The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 7
- 主要终点
- Change in pain intensity (NRS-11)
研究概览
简要总结
The investigators designed the multicenter randomized parallel controlled clinical trial of electroacupuncture on PHN which is rigorously designed and have an appropriate sample size, aiming to evaluate the efficacy and safety of electroacupuncture in pain relieving and pain removing in the treatment of patients with PHN.
详细描述
Postherpetic neuralgia(PHN) is the most common complication of herpes zoster, is a severe and intractable pain with a high incidence. Nearly 50% of PHN patients have experienced persistent pain for more than one year. Although it is not directly life-threatening, will lead to sleep disorders, even depression, seriously affecting the quality of life of patients. This project is a multi-center randomized controlled trial, which will recruit 448 patients with PHN in 7 hospitals, aiming to evaluate the analgesic effect and safety of electroacupuncture on postherpetic neuralgia, and provide evidence-based medical evidence for electroacupuncture treatment of PHN.
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)
盲法说明
The randomization scheme is generated, validated and imported into the central randomization system by a statistician who do not participate in this trial by using R software. The central randomization system has set strict personnel permissions, and no one has right to view the randomization scheme except the highest-level system administrator. Patients and study investigators (i.e., outcome assessors, data recorders, data entry clerks and statistical analysts) will be blinded to the group assignment. Due to the nature of the intervention, acupuncturists will not be blinded to the treatment.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnostic criteria for postherpetic neuralgia (with a clear history of acute herpes zoster, and the duration of postherpetic pain exceeds 90 days)
- •Aged 45 to 75 years old
- •Patients who were diagnosed with moderate or above pain during the observation period (the daily pain score was continuously collected within 7 days during the observation period, and the average NRS-11 pain score was >=4)
- •Subjects who did not participate in other ongoing clinical studies
- •Sign informed consent and volunteer to participate in the study
排除标准
- •Patients who are currently receiving or receiving more than one of the "permitted combinations" or any "prohibited combination and treatment" for PHN listed in the following part at least 14 days before screening, and are unwilling to undergo washout period, or patients with serious safety problems during washout period or observation period
- •Patients who are expected to receive any new prescription drug or other treatment for PHN after the start of the trial
- •Patients with serious uncontrolled medical conditions, such as cardiovascular, lung, liver, kidney, gastrointestinal tract, metabolism, endocrine, nervous system, respiratory system, urogenital system and other serious diseases, or systemic organ dysfunction, malignant tumor, hematologic disease such as bleeding tendency or coagulation dysfunction, serious mental illness such as depression or schizophrenia Symptoms, hepatitis B antigen or hepatitis C antibody positive known state or history of immune dysfunction, history of HIV infection, etc.
- •Patients with severe pain unrelated to PHN, such as after surgery for clinical major diseases
- •Patients with PHN who have received nerve intervention or other neurosurgical treatment, such as selective nerve damage, percutaneous radiofrequency thermocoagulation or pulsed nerve modulation technology, etc.
- •Patients with some special types of herpes zoster, such as those with meninges, cornea, conjunctiva, ear involvement, visceral herpes zoster, generalized herpes zoster
- •Patients with skin ulceration, new herpes, or skin infection
- •Patients with cardiac pacemaker, metal allergy or severe fear of needle
- •Patients who are unable to give full informed consent or cannot cooperate with pain scale assessment due to mental, mental, linguistic or behavioral disorders
- •Patients who have poor compliance or are prone to fall off due to other reasons, such as the current residence is not in the city where the recruitment hospital is located, or the working environment changes frequently
- •Pregnant and lactating women
研究组 & 干预措施
Electroacupuncture group
Choose the appropriate position according to the patient's herpes site, and routinely disinfect the skin. Paste the fixed insulating pad on the acupoint, and use a 0.30×40mm acupuncture needle to penetrate the skin 10mm obliquely through the fixed insulating gasket at Ashi point; According to the above operation, the SJ6 and GB34 point of the affected side are directly penetrated into the skin 15-20mm. The local Ashi point connects the two poles of the electroacupuncture device according to the first and last points of the long axis of the painful part, and the SJ6 and GB34 point on the affected side are connected to the poles of the electroacupuncture device. Electroacupuncture waveform is continuous wave, frequency is 2Hz, and current intensity is 1-5mA (causing slight tremor of the skin around the acupuncture point without pain). Continue the electroacupuncture treatment for 30 minutes.
干预措施: Electroacupuncture treatment (Other)
Sham electroacupuncture group
Participants randomly assigned to the sham electroacupuncture (SA) group received sham electroacupuncture by using placebo blunt needles at the same acupoints. After disinfecting the skin and placing the sterile insulating adhesive pads on unilateral Zhigou, Yanglingquan and Ashi points, placebo blunt needles are inserted through the pads and reach the insulating adhesive layer, causing the participants to feel the needle resistance (a sensation of needle insertion). Other procedures, electrode placements, parameter of electroacupuncture apparatus and treatment settings are the same as in the EA group, but with no skin penetration or electricity output.
干预措施: Sham electroacupuncture treatment (Other)
结局指标
主要结局
Change in pain intensity (NRS-11)
时间窗: Change from Baseline at 4 weeks after treatment
11-point numeric rating scale (NRS-11): range from 0 (no pain) to 10 (worst possible pain), with 1-3 points representing mild pain, 4-6 points representing moderate pain, and 7-10 points representing severe pain. A reduction of ≥30% in NRS-11 scores from baseline were considered responders.
次要结局
- Change in degree of pain and its impact on work life, interpersonal relationships and sleep(Change from Baseline at 4 weeks after treatment)
- Change in overall impression of PHN(4 weeks)
- Change in the interference of pain on sleep(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in pain area of PHN (PAP)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in average duration of each pain episode (ADEPE)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in mechanical pain threshold (MPT)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in average number of pain episodes per day(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in depression, anxiety and positive outlook scale (DAPOS)(Change from Baseline at 4 weeks after treatment)
- Change in pain intensity (VAS)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment)
- Change in the nature and intensity of pain(Change from Baseline at 4 weeks after treatment)
- Change in pain intensity (NRS-11)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 1-month follow-up.)
- Change in pain intensity (VAS)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.)
- Interference of pain on sleep(1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.)
- Change in mechanical pain threshold (MPT)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.)
- Change in pain area of PHN (PAP)(Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.)
- Average number of pain episodes per day(1 day, 3 days, 1 week, 2 weeks, 3 weeks, 4 weeks after treatment and 1-month follow-up.)
- Average duration of each pain episode (ADEPE)(1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment and 1-month follow-up.)
- Change in the nature and intensity of pain(Change from Baseline at 4 weeks after treatment and 1-month follow-up.)
- Change in degree of pain and its impact on work life, interpersonal relationships and sleep(Change from Baseline at 4 weeks after treatment and 1-month follow-up.)
- Change in depression, anxiety and positive outlook scale (DAPOS)(Change from Baseline at 4 weeks after treatment and 1-month follow-up.)
- Overall impression of PHN(Week 4 and week 8.)
研究者
Qianyan Liu
Principal Investigator
Nanjing University of Traditional Chinese Medicine