EUCTR2009-015242-30-GB进行中（未招募）1 期
An open study to compare the efficacy of immunoglobulin administered subcutaneoulsy (SCIG) with current best practice in patients with Complex Regional Pain Syndrome (CRPS) - SCIG in CRPS over 12 months
The Walton Centre for Neurology and Neurosurgery NHS Trust0 个研究点目标入组 12 人开始时间: 2009年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients will be suitable for consideration for screening and enrollment if they have received a diagnosis of CRPS according to the ‘Bruehl’ criteria1. In the first step, patients for the SCIG group will be chosen from patients who participated in a previous RCT in London and who responded better to IVIG than to normal saline. There are seven potential patients in that group, but one patient has a concomitant coagulatory problem and is not suitable for the priming intermediate dose treatment. Patients in either the SCIG or BMC group who agree to be invited for pre-screening will be reexamined by the principal investigator (PI) and, if still fulfilling the Bruehl criteria and the inclusion and exclusion criteria will be accepted for enrolment in the study. For the purpose of this trial, patients must be assumed to have at least a 24h average pain intensity of 6 over one week, with one day of a lower pain intensity of 5 acceptable. The patient’s pain intensity must be judged as stable by the PI. If a patient has concomitant medical conditions, then these must be judged as stable by the PI. Patients who wish not to follow recommendations of the Trial Team as to receiving concomitant treatment according to best medical care will nevertheless be suitable for enrollment. For each SCIG patient who successfully passes the screening and assessment of the first treatment and is enrolled into the trial, two patients matched to age +/- 10 years, sex, average 24h pain intensity and acute limb activity related pain intensity +/- 2 points (but not below 5 on the NRS) and disease duration +/- 18 months, will be selected for screening from those patients seen at the Walton Centre over the prior 18 months. It should be ensured that patients in both groups have used routine medications before enrollment including gabapentin and/or pregabalin, duloxetin and/or venlaflaxine, a tricyclic antidepressant, lignocaine patches, both a strong and weak opioid in an appropriate dose without sufficient benefit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •All patients in the SCIG group have already been tested for their IgA serum levels which were normal in all cases. Patients with progressive renal failure, and any patient requiring IVIG for another disorder are excluded. Treatment will be deferred in patients with an infection such as cold, flu or infected pressure sores until the infection has resolved, because IG is contraindicated in cases of untreated bacterial infection.
- •Further, patients in both groups are excluded, should they:
- •Have evidence of significant organic disease on history or physical examination, which may be severe enough to prevent the patient from being able to complete the study.
- •Suffer from another severe chronic pain syndrome such as fibromyalgia which may in the judgement of principle investigator hinder the appropriate assessment of pain from CRPS
- •Have a history of abuse or are currently abusing alcohol or drugs [using DSM-IV criteria].
- •Have a psychiatric disorder which may in the judgement of the site investigator interfere with successful study participation.
- •Are unwilling or not able to complete daily diaries
- •Do not understand the psychological questionnaires because appropriate validated translations into the patient’s language are not available
- •For the following patients in the SCIG group suitability for participation needs to be discussed with a specialist consultant:
- •Patients with compensated renal failure, patients suffering from epilepsy
- •Patients with a history of stroke or myocardial infarction
- •Patients with a known pro-coagulatory or blood-hyperviscosity disorder
- •- Patients on loop diuretics
- •Patients with cancer other than basal cell carcinoma within the last 5 years. Those patients who have received definite treatment, such as curative surgery, with no known recurrence can be included without further discussion.
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