Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in sensory thresholds
研究概览
简要总结
Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.
详细描述
This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have a medical history of herpes zoster;
- •Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
- •20 ≤ age ≤80 years, male or female
- •Participants can fully understand the study protocol and written informed consent is signed.
排除标准
- •Acute herpes zoster, herpes zoster has not disappeared;
- •Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
- •Pregnant or lactating women;
- •Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
- •Patients have severe cognitive impairment and can not understand the study protocol;
- •Patients can not receive electroacupuncture treatment due to any reasons.
研究组 & 干预措施
EA combined with medication group
Patients in this group will receive electroacupuncture combined with gabapentin.
干预措施: EA combined with medication (Procedure)
EA combined with medication group
Patients in this group will receive electroacupuncture combined with gabapentin.
干预措施: Medication (Drug)
Medication group
Participants in this group will only receive gabapentin.
干预措施: Medication (Drug)
结局指标
主要结局
Change in sensory thresholds
时间窗: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Sensory thresholds is measured by quantitative sensory testing
Change in pain intensity
时间窗: before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up
Pain intensity is measured by Zoster Brief Pain Inventory (ZBPI)
次要结局
- Adverse events(Up to 6 weeks of treatment)
- Change in dosage of analgetic(before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up)
- Change in score of anxiety and depression severity(before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up)
- Change in score of quality of life(before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up)
- Change in score of sleep quality(before treatment, 2 weeks after treatment, 4 weeks after treatment, 6 weeks after treatment, at 8-week follow-up)
研究者
Dexiong Han
Head of the Acupuncture Department
The Third Affiliated hospital of Zhejiang Chinese Medical University