- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548711
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
September 2, 2025 updated by: Kong Fanming
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fanming Kong, PhD
- Phone Number: + 86 22 27986525
- Email: kongfanming08@163.com
Study Locations
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300193
- Recruiting
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
-
Contact:
- Fanming Kong, PhD
- Phone Number: + 86 22 27986525
- Email: kongfanming08@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEAS group
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.
|
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.
|
|
Sham Comparator: Sham TEAS group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2024
Primary Completion (Estimated)
April 17, 2026
Study Completion (Estimated)
June 17, 2026
Study Registration Dates
First Submitted
July 29, 2024
First Submitted That Met QC Criteria
August 7, 2024
First Posted (Actual)
August 12, 2024
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYLL2024[Z]026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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