■经皮穴位电刺激（TEAS）治疗为癌症引起的骨痛（CIBP）患者提供了家庭治疗的可能性，患者控制的疼痛管理方法。这项研究的目的是评估患者控制的TEAS（PC-TEAS）在非小细胞肺癌（NSCLC）患者中缓解CIBP的疗效。
■这是一个前瞻性的研究方案，三盲，随机对照试验。我们预计从4个中国医疗中心招募188名NSCLC骨转移患者，他们也在使用有效的阿片类镇痛药。这些参与者将以1：1的比例随机分配到真正的PC-TEAS或假PC-TEAS组。所有参与者将接受标准的肿瘤辅助治疗。真正的小组将根据需要接受患者控制的TEAS干预，而假手术组将遵循相同的治疗方案，但使用非导电凝胶贴片。每个疗程将持续7天，共管理4个课程。将有4个评估时间点：基线，第4、8和12周的结论。该研究的主要结果是治疗后第4周的简短疼痛量表（BPI）量表的平均疼痛缓解率。次要结果包括疼痛相关指标，生活质量量表，情绪量表,以及评估日的血常规.如果发生任何不良事件，将及时处理和报告。我们将使用EDC平台管理试验数据，与数据监测委员会提供定期的质量监督。
■PC-TEAS干预提供了实现家庭针灸治疗的尝试，以及在针灸研究中实现三重致盲的可行性。本研究旨在为针灸辅助治疗癌症相关性疼痛提供更严格的试验证据，并探索一种安全有效的CIBP中西医结合方案。
■ClinicalTrials.govNCT05730972，注册于2023年2月16日。
UNASSIGNED: Transcutaneous Electrical Acupoint Stimulation (TEAS) therapy opens up the possibility for individuals with Cancer-induced bone pain (CIBP) to receive a home-based, patient-controlled approach to pain management. The aim of this study is designed to evaluate the efficacy of patient-controlled TEAS (PC-TEAS) for relieving CIBP in patients with non-small cell lung cancer (NSCLC).
UNASSIGNED: This is a study protocol for a prospective, triple-blind, randomized controlled trial. We anticipate enrolling 188 participants with NSCLC bone metastases who are also using potent opioid analgesics from 4 Chinese medical centers. These participants will be randomly assigned in a 1:1 ratio to either the true PC-TEAS or the sham PC-TEAS group. All participants will receive standard adjuvant oncology therapy. The true group will undergo patient-controlled TEAS intervention as needed, while the sham group will follow the same treatment schedule but with non-conductive gel patches. Each treatment course will span 7 days, with a total of 4 courses administered. There will be 4 assessment time points: baseline, the conclusion of weeks 4, 8, and 12. The primary outcome of this investigation is the response rate of the average pain on the Brief Pain Inventory (BPI) scale at week 4 after treatment. Secondary outcomes include pain related indicators, quality of life scale, mood scales, and routine blood counts on the assessment days. Any adverse events will be promptly addressed and reported if they occur. We will manage trial data using the EDC platform, with a data monitoring committee providing regular quality oversight.
UNASSIGNED: PC-TEAS interventions offer an attempt to achieve home-based acupuncture treatment and the feasibility of achieving triple blinding in acupuncture research. This study is designed to provide more rigorous trial evidence for the adjuvant treatment of cancer-related pain by acupuncture and to explore a safe and effective integrative medicine scheme for CIBP.
UNASSIGNED: ClinicalTrials.gov NCT05730972, registered February 16, 2023.
PDF(Pubmed)