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)

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