Assessing the efficacy and safety of Craniosacral therapy for migraine: A single center randomized controlled trial.

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 (P☆= 0.01 < 0.05, 95% CI, -3.06 to -1.87; P※= 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.