Overall success rate: pain interference % (n/N)† | Average PGIC score Mean (SD, n) | % Reduction in BDI-II Mean (SD, n) | |
PNS therapy | |||
Baseline score | NA | NA | 7.6 (6.0, 12) |
Week 4 | 55 (6/11) | 1.4 (1.1, 11) | 16 (49, 11)* |
Week 8 | 80 (8/10)* | 2.2 (0.9, 10)* | 32 (63, 10)* |
Month 3 | 60 (6/10)* | 1.9 (0.9, 10)* | 17 (87, 10)* |
Month 4 | 70 (7/10)* | 2.1 (0.6, 8)* | 36 (78, 8)* |
Month 5 | 70 (7/10)* | 1.7 (1.1, 10) | 46 (66, 10)* |
Month 6 | 60 (6/10)* | 1.1 (1.0, 8) | 50 (49, 8)* |
Placebo‡ | |||
Baseline score | NA | NA | 12.6 (5.0, 14) |
Week 4 | 15 (2/13) | 0.6 (1.3, 13) | −8 (60, 13) |
Week 8 | 18 (2/11) | 1.3 (1.0, 11) | −1 (68, 11) |
Month 3 | 20 (2/10) | 1.0 (0.8, 10) | −14 (71, 10) |
Month 4 | 44 (4/9) | 1.0 (1.2, 8) | 22 (46, 8) |
Month 5 | 25 (2/8) | 1.0 (1.3, 7) | 20 (59, 7) |
Month 6 | 25 (2/8) | 0.1 (2.1, 7) | −16 (75, 7) |
*P<0.01, vs placebo group at the end of the placebo period.
†Overall success is calculated based on long-term follow-up population.
‡Placebo group received active stimulation during weeks 5–8.
BDI-II, Beck Depression Inventory-II; NA, not applicable; PGIC, Patient Global Impression of Change; PNS, peripheral nerve stimulation.