Clinical Trial

Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate the safety of the Octane Aether device and to determine whether the device is effective in treating symptoms of non-specific chronic low back pain in adults. The Octane Aether is a wearable device that produces specific magnetic field outputs and is designed for daily use in a home setting. The main objectives of the trial are: * To measure the change in patient-reported pain scores during active treatment with the device compared to a sham treatment, and * To define and describe the adverse effects, if any, of the Octane Aether device when administered according to the protocol. Every participant will evaluate three active output modes and a sham output using the same device. Patient-reported outcomes will inform the effectiveness of each output mode and help identify the need for personalization in magnetic field therapy. Participants will: * Use the device at home for 60 minutes every day for 10 weeks, * Report daily pain scores using an electronic visual analog scale for pain intensity, * Visit the clinic 5 times over the course of the 13 week trial for checkups and device changes, * Respond to 3 phone calls for checkups, and * Fill various questionnaires related to disability, quality of life, and their back pain.
Trial Details
NCT Number NCT07614568
Lead Sponsor Octane Innovation Inc.
Collaborators: Limestone Clinical Trial Unit, Kingston Health Sciences Centre, Providence Care, Kingston, ON, Canada
Conditions Non-specific Chronic Low Back Pain
Enrollment 24 participants
Start Date 2026-06
Primary Completion 2027-06 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-29