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

Part of paid clinical trials in Eden Prairie, Minnesota.

Sponsor
Hinge Health, Inc
Study ID
NCT07011537
Status
Enrolling By Invitation

Conditions

  • Back Pain Lower Back Chronic
  • Chronic Pain
  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital Musculoskeletal (MSK) Program — BEHAVIORAL
    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.
  • Transcutaneous Electrical Nerve Stimulation (TENS) — DEVICE
    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).
  • Standard of Care (SOC) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hinge Health + Enso
    The intervention group will receive access to the Hinge Health program and an Enso device.
  • Other: Standard of Care
    The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider.

Primary Outcome Measure

Change in Pain [ Time Frame: Baseline, 2, 6, and 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Optum LabsEden PrairieMinnesota55344-

Find similar trials in Eden Prairie, MN

By research site
Optum Labs· Eden Prairie, MN

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