Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- The area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment.
概览
简要总结
This study aims to objectively evaluate the effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation (PC-TEAS) on improving the quality of life in patients with chronic cancer pain, thereby providing evidence-based medical support for its efficacy and offering practical basis for patients to achieve home-based auxiliary treatment based on their own needs. Furthermore, by observing and comparing changes in indicators such as pain-related scores, analgesic consumption, emotional scores, spontaneous bowel movements, and adverse events, this research will comprehensively assess the advantages of PC-TEAS in the management of chronic cancer pain and explore other potential benefits of this intervention for 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, Outcomes Assessor)
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, regardless of gender;
- •Diagnosis of primary or metastatic malignant tumor confirmed by histopathology and/or cytology, consistent with the American Cancer Society criteria for malignancy;
- •Presence of cancer-related pain, defined as an average Numeric Rating Scale (NRS) score ≥ 2 over the preceding week or current regular use of opioid analgesics;
- •Life expectancy ≥ 3 months;
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score ≤ 2, stable vital signs, clear consciousness, intact pain perception, unimpaired communication, ability to cooperate with study procedures and complete assessments;
- •Provision of signed informed consent by the patient or their legal guardian after comprehensive explanation of the study;
排除标准
- •Pain not attributable to cancer;
- •Severe cardiopulmonary dysfunction or respiratory depression;
- •Implantation of cardiac pacemaker or metallic implants at stimulation sites;
- •Local skin lesions or conditions unsuitable for TEAS at the acupoint sites;
- •Severe psychiatric disorders or significant cognitive impairment;
- •Concurrent participation in other clinical trials that may interfere with the outcome evaluation of this study;
- •Previous history of transcutaneous electrical acupoint stimulation (TEAS) or transcutaneous electrical nerve stimulation (TENS);
结局指标
主要结局
The area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment.
时间窗: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12
the FACT-G comprises 27 items grouped into 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being; some items require reverse scoring, with the total score ranging from 0 to 108. Higher scores indicate better quality of life. Using the area under the curve scoring method allows for the observation of the cumulative benefit of PC-TEAS usage in patients over the entire treatment period
次要结局
- The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days(Baseline; Week 4; Week 8; Week 12)
- the changes in BPI score from baesline(Baseline; Week 4; Week 8; Week 12)
- Dosage of analgesics used on the assessment days(Baseline; Week 4; Week 8 ; Week 12)
- Spontaneous bowel movements (SBM) during assessment days(Baseline; Week 4; Week 8; Week 12)
- Bowel Function Index (BFI) during assessment days(Baseline; Week 4; Week 8; Week 12)
- The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days(Baseline; Week 4; Week 8;Week 12)
- Frequency of breakthrough pain in the week preceding the assessment days(Baseline; Week 4;Week 8; Week 12)
研究者
Yi Liang
Director
The Third Affiliated hospital of Zhejiang Chinese Medical University