Introduction
Methods
Study design and patient recruitment
Outcomes and data collection
Statistical analysis
Results
All participants (n = 60) | CMP group (n = 20) | SCS group (n = 40) | |
---|---|---|---|
Male, n (%) | 38 (63) | 13 (65) | 25 (63) |
Age in years, mean (SD) | 59 (11) | 61 (12) | 58 (11) |
Type I diabetes, n (%) | 15 (25) | 5 (25) | 10 (25) |
Type II diabetes, n (%) | 45 (75) | 15 (75) | 30 (75) |
Duration of diabetes in years, mean (SD) | 16 (12) | 17 (12) | 15 (11) |
Duration of pain in years, mean (SD) | 7 (5) | 7 (6) | 7 (6) |
Pain VASPI, mean (SD) | 72 (15) | 67 (18) | 73 (16) |
EQ-5D, mean (SD) | 0.33 (0.29) | 0.47 (0.31) | 0.27 (0.26) |
EQ VAS, mean (SD) | 49 (18) | 48 (16) | 50 (19) |
Baseline | 6 months | Within-group difference | ||||||
---|---|---|---|---|---|---|---|---|
SCS (n = 40) | CMP (n = 20) | SCS-CMP difference | SCS (n = 36) | CMP (n = 18) | SCS-CMP difference | SCS (n = 36) | CMP (n = 18) | |
Mean (SD) | Mean (SD) | Mean (95 % CI) | Mean (SD) | Mean (SD) | Mean (95 % CI) | Mean (95 % CI) | Mean (95 % CI) | |
VASPI | 73 (16) | 67 (18) | −6 (−15 to 3) | 29 (27) | 66 (22) | 37 (22–52)^^^ | 46 (35–)** | 0.5 (−10 to 11) |
EQ-5D index | 0.27 (0.26) | 0.47 (0.31) | 0.20 (0.05–0.36)^ | 0.65 (0.28) | 0.44 (0.33) | −0.21 (−0.39 to −0.04)^ | −0.39 (−0.50 to −0.29)** | 0.00 (−0.10 to 0.11) |
EQ VAS | 50 (19) | 48 (16) | −1 (−11 to 8) | 61 (23) | 41 (20) | −20 (−34 to −7)^^ | −12 (−22 to −1)* | 7 (−1 to 15) |
SCS | CMP | Difference | 95 % CIs* | ||
---|---|---|---|---|---|
QALYs—unadjusted for baseline EQ-5D score | 0.226 | 0.220 | 0.006 | −0.070 | 0.085 |
QALYs—adjusted for baseline EQ-5D score | 0.258 | 0.178 | 0.080^^^ | 0.044 | 0.114 |