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

Summary

The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain.

Conditions

• Back Pain Lower Back Chronic
• Chronic Pain
• Musculoskeletal 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 & Collaborators

• Optum, Inc.

  collaborator INDUSTRY

• Hinge Health, Inc

  lead INDUSTRY

Principal Investigators

• Ken Cohen, MD, FACP · Optum, Inc.

• Jeff Krauss, MD · Hinge Health

• Cynthia Castro Sweet, PhD · Hinge Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-16

Primary Completion

2026-06-30

Completion

2026-07-31

FDA Device

Yes

Countries

• United States

Study Locations