Pulsed Electromagnetic Field Stimulator for Lower Back Pain

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Octane Innovation Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Octane Aether device for treating non-specific chronic low back pain. The wearable device uses magnetic fields and is designed for daily home use. Participants will use the device for 60 minutes each day over 10 weeks, reporting their pain levels and any side effects. The trial suits individuals who have experienced chronic low back pain for at least three months and have not found relief from treatments like physical therapy or medication. As an unphased trial, this study offers patients a unique opportunity to explore a new treatment option that could potentially provide relief where other methods have failed.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you can continue conservative treatments like physical therapy and NSAIDs. Just keep in mind that any changes in use or frequency will be tracked.

What prior data suggests that the Octane Aether device is safe for treating lower back pain?

Research has shown that pulsed electromagnetic field (PEMF) therapy, such as the Octane Aether device, is generally safe for treating low back pain. Studies have found it can reduce pain and improve movement without major side effects. For example, a review found that PEMF therapy helps lessen pain and improve mobility in people with low back pain. Additionally, the therapy is non-invasive, meaning it doesn't involve surgery or entering the body, and it doesn't need to touch the skin directly. This makes it a low-risk option for managing pain.

In another study, experts found that this therapy is safe and can even help wounds heal faster. The consistent results from these studies suggest that PEMF therapy, like that used in the Octane Aether device, is well-tolerated by patients. Most people don't experience harmful side effects, making it a promising treatment option for those with chronic low back pain.12345

Why are researchers excited about this trial?

Researchers are excited about the Pulsed Electromagnetic Field (EMF) Stimulator for lower back pain because it offers a different approach compared to standard treatments like pain medications, physical therapy, or surgery. Unlike these traditional methods, the EMF stimulator uses electromagnetic fields to target the source of pain non-invasively, potentially reducing inflammation and promoting healing. This method is particularly appealing as it may lead to pain relief without the side effects associated with medications or the recovery time needed after surgery. Additionally, the varied sequences of active and sham treatments allow researchers to finely tune the device's effectiveness, offering a personalized approach to pain management.

What evidence suggests that the Octane Aether device is effective for treating chronic low back pain?

Research has shown that pulsed electromagnetic field (PEMF) therapy effectively reduces pain and improves movement in people with low back pain. Several studies have found that PEMF therapy alone provides better pain relief than sham treatments. For example, one study found that PEMF significantly reduced pain compared to treatments that only seemed real. Another review noted that PEMF therapy improves blood flow, reduces swelling, and helps repair damaged tissues, all of which are important for easing back pain. In this trial, participants will receive different sequences of active and sham PEMF treatments, including the Octane Aether device, to evaluate its potential in managing chronic low back pain.12356

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back pain that isn't caused by a specific injury or condition. Participants should be able to use a wearable device daily at home and attend regular clinic visits. People with certain medical devices, severe health issues, or other exclusions may not qualify.

Inclusion Criteria

My pain is mainly in my lower back.
Able to provide informed consent
My pain level is at least 5 out of 10.
See 4 more

Exclusion Criteria

Any condition or diagnosis that could interfere with compliance, confound study results, or put participant at risk as judged by Principal Investigator or delegate
I have had lumbar spine surgery in the past year.
No or inconsistent access to internet (emailed surveys used for daily data collection)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants use the Octane Aether device at home for 60 minutes every day, evaluating different output modes and reporting daily pain scores

10 weeks
5 visits (in-person), 3 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of the longevity of treatment effects

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Octane Aether

Trial Overview

The study tests the Octane Aether, a wearable device that uses pulsed electromagnetic fields, to see if it helps reduce chronic low back pain. Each participant tries different settings of the device and a sham (inactive) mode in random order over about 10 weeks.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Sequence Group 4Experimental Treatment1 Intervention
Group II: Sequence Group 3Experimental Treatment1 Intervention
Group III: Sequence Group 2Experimental Treatment1 Intervention
Group IV: Sequence Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Octane Innovation Inc.

Lead Sponsor

Limestone Clinical Trial Unit

Collaborator

Providence Care, Kingston, ON, Canada

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials
32
Recruited
34,400+

Citations

Pulsed electromagnetic field therapy effectiveness in low back ...

Conclusion: PEMF therapy seems to be able to relieve the pain intensity and improve functionality in individuals with low back pain conditions. Further research ...

Variable Low Frequency-High Intensity-Pulsed ...

In a systematic review [27], the main findings were that PEMF therapy reduces pain intensity and enhance better functionality in low back pain. When used alone, ...

Evaluating the Efficacy and Safety of Octane Aether for ...

Patient-reported outcomes will inform the effectiveness of each output mode and help identify the need for personalization in magnetic field ...

The Effect of PEMF Therapy on Chronic Non-Specific Back ...

In the experimental group undergoing pulsed magnetic field applications, better pain relief and greater overall back functionality were observed ...

Effectiveness of Electromagnetic Field Therapy in ...

Patients suffering from mechanical back pain can find relief from their discomfort and functional impairment through the use of electromagnetic field therapy.

Pulsed Electromagnetic Stimulation

The authors concluded that the results of this study suggested that non-thermal pulsed electromagnetic energy treatment is safe and accelerates wound healing in ...