Goebel Andreas, Shenker Nicholas, Padfield Nick, Shoukrey Karim, McCabe Candida, Serpell Mick, Sanders Mark, Murphy Caroline, Ejibe Amaka, Milligan Holly, Kelly Joanna, Ambler Gareth
The University of Liverpool, Brownlow Hill, L69 7ZX Liverpool, UK.
Trials. 2014 Oct 24;15:404. doi: 10.1186/1745-6215-15-404.
Longstanding complex regional pain syndrome (CRPS) is refractory to treatment with established analgesic drugs in most cases, and for many patients, alternative pain treatment approaches, such as with neuromodulation devices or rehabilitation methods, also do not work. The development of novel, effective treatment technologies is, therefore, important. There are preliminary data suggesting that low-dose immunoglobulin treatment may significantly reduce pain from longstanding CRPS.
METHODS/DESIGN: LIPS is a multicentre (United Kingdom), double-blind, randomised parallel group, placebo-controlled trial, designed to evaluate the efficacy, safety, and tolerability of intravenous immunoglobulin (IVIg) 0.5 g/kg plus standard treatment, versus matched placebo plus standard treatment in 108 patients with longstanding complex regional pain syndrome. Participants with moderate or severe CRPS of between 1 and 5 years duration will be randomly allocated to receive IVIg 0.5 g/kg (IntratectTM 50 g/l solution for infusion) or matching placebo administered day 1 and day 22 after randomisation, followed by two optional doses of open-label medication on day 43 after randomisation and on day 64 after randomisation. The primary outcome is the patients' pain intensity in the IVIG group compared with the placebo group, between 6 and 42 days after randomisation. The primary trial objective is to confirm the efficacy and confidently determine the effect size of the IVIG treatment technology in this group of patients.
ISRCTN42179756 (Registered 28 June 13).
在大多数情况下，长期复杂性区域疼痛综合征（CRPS）对已有的镇痛药治疗无效，而且对许多患者来说，诸如神经调节装置或康复方法等替代性疼痛治疗方法也不起作用。因此，开发新型有效的治疗技术很重要。有初步数据表明，低剂量免疫球蛋白治疗可能会显著减轻长期CRPS引起的疼痛。
方法/设计：LIPS是一项多中心（英国）、双盲、随机平行组、安慰剂对照试验，旨在评估静脉注射免疫球蛋白（IVIg）0.5 g/kg加标准治疗与匹配安慰剂加标准治疗对108例长期复杂性区域疼痛综合征患者的疗效、安全性和耐受性。病程在1至5年之间的中度或重度CRPS患者将被随机分配接受IVIg 0.5 g/kg（IntratectTM 50 g/l输注溶液）或匹配安慰剂，在随机分组后的第1天和第22天给药，随后在随机分组后的第43天和第64天给予两剂可选的开放标签药物。主要结局是随机分组后6至42天内IVIG组与安慰剂组患者的疼痛强度。主要试验目标是确认疗效并确切确定IVIG治疗技术在该组患者中的效应大小。
ISRCTN42179756（2013年6月28日注册）
