Usual Light Touch Osteopathic Treatment Versus Simple Light Touch Without Intent in the Reduction of Infantile Colic Crying Time: A Randomised Controlled Trial

Abstract

Abstract Background: In many countries, it is common for parents to seek osteopathic care for their infants with colic. The aim of this study was to measure the effectiveness of usual light touch osteopathic treatment on crying time for infants with ‘colic’. Methods: Between September 2019 and July 2021, a superiority, two arm, single blinded (parent) multi-centre, randomised controlled trial, recruited healthy infants between 1 – 69 days of age who excessively cried, fussed, or were distressed and difficult to console. They were recruited by 22 private practice osteopaths in the UK, Australia and Switzerland. Infants were randomly allocated on a 1:1 ratio to either the Test or Control group. The Test intervention consisted of usual light touch osteopathic treatment, whereas the Control intervention consisted of simple light touch to random body locations with no treatment intent. Both groups received best practice advice and guidance. The primary outcome was the daily crying time, reported hourly by parents in a diary, over a two-week period. Secondary outcomes were parenting confidence, global change, satisfaction, and experience of care. Results: Sixty-six infants were recruited, 32 were allocated to the Test group and 34 to the Control group. All participants received the treatment they were allocated to and blinding was successful. Mean average daily crying time was 124 minutes (SD=69, n=26) in the Test group and 115 minutes (SD=49, n=29) in the Control group. Adjusting for baseline crying time, infant age, prior expectations for osteopathic care, and days within trial, infants in the Test group cried 2.2 minutes more per day than those in the Control group (CI95% -20 to 25 minutes, p=0.849). Parents’ perceptions of global change in symptoms, satisfaction with, and experience of care were high and similar in both groups. There were no serious adverse events related to the treatments or the trial. Conclusion: Usual light touch osteopathictreatment was not superior to simple light touch without treatment intent. Both interventions had similar effects in reducing crying time in infants with colic. The biomechanical explanatory models and underpinning assumptions about the mechanisms at play during osteopathic light touch care require reconsideration. Trial registration: ACTRN12620000047998 (22/01/2020)