Evidence-Based Complementary and Alternative Medicine / 2015 / Article / Tab 7

Research Article

Structural Integration as an Adjunct to Outpatient Rehabilitation for Chronic Nonspecific Low Back Pain: A Randomized Pilot Clinical Trial

Table 7

Participants with AE.

Participants
number (%)RR (CI)22
SI + OR ()1OR alone ()

Participants with ≥1 AE
 Study-related AE 15 (68%)114 (61%)1.12 (0.73–1.73)0.76
 Any AE 16 (70%)316 (70%)1.00 (0.68–1.47)1.00
Participants endorsing study-related AE by severity
 Mild12 (55%)17 (30%)1.79 (0.87–3.70)0.14
 Moderate10 (45%)111 (48%)0.95 (0.51–1.78)1.00
 Serious00
Participants endorsing types of study-related AE
 Sharp, burning, aching, or other pain13 (59%)19 (39%)1.51 (0.81–2.80)0.24
 VAS Pain rating ≥30 mm above baseline4 (18%)16 (26%)0.70 (0.23–2.14)0.72
 Numbness3 (14%)12 (9%)1.57 (0.29–8.51)0.67
 Tingling5 (23%)12 (9%)2.6 (0.56–12.10)0.24
 Pulsating sensation2 (9%)12 (9%)1.05 (0.16–6.78)1.00
Heat, sweating, feeling dizzy or spinning, less coordinated walking, less secure on feet, more difficulty to move, and other nonpain events12 (55%)13 (13%)4.18 (1.36–12.84)0.0054

AE: adverse event; RR: risk ratio; CI: 95% confidence interval; 1 because one participant dropped out before receiving any treatment; 2RR, CI, and 2-sided from Fisher’s exact tests; 3 to include 1 drop out with a non-study-related AE; 4 ≤ 0.01.

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