Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 主要终点
- The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
研究概览
简要总结
This multicenter, prospective, randomized controlled research study aims to objectively evaluate the role of transcutaneous electrical acupoint stimulation (TEAS), which combines the theory of acupuncture with transcutaneous electrical nerve stimulation (TENS) therapy, for the treatment of pain in patients with bone metastases from lung cancer.
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
- Triple (Participant, Investigator, 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
- •Fulfilled the diagnostic criteria of non-small cell lung cancer and had a diagnosis of definite bone-metastatic-related pain.
- •Potent opioid analgesics have been prescribed regularly.
- •Bone protective agents (bisphosphonates or desumumab) have been used regularly.
- •Expected survival ≥ 3 months with no obvious contraindication to opioid therapy.
- •Stable vital signs and ECOG-PS score ≤ 2 points; able to cooperate with researchers to complete relevant study evaluations.
- •Signed informed consent.
排除标准
- •Definitively diagnosed with pain unrelated to lung cancer.
- •Received local radiation therapy or surgery targeting bone metastases within 1 week before enrollment or will receive during the intervention period. The surgery including vertebroplasty, radioparticle implantation, neurological lesions, and other minimally invasive interventions.
- •Venous thrombosis in the upper and lower extremities (below the elbow / knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or those with respiratory depression.
- •Pacemaker implantation or metallic implants in vivo.
- •Skin lesions at the acupoints, poor skin condition, or other situations that are not suitable for treatment with TEAS.
- •Opioid hypersensitivity.
- •Psychiatric disorders or severe cognitive deficits.
- •Participating in other clinical trialists influencing the evaluation of the results of this study.
研究组 & 干预措施
true TEAS
A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side.
A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2Hz and stimulus current intensity in degrees as tolerated by the patient.
7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session.
A total of 4 sessions of treatment were administered.
干预措施: Transcutaneous electrical acupoint stimulation (Device)
true TEAS
A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side.
A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2Hz and stimulus current intensity in degrees as tolerated by the patient.
7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session.
A total of 4 sessions of treatment were administered.
干预措施: Routine palliative treatment (Drug)
sham TEAS
Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial.
干预措施: Sham transcutaneous electrical acupoint stimulation (Device)
sham TEAS
Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial.
干预措施: Routine palliative treatment (Drug)
结局指标
主要结局
The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
时间窗: week 4
According to the international consensus on palliative radiotherapy endpoints for bone metastasis clinical trials, the degree of therapeutic response for bone metastatic pain can be classified as complete response (CR: pain score of 0 and no increase in daily oral morphine equivalent dose (OMED) ), partial response (PR: ①pain score decrease of ≥ 2 and no increase in OMED; ②pain score no increase and decrease of ≥ 25% in OMED), pain progression (PP: ①≥ 2 increase in pain score with no decrease in OMED; ②≥ 1 increase in pain score with ≥ 25% increase in OMED) and indeterminate response (IR: cases not classified as CR / PR / PP). Subjects in which complete or partial relief of pain was achieved were pain responders; Subjects whose pain progressed or was indeterminate response were non responders. The response rate of average pain = ((CR+PR) / No. of subjects) \*100%.
次要结局
- The changes of pain and inference scores in Brief Pain Inventory(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)
- The changes of frequency of breakthrough pain within 1 week(week 4, week 8, week 12)
- The changes of OMED on assessment days(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 of tri-lineage cell counts in blood(week 4, week 8, week 12)
- Quality of life measured by EORTC QLQ-C30 score(week 4, week 8, week 12)
研究者
Yi Liang
Professor, Chief Chinese Medicine Practitioner
The Third Affiliated hospital of Zhejiang Chinese Medical University