Trials / Active Not Recruiting
Active Not RecruitingNCT05821530
HFIT Versus TENS Study for Chronic Low Back and Knee Pain
A Randomized Controlled Clinical Trial Evaluating the Effectiveness of High-frequency Impulse Therapy (HFIT) Versus Transcutaneous Electronic Nerve Stimulator (TENS) for Treatment of Chronic Low Back and Knee Pain
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 325 (actual)
- Sponsor
- Hinge Health, Inc · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HFIT | At least 1 hour daily for 4 weeks |
| DEVICE | TENS | At least 1 hour daily for 4 weeks |
| OTHER | Control | Users will continue to use the digital MSK program as needed |
Timeline
- Start date
- 2023-04-24
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2023-04-20
- Last updated
- 2023-06-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05821530. Inclusion in this directory is not an endorsement.