Table A4:
Comparative Trials Evaluating 10-kHz High-Frequency SCS for Chronic Noncancer Pain
| Author, Year Country Sites | Study Design | Patient Eligibility Criteria | Conversion Rate: Trial to Permanent Implant | Primary Outcome | Length of Follow-Up Outcomes |
|---|---|---|---|---|---|
| Randomized Controlled Trials | |||||
| Bolash et al, 201928 United States 7 sites |
Prospective RCT comparing 2 SCS protocols with the same device: conventional (0-1,500 Hz) and 10-kHz high-frequency with the Freedom SCS system external PG | Chronic pain of trunk or limbs, refractory to conservative therapy for a minimum of 3 months | Screened: n = 241 Randomized: n = 198 Implant trial: n = 189 Permanent implant: n = 171 |
Primary 6-month efficacy ≥50% reduction back pain over baseline | 12 months Back pain intensity, leg pain intensity opioid use, GAF, ODI, patient satisfaction, adverse events |
| De Andres et al, 201729 Spain 1 site |
Prospective superiority RCT comparing 2 rechargeable SCS systems: Senza HF10 (Nevro Corp.) and Surescan RestoreSensor (Medtronic) | One or more back surgeries followed by FBSS (chronic pain of the back and/or limbs refractory to conservative therapy for at least 6 months) | Screened: n = 78 Randomized: n = 60 Implant trial: n = 60 Permanent implant: n = 55 |
≥50% reduction in pain intensity NRS | 12 months ODI, PDQ, SF-12, HAD, MOS-SS, patient GIC, adverse outcomes |
| Kapural et al, 201530 Kapural et al,201631 Amirdelfan et al, 201832 United States 10 sites |
Prospective pragmatic multicentre noninferiority trial comparing 2 rechargeable SCS systems: Senza HF10 (Nevro Corp.) and Precision Plus (Boston Scientific) | Chronic back and/or limb pain refractory to conservative therapy for at least 3 months | Screened: n = 241 Randomized: n = 198 Implant trial: n = 189 Implant success: n = 171 |
3-month composite outcome of safety (no stimulation-related neurological deficit) and efficacy (percentage reporting ≥50% reduction in back pain VAS score) | 12 months Back pain intensity VAS, leg pain intensity VAS, analgesic medication, GAF, ODI, patient satisfaction adverse events |
| 12 months SF-12, GIC, ODI, GAF, SF-MPQ-2, sleep quality (PSQI), reliance on programmer |
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| 24 months Back pain intensity VAS, leg pain intensity VAS, responders (≥50% reduction VAS), remitters (VAS ≤ 2.5), ODI, analgesic medication, patient/physician GIC and satisfaction, adverse events |
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| Randomized Crossover Trials | |||||
| Bocci et al, 201836 Italy 1 site |
Prospective crossover trial comparing 3 SCS protocols: conventional (10 Hz to 200 Hz), burst and 10-kHz high-frequency | Chronic lower back pain with or without surgery with neuropathic or mixed low-back pain spreading to both legs and implanted with a SCS for >3 months | NR | Electrophysiologic changes during 3 SCS protocols | Duration to pain recurrence, pain intensity |
| Thomson et al, 201838 United Kingdom 4 sites |
Prospective, multicentre double-blind crossover trial (PROCO) comparing effects of SCS protocols at various kHz levels (1, 4, 7, and 10 kHz) with the Precision SCS (Boston Scientific) | Persistent or recurrent low back pain with or without lesser leg pain for at least 3 months prior to screening and 3 months of unsuccessful pain management and no back surgery in previous 6 months | Screened: n = 39 Implanted: n = 34 Included: n = 34 1-week paresthesia SCS trial to ensure usual care, those unresponsive (<50% pain reduction) to the paresthesia trial underwent a 1-week 10-kHz SCS trial |
3-month mean low back pain reduction over baseline across kHz frequency | 3 months Leg pain, overall pain relief, ODI, EQ-5D-5L, PSQI, patient GIC |
Abbreviations: BDI, Beck Depression Inventory; EQ-5D-5L, 5-layer ED-5D quality-of-life questionnaire; FBSS, failed back surgery syndrome; GAF, Global Assessment of Function; GIC, Global Impression of Change; HAD, Hospital Anxiety and Depression scale; MOS-SS, Medical Outcomes Study Sleep Scale; NRS, numeric rating scale; ODI, Oswestry Disability Index; PDQ, painDETECT questionnaire; PSQI, Pittsburgh Sleep Quality Index; RCT, randomized controlled trial; SCS, spinal cord stimulation; SF-12, SF-12 Health Questionnaire; SF-MPQ-2, Short Form McGill Pain Questionnaire; VAS, visual analogue scale.