Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Kingston, Ontario, Canadá, K7K 0J7
- Kingston Orthopaedic Pain Institute
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Contacto:
- Thomas Gregory
- Número de teléfono: 613-507-7246
- Correo electrónico: thomas.gregory@queensu.ca
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Investigador principal:
- Thomas Gregory
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Sequence Group 1
Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C
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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.
Otros nombres:
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Experimental: Sequence Group 2
Participants receive active/sham treatments in the following sequence: EMF B, EMF C, EMF A, Sham
|
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.
Otros nombres:
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Experimental: Sequence Group 3
Participants receive active/sham treatments in the following sequence: EMF C, Sham, EMF B, EMF A
|
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.
Otros nombres:
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Experimental: Sequence Group 4
Participants receive active/sham treatments in the following sequence: Sham, EMF A, EMF C, EMF B
|
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in patient-reported pain scores during active treatment compared to the sham treatment period
Periodo de tiempo: From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)
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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.
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From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse effects associated with the use of the Octane Aether
Periodo de tiempo: From start of device use (Week 2) to follow-up appointment (Week 13 - end of study)
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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.
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From start of device use (Week 2) to follow-up appointment (Week 13 - end of study)
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Effect of treatment on quality of life and disability index
Periodo de tiempo: From end of first treatment period (Week 3) to end of fourth treatment period (Week 9)
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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.
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From end of first treatment period (Week 3) to end of fourth treatment period (Week 9)
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Net change in perceived pain intensity (start to end)
Periodo de tiempo: From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)
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The change in mean pain VAS scores from the baseline week to the final week of Treatment Period 4 (Week 9).
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From baseline week (pre-intervention) to end of Treatment Period 4 (Week 9)
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Net effect of intervention on disability index
Periodo de tiempo: From baseline (Week 1) to end of Treatment Period 4 (Week 9)
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Change in Roland-Morris Disability questionnaire responses from Baseline to end of Treatment Period 4.
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From baseline (Week 1) to end of Treatment Period 4 (Week 9)
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Effect of Octane Aether EMF treatment on general health (physical and emotional)
Periodo de tiempo: From Week 1 to Week 9
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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.
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From Week 1 to Week 9
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Longevity of the effect of Octane Aether treatment
Periodo de tiempo: From end of device use (Week 11) to follow-up appointment (Week 13)
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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.
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From end of device use (Week 11) to follow-up appointment (Week 13)
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Longevity of the intervention effect on disability and quality of life
Periodo de tiempo: From end of device use (Week 11) to follow-up appointment (Week 13)
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Roland-Morris Disability Questionnaire responses are used to evaluate the potential lasting effect of the interventional device after stopping daily use.
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From end of device use (Week 11) to follow-up appointment (Week 13)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effectiveness of EMF A vs B vs C
Periodo de tiempo: From Treatment Period 1 (Week 2) to 4 (Week 9)
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Compare the change in pain VAS scores reported from start to finish of each active and sham output mode.
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From Treatment Period 1 (Week 2) to 4 (Week 9)
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Output mode preference
Periodo de tiempo: Treatment Period 5 (Week 10)
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Tally of output mode that each participant chose to repeat during Treatment Period 5. Participants are asked to select their preferred mode.
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Treatment Period 5 (Week 10)
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Changes in medication use
Periodo de tiempo: Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13)
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To assess whether the use of the interventional device affects how participants report using (non-prescription) medication (dosage and frequency).
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Responses recorded at Baseline and all scheduled appointments (after Week 1, 3, 5, 7, 9, 11, and 13)
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Device performance - Temperature
Periodo de tiempo: Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Device performance is assessed by analyzing coil temperature sensor measurements recorded whenever the device is in use.
Temperature data is compared to calibration measurements.
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Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Device performance - Magnetic Flux Density
Periodo de tiempo: Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Device performance is assessed by analyzing magnetic flux density measurements collected using a Hall-effect sensor embedded in the coil applicator.
Magnetic flux density data recorded during each treatment session is compared to calibration measurements as a measure of performance and consistency.
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Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Device performance - Current
Periodo de tiempo: Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Device performance is assessed by analyzing data received from a current sensor that measures the current through the coil applicator.
Current measurements, recorded during each treatment session, are compared to calibration data at the end of the study.
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Measurement data exported from the device after the device is returned during the Week 11 appointment.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bioelectricity_FP01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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