Product Highlight
Condition targeted:
Migraine and Chronic Lower Back Pain
How it works:
JOGO-Gx uses EMG-Biofeedback to break the pain-anxiety-muscle tension cycle
Impact:
Chronic Lowe Back Pain: In clinical studies, JOGO-Gx showed superior outcome than opioids in treating chronic lower back pain.
Migraine: Studies showed patients having superior quality of life than medications alone when treated with JOGO-Gx
Product Overview
Medical condition:
Migraine and Chronic Lower Back Pain
Target patient population:
Patients who do not fully respond to medications for chronic lower back pain or migraine , and patients looking for non-invasive treatments for chronic lower back pain or migraine
What to expect:
Chronic Lower Back Pain: In clinical studies, JOGO-Gx showed superior outcome than opioids in treating chronic lower back pain.
Migraine: Studies showed patients having superior quality of life than medications alone when treated with JOGO-Gx
Note: for more information, please visit https://www.jogohealth.com/
Clinical Overview
Indications for use:
JOGO-Gx is FDA 510K exempted to provide EMG-Biofeedback for the treatment of chronic lower back pain and migraine
Outcomes:
- Chronic Lower Back Pain: JOGO-Gx showed superior outcomes than treatment as usual in pain intensity(p<0.01), pain interference (p<0.01) and disability(p<0.001).
- Migraine: JOGO-Gx showed superior outcomes than treatment as usual in disability (p<0.05), anxiety(p<0.01) and quality of life (p<0.001)
Directions:
Patients use the product minimum 3 times a day for 20 minutes for a minimum of 8 weeks
Risks & warnings:
Product is not suitable for individuals who are not tech adaptive
Place in therapy:
Complement to current therapy
Product Access
Product description:
JOGO-Gx uses a wearable sensor and a software. It may be used on a mobile device or tablet
Prescription status:
A prescription is not required. Biofeedback doesn’t require a prescription
Patient access:
JOGO-Gx has hardware and software. Patients receive a JOGO kit shipped home (or pickedup from a doctors office/store). JOGO App is downloaded from App stores.
Use of the product requires
- internet or wifi (only during setup)
- a mobile phone or tablet is required
Provider access:
Healthcare providers have access to an App to monitor patients. Currently the App is not integrated with any EHR platforms. It’s in development.
Coverage options:
Currently JOGO-Gx is paid by patients out of pocket or covered by some self insured company benefits. JOGO-Gx is covered under FSA/HSA
Product availability:
JOGO-Gx is available in:
- USA: FDA 510K exempted (reviewed by the FDA and registered)
JOGO-Gx is the first biofeedback product to show improved quality of life and reduced migraine impact. JOGO-Gx is also the first product to show superior outcomes than opioids in treating chronic lower back pain.
Clinical Trials
The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.
- Study Title: Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study)
Study Design: Randomized Control Trial (RCT)
Outcomes: Statistically significant reduction in pain intensity, pain interference and disability compared to treatment as usual. - Study Title: Biofeedback EMG alternative therapy for chronic low back pain: Study protocol of a pilot randomized controlled trial
Study Design: Qualitative Cohort Study
Outcomes: Both physical and psychological improvements following JOGO intervention in patients with chronic lower back pain - Study Title: sEMG Biofeedback for Episodic Migraines: A Pilot Randomized Clinical Trial
Study Design: Randomized Control Trial (RCT)
Outcomes: Statistically significant reduction in Migraine Impact, Migraine Disability and Improved Quality of Life compared to treatment as usual
Note: for more research, please visit https://clinicaltrials.gov/study/NCT04607460 and https://www.mayoclinic.org/tests-procedures/biofeedback/about/pac-20384664