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Shockwave or sham? new wearable device takes on back pain

NCT ID NCT07614568

Symptom relief Sponsor: Octane Innovation Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small study tests a wearable device called Octane Aether that sends magnetic pulses to the lower back. 24 adults with chronic low back pain will use the device at home for 60 minutes daily over 10 weeks. The goal is to see if it reduces pain compared to a sham (inactive) device and to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pulsed electromagnetic field (PEMF) device (Octane Aether)
What this could lead to
If it works, this could offer a non-drug, at-home option for easing chronic low back pain without medication.
What could go wrong
This is a very small early trial with only 24 people. The device may not reduce pain better than a sham, and individual results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

agnosia Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non specific chronic low back pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kingston Orthopaedic Pain Institute

    Kingston, Ontario, K7K 0J7, Canada

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