NCT05837234

Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients With Chronic Low Back Pain

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Presidio Medical, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

Detailed description

This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 3-year period.

Conditions

• Chronic Pain
• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	ULF SCS	Ultra low frequency spinal cord stimulation

Timeline

• Start date: 2023-05-09
• Primary completion: 2025-05-19
• Completion: 2028-03-01
• First posted: 2023-05-01
• Last updated: 2025-08-29

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated device study