ISRCTN88145753已完成不适用
Intrathecal steroids for intractable postherpetic neuralgia: a randomised controlled trial
niversity Medical Centre Utrecht (UMCU), Department of Perioperative Care and First Aid (DPenS) (Netherlands)0 个研究点目标入组 42 人开始时间: 2009年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Outpatient, male or female, aged 18 years or older
- •2. History of PHN for at least 6 months after onset of the vesicular eruption
- •3. Global pain intensity due to PHN must be at least 40 mm on 100 mm Visual Analogue Scale (VAS) for the last 24 hours despite conventional therapies, as recorded at Visit 1
- •4. The PHN must be restricted to the dermatomes involved in the original eruption of herpes zoster
- •5. Patient does not use concomitant medication for PHN, or is using concomitant PHN medication on a stable dose for at least 4 weeks prior to randomisation
- •6. Patients must be willing and able to give informed consent
排除标准
- •1. PHN in regions innervated by the trigeminal nerve
- •2. Previous neurolytic or neurosurgical treatment for PHN (radiofrequency neuroablation [RF] treatment of the dorsal root ganglion is allowed)
- •3. Patients who have other pain, which could confound the assessment of the neuropathic pain due to PHN
- •4. Patients with polyneuropathy or other severe neurologic disease (e.g., multiple sclerosis)
- •5. Patients with diseases accompanied with a severe immunocompromised state (e.g., during chemotherapy, AIDS; HIV is not an exclusion criterion)
- •6. Use of coumarin anticoagulants
- •7. Contra-indications for spinal anaesthesia
- •8. Contra-indications for oral non-steroidal anti-inflammatory drug (NSAID) use
- •9. Satisfactory pain relief with conventional treatment (including at least one trycyclic antidepressant and at least one anti-epileptic)
- •10. Adjustments in concomitant PHN medication during the past 4 weeks
- •11. Previous spinal anaesthesia with steroids for PHN
- •12. Skin conditions in the area affected by the neuralgia that could alter sensation
- •13. Clinically significant psychiatric diagnoses, in particular depression, that would impair their reliable participation in this trial
- •14. Body Mass Index (BMI) >35 kg/m^2
- •15. Woman of childbearing potential who is not willing or unable to take adequate birth control measures during the study and for at least 6 months after the last injection
- •16. Pregnant patients and women who are lactating
- •17. Problems with communication (language, deafness, aphasia)
研究者
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