Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05821530

HFIT Versus TENS Study for Chronic Low Back and Knee Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Pain Back Pain Back Pain, Low Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Knee Pain Chronic Low Back Pain Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hinge Health, Inc

San Francisco, California, 94105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HFIT

Device

At least 1 hour daily for 4 weeks

Other names: Enso

TENS

Device

At least 1 hour daily for 4 weeks

Control

Other

Users will continue to use the digital MSK program as needed

Other names: Digital MSK program

Primary outcomes

  1. Pain MCID

    Time frame: 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.

Secondary outcomes

  1. Function MCID (Back)

    Time frame: Baseline and Week 4

    Back function will be measured by the Roland-Morris Disability Questionnaire 11-item (RMDQ-11, 0-100, higher indicates worse function) scores for back users. Function MCID will be achieved (0/1) if there is at least a 30% improvement in RMDQ-11, as based on literature.

  2. Function MCID (Knee)

    Time frame: Baseline and Week 4

    Knee function will be measured by the Knee Injury and Osteoarthritis Outcome Score - Physical Short Form (KOOS-PS, 0-100, higher indicates worse function). Function MCID will be achieved (0/1) if there is at least an 8 point improvement in KOOS-PS, as based on literature.

  3. Anxiety

    Time frame: Baseline and Week 4

    Anxiety will be assessed by the Generalized Anxiety Disorder 2-item (GAD-2, 0-6, higher is worse) scores. A score of 3 or higher is defined as screening in for having anxiety, based on literature. The percentage of users who screen in for anxiety in each group will be compared.

  4. Depression

    Time frame: Baseline and Week 4

    Depression will be assessed by the Patient Health Questionnaire 2-item (PHQ-2, 0-6, higher is worse) scores. A score of 3 or higher is defined as screening in for having depression, based on literature. The percentage of users who screen in for depression in each group will be compared.

  5. Opioid use

    Time frame: Baseline and Week 4

    Opioid use data will be collected through survey questions. The percentage of users who use opioids in each group during the study will be compared.

Sponsors and collaborators

Lead sponsor

Hinge Health, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.