The Prophylactic Value of Subcutaneous Calcitonin in Acute Herpes Zoster Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
研究概览
简要总结
This prospective randomized controlled study will be conducted to evaluate the effect of adding calcitonin to the standard treatment protocol in patients with acute herpes zoster infection.
详细描述
Herpes zoster is associated with inflammation of the dorsal root ganglion and peripheral nerves, and this inflammation is considered to be an important causative factor for postherpetic neuralgia.
Interventions aimed at reducing this inflammation should therefore be effective in decreasing the likelihood of developing postherpetic neuralgia. Epidural administration of corticosteroids and local anesthetics has been shown to be effective, but is associated with the risk of arachnoiditis. Subcutaneous injection in an outpatient setting may be effective in preventing postherpetic neuralgia and is also considerably safer. Calcitonin has previously been shown to be effective in the management of acute pain following amputation. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke. Also, a previous case report revealed that IV calcitonin provided immediate and sustained improvement in post herpetic neuralgia for over two months, without adverse effects from the calcitonin therapy.
However, no previous trials evaluated the effect of subcutaneous calcitonin as a preventive measure against the development of postherpetic neuralgia. We will conduct this study as we hypothesize that calcitonin therapy in patients with acute herpes zoster may be associated with better acute pain control and therefore may decrease the incidence of postherpetic neuralgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥ 50 years, with acute herpes zoster infection (rash duration < 7 days) and moderate to severe pain.
排除标准
- •Coagulation abnormalities
- •Pre-existing other pain syndrome or psychological disorders.
- •Severe hepatic, cardiovascular, or renal disorders.
- •Allergy to calcitonin.
研究组 & 干预措施
Control group
patients will receive subcutaneous saline (1 ml) daily for three weeks.
干预措施: Saline (Other)
Calcitonin group
patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks.
干预措施: Calcitonin (Drug)
研究者
Amira Elkabalawy
Assistant professor of anesthesiology, surgical intensive care and pain medicine Tanta university
Tanta University
