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

NCT07614568 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Non-specific Chronic Low Back Pain

Interventions

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.

Sponsors & Collaborators

  • Limestone Clinical Trial Unit

    collaborator UNKNOWN

  • Kingston Health Sciences Centre

    collaborator OTHER

  • Providence Care, Kingston, ON, Canada

    collaborator UNKNOWN

  • Octane Innovation Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614568 on ClinicalTrials.gov