NL-OMON28022招募中不适用
A randomized, double blind study on the effects of Continuous Intravenous Magnesium on Features of Central Sensitisation in CRPS1 patients.
VU University Medical center, Department of Anesthesiology.0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Diagnostic criteria for CRPS1 according to the IASP (1):
- •a. Presence of an initiating noxious event or cause for immobilisation;
- •b. Continuing pain, allodynia or hyperalgesia, with which the pain is disproportioned to any inciting event and is not limited to the area of an individual peripheral nerve;
- •c. Evidence at any time of oedema. Skin blood flow abnormality, or abnormal sudomotor activity in the painful area since the inciting event;
- •d. Conditions which could otherwise account for the level of pain and dysfunction should be excluded;
- •Note: criteria b-d have to be met.
- •2. A VAS-spontaneous pain score of 5 cm or higher;
- •3. Patients should be between 18 -70 years old;
- •4. CRPS1 in one extremity;
- •5. First time experience of patient with CRPS1;
- •6. Other medication has to be stopped for more then one week before the trial starts;
- •7. Patients should give written informed consent.
排除标准
- •1. Not being able to give informed consent;
- •2. Another (2nd) chronic pain syndrome, interfering with pain ratings;
- •3. Another syndrome interfering with functional tests;
- •4. CRPS1 in both hands or feet;
- •5. Patient has experienced CRPS1 before;
- •6. Known kidney and/or severe liver disease;
- •7. Known nerve damage in the affected area;
- •8. Active infection;
- •9. Mental retardation;
- •10..Psychiatric abnormality ;
- •11. Malignant disease;
- •12. Patients with heart failure;
- •13. Patients with pacemakers or implanted defibrillators;
- •14. Patients with pulmonary congestion;
- •15. Pregnancy.
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