HFIT Versus TENS Study for Chronic Low Back and Knee Pain
Active, not recruitingNot applicableNCT05821530
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Interventions
- Device: HFIT
- Device: TENS
- Other: Control
- Sponsor
- Hinge Health, Inc
- Start date
- 2023-04-24
- Primary completion
- 2023-06-30
- Sex
- All
- Age range
- from 18 Years to 64 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 18 or over and under age 65 * Baseline pain is 40 or more out of 100 on a NPRS * Member of digital MSK program's chronic back or knee pain program, after January 1, 2023 * Member engaged in the most recent 3 weeks * Experiencing chronic pain for at least 3 months * Subject able to understand and provide informed consent * Has an email account Exclusion Criteria: * Diagnosis of cancer/malignant tumors in the last 5 years * Back or knee surgery in the last 6 months * Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device * Patients with history of opioid, alcohol, or drug abuse in the last 1 year * Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol * Pregnant or plan on becoming pregnant in the next year * Have epilepsy * Have cardiovascular disease * Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05821530