HFIT Versus TENS Study for Chronic Low Back and Knee Pain

NCT05821530 | Active Not Recruiting FDA Device

• 1 other identifier: HFIT20223468
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Knee Pain Chronic; Back Pain, Low

Keywords

musculoskeletal; chronic; pain; knee pain; back pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 4

Secondary Outcomes (5)

• Function MCID (Back)

  Baseline and Week 4

• Function MCID (Knee)

  Baseline and Week 4

• Anxiety

  Baseline and Week 4

• Depression

  Baseline and Week 4

• Opioid use

  Baseline and Week 4

Study Arms (3)

HFIT

EXPERIMENTAL

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.

Device: HFIT

TENS

EXPERIMENTAL

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.

Device: TENS

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

HFIT DEVICE

At least 1 hour daily for 4 weeks

Also known as: Enso

HFIT

TENS DEVICE

At least 1 hour daily for 4 weeks

TENS

Control OTHER

Users will continue to use the digital MSK program as needed

Also known as: Digital MSK program

Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hinge Health, Inc: lead

Study Sites (1)

Hinge Health, Inc

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Bronchiolitis Obliterans Syndrome; Pain; Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: April 24, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)