Aug 2024 (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.
Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the change in total score of Leicester Cough Questionnaire-Mandarin Chinese version (LCQ-MC) compared to baseline, and overall evaluation of treatment effectiveness by patients. A total of 84 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. Clinical observation forms were completed and clinical data were recorded in the database. Statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.
Detailed description
To obtain sufficient evidence from evidence-based medicine, prospective, random, blind, and controlled clinical trials are adopted to evaluate the effectiveness and safety of TEAS in treating postoperative cough in lung cancer patients. This study aims to provide a potential non-pharmacological treatment option for postoperative cough patients with lung cancer, improve the quality of life of postoperative lung cancer patients, identify the population that is more likely to benefit from TEAS treatment and provide a solid scientific basis and guidance for personalized acupuncture treatment for postoperative cough in lung cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Other: Transcutaneous Acupoint Electrical Stimulation (TAES)The patient takes a sitting position, uses alcohol to wipe the skin at the selected acupoint, waits for it to dry, and then applies the electrode patch. Connect the percutaneous acupoint electric stimulator and provide transcutaneous acupoint electric stimulation, selecting a continuous wave at 2 Hz. |
| Sham TEAS group | Sham comparator | Other: Transcutaneous Acupoint Electrical Stimulation (TAES)The electrode patch is placed on the acupoint, similar to the TEAS group patients, but without starting the electric stimulation, and indicates to the patient that there will be no special sensation during the treatment process. The electrode is well protected during the operation and will not come off. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old - Surgery performed under general anesthesia for radical resection of lung cancer or lung cancer resection combined with lymph node dissection.
- Pathological confirmation of primary lung cancer after surgery.
- Duration of persistent dry cough after lung surgery ≥2 weeks.
- Consciousness, ability to express opinions clearly, and voluntary signing of informed consent.
Key exclusion criteria (10 listed)
- Patients diagnosed with acute respiratory system diseases within 1 month.
- Patients diagnosed with pneumonia based on chest X-ray.
- Patients with a history of asthma or tuberculosis.
- Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, coagulation disorders (hypercoagulable state or bleeding tendency), or other severe systemic diseases.
- Patients who have used steroid drugs within the past 3 months.
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 |
|---|---|---|
| Transcutaneous Acupoint Electrical Stimulation (TAES)Transcutaneous acupoint electrical stimulation (TAES) is a non-invasive treatment method that delivers gentle electrical pulses through the skin to specific acupuncture points on the body. This technique aims to mimic the effects of traditional acupuncture, providing a convenient and painless method of treatment. | Other | Sham TEAS group, TEAS group |
Primary outcome
LCQ-MC
Time frame: Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
The questionnaire consists of 19 items, each of which is divided into 7 levels according to the severity, including the impact of chronic cough on the physiological domain (chest pain, cough, sputum, fatigue, sleep, hoarseness, etc.), psychological domain (feeling embarrassed, anxious, depressed, annoyed, etc.), and social domain (work, daily life, leisure activities, conversation, phone calls, interference with friends or family members). The score for each domain is the total score of each item in that domain divided by the number of questions (scored from 1 to 7), and the total score is the sum of the scores for the three domains (scored from 3 to 21). A higher score represents a better patient's health condition.
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 8 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Acupoint Electrical Stimulation (TAES) in people with Postoperative Cough and Lung Cancer, run by Kong Fanming at 1 site 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 10 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Fanming Kong, PhD (+ 86 22 27986525, kongfanming08@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCQ-MC (time frame: Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.