Table A9:
Safety Outcomes, 10-kHz SCS Studies for Chronic Pain
| Author, Year Country Sites | Study Size Patient Mean Age Pain Etiology | Follow-Up Study Design | Leads and Placement | Adverse Neurological Events | Adverse Events | Major Adverse Eventsa |
|---|---|---|---|---|---|---|
| Kapural et al, 201530 Kapural et al, 201631 United States 11 sites |
10-kHz high-frequency SCS n = 101 54.6 ± 12.4 y Back and leg pain with (87%) or without prior back surgery |
3 months, 24 months RCT |
Percutaneous epidural placement of 2 leads with anchoring to the supraspinous ligaments |
No stimulation-related neurological deficits | Implant site pain (11.9%) | Lead migration requiring surgical revision (3%) Wound complications (Ne = 5 Np = 4; 4%) Paresis (Ne = 1, Np = 1; 1%) |
|
Conventional SCS n = 97 55.2 ± 13.4 y Back and leg pain with (86%) or without prior back surgery |
No stimulation-related neurological deficits | Implant site pain (10.3%) Uncomfortable paresthesia (11.3%) |
Lead migration requiring surgical revision (5.2%) Wound complications (Ne = 3 Np = 3; 3.1%) Arrhythmia (Ne = 1, Np = 1; 1%) Cardiac arrest (Ne = 1, Np = 1; 1%) Extradural abscess (Ne = 1, Np = 1; 1%) Intracranial hypotension (Ne = 1, Np = 1; 1%) Post lumbar puncture syndrome (Ne = 1, Np = 1; 1%) |
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| De Andres et al, 201729 Spain 1 site |
10-kHz high-frequency SCS n = 26 51.6 ± 9.3 y FBSS (100%) |
12 months RCT |
Percutaneous epidural placement of 2 leads with 8-contact electrodes and anchoring to the supraspinous ligaments | No stimulation-related neurological deficits | Lead migration (Ne = 4; 10.3%) | Lead migration with replacement (Ne = 1; 3.4%) |
|
Conventional SCS n = 29 53.8 ± 11.5 y FBSS (100%) |
No stimulation-related neurological deficits | — | Lead migration with replacement (Ne = 2; 6.5%) |
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| Bolash et al, 201928 United States 7 sites |
10-kHz high-frequency SCS n = 50 58.5 ± 12 y |
6 months RCT | Percutaneous epidural lead placement with 8-contact electrodes and external wireless IPG | No stimulation-related neurological deficits | Lead migration 12% Lead breakage 2% Loss of stimulation 4% Unintended stimulation 0 Redness/drainage 4% Unintended stimulation 0 Redness/drainage 4% Incisional pain 0 Other minor 8% |
|
|
Comparator SCS (low-frequency, burst, 1.2–1.5 kHz) n = 49 58.2 ± 12 y FBSS (100%) |
No stimulation-related neurological deficits | Lead migration 20% Lead breakage 2% Loss of stimulation 6% Unintended stimulation 8% Redness/drainage 4% Unintended stimulation 0 Redness/drainage 0 Incisional pain 6% Other minor 8% |
Serious infection 1% |
Abbreviations: FBSS, failed back surgery syndrome; IPG, implant pulse generator; Ne, number of events; Np, number of patients; RCT, randomized controlled trial; SUNA, short-lasting unilateral neuralgiform headache attacks with autonomic symptoms.