Fulltext available free at: http://www.trialsjournal.com/content/14/1/444/abstract
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Trials. 2013 Dec 26;14(1):444. [Epub ahead of print]
Comparing specialist medical care with specialist medical care plus the Lightning Process(R) for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial).
Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A.
Abstract*
BACKGROUND:
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(R) (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.
METHODS:
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).
DISCUSSION:
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.Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).
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