HFIT Versus TENS Study for Chronic Low Back and Knee Pain

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Pain, Knee Pain Chronic, Back Pain, Low

Intervention / Treatment
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* Device: HFIT
* Device: TENS
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFIT<br>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<br>* At least 1 hour daily for 4 weeks<br>* Other names: Enso;|
| Experimental: TENS<br>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<br>* At least 1 hour daily for 4 weeks<br>|
| Active Comparator: Control<br>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<br>* Users will continue to use the digital MSK program as needed<br>* Other names: Digital MSK program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic, musculoskeletal, pain, knee pain, back pain