Category | Active (n = 38) |
Sham (n = 38) |
All patients (n = 76) |
Mechanistic study (n = 19)# | |
---|---|---|---|---|---|
Age | 47.3 ± 15.9 | 53.6 ± 11.2 | 50.4 ± 14.0 | 61.8 ± 14.9 | |
Gender | Female | 22 (58%) | 18 (47%) | 40 (53%) | 9 |
Male | 16 (42%) | 20 (53%) | 36 (47%) | 10 | |
Duration Pain (months) | 44 [27, 96] | 48 [26, 72] | 47 [27, 87] | 61 [23,63] | |
Mechanism of Injury | Nerve entrapment | 1 (3%) | 2 (5%) | 3 (4%) | 2 (11%) |
Nerve injury | |||||
Surgery | 29 (76%) | 25 (66%) | 54 (71%) | 8 (42%) | |
Other mech. Trauma | 6 (16%) | 7 (18%) | 13 (17%) | 6 (32%) | |
Radiotherapy | 2 (5%) | 0 (0%) | 2 (3%) | 0 (0%) | |
Medication | 0 (0%) | 1 (3%) | 1 (1%) | 0 (0%) | |
Post-herpetic neuralgia | 0 (0%) | 3 (8%) | 3 (4%) | 2 (11%) | |
Number pain meds | 1.6 ± 1.5 | 1.7 ± 1.4 | 1.7 ± 1.4 | 1.8 ± 1.1 | |
Pain medications+ | General pain meds | 18 (58%) | 24 (69%) | 42 (64%) | 3 (16%) |
NSAIDs | 9 (29%) | 13 (37%) | 22 (33%) | 2 (11%) | |
Opioids | 9 (29%) | 7 (20%) | 16 (24%) | 7 (37%) | |
Anti-Epileptics | 15 (48%) | 20 (57%) | 35 (53%) | 10 (53%) | |
Anti-Depressants | 16 (52%) | 11 (31%) | 27 (41%) | 6 (32%) | |
Muscle relaxants | 1 (3%) | 2 (6%) | 3 (5%) | 0 (0%) | |
Baseline assessments | |||||
Primary | Pain in last 7 days | 7.2 ± 1.2 | 7.5 ± 1.4 | 7.3 ± 1.3 | 7.42 ± 1.3 |
Variability pain* | 0.85 ± 0.51 | 0.84 ± 0.44 | 0.85 ± 0.47 | 0.65 ± 0.55 | |
Secondary | EQ VAS | 51 ± 18 | 57 ± 25 | 54 ± 22 | 48 ± 27 |
EQ-5D index | 0.35 ± 0.23 | 0.34 ± 0.29 | 0.35 ± 0.26 | 0.27 ± 0.29 | |
BPI I | 6.2 ± 1.9 | 6.4 ± 2.0 | 6.3 ± 1.9 | 6.3 ± 2.9 | |
Exploratory | BPI W | 8.4 ± 1.1 | 8.2 ± 1.4 | 8.3 ± 1.2 | 8.5 ± 0.9 |
HADS anxiety | 10.7 ± 4.3 | 10.4 ± 5.2 | 10.5 ± 4.8 | 9.8 ± 5.6 | |
HADS depression | 9.3 ± 4.6 | 9.0 ± 4.5 | 9.1 ± 4.5 | 9.5 ± 5.7 | |
PESQ | 24 ± 14 | 23 ± 14 | 24 ± 14 | 19.7 ± 13 | |
DMA mapped area | 207 ± 192 | 175 ± 141 | 191 ± 168 | 204 ± 166 | |
NPSI total score | 63 ± 15 | 61 ± 19 | 62 ± 15 | 53 ± 19 |