Table 2.
Subject baseline characteristics
| Population | N | % female | Age (years) | BMI | Months since surgery | Number of surgeries | Baseline scores
|
||
|---|---|---|---|---|---|---|---|---|---|
| Back PI | Leg PI | ODI | |||||||
| Intent-to-treat | 34 | 67.6 | 55.0±11.1 | 31.1±5.6 | 16.3±9.6 | 1.3±0.5 | 6.0±1.6 | 5.3±2.3 | 42.4±12.7 |
| Per-protocol | 30 | 66.7 | 54.7±10.8 | 31.2±6.0 | 16.9±9.7 | 1.3±0.4 | 6.0±1.6 | 5.3±2.5 | 43.1±12.7 |
| Discectomy | 10 | 70 | 57.3±10.1 | 32.7±6.5 | 14.6±10.2 | 1.3±0.5 | 5.3±1.8 | 5.3±2.1 | 41.4±12.0 |
| Decompression | 14 | 50 | 54.5±9.2 | 31.1±6.1 | 21.2±8.4 | 1.2±0.4 | 6.2±1.2 | 5.3±2.3 | 41.6±12.1 |
| Fusion | 6 | 100 | 50.7±13.7 | 29.0±3.7 | 10.7±6.3 | 1.3±0.5 | 6.9±1.7 | 5.5±3.3 | 49.7±12.8 |
Notes: Data reported as a percentage (% female) or mean ± standard deviation. Baseline PI scores are mean scores reported for the 5 consecutive days beginning the day of the screening visit. The discectomy subpopulation includes two subjects with both discectomy and decompression.
Abbreviations: BMI, body mass index; N, number; ODI, Oswestry Disability Index; PI, pain intensity.