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Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation
Published on: June 26, 2018
Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent
Richard B North1, Aaron Calodney2, Robert Bolash3
1Departments of Neurosurgery, Anesthesiology, and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USA.
Summary
New wireless spinal cord stimulation (SCS) offers a high success rate for chronic pain relief. This fully implanted system allows for extended trials, minimizing infection risks associated with traditional SCS methods.
Area of Science:
- Neuromodulation
- Pain Management
- Medical Devices
Background:
- Traditional spinal cord stimulation (SCS) trials are limited by infection risks due to externalized pulse generators.
- Miniaturized wireless SCS technology enables single-stage implantation and indefinite device use.
Purpose of the Study:
- To evaluate fully implanted wireless SCS devices in a 30-day screening trial.
- To assess efficacy and safety in patients with chronic low back and leg pain post-lumbar spine surgery.
Main Methods:
- A randomized controlled trial involving 99 subjects with chronic pain.
- Subjects received either 10 kHz high-frequency stimulation (HFS) or lower-frequency stimulation (LFS).
- Evaluated 30-day trial success rate (≥50% pain relief) and complications.
Main Results:
- Overall trial success rate was 88% (92% for HFS, 84% for LFS).
- High success rates observed in patients with predominant low back pain (92%).
- Minimal complications: one infection (1%) and one explant (1%); 10% electrode migration.
Conclusions:
- Wireless SCS devices demonstrate high trial success rates for both HFS and LFS waveforms.
- The technology facilitates single-stage implantation with a low incidence of infection.
- Further long-term follow-up is needed to assess cost-effectiveness and morbidity.
