Developing the Necessary Information for Sample Size Calculations in Future Spinal Cord Stimulation Clinical Trials

Area of Science:

• Neurology
• Pain Management
• Clinical Trial Design

Background:

• Spinal cord stimulation (SCS) is a minimally invasive treatment for chronic low back pain.
• Current evidence supporting SCS efficacy is limited by a lack of high-quality clinical trials.
• This study addresses the need for robust data to inform future SCS trial design.

Purpose of the Study:

• To provide effect estimates and variances for patient-reported outcomes and biometrics in SCS patients.
• To inform sample size calculations for future statistically powered clinical trials.
• To identify valuable patient-reported outcomes and digital biomarkers for SCS research.

Main Methods:

• A cohort of 18 patients was monitored for 7 months pre- and post-SCS implantation.
• Monthly patient-reported outcomes and daily biometrics were collected.
• Multilevel Bayesian models quantified median and variance changes over time.

Main Results:

• Sustained improvements in pain scales with stable variance were observed.
• No significant changes in quality-of-life medians or variance were detected.
• Improvements in fatigue and sleep quality were noted, but not total sleep hours.
• Resting heart rate decreased, while heart rate variability showed high variance, indicating poor biomarker utility.

Conclusions:

• This study offers essential data on patient-reported outcomes and digital biomarkers for SCS.
• Identified measures and their statistical properties are crucial for planning high-quality SCS clinical trials.
• Provides necessary information to overcome criticisms regarding sample size in current SCS evidence.