Back to resultsHFIT Versus TENS Study for Chronic Low Back and Knee Pain
Primary Purpose
Chronic Pain, Knee Pain Chronic, Back Pain, Low
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HFIT
TENS
Control
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring musculoskeletal, chronic, pain, knee pain, back pain
Eligibility Criteria
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
Sites / Locations
- Hinge Health, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
HFIT
TENS
Control
Arm Description
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.
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.
Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05821530
Brief Title
HFIT Versus TENS Study for Chronic Low Back and Knee Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hinge Health, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Knee Pain Chronic, Back Pain, Low
Keywords
musculoskeletal, chronic, pain, knee pain, back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HFIT
Arm Type
Experimental
Arm Description
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.
Arm Title
TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists.
Intervention Type
Device
Intervention Name(s)
HFIT
Other Intervention Name(s)
Enso
Intervention Description
At least 1 hour daily for 4 weeks
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
At least 1 hour daily for 4 weeks
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Digital MSK program
Intervention Description
Users will continue to use the digital MSK program as needed
Primary Outcome Measure Information:
Title
Pain MCID
Description
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.
Time Frame
Baseline and Week 4
Secondary Outcome Measure Information:
Title
Function MCID (Back)
Description
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.
Time Frame
Baseline and Week 4
Title
Function MCID (Knee)
Description
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.
Time Frame
Baseline and Week 4
Title
Anxiety
Description
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.
Time Frame
Baseline and Week 4
Title
Depression
Description
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.
Time Frame
Baseline and Week 4
Title
Opioid use
Description
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.
Time Frame
Baseline and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hinge Health, Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HFIT Versus TENS Study for Chronic Low Back and Knee Pain
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