Back Pain, Low, Chronic Pain, Knee Pain Chronic
Conditions
Keywords
musculoskeletal, chronic, pain, knee pain, back pain
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.
Interventions
DEVICEHFIT
At least 1 hour daily for 4 weeks
DEVICETENS
At least 1 hour daily for 4 weeks
OTHERControl
Users will continue to use the digital MSK program as needed
Sponsors
Hinge Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain MCID | Baseline and Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Function MCID (Back) | Baseline and Week 4 | 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. |
| Function MCID (Knee) | Baseline and Week 4 | 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. |
| Anxiety | Baseline and Week 4 | 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. |
| Depression | Baseline and Week 4 | 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. |
| Opioid use | Baseline and Week 4 | 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. |
Countries
United States
Outcome results
None listed