Twelve-Month Clinical Trial Results of a Novel, Dorsal Horn Dendrite Stimulation Waveform for Chronic Neuropathic Low Back Pain

Abstract

Objectives: The aim of this study was to evaluate the effectiveness and safety of a novel subperception spinal cord stimulation (SCS) waveform paradigm designed to target the dorsal horn dendrites for treating chronic neuropathic low back pain (LBP). The final 12-month results are reported here.

Materials and methods: Twenty-seven participants were implanted with a commercial SCS system. Devices were programmed to deliver the waveform (frequency 100 Hz, pulse width 1000 μsec, T9-T10 disk bipole) at decreasing stimulation perception threshold amplitudes (80%, 60%, then 40%) over a 14-week period. Participants were blinded to the program settings. Participants then received their preferred program for further evaluation at 26 and 52 weeks after activation. Outcome measures included back pain score (visual analogue scale [VAS]), Brief Pain Inventory (BPI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), 36-Item Short Form Health Survey (SF-36), treatment satisfaction, and clinician global impression of change (CGIC).

Results: At 52 weeks (n = 24), the responder rate (≥50% pain relief) was 65.6%, and the high-responder rate (≥80% pain relief) was 56.5%. The mean change from baseline in pain VAS was -43.94 mm (95% CI -57.89, -30.00; p < 0.001) and mean pain relief was 64.69% ± 39.43%. BPI and SF-36 scores remained significantly improved (p ≤ 0.001). EQ-5D-5L index and EuroQoL-VAS further improved, and 87.0% of participants met the minimum clinically important difference for the EQ-5D-5L index. Treatment satisfaction was 83%, and 91% of participants had a CGIC rating of "much improved" or above. No serious study-related adverse events were reported.

Conclusions: The 12-month trial results show sustained improvements in pain, quality of life, and health-related outcomes. This novel subperception dorsal horn dendrite SCS approach seems a safe and promising treatment option for patients with chronic neuropathic LBP. The open-source availability of this waveform on commercial SCS platforms allows widespread patient access. Further evaluation seems warranted.

Clinical trial registration: The Clinicaltrials.gov registration number for the study is ACTRN12618000647235 (anzctr.org.au).