To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer
NCT ID:
NCT06548711
Condition:
Postoperative Cough
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Cough
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Due to the specific nature of acupuncture clinical research, it is difficult to
accomplish double blinding of subjects and operators, so this trial was blinded to
subjects and statisticians only. The statistical analyst was a non-subject and was not
aware of the patient treatment or the trial protocol. For all patients who participated
in acupuncture, blinded evaluation questions were asked at the 1 week after acupuncture.
Intervention:
Intervention type:
Other
Intervention name:
Transcutaneous Acupoint Electrical Stimulation (TAES)
Description:
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.
Arm group label:
Sham TEAS group
Arm group label:
TEAS group
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 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 120 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Address:
City:
Tianjin
Zip:
300193
Country:
China
Status:
Recruiting
Contact:
Last name:
Fanming Kong, PhD
Phone:
+ 86 22 27986525
Email:
kongfanming08@163.com
Start date:
April 17, 2024
Completion date:
June 17, 2026
Lead sponsor:
Agency:
Kong Fanming
Agency class:
Other
Source:
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06548711
