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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFIT | Device | At least 1 hour daily for 4 weeks |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinge Health, Inc | San Francisco | California | 94105 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2025 | Mar 25, 2025 | 2 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| TENS | Device | At least 1 hour daily for 4 weeks |
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| Control | Other | Users will continue to use the digital MSK program as needed |
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| 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 |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |