Non-specific Chronic Low Back PainNCT07614568
Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain
A study testing Pulsed electromagnetic field stimulator in people with Non-specific Chronic Low Back Pain, run by Octane Innovation Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- Pulsed electromagnetic field stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kingston Orthopaedic Pain Institute
Kingston, Ontario, K7K 0J7
Thomas Gregory, 613-507-7246, thomas.gregory@queensu.ca
Thomas Gregory
About this study
Official 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
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.
Read more
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
- Being tested
- Pulsed electromagnetic field stimulator
- Keywords
- low back pain, Electromagnetic field stimulation, Octane Aether, Pain management, EMF therapy
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field stimulatorDevice
Also called Octane Aether, Octane Bioelectricity Device, PEMF device, EMF therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group 1 | Experimental | Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C Receives: Device: Pulsed electromagnetic field stimulator |
| Sequence Group 2 | Experimental | Participants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham Receives: Device: Pulsed electromagnetic field stimulator |
| Sequence Group 3 | Experimental | Participants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A Receives: Device: Pulsed electromagnetic field stimulator |
| Sequence Group 4 | Experimental | Participants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B Receives: Device: Pulsed electromagnetic field stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From end of device use (Week 11) to follow-up appointment (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The interventional device has four different output modes, each of which will be assessed by every participant. Each output mode is used for two weeks (1h treatment per day) before changing to the next mode. Participants are randomized into one of four arms that vary by sequence of output modes, e.g., "output mode A then B then Sham then C" or "output mode B then C then A then Sham". All participants will evaluate the active and sham output modes. An optional open-label extension phase is available to participants who complete the procedures of the parent study. In this open-label phase, participants can choose which output mode from the parent study to continue with.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Octane Innovation Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Limestone Clinical Trial Unit, Kingston Health Sciences Centre, Providence Care, Kingston, ON, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614568
- Sponsor's protocol ID
- Bioelectricity_FP01
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07614568
- Acronym / sponsor ID
- Bioelectricity_FP01
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- low back pain, Electromagnetic field stimulation, Octane Aether, Pain management, EMF therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Octane Innovation Inc.Industry (pharma, biotech, devices)
- Collaborators
- Limestone Clinical Trial Unit, Kingston Health Sciences Centre, Providence Care, Kingston, ON, Canada
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The interventional device has four different output modes, each of which will be assessed by every participant. Each output mode is used for two weeks (1h treatment per day) before changing to the next mode. Participants are randomized into one of four arms that vary by sequence of output modes, e.g., "output mode A then B then Sham then C" or "output mode B then C then A then Sham". All participants will evaluate the active and sham output modes. An optional open-label extension phase is available to participants who complete the procedures of the parent study. In this open-label phase, participants can choose which output mode from the parent study to continue with.
| Arm | Type | Receives |
|---|---|---|
| Sequence Group 1 | Experimental | Device: Pulsed electromagnetic field stimulatorParticipants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C |
| Sequence Group 2 | Experimental | Device: Pulsed electromagnetic field stimulatorParticipants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham |
| Sequence Group 3 | Experimental | Device: Pulsed electromagnetic field stimulatorParticipants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A |
| Sequence Group 4 | Experimental | Device: Pulsed electromagnetic field stimulatorParticipants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electromagnetic field stimulatorAlso: Octane Aether, Octane Bioelectricity Device, PEMF device, EMF therapyThe 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. | Device | Sequence Group 1, Sequence Group 2, Sequence Group 3, Sequence Group 4 |
Primary outcome
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.
7 secondary outcomes
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)
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)
Net change in perceived pain intensity (start to end)
Time frame: From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)
Net effect of intervention on disability index
Time frame: From baseline (Week 1) to end of Treatment Period 4 (Week 9)
Effect of Octane Aether EMF treatment on general health (physical and emotional)
Time frame: From Week 1 to Week 9
Longevity of the effect of Octane Aether treatment
Time frame: From end of device use (Week 11) to follow-up appointment (Week 13)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field stimulator in people with Non-specific Chronic Low Back Pain, run by Octane Innovation Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.