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Table 2 Evidence Table: Randomized Controlled Trialsa

From: The safety of spinal manipulative therapy in children under 10 years: a rapid review

Randomized Controlled Trialsa
Author(s), YearSubjects & Setting; nInterventions; nComparisons; nFollow-upOutcomesKey Findings
Description
Incidence: %, (95% CI)
Miller et al., 2012 [61]Infants (< 8 wks), born at gestational age > 37 wks, birth weight > 2500 g, no other conditions or illness, unexplained persistent crying, Anglo-European College of Chiropractic; n = 104SMT w/o blinding; n = 33
SMT w/ blinding; n = 35
SMT: low force tactile pressure to spinal joints and paraspinal muscles (estimated at 2 N of force without rotation of the spine), where dysfunction was noted on
palpation, pragmatic, individualized to exam findings of the individual; chiropractic manual therapy of the spine
No SMT w/ blinding; n = 3410 days or complete resolution of symptoms (discharged)
SMT w/o blinding: 10 day, n = 26; discharged, n = 7
SMT w/ blinding: 10 day, n = 30; discharged, n = 5
No tx w/ blinding: 10 day, n = 22; dropped out, n = 12
Parent report of any AE during tx periodOne child in comparison group reported an AE of increased crying.
Incidence of increased crying in comparison group: 2.94% (0.52, 14.92)
Sawyer et al., 1999 [32]6 mos – 6 years, > 3 episodes acute otitis media in last year, middle ear effusion at first 2 visits;
Northwestern College of Chiropractic, Bloomington, Minnesota; n = 20
10 tx over 4 weeks; n = 9
Full spine HVLA SMT, emphasis on upper cervical area
10 placebo over 4 weeks; n = 11
Manual static and motion palpation and light touch of specific spinal segments. Identical to active tx without HVLA.
Immediately after completion of tx, 1 month after completion of txDirect verbal inquiry at each visitOne parent in tx group reported their child had mid-back soreness after 1 tx which resolved after a few days.
Another child was reported to be irritable for a short time after tx.
Incidence of AE in the tx group: 22.22% (6.32, 54.74)
One parent of a child in the placebo group reported excessive crying after tx.
Incidence of AE in the placebo group: 9.09% (1.62, 37.74)
RR: 2.44 (0.26, 22.8)
  1. AE Adverse events, D/t Due to, FU Follow-up, HA Headache, HVLA high velocity low amplitude, SMT spinal manipulative therapy, Months mos, RR relative risk, Tx Treatment, W/o Without, W/ With, Wks Weeks
  2. aData reported in this table only relates to adverse events, not benefits of treatment