HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Last updated: June 6, 2023
Sponsor: Hinge Health, Inc
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

HFIT

Control

TENS

Clinical Study ID

NCT05821530
HFIT20223468
  • Ages 18-64
  • All Genders

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 Criteria

Inclusion

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

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 thesubject 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

Study Design

Total Participants: 325
Treatment Group(s): 3
Primary Treatment: HFIT
Phase:
Study Start date:
April 24, 2023
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Hinge Health, Inc

    San Francisco, California 94105
    United States

    Site Not Available

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