Effectiveness of craniosacral therapy in the treatment of infantile colic. A randomized controlled trial.

OBJECTIVES: To determine the effectiveness of Craniosacral Therapy (CST) for the treatment of infantile colic. MATERIAL AND METHODS: This randomized controlled trial was conducted on 58 infants, aged 0-84 days, diagnosed with infantile colic. The babies received a 30-40 minute CST session once a week (experimental group) or no treatment (control group). Babies in the CST group received either 1, 2 or 3 CST sessions over a 14-day period. Data were collected at 4 different times over the 24-day period, day 0 (baseline), day 7, day 14 and day 24. Crying (primary outcome) and sleep (secondary outcome) were evaluated using a crying and sleep diary, and colic severity was measured using the Infant Colic Severity Questionnaire (secondary outcome). RESULTS: There was a statistically significant difference between groups (CST and control) in crying hours (F = 188.47; p < 0.0005; η2 = 0.78), sleep hours (F = 61.20; p < 0.0005, η2 = 0.54) and colic severity (F = 143.74; p < 0.0005, η2 = 0.73) across all the time points. In comparison with the control group, CST babies reported significant and clinically relevant effects in crying hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73), on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54); in sleep hours on day 7 (-2.47 h (95%CI, -2.95 to -1.99); p < 0.0005; d = 1.73) on day 14 (-3.29 h (95%CI, -3.7 to -2.8); p < 0.0005; d = 2.87) and on day 24 (-3.20 h (95%CI, -3.7 to -2.6); p < 0.0005; d = 2.54). CONCLUSIONS: Craniosacral therapy appears to be effective and safe for infantile colic by reducing the number of crying hours, the colic severity and increasing the total hours of sleep.