Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Fanming Kong, PhD
- Phone Number: + 86 22 27986525
- Email: kongfanming08@163.com
Study Locations
-
-
Tianjin Municipality
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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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
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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.
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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
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)
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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.
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Prior to treatment (baseline), at the end of treatment (week 2), and 2 weeks after the end of treatment (week 4)
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- TYLL2024[Z]026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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