Table 2 Evidence Table: Randomized Controlled Trials^a

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 = 104

SMT 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 = 34

10 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 period

One 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 tx

Direct verbal inquiry at each visit

One 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)