Non-specific Chronic Low Back Pain
Conditions
Keywords
low back pain, Electromagnetic field stimulation, Octane Aether, Pain management, EMF therapy
Brief 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.
Interventions
DEVICEPulsed 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
Octane Innovation Inc.
Limestone Clinical Trial Unit
Kingston Health Sciences Centre
Providence Care, Kingston, ON, Canada
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported pain scores during active treatment compared to the sham treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects associated with the use of the Octane Aether | From start of device use (Week 2) to follow-up appointment (Week 13 - end of study) | 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. |
| Effect of treatment on quality of life and disability index | From end of first treatment period (Week 3) to end of fourth treatment period (Week 9) | 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. |
| Net change in perceived pain intensity (start to end) | From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9) | The change in mean pain VAS scores from the baseline week to the final week of Treatment Period 4 (Week 9). |
| Net effect of intervention on disability index | From baseline (Week 1) to end of Treatment Period 4 (Week 9) | Change in Roland-Morris Disability questionnaire responses from Baseline to end of Treatment Period 4. |
| Effect of Octane Aether EMF treatment on general health (physical and emotional) | From Week 1 to Week 9 | 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. |
| Longevity of the effect of Octane Aether treatment | From end of device use (Week 11) to follow-up appointment (Week 13) | 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. |
| Longevity of the intervention effect on disability and quality of life | From end of device use (Week 11) to follow-up appointment (Week 13) | Roland-Morris Disability Questionnaire responses are used to evaluate the potential lasting effect of the interventional device after stopping daily use. |
Countries
Canada
Outcome results
None listed