Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07614568

Evaluating the Efficacy and Safety of Octane Aether for Treating 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-specific Chronic Low Back Pain Agnosia Back Pain Low Back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Orthopaedic Pain Institute

Kingston, Ontario, K7K 0J7, Canada

Location contact

Thomas Gregory

CONTACT

[email protected]

613-507-7246

Thomas Gregory

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Octane Aether, Octane Bioelectricity Device, PEMF device, EMF therapy

Primary outcomes

  1. Change in patient-reported pain scores during active treatment compared to the sham treatment period

    Time frame: From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)

    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.

Secondary outcomes

  1. Adverse effects associated with the use of the Octane Aether

    Time frame: From start of device use (Week 2) to follow-up appointment (Week 13 - end of study)

    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.

  2. Effect of treatment on quality of life and disability index

    Time frame: From end of first treatment period (Week 3) to end of fourth treatment period (Week 9)

    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.

  3. Net change in perceived pain intensity (start to end)

    Time frame: From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)

    The change in mean pain VAS scores from the baseline week to the final week of Treatment Period 4 (Week 9).

  4. Net effect of intervention on disability index

    Time frame: From baseline (Week 1) to end of Treatment Period 4 (Week 9)

    Change in Roland-Morris Disability questionnaire responses from Baseline to end of Treatment Period 4.

  5. Effect of Octane Aether EMF treatment on general health (physical and emotional)

    Time frame: From Week 1 to Week 9

    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.

  6. Longevity of the effect of Octane Aether treatment

    Time frame: From end of device use (Week 11) to follow-up appointment (Week 13)

    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.

  7. Longevity of the intervention effect on disability and quality of life

    Time frame: From end of device use (Week 11) to follow-up appointment (Week 13)

    Roland-Morris Disability Questionnaire responses are used to evaluate the potential lasting effect of the interventional device after stopping daily use.

Other outcomes

  1. Effectiveness of EMF A vs B vs C

    Time frame: From Treatment Period 1 (Week 2) to 4 (Week 9)

    Compare the change in pain VAS scores reported from start to finish of each active and sham output mode.

  2. Output mode preference

    Time frame: Treatment Period 5 (Week 10)

    Tally of output mode that each participant chose to repeat during Treatment Period 5. Participants are asked to select their preferred mode.

  3. Changes in medication use

    Time frame: Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13)

    To assess whether the use of the interventional device affects how participants report using (non-prescription) medication (dosage and frequency).

  4. Device performance - Temperature

    Time frame: Measurement data exported from the device after the device is returned during the Week 11 appointment.

    Device performance is assessed by analyzing coil temperature sensor measurements recorded whenever the device is in use. Temperature data is compared to calibration measurements.

  5. Device performance - Magnetic Flux Density

    Time frame: Measurement data exported from the device after the device is returned during the Week 11 appointment.

    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.

  6. Device performance - Current

    Time frame: Measurement data exported from the device after the device is returned during the Week 11 appointment.

    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.

Sponsors and collaborators

Lead sponsor

Octane Innovation Inc.

Industry

Collaborators

  • Kingston Health Sciences Centre
  • Limestone Clinical Trial Unit
  • Providence Care, Kingston, ON, Canada

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.