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;
Crossover
Pulsed electromagnetic field stimulator
DeviceThe Octane Aether is a body-worn device that generates pulsed magnetic fields of specific characteristics designed to target cellular behaviour in relation to chronic pain signalling. The device features four different output modes (3 active and 1 sham) to enable an investigation of the need for personalized pain management. The specific characteristics of the output modes are blinded from the participants and study team and are labelled here as EMF A, EMF B, EMF C, and Sham. The device firmware is programmed to automatically change the output mode every two weeks. The device produces no sound or thermal effects. When operating in the sham mode, the device appears identical to active output, but no current is applied to the body-worn coil applicator and no magnetic field is generated.
Change in patient-reported pain scores during active treatment compared to the sham treatment period
The difference in the mean pain VAS of scores reported in the second week of each active treatment period and the mean VAS of the second week of the same participant's sham period.
Adverse effects associated with the use of the Octane Aether
To define and describe the adverse effects of the Octane Aether when administered according to the clinical trial protocol. Participants and the study team will report adverse events associated with use of the device or device malfunctions.
Effect of treatment on quality of life and disability index
The Octane Aether's effect is evaluated using the Roland-Morris Disability questionnaire, which assesses low back pain's influence on disability and quality of life. The questionnaire is completed after each active and sham treatment period and compared.
Net change in perceived pain intensity (start to end)
The change in mean pain VAS scores from the baseline week to the final week of Treatment Period 4 (Week 9).
Net effect of intervention on disability index
Change in Roland-Morris Disability questionnaire responses from Baseline to end of Treatment Period 4.
Effectiveness of EMF A vs B vs C
Compare the change in pain VAS scores reported from start to finish of each active and sham output mode.
Output mode preference
Tally of output mode that each participant chose to repeat during Treatment Period 5. Participants are asked to select their preferred mode.
Changes in medication use
To assess whether the use of the interventional device affects how participants report using (non-prescription) medication (dosage and frequency).
Device performance - Temperature
Device performance is assessed by analyzing coil temperature sensor measurements recorded whenever the device is in use. Temperature data is compared to calibration measurements.
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Octane Innovation Inc.
Lead sponsor
Limestone Clinical Trial Unit
Collaborator
Kingston Health Sciences Centre
Collaborator
Providence Care, Kingston, ON, Canada
Collaborator
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