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)2
2
SI + OR ()1
OR alone ()
Participants with ≥1 AE
Study-related AE
15 (68%)1
14 (61%)
1.12 (0.73–1.73)
0.76
Any AE
16 (70%)3
16 (70%)
1.00 (0.68–1.47)
1.00
Participants endorsing study-related AE by severity
Mild
12 (55%)1
7 (30%)
1.79 (0.87–3.70)
0.14
Moderate
10 (45%)1
11 (48%)
0.95 (0.51–1.78)
1.00
Serious
0
0
Participants endorsing types of study-related AE
Sharp, burning, aching, or other pain
13 (59%)1
9 (39%)
1.51 (0.81–2.80)
0.24
VAS Pain rating ≥30 mm above baseline
4 (18%)1
6 (26%)
0.70 (0.23–2.14)
0.72
Numbness
3 (14%)1
2 (9%)
1.57 (0.29–8.51)
0.67
Tingling
5 (23%)1
2 (9%)
2.6 (0.56–12.10)
0.24
Pulsating sensation
2 (9%)1
2 (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 events
12 (55%)1
3 (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.
