Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Analgesia after block
研究概览
简要总结
This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
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
- Triple (Participant, Care Provider, 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
- •Complex regional pain syndrome (IASP, 1994) involving an upper limb;
- •Pain scores in excess of five visual analog scale (VAS);
- •Poor outcome to treatment (less than 50% reduction in VAS scores) -
排除标准
- •History of severe brain injury, epilepsy and stroke
- •Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
- •Severe systemic disease
- •Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
- •Refusal to participate or not initial adherence to orientations
- •Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
结局指标
主要结局
Analgesia after block
时间窗: 1 month
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
次要结局
- analgesia quality of life(1 year)
研究者
Roberto O Rocha
MD
University of Sao Paulo