The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial
Abstract Background Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. Method This is a multicenter, single-blind randomized cont...
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doaj-9e6dc9ff78da4716b850cf9ef260495e2021-04-25T11:50:26ZengBMCChiropractic & Manual Therapies2045-709X2021-04-0129111110.1186/s12998-021-00371-8The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trialLise Vilstrup Holm0Dorte Ejg Jarbøl1Henrik Wulff Christensen2Jens Søndergaard3Lise Hestbæk4The Chiropractic Knowledge Hub, University of Southern DenmarkResearch Unit of General Practice, Department of Public Health, University of Southern DenmarkThe Chiropractic Knowledge Hub, University of Southern DenmarkResearch Unit of General Practice, Department of Public Health, University of Southern DenmarkThe Chiropractic Knowledge Hub, University of Southern DenmarkAbstract Background Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. Method This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015–2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2–14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child’s allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire. Results Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference − 0.6, 95% CI − 1.1 to − 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes. Conclusion Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care. Trial registration Clinical Trials NCT02595515 , registered 2 November 2015https://doi.org/10.1186/s12998-021-00371-8Infantile colicChiropracticRandomized controlled trialManipulative treatmentExcessive crying |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Lise Vilstrup Holm Dorte Ejg Jarbøl Henrik Wulff Christensen Jens Søndergaard Lise Hestbæk |
spellingShingle |
Lise Vilstrup Holm Dorte Ejg Jarbøl Henrik Wulff Christensen Jens Søndergaard Lise Hestbæk The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial Chiropractic & Manual Therapies Infantile colic Chiropractic Randomized controlled trial Manipulative treatment Excessive crying |
author_facet |
Lise Vilstrup Holm Dorte Ejg Jarbøl Henrik Wulff Christensen Jens Søndergaard Lise Hestbæk |
author_sort |
Lise Vilstrup Holm |
title |
The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
title_short |
The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
title_full |
The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
title_fullStr |
The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
title_full_unstemmed |
The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
title_sort |
effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial |
publisher |
BMC |
series |
Chiropractic & Manual Therapies |
issn |
2045-709X |
publishDate |
2021-04-01 |
description |
Abstract Background Chiropractic care is commonly used to treat infantile colic. However large trials with parental blinding are missing. Therefore, the purpose of this study is to evaluate the effect of chiropractic care on infantile colic. Method This is a multicenter, single-blind randomized controlled trial conducted in four Danish chiropractic clinics, 2015–2019. Information was distributed in the maternity wards and by maternal and child health nurses. Children aged 2–14 weeks with unexplained excessive crying were recruited through home visits and randomized (1:1) to either chiropractic care or control group. Both groups attended the chiropractic clinic twice a week for 2 weeks. The intervention group received chiropractic care, while the control group was not treated. The parents were not present in the treatment room and unaware of their child’s allocation. The primary outcome was change in daily hours of crying before and after treatment. Secondary outcomes were changes in hours of sleep, hours being awake and content, gastrointestinal symptoms, colic status and satisfaction. All outcomes were based on parental diaries and a final questionnaire. Results Of 200 recruited children, 185 completed the trial (treatment group n = 96; control group n = 89). Duration of crying in the treatment group was reduced by 1.5 h compared with 1 h in the control group (mean difference − 0.6, 95% CI − 1.1 to − 0.1; P = 0.026), but when adjusted for baseline hours of crying, age and chiropractic clinic, the difference was not significant (P = 0.066). The proportion obtaining a clinically important reduction of 1 h of crying was 63% in the treatment group and 47% in the control group (p = 0.037), and NNT was 6.5. We found no effect on any of the secondary outcomes. Conclusion Excessive crying was reduced by half an hour in favor of the group receiving chiropractic care compared with the control group, but not at a statistically significant level after adjustments. From a clinical perspective, the mean difference between the groups was small, but there were large individual differences, which emphasizes the need to investigate if subgroups of children, e.g. those with musculoskeletal problems, benefit more than others from chiropractic care. Trial registration Clinical Trials NCT02595515 , registered 2 November 2015 |
topic |
Infantile colic Chiropractic Randomized controlled trial Manipulative treatment Excessive crying |
url |
https://doi.org/10.1186/s12998-021-00371-8 |
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