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Telephone screen for eligibility (Expected n = 240). Expected to be ineligible = 140 Headache characteristics Other medical exclusions No physician Scheduling difficulties. First confirmation of eligibility Baseline study visit with neurologist (PI)
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Telephone screen for eligibility (Expected n = 240) Expected to be ineligible = 140 Headache characteristics Other medical exclusions No physician Scheduling difficulties First confirmation of eligibility Baseline study visit with neurologist (PI) Consent for study, begin baseline diary collection Baseline instruments (HIT-6, MIDAS, SF-36) Expected to be excluded = 6 Headache characteristics Unstable co-morbid conditions Medications Second confirmation of eligibility Baseline diaries reviewed Expected to be excluded = 24 Failure to keep diaries Headache characteristics Other intervening problems Expected to be randomized = 70 Allocate to craniosacral therapy CST = 8 weekly 45-minute treatments Assessment at beginning of therapy (HIT-6) Collection of diary data continues Allocate to magnet therapy LSSM = 8 weekly 45-minute treatments Assessment at beginning of therapy (HIT-6) Collection of diary data continues Follow-up assessment at end of therapy (HIT-6, Diary data) Expected withdrawal = 5 Follow-up assessment at end of therapy (HIT-6, Diary data) Expected withdrawal = 5 Follow-up assessment 4 weeks post (MIDAS, SF-36, Diary data) Quality control assessment of intervention Follow-up assessment 4 weeks post (MIDAS, SF-36,Diary Data) Quality control assessment of intervention ITT analysis of diary and HIT-6 data Expected n = 30 ITT analysis of diary and HIT-6 data Expected n = 30