Table. Six-Month Follow-up of a Trial of Spinal Cord Burst Stimulation vs Placebo Stimulation on Self-reported Back Pain–Related Disabilitya.
| Outcome | Trial enrollment | Placebo stimulation including 89 stimulation periods | Posttrial follow-up including 34 observations | Difference between posttrial follow-up and placebo stimulation | |
|---|---|---|---|---|---|
| Difference (95% CI) | P value | ||||
| Oswestry Disability Index score (95% CI) | |||||
| Full analysis set (n = 47)b | 44.7 (41.4-47.9) | 35.4 (31.4-39.4) | 34.7 (29.5-39.9) | −0.7 (−4.5 to 3.2) | .73 |
| Complete case set (n = 30)c | 44.3 (40.5-48.1) | 35.5 (30.7-40.3) | 34.2 (28.3-40.2) | −1.3 (−5.6 to 3.0) | .55 |
a
All patients were provided with spinal cord stimulator programmers when the trial ended.
b
Patients who had 1 or more Oswestry Disability Index measurements following randomization.
c
Patients with Oswestry Disability Index measurements at all points during the trial and posttrial follow-up.