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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-specific Chronic Low Back Pain
• Intervention / Treatment: Device: Pulsed electromagnetic field stimulator

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7K 0J7
      • Kingston Orthopaedic Pain Institute
      • Contact: Thomas Gregory; Phone Number: 613-507-7246; Email: thomas.gregory@queensu.ca
      • Principal Investigator: Thomas Gregory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;
• Pain localized primarily to the lumbar spine region;
• Conservative treatments, such as physical therapy, NSAIDs and lifestyle changes, have failed over the past 6 months. Participants are allowed to continue conservative treatments, but changes to use/frequency will be tracked; and
• Must be able to attend 5 in-person clinic appointments over the 13-week study period.

Exclusion Criteria:

• 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;
• Pregnancy or breastfeeding;
• Presence of ferromagnetic implants or body piercings (e.g., navel piercings) in the lumbar region, including hip implants/replacements or similar in the pelvic region, that could interfere with device function;
• Inability to put on, adjust, and/or operate the wearable device without assistance;
• Prior use of PEMF, or other electromagnetic field-emitting device, for the treatment of pain symptoms;
• No, or inconsistent, access to internet (emailed surveys are used for daily data collection); and
• Any condition or diagnosis that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence Group 1; Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C	Device: Pulsed electromagnetic field stimulator; 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.; Other Names: Octane Aether; Octane Bioelectricity Device; PEMF device; EMF therapy
Experimental: Sequence Group 2; Participants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham	Device: Pulsed electromagnetic field stimulator; 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.; Other Names: Octane Aether; Octane Bioelectricity Device; PEMF device; EMF therapy
Experimental: Sequence Group 3; Participants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A	Device: Pulsed electromagnetic field stimulator; 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.; Other Names: Octane Aether; Octane Bioelectricity Device; PEMF device; EMF therapy
Experimental: Sequence Group 4; Participants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B	Device: Pulsed electromagnetic field stimulator; 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.; Other Names: Octane Aether; Octane Bioelectricity Device; PEMF device; EMF therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Octane Innovation Inc.
• Collaborators: Kingston Health Sciences Centre; Limestone Clinical Trial Unit; Providence Care, Kingston, ON, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: low back pain; Pain management; Electromagnetic field stimulation; Octane Aether; EMF therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Back Pain; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Agnosia
• Other Study ID Numbers: Bioelectricity_FP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No