Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Alteration of pain intensity after treatment
研究概览
简要总结
Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life.
The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of acute HZ
- •Pain intensity > 30 mm visual analog scale
排除标准
- •Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
- •Patients under age
- •Uncompliance
- •Pregnancy or lactation
- •Surgery within the last 3 month
- •Severe heart/lung/kidney disease
- •Diseases influencing the quality of life
- •Psychiatric diseases (e.g., depression, schizophrenia, dementia)
- •Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
- •Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
- •Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)
研究组 & 干预措施
Sham-laser acupuncture
Sham laser acupuncture (c) is applied at equivalent points as needle acupuncture. Laser irradiation is faked.
干预措施: Sham-laser acupuncture (Device)
gabapentine
standard analgesic treatment
干预措施: gabapentine (Drug)
Acupuncture
Acupuncture treatment is semi-standardized, i.e. beside a scheme of basic points, individual points can be chosen according to the TCM diagnostic pattern.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Alteration of pain intensity after treatment
时间窗: 5 weeks
次要结局
- Quantitative sensory testing(6 months)
研究者
Dominik Irnich
PD Dr. Dominik Irnich
Ludwig-Maximilians - University of Munich