Scharff 2002.
| Methods | Design: three group parallel trial Purpose: examine the effect of minimal‐contact thermal biofeedback and attention‐placebo on children's migraine | |
| Participants | Patients: children 7 to 17 years with migraine (minimum average 5 attacks a month) referred by neurologists Baseline comparability: yes (age, gender, headache index, days with headache, etc) | |
| Interventions | Placebo: four 1‐hour sessions within a period of 6 weeks with 'handcooling' sham biofeedback and general discussion about 'their lives and headache' Untreated: no sessions Experimental: sessions of thermal biofeedback ('hand warming') (Co‐intervention: ibuprofen and acetaminophen for headache. Instruction of 'not to change' medication habits) | |
| Outcomes | Incidence of patients with decrease in headache index of 50% or more Pain (Headache Index, 4‐point Likert scale) Temperature change Treatment credibility Child depression index (CDI) State‐trait anxiety inventory for children (STAIC) | |
| Notes | We have presented the outcome as no improvement for consistency of direction of outcomes. We excluded one patient from the numerators of both the placebo and no‐treatment groups to be able to compute the result, as relative risk cannot be calculated when all patients in a group have a negative outcome. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | 'randomization table stratified by two age groups' |
| Allocation concealment? | Unclear risk | NS |
| Blinding? Treatment provider | High risk | Not described as double‐blind (placebo/biofeedback) |
| Blinding? Outcome assessor | Unclear risk | Not relevant as patient reported outcome |
| Incomplete outcome data addressed? All outcomes | Low risk | Drop‐out < 15% |
| Free of selective reporting? | Unclear risk | No protocol available |
| Free of other bias? | Low risk | |
| No signs of variance inequality or skewness? | Unclear risk | Not relevant (binary outcome) |
| Trial size > 49? | High risk | N = 23 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% | High risk | Trial size < 49, unclear allocation concealment |