HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Chronic Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05821530
• Other study ID #: HFIT20223468
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Hinge Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 325
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Chronic Pain
• Knee Pain Chronic
• Low Back Pain

Intervention

Device:
• HFIT
At least 1 hour daily for 4 weeks
• TENS
At least 1 hour daily for 4 weeks

Other:
• Control
Users will continue to use the digital MSK program as needed

Locations

Country	Name	City	State
United States	Hinge Health, Inc	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Hinge Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Function MCID (Back)	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.	Baseline and Week 4
Secondary	Function MCID (Knee)	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.	Baseline and Week 4
Secondary	Anxiety	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.	Baseline and Week 4
Secondary	Depression	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.	Baseline and Week 4
Secondary	Opioid use	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.	Baseline and Week 4