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Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain

NCT06763653 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2025-01-24

No results posted yet for this study

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

Conditions

  • Nociceptive Pain
  • Axial Back Pain

Interventions

DEVICE

ULF therapy

ultra low frequency spinal cord stimulation

OTHER

CMM

conventional medical management

Sponsors & Collaborators

  • Presidio Medical, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2027-01-31
Completion
2029-04-30
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763653 on ClinicalTrials.gov