Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Intensity of neuropathic pain
研究概览
简要总结
This prospective randomized double blinded study will be conducted to evaluate the effect of early pharmacologic intervention with calcitonin on the incidence or the severity of neuropathic pain after spinal cord injury
详细描述
Pain after spinal cord injury can be classified into five categories: musculoskeletal, visceral, at-level, above-level, and below-level neuropathic pain. Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions. Also it was used in a previous study to prevent complex regional pain syndrome in severe hemiplegic patients after stroke
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma.
排除标准
- •Intake of anticonvulsants medications.
- •Evidence of neuropathic pain.
- •Evidence of previous allergic reaction to calcitonin.
- •Patients with renal, hepatic and cardiac dysfunction or neurological disorders .
- •brain damage or major trauma to extremities or abdomen.
研究组 & 干预措施
Placebo group
patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.
干预措施: Placebo (Drug)
Calcitonin group
patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.
干预措施: Calcitonin (Drug)
结局指标
主要结局
Intensity of neuropathic pain
时间窗: 6 months after spinal cord injury
Intensity of neuropathic pain will be evaluated by visual analogue scale (VAS) scores at 6 months after spinal cord injury
Incidence of chronic pain
时间窗: 12 months after spinal cord injury
Incidence of chronic pain at 12 months after spinal cord injury
次要结局
- Intensity of nociceptive pain(12 months after spinal cord injury)
- The incidence of adverse reactions(2 weeks after spinal cord injury)
- The consumption of medications for neuropathic pain or musculoskeletal pain(12 months after spinal cord injury)
- Intensity of neuropathic pain(12 months after spinal cord injury)
- Incidence of neuropathic pain(12 months after spinal cord injury)
研究者
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university
Tanta University