TABLE 1.
Outcomes Assessed
| Outcome | Variables |
|---|---|
| Pain relief | |
| Pain assessment (VAS) | 0-10 cm |
| Responder rates | % of subjects with ≥50% pain relief compared to baseline |
| Remitter rates | % of subjects with ≤2.5 cm VAS |
| Short Form McGill Pain Questionnaire (SF-MPQ-2) | 0-10 |
| Quality of life | |
| Pain Disability Index (PDI) | 0-70 |
| SF-12 (PCS & MCS subscales) | 0-50 |
| Global Assessment of Functioning (GAF) | 0-100 |
| Global impression of change (PGIC and CGIC) | No change, almost same, somewhat or a little bit better, better, moderately better, a great deal better |
| Sleep (PSQI and PSQ-3) | 0-21 for PSQI; 0-10 cm for PSQ-3 |
| Subject satisfaction | Dissatisfied, very dissatisfied, not sure, satisfied, very satisfied |
| Opioids | |
| Medication usage | Increased, no change, decreased, eliminated |
| Dosage | Morphine milliequivalents (MME) |
| Safety | |
| Neurological assessments | Deficit, maintained, improved |
| Adverse events | Grade I-IV |