Table 1.
Characteristics and baseline clinical outcomes for subjects recruited to the SENZA‐RCT and SENZA‐EU trials. Values are mean (SD), mean (SEM) or number (proportion)
| SENZA‐RCT | SENZA‐EU | Combined | |
|---|---|---|---|
| Number of subjects | 12 | 15 | 27 |
| Age | 47.8 (11.5) | 52.3 (9.1) | 50.3 (10.3) |
| Female gender | 6 (50.0%) | 12 (80%) | 18 (67%) |
| Years since diagnosis | 6.8 (5.3) | 9.1 (8.3) | 8.0 (7.1) |
| Aetiology (subjects could have more than one) | |||
| Degenerative disc/back disease | 9 (75%) | 8 (53%) | 17 (67%) |
| Radiculopathy | 11 (91%) | 1 (7%) | 12 (46%) |
| Spondylosis | 10 (83%) | 0 | 10 (39%) |
| Sacroiliac dysfunction | 7 (58%) | 0 | 7 (27%) |
| Others | 5 (42%) | 7 (47%) | 12 (46%) |
| Pain location | |||
| Back and leg | 12 (100%) | 11 (73%) | 23 (85%) |
| Back only | 0 | 4 (27%) | 4 (15%) |
| Leg only | 0 | 0 | 0 |
| Pain intensity | |||
| Baseline back pain VAS in cm | 7.2 (0.3) | 8.1 (0.2) | 7.7 (0.2) |
| Baseline leg pain VAS in cm | 7.2 (0.3) | 7.4 (0.5) | 7.3 (0.3) |
| Disability | |||
| Baseline ODI score in % | 51.7 (2.4) | 52.9 (2.4) | 52.3 (1.7) |
| Opioid use | |||
| Number of subjects using opioids at baseline | 10 (83%) | 9 (60%) | 19 (70%) |
| Average dose of opioids at baseline in MME | 111.1 (31.4) | 50.9 (26.8) | 85.3 (21.9) |
| Subjects taking opioids at doses ≥ 50 MME | 7 (58%) | 2 (13%) | 9 (33%) |
| Opioid dose in subjects taking ≥ 50 MME | 176.9 (36.6) | 160.0 (100.0) | 173.2 (32.6) |
MME, morphine milligram equivalents; ODI, Oswestry Disability Index; VAS, visual analogue scale.