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Table 9 Data extraction for the special needs studies

From: Manual therapy for the pediatric population: a systematic review

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.