HFIT Versus TENS Study for Chronic Low Back and Knee Pain

N/AActive Not RecruitingNCT05821530

Hinge Health, Inc325 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

325

Conditions

Chronic Pain Knee Pain Chronic Back Pain, Low

Interventions

HFITDEVICE

At least 1 hour daily for 4 weeks

TENSDEVICE

At least 1 hour daily for 4 weeks

ControlOTHER

Users will continue to use the digital MSK program as needed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Hinge Health, Inc

San Francisco, California, United States

Outcomes

Primary Outcomes

Pain MCID

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.