Table 2.
3 months | 12 months | 24 months | ||||
Closed-loop SCS | Open-loop SCS | Closed-loop SCS | Open-loop SCS | Closed-loop SCS | Open-loop SCS | |
Multimodal treatment responders (MCID in at least two impaired domains out of VAS≥30%, ODI≥10, EQ-5D≥0.074, PSQI≥3, POMS≥10) | ||||||
Responders in ≥1 impaired domain (%) | 63/67 (94.0) | 58/67 (86.6) | 63/67 (94.0) | 56/67 (83.6) | 63/67 (94.0) | 56/67 (83.6) |
Responders in ≥2 impaired domains (%) | 56/67 (83.6) | 51/67 (76.1) | 55/67 (82.1) | 45/67 (67.2) | 53/67 (79.1) | 45/67 (67.2) |
Responders in ≥3 impaired domains (%) | 54/67 (80.6) | 46/67 (68.7) | 49/67 (73.1) | 39/67 (58.2) | 47/67 (70.1) | 39/67 (58.2) |
Responders in ≥4 impaired domains (%) | 41/66 (62.1) | 34/66 (51.5) | 41/66 (62.1) | 30/66 (45.5) | 38/66 (57.6) | 27/66 (40.9) |
Responders in five impaired domains (%) | 25/44 (56.8) | 9/36 (25.0) | 28/44 (63.6) | 10/36 (27.8) | 23/44 (52.3) | 6/36 (16.7) |
Holistic treatment responder (%) | 36/67 (53.7) | 26/67 (38.8) | 38/67 (56.7) | 26/67 (38.8) | 33/67 (49.3) | 18/67 (26.9) |
Risk difference (%) and 95% CI | 14.9 (-1.8, 31.6), p=0.12 | 17.9 (1.3, 34.6), p=0.06 | 22.4 (6.4, 38.4), p=0.01 |
The denominator for the number of patients varies according to the number of domains impaired at baseline.
.MCID, minimal clinical important difference; ODI, Oswestry Disability Index; POMS, Profile of Mood States; PSQI, Pittsburgh Sleep Quality Index; SCS, spinal cord stimulation; VAS, Visual Analog Scale.