Prospective, Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Effect of Intravenous Immunoglobulins on Complex Regional Pain Syndrome (CRPS, M. Sudeck)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in impairment Level SumScore (ISS)
研究概览
简要总结
The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.
详细描述
CRPS, a chronic pain syndrome associated with trophic disturbances is a frequent complication after limb trauma. More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRPS 1 (according to the IASP criteria) between 6 weeks and 6 months after diagnosis
- •skin temperature of the affected side equal or higher than on non-affected side
- •no change of the analgetic or co-analgetic medication within the last 10 days
排除标准
- •Immunosuppressive or immunomodulatory treatment within the last three months
- •CRPS previously treated with sympathetic block, lidocaine patch, local DMSO, spinal cord stimulation, intrathecal drug administration
- •Known immune-mediated neuropathy (CIDP, MMN, MADSAM)
- •Selective IgA-deficiency
- •Severe heart disease
- •Tumour disease in the last 5 years
- •Allergy against Gamunex 10%
- •Chronic renal disease Vaccination with live vaccine within the last three months
- •Member of another clinical trial within the last 3 months
研究组 & 干预措施
Intravenous immunoglobulins (IvIg)
3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks
干预措施: intravenous immunoglobulins (Biological)
NaCl 0.9%
NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks
干预措施: intravenous immunoglobulins (Biological)
结局指标
主要结局
Change in impairment Level SumScore (ISS)
时间窗: after 0,3,6,9 months
次要结局
- Pain disability score(0,3,6,9 months)
- Titer of surface-binding neuronal autoantibodies in the serum(0,3,6,9 months)
- Quality of life (SF-36)(0,3,6,9 months)
- Serum concentration of B-cell activating factors BAFF, APRIL(0,3,6,9 months)
研究者
Dr. Marlene Tschernatsch
Dr.
University of Giessen