Not Yet RecruitingNot Applicable

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

Canada24 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Inve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07614568

SponsorOctane Innovation Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Non-specific Chronic Low Back Pain trials