HFIT Versus TENS Study for Chronic Low Back and Knee Pain
NCT ID: NCT05821530
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
325 participants
INTERVENTIONAL
2023-04-24
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HFIT
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.
HFIT
At least 1 hour daily for 4 weeks
TENS
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.
TENS
At least 1 hour daily for 4 weeks
Control
Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.
Control
Users will continue to use the digital MSK program as needed
Interventions
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HFIT
At least 1 hour daily for 4 weeks
TENS
At least 1 hour daily for 4 weeks
Control
Users will continue to use the digital MSK program as needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Hinge Health, Inc
INDUSTRY
Responsible Party
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Locations
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Hinge Health, Inc
San Francisco, California, United States
Countries
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Other Identifiers
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HFIT20223468
Identifier Type: -
Identifier Source: org_study_id
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