Patient-Controlled Transcutaneous Acupoint Electrical Stimulation to Improve Quality of Life in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 主要终点
- Trial feasibility
研究概览
简要总结
The conduct of a pilot trial is of great significance as a means of assessing the feasibility and harmonization of the research and is a very necessary precursor to the better conduct of formal trials. The primary aim of this pilot study is to assess the feasibility of a PC-TEAS in improving the quality of life of cancer patients with pain, with the aspiration of providing process evidence base and an assessment of the intervention for conducting a formal trial. the secondary outcome is to assess the clinical efficacy of the PC-TEAS.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who had been diagnosed with cancer pain were eligible if they ①were 18 to 75 years old, ②had NRS pain score of ≥4 in the previous 1 week, or had regular use of analgesics, ③ anticipated survival of at least 6 months, ④ECOG-PS score ≤2 points, ⑤stable vital signs, clear consciousness, and the ability to correctly judge their pain, communication is unhindered, able to cooperate with researchers to complete relevant research assessments, ⑥voluntarily participate in this study and sign the informed consent form.
排除标准
- •included the following: ①Have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or patient is clinically unstable (eg, acute infections, electrolyte disturbances).②Patients with pacemaker implantation or metal implantation in the body. ③People with local skin at acupoints lesions, poor skin conditions, or other people unsuitable for PC-TEAS treatment. ④Cancer patients who are planning to become pregnant recently or are pregnant. ⑤Have a psychiatric disorder or severe cognitive impairment who are unable to communicate. ⑥Participating in other clinical trials.
研究组 & 干预措施
TEAS
transcutaneous acupoint electrical stimulation was performed at the bilateral Hegu and Waiguan acupoints for 30 minutes, and then transcutaneous acupoint electrical stimulation was performed at the Sanyinjiao and Zusanli acupoints of the bilateral lower limbs for 30 minutes.
干预措施: Transcutaneous electrical acupoint stimulation (Other)
sham TEAS
Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS group
干预措施: sham Transcutaneous electrical acupoint stimulation (Other)
结局指标
主要结局
Trial feasibility
时间窗: week 4
The feasibility of the proposed approach will be evaluated by the number who agreed to participate in the trial.
次要结局
- the changes in BPI score of mean pain, severe Pain, least pain and current pain from baesline(week 4, week 8, week 12)
- the amounts of analgesics used(week 4, week 8, week 12)
- the changes of EORTC QLQ-C30 score from baseline(week 4, week 8, week 12)
- Index of spontaneous bowel movements(week 4, week 8, week 12)
- The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)(week 4, week 8, week 12)
- The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)(week 4, week 8, week 12)
研究者
Yi Liang
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University