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.
Able to provide informed consent;
Aged 18-65;
Pain intensity of at least 5 on a numerical rating scale (0-10);
Experiencing chronic low back pain that has persisted for ≥3 months;
Began using new prescription medication for pain within the past 3 months;
Lumbar spine surgery (within the past 12 months);
Body Mass Index (BMI)> 35. The device may have diminished effectiveness and/or may not fit individuals with high BMI;
Presence of a cardiac pacemaker;
Octane Innovation Inc.
Lead sponsor
Limestone Clinical Trial Unit
Collaborator
Kingston Health Sciences Centre
Collaborator
Providence Care, Kingston, ON, Canada
Collaborator