Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain
← catalyst calendarSponsored by Hinge Health, Inc (industry) · HNGE — their whole pipeline →. With Optum, Inc..
Phase
Not applicable
Status
Enrolling by invitation
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
196estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-01-16 | actual | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Back Pain Lower Back Chronic
- Chronic Pain
- Musculoskeletal Pain
Interventions
- Behavioral: Digital Musculoskeletal (MSK) Program — also filed as Hinge Health Program
- Device: Transcutaneous Electrical Nerve Stimulation (TENS) — also filed as ENSO Device
- Other: Standard of Care (SOC) — also filed as Traditional Medical Care
Primary outcomes
what the primary-completion date above is the date OFChange in Pain
measured Baseline, 2, 6, and 12 weeks
Change in Pain
measured Baseline, 2, 6, and 12 weeks
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