Control: Users will continue to use the digital MSK program as needed
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Pain MCID — Baseline and Week 4 Pain will be measured by the Numeric Pain Rating Scale, ranging from 0 (no pain) to 100 (worst possible pain). The minimal clinically important difference (MCID) of pain will be achieved (0/1) if there is at least a 34% or 23 point improvement, as based on literature.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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