The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study). — CFSMEATLAS
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study).
Crawley, Esther, Mills, Nicola, Beasant, Lucy et al. · Trials · 2013 · DOI
Quick Summary
This study tested whether it was possible to run a fair comparison trial between standard medical care and a treatment called the Lightning Process for children with ME/CFS. Researchers recruited 56 young people aged 12-18 from a specialist clinic and found that running this type of trial was workable and acceptable to patients. The study helped identify practical changes to improve how future trials should be conducted.
Why It Matters
This study is important because it established that rigorous randomized trials testing alternative treatments for pediatric ME/CFS are logistically feasible, paving the way for evidence-based evaluation of interventions like the Lightning Process. For patients, this means future research can be conducted in ways that are realistic and respectful of their needs. The integration of patient feedback into trial design demonstrates a commitment to patient-centered research.
Observed Findings
56 of 156 eligible children (35.9%) were successfully recruited to the feasibility trial
Recruitment, randomization, and both interventions were rated as feasible and acceptable by participants
Participants identified specific protocol improvements, including elimination of 6-week outcome collection and introduction of telephone follow-up for non-responders
The primary outcome measure was changed from school attendance to SF-36 physical function and Chalder Fatigue Scale based on participant input
Integration of qualitative methodology enabled iterative refinement of trial protocols prior to full-scale trial launch
Inferred Conclusions
Conducting RCTs to evaluate alternative treatments such as the Lightning Process in children with CFS/ME is both logistically feasible and acceptable to participants
Incorporating qualitative methodology and patient feedback into feasibility studies improves trial protocol design and likely enhances recruitment and retention rates
Patient-centered iterative design processes are essential for developing pragmatic, acceptable trial protocols for pediatric ME/CFS research
Remaining Questions
Is the Lightning Process effective, ineffective, or harmful compared to specialist medical care alone in children with ME/CFS?
What This Study Does Not Prove
This feasibility study does NOT determine whether the Lightning Process is effective, ineffective, or harmful—it only assesses whether a trial comparing it to standard care can be conducted. It does not provide safety data or efficacy data for the Lightning Process. The study cannot establish causation or treatment outcomes, as it was designed solely to test trial procedures and acceptability.
Tags
Symptom:Cognitive DysfunctionFatigue
Phenotype:Pediatric
Method Flag:Weak Case DefinitionSmall SampleExploratory Only