Treatment of infant colic with craniosacral therapy. A randomized controlled trial.

OBJECTIVE: To evaluate the number of craniosacral therapy sessions that can be helpful to obtain a resolution of the symptoms of infantile colic and to observe if there are any differences in the evolution obtained by the groups that received a different number of Craniosacral Therapy sessions at 24 days of treatment, compared with the control group which did not received any treatment. METHODS: Fifty-eight infants with colic were randomized into two groups of which 29 babies in the control group received no treatment and those in the experimental group received 1-3 sessions of craniosacral therapy (CST) until symptoms were resolved. Evaluations were performed until day 24 of the study. In this study crying hours served as primary outcome. The secondary outcome were the hours of sleep and the severity, measured by an Infantile Colic Severity Questionnaire (ICSQ). RESULTS: Significant statistical differences were observed in favor of experimental group compared to the control group on day 24 in crying hours (mean difference = 2.94, at 95 %CI = 2.30-3.58; p < 0.001) primary outcome, and also in hours of sleep (mean difference = 2.80; at 95 %CI = - 3.85 to - 1.73; p < 0.001) and colic severity (mean difference = 17.24; at 95 %CI = 14.42-20.05; p < 0.001) secondary outcomes. Also, the differences between the groups ≤ 2 CST sessions (n = 19), 3 CST sessions (n = 10) and control (n = 25) were statistically significant on day 24 of the treatment for crying, sleep and colic severity outcomes (p < 0.001). CONCLUSION: Babies with infantile colic may obtain a complete resolution of symptoms on day 24 by receiving 2 or 3 CST sessions compared to the control group, which did not receive any treatment.

[Translation and cross-cultural adaptation of the Gross Motor Function Measure to the Spanish population of children with cerebral palsy]. / Traducción y adaptación transcultural del Gross Motor Function Measure a la población española de niños con parálisis cerebral.

INTRODUCTION: The Gross Motor Function Measure (GMFM) is a measure designed to assess changes in gross motor function over time in children with cerebral palsy. It is an observation instrument, valid, reliable and responsive, widely used both in research and in clinical practice. AIM: To perform the translation and cross-cultural adaptation to the Spanish population of the GMFM. SUBJECTS AND METHODS: The forward-backward translation methodology was used, subjecting the resulting versions to a qualitative analysis of equivalence. Both the score sheet and the instructions were translated through strategies of omission, incorporation, substitution of words or contribution of examples. In addition, understandability, applicability and feasibility were assessed through a pilot study in which assessors and subjects with a heterogeneous profile participated. RESULTS: The items that generated the most difficulty were those that included clinical terms or expressions whose use is not considered natural or equivalent in the Spanish language. Although 57% and 58% of the items of forward and backward translation, respectively, were classified as «partially equivalent¼, no correction was necessary since the modifications made came from the cultural and linguistic adaptation of the items to the Spanish population. CONCLUSIONS: The Spanish version maintains the highest degree of equivalence concerning the original English version and is understandable by all professionals regardless of their professional experience or geographic origin.

TITLE: Traducción y adaptación transcultural del Gross Motor Function Measure a la población española de niños con parálisis cerebral.Introducción. El Gross Motor Function Measure (GMFM) es un instrumento diseñado para evaluar los cambios en la función motora gruesa producidos a lo largo del tiempo en niños con parálisis cerebral. Se trata de un instrumento de observación válido, fiable y sensible, ampliamente utilizado tanto en investigación como en la práctica clínica. Objetivo. Realizar la traducción y adaptación transcultural a la población española de la herramienta de evaluación GMFM. Sujetos y métodos. Se utilizó la metodología de traducción directa e inversa, sometiendo las versiones resultantes a un análisis cualitativo de la equivalencia. Se tradujeron tanto la hoja de puntuación como las instrucciones mediante estrategias de omisión, incorporación, sustitución de palabras o aportación de ejemplos. Además, se valoraron la comprensibilidad, la aplicabilidad y la viabilidad mediante un estudio piloto en el que participaron evaluadores y sujetos con un perfil heterogéneo. Resultados. Los ítems que generaron más dificultad fueron los que incluían términos clínicos o expresiones cuyo uso no se considera natural o equivalente en la lengua española. Aunque el 57% y 58% de los ítems de la traducción directa e inversa, respectivamente, fueron calificados como «parcialmente equivalentes¼, no fue necesaria ninguna corrección porque las modificaciones realizadas provenían de la adaptación cultural y lingüística de los ítems a la población española. Conclusiones. La versión española mantiene el máximo grado de equivalencia con respecto a la versión original en inglés y se garantiza la comprensibilidad por parte de todos los profesionales independientemente de su experiencia profesional o procedencia geográfica.

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.