Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain

Launched by HINGE HEALTH, INC · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to see how effective a digital health program called Hinge Health and a wearable pain relief device called Enso can be for people suffering from chronic lower back pain. The goal is to find out if using these tools can help improve pain levels, daily activities, and reduce the need for medical care among patients who are not undergoing surgery.

To participate in this study, individuals must be at least 18 years old, have United Healthcare as their primary insurance, and experience significant back pain that has lasted for at least six months. Participants should have a high level of pain but minimal issues with pain radiating to other areas of the body. They will also need to have access to a smartphone or tablet and be able to understand and agree to the study's requirements. This trial is not currently recruiting participants, but it aims to help those with chronic back pain find better ways to manage their condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 or over
• • United Healthcare (UHC) is primary health plan
• • Mechanical (myofascial), axial back pain (focused around the spine)
• • 60/100 or greater level of pain on the Numerical Pain Rating Scale of 0-100.
• • Radicular component of pain is minimal (\<25% of pain)
• • Radicular component of pain has minimal effect on functionality, medication, quality of life
• • 80% or greater of disability is due to pain in the low back (as opposed to other areas)
• • Experiencing chronic pain for at least 6 months
• • Subject able to understand and provide informed consent
• • Has an email account
• Exclusion Criteria:
• • Patients that do not own or have access to a smartphone or tablet
• • Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
• • Primary symptoms due to spinal stenosis as evidenced by pseudoclaudication or other lower extremity symptoms
• • Source of back pain related to an acute nerve impingement
• • Diagnosis of cancer/malignant tumors in the last 5 years
• • Source of back pain is an infection
• • Source of pain is a prior spinal fusion surgery
• • Has a cardiac pacemaker, implanted defibrillator, or other implanted electronic device
• • Has radicular pain symptoms that affect functionality, quality of life or medication intake
• • Has undergone surgery to solve pain related to the study indication in the past 6 months
• • Is scheduled for upcoming surgery to solve pain related to the study indication
• • Patients with history of opioid, alcohol, or drug abuse in the last 5 years, per investigator discretion
• • Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in investigator's judgment
• • Pregnant women (as determined by self-report)
• • Have severe epilepsy
• • Have severe form of cardiovascular disease
• • Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
• • Inability to complete data collection as required
• • No secondary/coinsurance or plans to change insurance from UHC in the next 3 months
• • Participants who met with an orthopedic or neurosurgeon in the 3 months prior to the index month