Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial).
Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial).
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DOI：
10.1186/1745-6215-14-444
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发表时间：
2013-12-26
期刊：
影响因子：
2.5
通讯作者：
Montgomery A
中科院分区：
文献类型：
--
作者：
Crawley E;Mills N;Hollingworth W;Deans Z;Sterne JA;Donovan JL;Beasant L;Montgomery A
慢性疲劳综合征或肌痛性脑脊髓炎(CFS/ME)是一种相对常见且潜在严重的疾病，治疗的证据基础有限。儿科CFS/ME的专科治疗采用国家健康与临床卓越研究所(NICE)推荐的干预措施，包括认知行为疗法、分级运动疗法和活动管理。Lightning Process®(LP)是一种源自骨疗、生活指导和神经语言编程的商标干预措施，以小组会议的形式在连续三天内提供。虽然每年有超过250名患有儿童自闭症/自闭症的儿童参加自理课程，但并无有关其成效或成本效益的研究报告。这项务实的随机对照试验是在英格兰西南部的一家儿科CFS/ME专科服务机构进行的。12至18岁的儿童和患有慢性阻塞性肺病/多发性硬化症(n = 80-112)的儿童和年轻人将被随机分配到专科医疗或专科医疗加LP。主要结果将是身体功能(SF-36物理功能简写)和疲劳(Chalder疲劳量表)。这项研究将告诉我们，与单独使用SMC相比，将LP添加到SMC中是否有效和具有成本效益。这项研究还将提供关于执行LP和SMC的详细信息。当前对照试验ISRCTN81456207(2012年7月31日)。
Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and potentially serious condition with a limited evidence base for treatment. Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence (NICE) including cognitive behavioural therapy, graded exercise therapy and activity management. The Lightning Process® (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness. This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale). This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC. Current Controlled Trials ISRCTN81456207 (31 July 2012).
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影响因子：
4.1
作者：
Lloyd, Samantha;Chalder, Trudie;Rimes, Katharine A.
通讯作者：
Rimes, Katharine A.
影响因子：
3.3
作者：
Brooks, R
通讯作者：
Brooks, R
影响因子：
4.4
作者：
REILLY, MC;ZBROZEK, AS;DUKES, EM
通讯作者：
DUKES, EM
影响因子：
7.6
作者：
Jones, JF;Nisenbaum, R;Reeves, WC
通讯作者：
Reeves, WC
影响因子：
6.9
作者：
Chalder, T.;Deary, V.;Walwyn, R.
通讯作者：
Walwyn, R.