Table 6.
Adverse events during the 12-week treatment*
| Treatment group | Group difference | ||||
|---|---|---|---|---|---|
| ET | SMT+ET | SMT+ET minus ET (95% CI) |
|||
| n † (%) |
Median bothersomeness ^ |
n † (%) |
Median bothersomeness ^ |
||
| Different type of pain | 28 (31.1%) |
4 | 32 (34.4%) |
4 | 3.3% (−10.2 to 16.6) |
| Increased back pain severity | 25 (27.8%) |
4 | 20 (21.5%) |
4 | −6.3% (−18.6 to 6.2) |
| New or increased leg pain, numbness, or weakness |
20 (22.5%) |
3.5 | 16 (17.2%) |
3.5 | −5.3% (−16.9 to 6.3) |
| Unusual or increased soreness | 45 (50.6%) |
2.3 | 50 (53.8%) |
2.2 | 3.2% (−11.1 to 17.3) |
| Skin irritation | 5 (5.6%) |
5 | 1 (1.1%) |
7 | −4.5% (−11.5 to 1.2) |
| More fatigue than usual | 18 (20.2%) |
3 | 21 (22.6%) |
2.7 | 2.4% (−9.6 to 14.2) |
| Dizziness or lightheadedness | 18 (20.0%) |
3 | 13 (14.0%) |
3 | −6.0% (−17.0 to 4.9) |
| Upset stomach, nausea, or vomiting | 12 (13.5%) |
2 | 13 (14.0%) |
4 | 0.5% (−9.8 to 10.7) |
| Changes in bowel or bladder habits | 8 (8.9%) |
3 | 2 (2.2%) |
4.9 | −6.7% (−14.6 to 0.1) |
*
Analysis included 90 participants in ET group and 93 in SMT+ET group
†
Participants reporting at least one event during treatment, participants could report more than one event
^
Bothersomeness on 0–10 scale; bothersomeness was averaged for participants with more than one of the same event during the 12 weeks of treatment