Table 9.

Data extraction for the special needs studies

Condition	Author/year	Study objective	Study design sample size intervention	Patient description/condition	Primary/main outcome(s)	Main results/conclusions	Adverse events
ADHD	Accorsi A, et al. 2014 [48]	To evaluate efficacy of osteopathic manipulative treatment of children with ADHD.	RCT n = 28 OMT	Children ages 5–15, with primary diagnosis of ADHD	Biancardi-Stroppa Modified Bell Cancellation Test, accuracy and rapidity scores	Osteopathic manipulative treatment was positively associated with changes in the Biancardi-Stroppa Test accuracy and rapidity scores.	There was no mention of adverse events made in this study.
Autism	Bramati-Castellarin I, et al. 2016 [49]	Investigate the influence of visceral osteopathic technique on the behaviour and GI symptoms of children with autism.	Interrupted Time Series (without control group) n = 49 VOMT	Autistic children ages 3 1/2–8, with GI symptoms, impaired social interactions and communication	Parental completion of the Modified Autism Research Institute outcomes survey form (9 S.O.S. questionnaires) and secretin assessment used to assess GI signs and symptoms	Significant improvements reported in “social behavior and communication” and “digestive signs” subscale of the questionnaire and in vomiting and poor appetite comparing before and after VOMT.	“There was no mention of adverse events made in this study.”
	Khorshid K, et al. 2006 [50]	Identify the differences in efficacy between upper cervical and full spine adjustment in autistic children	RCT n = 14 CMT	Children diagnosed with autism	ATEC average scores and parental observations	Clinical improvements observed through parental observations and through a decrease in the ATEC scores in both groups. Upper cervical group had improved ATEC average scores of 32%. Full spine group had improved ATEC scores of 19%.	Clinical deterioration was shown in one of the children of the full spine group, but only marginal in one child of the upper cervical group.
Cerebral Palsy	Wyatt K, et al. 2011 [51]	Evaluate the general health and wellbeing effect of cranial osteopathy on cerebral palsy children.	RCT n = 142 Cranial Osteopathy	Children with CP, ages 5–12	Gross Motor Function Measure - (GMFMM-66) Quality of life Child Health Questionnaire-(CHQ) PF50	No statistical change in GMFM-66 or CHQ. PF50 Parents (unblinded) reported better global health.	No serious adverse events were reported.
	Duncan B, et al. 2004 [52]	Evaluate effectiveness of osteopathic manipulation or acupuncture as a supplemental therapies for children with spastic cerebral palsy.	RCT n = 50 OMT	Children with spastic CP, ages 20 months - 12 years	Parent reporting of changes observed (open-ended questions)	96% reported improvements. Most frequent seen in use of arms and legs (61 and 68%) and more restful sleep (39 and 68%) in osteopathic and acupuncture respectively. Additional improvements also noted in mood and bowel functions.	There was no mention of adverse events made in this study.
	Duncan B, et al. 2008 [53]	Evaluate effectiveness of osteopathic manipulation (cranial field, myofascial release or both) vs. acupuncture in spastic cerebral palsy patients.	RCT n = 55 OMT/Acupuncture	Children with CP, ages 20 months - 12 years	11 outcomes used: Primary-GMFCS, GMFM total percent, PEDI mobility, PEDI self-care, WeeFIM mobility, WeeFIM self-care; Secondary- DO rating of spasticity, MAS biceps, MAS hamstring, parent/guardian rating of arched back, parent/guardian rating of startle reflex	Osteopathic manipulation was associated with improvements in 2 of 11 outcomes; GMFM total percent and WeeFIM Mobility. Acupuncture was not associated with improvements in any of the outcomes variables.	There was no mention of adverse events made in this study.
Prematurity	Raith W, et al. 2016 [54]	Investigate neurological short term effects of craniosacral therapy on general movements in preterm infants.	RCT n = 30 OMT/CST	Preterm infants ages 25–33 weeks, free from medical complications in NICU	Primary outcome: General movement assessment tool. Secondary outcomes: General movement optimality score	No difference in the general movement could be observed between the groups. No change in general movement optimality score was noted.	There was no mention of adverse events made in this study.
	Cerretelli F, et al. 2015 [55]	Investigate whether osteopathic manipulation reduces the length of hospital stay, costs, and weight gain for preterms.	RCT n = 695 OMT/CST	Preterm infants ages 29–37 weeks, without congenital complications in NICU	1. Reducing length of hospital stay 2. Weight gain and hospital savings	Osteopathic treatment reduced days hospital (3.9 days) and reduced costs by 1250.65€ per newborn per length of stay. No change in weight gain was noted.	There were no complications associated to the intervention.
	Pizzolorusso G, et al. 2014 [56]	Investigate whether osteopathic manipulation reduces length of hospital stay, what effect the timing of introduction of osteopathic treatment may have on the outcome and hospital costs in preterm infants.	RCT n = 110 OMT/CST	Preterm infants ages 32–37 weeks, free from medical complications in NICU	1. Reducing length of hospital stay and impact on length of stay of timing of introduction of osteopathic manipulation 2. Reducing hospital cost	Sooner osteopathic manipulation introduced, shorter length of stay. There is a positive association of osteopathic manipulation with overall reduction in cost of care.	There were no complications associated to the intervention.
	Cerretelli F, et al. 2013 [57]	Determine effectiveness of osteopathic manipulative therapy in reducing the length of hospital stay, hospital costs and weight gain in preterm infants.	RCT n = 110 OMT/CST	Preterm infants ages >28 and <38 weeks, free from medical complications in NICU	1. Decreased length of hospital stay 2. Improved weight gain and reduced NICU costs	Osteopathic manipulation reduced length of stay and hospital costs but not effect weight gain.	No serious adverse events were reported.