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| Name | Class |
|---|---|
| Limestone Clinical Trial Unit | UNKNOWN |
| Kingston Health Sciences Centre | OTHER |
| Providence Care, Kingston, ON, Canada | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group 1 | Experimental | Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C |
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| Sequence Group 2 | Experimental | Participants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham |
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| Sequence Group 3 | Experimental | Participants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A |
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| Sequence Group 4 | Experimental | Participants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed electromagnetic field stimulator | Device | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of device use (Week 2) to follow-up appointment (Week 13 - end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Treatment Period 1 (Week 2) to 4 (Week 9) |
| Output mode preference |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Orthopaedic Pain Institute | Kingston | Ontario | K7K 0J7 | Canada |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The interventional device has four different output modes, each of which will be assessed by every participant. Each output mode is used for two weeks (1h treatment per day) before changing to the next mode. Participants are randomized into one of four arms that vary by sequence of output modes, e.g., "output mode A then B then Sham then C" or "output mode B then C then A then Sham".
All participants will evaluate the active and sham output modes.
An optional open-label extension phase is available to participants who complete the procedures of the parent study. In this open-label phase, participants can choose which output mode from the parent study to continue with.
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| 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. | From end of first treatment period (Week 3) to end of fourth treatment period (Week 9) |
| 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). | From baseline week (pre-intervention) to end 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. | From baseline (Week 1) to end of Treatment Period 4 (Week 9) |
| Effect of Octane Aether EMF treatment on general health (physical and emotional) | Participants respond to the RAND 36-item health survey after Week 1 and Week 9 and the change in category scores associated with physical and emotional health and quality of life are analyzed. | From Week 1 to Week 9 |
| Longevity of the effect of Octane Aether treatment | VAS for pain reports are used to assess changes in pain intensity two weeks after the end of intervention use to evaluate whether there is a lasting effect from the treatment. | From end of device use (Week 11) to follow-up appointment (Week 13) |
| Longevity of the intervention effect on disability and quality of life | Roland-Morris Disability Questionnaire responses are used to evaluate the potential lasting effect of the interventional device after stopping daily use. | From end of device use (Week 11) to follow-up appointment (Week 13) |
Tally of output mode that each participant chose to repeat during Treatment Period 5. Participants are asked to select their preferred mode.
| Treatment Period 5 (Week 10) |
| Changes in medication use | To assess whether the use of the interventional device affects how participants report using (non-prescription) medication (dosage and frequency). | Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13) |
| 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. | Measurement data exported from the device after the device is returned during the Week 11 appointment. |
| Device performance - Magnetic Flux Density | Device performance is assessed by analyzing magnetic flux density measurements collected using a Hall-effect sensor embedded in the coil applicator. Magnetic flux density data recorded during each treatment session is compared to calibration measurements as a measure of performance and consistency. | Measurement data exported from the device after the device is returned during the Week 11 appointment. |
| Device performance - Current | Device performance is assessed by analyzing data received from a current sensor that measures the current through the coil applicator. Current measurements, recorded during each treatment session, are compared to calibration data at the end of the study. | Measurement data exported from the device after the device is returned during the Week 11 appointment. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |