Spinal Cord Stimulation (SCS) Trial Outcomes After Conversion to a Multiple Waveform SCS System

Area of Science:

• Neurology
• Pain Management
• Biomedical Engineering

Background:

• Spinal cord stimulation (SCS) is a common treatment for chronic intractable pain, typically using pulse frequencies between 20-100 Hz.
• Recent research suggests 10 kHz SCS may offer superior pain relief, but trial outcomes can be inconsistent.
• Evaluating alternative SCS programming is essential for patients who do not achieve satisfactory relief with single-waveform trials.

Purpose of the Study:

• To assess the effectiveness of multiple waveform SCS in patients who failed a 10 kHz SCS trial.
• To compare patient outcomes and device preferences between 10 kHz SCS and multiple waveform SCS.
• To determine if a broader range of SCS waveforms improves pain management for chronic pain.

Main Methods:

• A multicenter, open-label, real-world observational study was conducted in the United States.
• Subjects who reported less than 50% pain relief with 10 kHz SCS underwent a trial with a multi-waveform stimulator.
• Pain relief scores and patient device preference data were collected.

Main Results:

• Of 16 subjects who failed the 10 kHz trial, 63% achieved ≥50% pain relief with multiple waveform SCS.
• 80% of those achieving significant relief with multiple waveforms had experienced no relief with 10 kHz SCS.
• 68% of subjects preferred the multiple waveform SCS, while none preferred the 10 kHz SCS.

Conclusions:

• Multiple waveform SCS can provide significant pain relief for patients who do not respond to 10 kHz SCS alone.
• Offering multiple waveforms during SCS trials may improve success rates and patient satisfaction.
• Variable patient needs and pain characteristics necessitate adaptable SCS treatment options.