NCT05821530Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 325 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 24 Apr 2023
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Hinge Health, Inc
- NCT number
- NCT05821530
What you commit to
- Study type: Interventional
- Participants enrolled: 325
- From 24 Apr 2023 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Back or knee surgery in the last 6 months
Other illness
- Diagnosis of cancer/malignant tumors in the last 5 years
- 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
- Have epilepsy
- Have cardiovascular disease
Other
- Pregnant or plan on becoming pregnant in the next year
- Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hinge Health, Inc. Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.