NCT06763653

Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

A Prospective, Multi-Center, Randomized, Controlled Trial to Compare the Safety and Efficacy of Ultra Low Frequency Spinal Cord Stimulation Plus Conservative Medical Management (CMM) to CMM Alone in the Treatment of Chronic Axial Low Back Pain With Prominent Nociceptive Etiology - The FULFILL Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 303 (estimated)
• Sponsor: Presidio Medical, Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are: * Does ULF neuromodulation reduce chronic low back pain? * What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation? Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will: * Be randomly assigned to either the study device or to conventional medical treatments * Undergo standard surgical procedures to place the study device if assigned to the device arm * Attend regular clinic visits over 24 months for checkups and data collection

Detailed description

This is a prospective, multi-center, randomized, controlled trial in which subjects with chronic, intractable axial low back pain with prominent nociceptive features will be randomized 2:1 into either Ultra Low Frequency (ULF) therapy combined with conventional medical management (CMM) or CMM alone. The purpose of this study is to compare the safety and efficacy of ULF neuromodulation to CMM in Subjects with chronic, intractable axial low back pain with prominent nociceptive features over a 24-month period. Subjects assigned to CMM will continue with further optimization of the best available medical treatments. Subjects assigned to ULF therapy will proceed with a temporary trial phase and be eligible for permanent device implant if they experience at least 50% back pain relief. An option to cross over to the alternative treatment arm will be permitted at the 6-month timepoint for subjects who meet the criteria. The study primary endpoint will be evaluated at 3 months and follow-up will continue for 24 months total.

Conditions

• Nociceptive Pain
• Axial Back Pain

Interventions

Type	Name	Description
DEVICE	ULF therapy	ultra low frequency spinal cord stimulation
OTHER	CMM	conventional medical management

Timeline

• Start date: 2025-01-17
• Primary completion: 2027-01-01
• Completion: 2029-04-01
• First posted: 2025-01-08
• Last updated: 2025-01-24

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated device study