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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ontario
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Kingston, Ontario, Canada, K7K 0J7
- Kingston Orthopaedic Pain Institute
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Contact:
- Thomas Gregory
- Numéro de téléphone: 613-507-7246
- E-mail: thomas.gregory@queensu.ca
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Chercheur principal:
- Thomas Gregory
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Sequence Group 1
Participants receive active/sham treatments in the following sequence: EMF A, EMF B, Sham, EMF C
|
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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in patient-reported pain scores during active treatment compared to the sham treatment period
Délai: 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.
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From start of Treatment Period 1 (Week 2) to end of Treatment Period 4 (Week 9)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse effects associated with the use of the Octane Aether
Délai: 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.
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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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.
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From end of device use (Week 11) to follow-up appointment (Week 13)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effectiveness of EMF A vs B vs C
Délai: From Treatment Period 1 (Week 2) to 4 (Week 9)
|
Compare the change in pain VAS scores reported from start to finish of each active and sham output mode.
|
From Treatment Period 1 (Week 2) to 4 (Week 9)
|
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Output mode preference
Délai: Treatment Period 5 (Week 10)
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Bioelectricity_FP01
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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