RESUMO
OBJECTIVE: Design a feasible study to assess the efficacy and safety of Craniosacral therapy (CST) in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving complementary light-touch sham treatments (CLST) as an attention control intervention. METHODS: This was a single-center, randomized, cross-over placebo-controlled experimental design. A total of 87 participants who suffered migraine attacks from 4 to 9 per month were randomly assigned into either 2 weekly units of CST or CLST for 4 weeks. And then the 2 groups were crossed and continued treatment for 4 weeks plus a follow-up observation for 4 weeks. As the primary outcome measures, Headache Impact Test-6 (HIT-6) and headache frequency were assessed every 4 weeks (at baseline, week 4, week 8 and week 12). The secondary outcome was the scores of Headache Disability inventory (HDI) and the Hamilton Anxiety Scale (HAMA) as well as the adverse events. RESULTS: All 87 individuals had been screened for eligibility, of which 60 were licensed for the study. The difference of HIT-6 and headache frequency between the 2 groups was not significant at the baseline. But the headache frequency and HIT-6 of 2 groups were all declined respectively after the CST at week 4 (group A) and week 8 (group B) than before (Pâ= 0.01 < 0.05, 95% CI, -3.06 to -1.87; Pâ»= 0.01 < 0.05, 95% CI, -3.52 to -2.53; P1A = 0.01 < 0.05, 95% CI, 4.55-11.7; P2B = 0.01 < 0.05, 95% CI, -11.78 to -6.01) while the changes were not obvious after CLST with previous treatment. The scores and frequency of fourth evaluation showed that there was no significant increase or decrease in both the 2 groups. Besides, we found that the mean scores of HIT-6 for all participants, compared with the baseline, were decreased significantly after the 3 round treatments (P3A = 0.01 < 0.05, 95% CI, -13.12 to -6.4; P3B = 0.01 < 0.05, CI, -12.73 to -6.69). We also showed the similar result in the scores of HDI and HAMA. CONCLUSION: The results indicated that standardized CST was both effective and safe in alleviating the migraine intensity and frequency as well as the headache-related disability. Further larger research is needed.