HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Hinge Health

Status: Active, not recruiting

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

Treatments: Device: TENS; Other: Control; Device: HFIT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05821530

HFIT20223468

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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325 participants in 3 patient groups

HFIT

Experimental group

Description:

Participants received a HFIT device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the HFIT device for at least 1 hour daily for 4 weeks.

Treatment:

Device: HFIT

TENS

Experimental group

Description:

Participants received a TENS device to treat their chronic pain and took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. Participants were encouraged to use the TENS device for at least 1 hour daily for 4 weeks.

Treatment:

Device: TENS

Control

Active Comparator group

Description:

Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.

Treatment:

Other: Control