NCT07215104

A Prospective Evaluation of Spinal Cord Induced Muscle Stimulation (MuscleSCS) for the Treatment of Chronic Low Back Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Saint Francis Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.

Conditions

• Chronic Low Back Pain (CLBP)

Interventions

Type	Name	Description
DEVICE	MuscleSCS	The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (\>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.

Timeline

• Start date: 2025-10-07
• Primary completion: 2026-10-07
• Completion: 2027-01-01
• First posted: 2025-10-10
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study