- Title
- A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study
- Creator
- Russo, Marc A.; Volschenk, Willem; Bailey, Dominic; Santarelli, Danielle M.; Holliday, Elizabeth; Barker, Daniel; Dizon, Jason; Graham, Brett
- Relation
- Neuromodulation : Technology at the Neural Interface Vol. 26, Issue 7, p. 1412-1423
- Publisher Link
- http://dx.doi.org/10.1016/j.neurom.2023.06.007
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2023
- Description
- Objectives: The aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP). Materials and Methods: Twenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated. Results: Mean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was −51.7 mm (95% CI, −60.7 to −42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures. Conclusions: This novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems. Clinical Trial Registration: This study is registered on anzctr.org.au with identifier ACTRN12618000647235.
- Subject
- dorsal horn; low back pain; neuropathic pain; spinal cord stimulation; stimulation waveform
- Identifier
- http://hdl.handle.net/1959.13/1494765
- Identifier
- uon:53877
- Identifier
- ISSN:1094-7159
- Language
- eng
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