Chronic PainNCT05821530
HFIT Versus TENS Study for Chronic Low Back and Knee Pain
A study testing HFIT and TENS in people with Chronic Pain and Knee Pain Chronic, run by Hinge Health, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain, Knee Pain Chronic, Back Pain, Low
- What is being tested?
- HFIT and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Have epilepsy
- Have cardiovascular disease
- Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Pain, Knee Pain Chronic, Back Pain, Low
- Being tested
- HFIT, TENS, Control
- Keywords
- musculoskeletal, chronic, pain, knee pain, back pain
- Medical subject headings
- Chronic Pain, Low Back Pain, Bronchiolitis Obliterans Syndrome, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFITDevice
Also called Enso
At least 1 hour daily for 4 weeks
TENSDevice
At least 1 hour daily for 4 weeks
ControlOther
Also called Digital MSK program
Users will continue to use the digital MSK program as needed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HFIT |
| 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. Receives: Device: TENS |
| 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 4
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start24 Apr 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hinge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821530
- Sponsor's protocol ID
- HFIT20223468
- Status last verified
- Jun 2023
- First submitted
- 6 Apr 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05821530
- Acronym / sponsor ID
- HFIT20223468
- Conditions
- Chronic Pain, Knee Pain Chronic, Back Pain, Low
- Keywords
- musculoskeletal, chronic, pain, knee pain, back pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Hinge Health, IncIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFIT | Experimental | Device: HFITParticipants 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. |
| TENS | Experimental | Device: TENSParticipants 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. |
| Control | Active comparator | Other: ControlParticipants took part in a digital MSK program, which provided customized exercise therapy sessions, educational articles, and access to coaches and physical therapists. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFITAlso: EnsoAt least 1 hour daily for 4 weeks | Device | HFIT |
| TENSAt least 1 hour daily for 4 weeks | Device | TENS |
| ControlAlso: Digital MSK programUsers will continue to use the digital MSK program as needed | Other | Control |
Primary outcome
Pain MCID
Time frame: 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.
5 secondary outcomes
Function MCID (Back)
Time frame: Baseline and Week 4
Function MCID (Knee)
Time frame: Baseline and Week 4
Anxiety
Time frame: Baseline and Week 4
Depression
Time frame: Baseline and Week 4
Opioid use
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFIT and TENS in people with Chronic Pain and Knee Pain Chronic, run by Hinge Health, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain MCID (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.