Director of Oncology Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- LCQ-MC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Transcutaneous Acupoint Electrical Stimulation (TAES) (Other)
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.
干预措施: Transcutaneous Acupoint Electrical Stimulation (TAES) (Other)
结局指标
主要结局
LCQ-MC
时间窗: 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.
次要结局
未报告次要终点
研究者
Kong Fanming
Director of Oncology Department
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine