A Randomized, Double-blind, Sham-controlled Study to Evaluate the Efficacy and Safety of the Octane [Aether] Bioelectricity Device for the Management of Chronic Low Back Pain

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.