HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Running, not enrolling · Not applicable

Conditions studied: Chronic Pain, Knee Pain Chronic, Back Pain, Low

In brief

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.

Key facts

Study ID

NCT05821530

Run by

Hinge Health, Inc

People needed

325

Starts

2023-04-24

Expected to finish

2023-06-30

Last updated by the study team

2023-06-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hinge Health, Inc — San Francisco, California, United States

Full record on ClinicalTrials.gov

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