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

NANot yet recruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

October 31, 2026

Conditions
Back Pain Lower Back ChronicChronic PainMusculoskeletal Pain
Interventions
BEHAVIORAL

Digital Musculoskeletal (MSK) Program

"Hinge Health is a digital MSK program to help participants manage chronic MSK pain through offering exercise therapy sessions, educational articles, and personal health coaching. Hinge Health delivers exercise therapy sessions and education through playlists accessed through the program app. Each playlist consists of three to seven exercises specific to the body region(s) the participant experiences pain in. Animations and videos, while paired with sensors and computer vision, demonstrate how to perform exercises, the number of repetitions for each exercise, and how long to hold positions. Playlists present more challenging exercises and/or more repetitions as participants progress further along in the program. After participants complete the exercises, the playlist delivers educational articles and resources focused on MSK pain-related topics, including lifestyle changes, pain neuroscience, and social support."

DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS)

The Enso is a strong complement/enhancement to the Hinge Health program, as it helps users to better manage their pain in order to work through their exercise sessions in the program. The Enso device is not intended to be a stand-alone solution; it provides pain relief, but exercise therapy provides important long-term benefits. Participants will use the digital MSK program (Hinge Health) in combination with a pain management device (Enso).

OTHER

Standard of Care (SOC)

The control group will continue to receive the access to traditional medical care for their MSK needs through their healthcare provider. Upon study completion, control group members who complete all follow-up surveys will receive Hinge Health membership and an Enso device for free for 12 months, starting at the conclusion of their participation in the study.

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Optum, Inc.

INDUSTRY

lead

Hinge Health, Inc

INDUSTRY

NCT07011537 - Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain | Biotech Hunter | Biotech Hunter