Table 1.
Characteristics of All Prospective Studies.
| Study | Study design | Age | Sex | Indications | Number of implants | Number of subjects at 12 months | Outcomes |
|---|---|---|---|---|---|---|---|
| Liem et al.27 | Prospective, single‐arm, observational | 54.3 ± 13.3 | 27 F/24 M | Study total | 32 | 25 | Pain (VAS), physical functioning (BPI), quality of life (EQ‐5D), mood (POMS), quality and intensity of pain (McGill Pain Questionnaire), paresthesia distribution, patient satisfaction, global impression of change, and safety |
| FBSS | 8 | ||||||
| CRPS‐I | 8 | ||||||
| Causalgia | 6 | ||||||
| Disc‐related pain | 4 | ||||||
| Radicular Pain | 2 | ||||||
| Lumbar Stenosis | 2 | ||||||
| Other | 2 | ||||||
| Deer et al.23 | Prospective, controlled, randomized | 52.4 ± 12.7 | 39 F/37 M | Study total | 61 | 55 |
Primary: treatment success rates for DRG vs SCS Secondary: positional effects on paresthesia intensity Non‐powered: pain (VAS), quality of life (SF‐36), mood (POMS), physical functioning (BPI), patient satisfaction, and safety |
| CRPS‐I | 30 | ||||||
| Causalgia | 25 | ||||||
| Morgalla et al.28 | Prospective, single‐arm, observational | 50.4 ± 13.4 | 13 F/21 M | Causalgia | 30 | 25 | Pain (VAS), disability (PDI), catastrophizing (PCS), physical functioning (BPI), depression (BDI), and safety |
| Morgalla et al.29 | Prospective, single‐arm, observational | 56.8 ± 14.4 | 27 F/35 M | Causalgia | 51 | 40 | Pain (VAS), disability (PDI), catastrophizing (PCS), physical functioning (BPI), depression (BDI), and safety |
| Huygen et al.24 | Prospective, single‐arm, observational | 52.0 ± 11.5 | 42 F/24 M | Study total | 56 | 49 | Pain (VAS), physical functioning (BPI), mood (POMS), quality of life (EQ‐5D), and safety |
| FBSS | 25 | 24 | |||||
| CRPS‐I | 11 | 9 | |||||
| Causalgia | 15 | 10 | |||||
| Post‐amputation | 2 | 2 | |||||
| Radicular pain | 2 | 2 | |||||
| Other | 2 | 2 | |||||
| Kallewaard et al.25 | Prospective, single‐arm, observational | 47.5 ± 13.4 | 13 F/7 M |
Nonoperated Discogenic Low back pain |
15 | 14 | Pain (NRS), quality of life (EQ‐5D), disability (ODI), mood (POMS), patient satisfaction, and safety |
| Kallewaard et al.26 | Prospective, single‐arm, observational | 51.0* ± 12.2 | 7 F/4 M* | Lumbar Discectomy | 11 | 9 | Pain (NRS), physical functioning (BPI), quality of life (EQ‐5D), disability (ODI), mood (POMS), and safety |
| Total in seven studies | 256 | 217 | |||||
*
At permanent implant.