Back Pain Lower Back ChronicNCT07011537
Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain
A study testing Digital Musculoskeletal (MSK) Program and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Back Pain Lower Back Chronic and Chronic Pain, run by Hinge Health, Inc at 1 site in United States.
Trial summary
The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic, Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Digital Musculoskeletal (MSK) Program and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- United Healthcare (UHC) is primary health plan
- Mechanical (myofascial), axial back pain (focused around the spine)
- Experiencing pain primarily in the low back area
- Radicular component of pain has minimal effect on functionality, medication, quality of life
- Experiencing low back pain for at least 3 months
Show all 9Show fewer
- Subject able to understand and provide informed consent
- Comfortable and willing to accept random assignment to one of two study conditions (intervention or standard care condition)
- Has an email account
Who cannot join
- Patients that do not own or have access to a smartphone or tablet
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis as evidenced by pseudoclaudication, leg weakness or numbness
- Source of back pain related to an acute nerve impingement
- Diagnosis of cancer/malignant tumors in the last 5 years
- Source of back pain is an infection
Show all 27Show fewer
- History of spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, or any other implanted electronic device
- Has had myocardial infarction within the past 6 months
- Has had a coronary stent in the past 3 months
- Has radicular pain symptoms that affect functionality, quality of life or medication intake
- Has undergone surgery to solve pain related to the study indication in the past 12 months
- Is scheduled for upcoming surgery to solve pain related to the study indication
- History of opioid or drug use, or excessive alcohol use (excessive alcohol use defined as greater than 3 drinks a day on average), per investigator discretion
- History of rheumatological or other inflammatory conditions such as rheumatoid arthritis, systemic lupus, erythematosus, etc.
- Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in investigator's judgment
- Pregnant women (as determined by self-report)
- Has a heart condition that limits the ability to do mild exercise due to symptoms such as fatigue, palpitations, shortness of breath, or chest pain
- Has any health condition that limits the ability to do light-intensity exercise such as slow walking or light household chores
- Diagnosed with dementia or a similar memory disorder
- Has had a fall in the past three months
- Unable to move from sitting to standing without help from another person
- Unable to stand without assistance from another person or device
- Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
- Inability to complete data collection as required
- No secondary/coinsurance or plans to change insurance from UHC in the next 3 months
- Patients who were recommended spine surgery from a spine surgeon in the 3 months prior to the index month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Hinge Health and ENSO Back Pain Study: Prospective, Open-label, Randomized Superiority Trial of a Digital Health Program and High Frequency Impulse Therapy (HFIT) Versus Standard of Care in Treatment of Chronic Low Back Pain
The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain.
Read the detailed description
Digital health approaches are a way to deliver conservative therapy through interactive methods. These approaches may expand access to care due to the convenience of digital health, as participants can access care services at all hours and locations. Research has shown that participants of digital health programs show significant improvements in pain.
Hinge Health is a digital musculoskeletal (MSK) program that aims to help people manage their MSK pain through exercise, education, and personal coaching. In previous research, Hinge Health has shown improvements in pain, functional, and health care use outcomes. Enso is a portable device for the treatment of chronic and acute types of MSK pain. The electrical pulses delivered by Enso incorporate neuromodulation at high frequency (0.1 to 10 MHz) in addition to the low frequency (0 to 1 KHz) pulses transmitted by more traditional transcutaneous electrical nerve stimulation (TENS) units. The result is a unique mechanism of action compared to the paresthesia resulting from the electrical pulses delivered by traditional TENS devices. Furthermore, Enso has shown promising clinical outcomes in a small, pilot RCT.
While the pilot study provided preliminary results demonstrating clinical improvements in the short term, there is a need for evidence about medium to long term outcomes, impact on mood, and the effect on healthcare utilization. Therefore, the purpose of this study is to examine the extent to which Hinge Health, with Enso, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for their chronic lower back pain in the medium and long term.
- Being tested
- Digital Musculoskeletal (MSK) Program, Transcutaneous Electrical Nerve Stimulation (TENS), Standard of Care (SOC)
- Keywords
- Chronic Pain, Chronic Back Pain, Chronic Lower Back Pain, Mechanical Back Pain, Degenerative Disc Disease, Degenerative Arthritis, Disc Compression
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Intervertebral Disc Degeneration, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Musculoskeletal (MSK) ProgramBehavioural
Also called Hinge Health Program
Hinge Health is a digital MSK program to help participants manage chronic MSK pain through offering exercise therapy sessions, educational articles, and personal health coaching. Hinge Health delivers exercise therapy sessions and education through "playlists" accessed through the program app. Each playlist consists of three to seven exercises specific to the body region(s) the participant experiences pain in. Animations and videos, while paired with sensors and computer vision, demonstrate how to perform exercises, the number of repetitions for each exercise, and how long to hold positions. Playlists present more challenging exercises and/or more repetitions as participants progress further along in the program. After participants complete the exercises, the playlist delivers educational articles and resources focused on MSK pain-related topics, including lifestyle changes, pain neuroscience, and social support.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
Also called ENSO Device
The Enso is a strong complement/enhancement to the Hinge Health program, as it helps users to better manage their pain in order to work through their exercise sessions in the program. The Enso device is not intended to be a stand-alone solution; it provides pain relief, but exercise therapy provides important long-term benefits. Participants will use the digital MSK program (Hinge Health) in combination with a pain management device (Enso).
Standard of Care (SOC)Other
Also called Traditional Medical Care
The control group will continue to receive the access to traditional medical care for their MSK needs through their healthcare provider. Upon study completion, control group members who complete all follow-up surveys will receive Hinge Health membership and an Enso device for free for 12 months, starting at the conclusion of their participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Hinge Health + Enso | Experimental | The intervention group will receive access to the Hinge Health program and an Enso device. Receives: Behavioral: Digital Musculoskeletal (MSK) Program; Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Standard of Care | Other | The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Pain in the last 24 hours and at its worst in the last week will be measured via a Numerical Pain Rating Score (NPRS) with 0 indicating no pain and 100 indicating worst imaginable pain.
Measured: Baseline, 2, 6, and 12 weeks
Change in Pain
In addition to the NPRS, Patient Global Impression of Change (PGIC) in pain will be collected based on the response to the question, "Compared to before starting this study, how would you rate your back pain now?" (Much Worse, Worse, A Little Worse, No Change, A Little Better, Better, Much Better), on a 0 to 7 scale.
Measured: Baseline, 2, 6, and 12 weeks
Secondary outcomes (3)
Function
Function will be measured using the Roland Morris Disability Questionnaire 11-item scale (RMDQ-11), ranging from 0 to 11. Change will be measured as baseline score minus follow-up score.
Measured: Baseline, 2, 6, and 12 weeks
Depression
Depression symptoms will be measured with the Patient Health Questionnaire 8-item scale (PHQ-8), ranging from 0 to 24. Change will be measured as baseline score minus follow-up score.
Measured: Baseline, 2, 6, and 12 weeks
Anxiety
Anxiety symptoms will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7), ranging from 0 to 21. Change will be measured as baseline score minus follow-up score.
Measured: Baseline, 2, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinge Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optum, Inc.
- Responsible party
- Sponsor
- Investigators
- Ken Cohen, MD, FACP, Principal investigator, Optum, Inc.Jeff Krauss, MD, Principal investigator, Hinge HealthCynthia Castro Sweet, PhD, Principal investigator, Hinge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011537
- Sponsor's protocol ID
- 1389625
- Status last verified
- Jan 2026
- First submitted
- 5 Jun 2025
- Last updated
- 23 Jan 2026
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hinge Health and ENSO Back Pain Study: Prospective, Open-label, Randomized Superiority Trial of a Digital Health Program and High Frequency Impulse Therapy (HFIT) Versus Standard of Care in Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07011537
- Acronym / sponsor ID
- 1389625
- Keywords
- Chronic Pain, Chronic Back Pain, Chronic Lower Back Pain, Mechanical Back Pain, Degenerative Disc Disease, Degenerative Arthritis, Disc Compression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Hinge Health, IncIndustry (pharma, biotech, devices)
- Collaborators
- Optum, Inc.
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jun 2025 (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.
The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain.
Detailed description
Digital health approaches are a way to deliver conservative therapy through interactive methods. These approaches may expand access to care due to the convenience of digital health, as participants can access care services at all hours and locations. Research has shown that participants of digital health programs show significant improvements in pain.
Hinge Health is a digital musculoskeletal (MSK) program that aims to help people manage their MSK pain through exercise, education, and personal coaching. In previous research, Hinge Health has shown improvements in pain, functional, and health care use outcomes. Enso is a portable device for the treatment of chronic and acute types of MSK pain. The electrical pulses delivered by Enso incorporate neuromodulation at high frequency (0.1 to 10 MHz) in addition to the low frequency (0 to 1 KHz) pulses transmitted by more traditional transcutaneous electrical nerve stimulation (TENS) units. The result is a unique mechanism of action compared to the paresthesia resulting from the electrical pulses delivered by traditional TENS devices. Furthermore, Enso has shown promising clinical outcomes in a small, pilot RCT.
While the pilot study provided preliminary results demonstrating clinical improvements in the short term, there is a need for evidence about medium to long term outcomes, impact on mood, and the effect on healthcare utilization. Therefore, the purpose of this study is to examine the extent to which Hinge Health, with Enso, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for their chronic lower back pain in the medium and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hinge Health + Enso | Experimental | Behavioral: Digital Musculoskeletal (MSK) Program, Device: Transcutaneous Electrical Nerve Stimulation (TENS)The intervention group will receive access to the Hinge Health program and an Enso device. |
| Standard of Care | Other | Other: Standard of Care (SOC)The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or over
- United Healthcare (UHC) is primary health plan
- Mechanical (myofascial), axial back pain (focused around the spine)
- Experiencing pain primarily in the low back area
- Radicular component of pain has minimal effect on functionality, medication, quality of life
Key exclusion criteria (27 listed)
- Patients that do not own or have access to a smartphone or tablet
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis as evidenced by pseudoclaudication, leg weakness or numbness
- Source of back pain related to an acute nerve impingement
- Diagnosis of cancer/malignant tumors in the last 5 years
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 |
|---|---|---|
| Digital Musculoskeletal (MSK) ProgramAlso: Hinge Health ProgramHinge Health is a digital MSK program to help participants manage chronic MSK pain through offering exercise therapy sessions, educational articles, and personal health coaching. Hinge Health delivers exercise therapy sessions and education through "playlists" accessed through the program app. Each playlist consists of three to seven exercises specific to the body region(s) the participant experiences pain in. Animations and videos, while paired with sensors and computer vision, demonstrate how to perform exercises, the number of repetitions for each exercise, and how long to hold positions. Playlists present more challenging exercises and/or more repetitions as participants progress further along in the program. After participants complete the exercises, the playlist delivers educational articles and resources focused on MSK pain-related topics, including lifestyle changes, pain neuroscience, and social support. | Behavioural | Hinge Health + Enso |
| Transcutaneous Electrical Nerve Stimulation (TENS)Also: ENSO DeviceThe Enso is a strong complement/enhancement to the Hinge Health program, as it helps users to better manage their pain in order to work through their exercise sessions in the program. The Enso device is not intended to be a stand-alone solution; it provides pain relief, but exercise therapy provides important long-term benefits. Participants will use the digital MSK program (Hinge Health) in combination with a pain management device (Enso). | Device | Hinge Health + Enso |
| Standard of Care (SOC)Also: Traditional Medical CareThe control group will continue to receive the access to traditional medical care for their MSK needs through their healthcare provider. Upon study completion, control group members who complete all follow-up surveys will receive Hinge Health membership and an Enso device for free for 12 months, starting at the conclusion of their participation in the study. | Other | Standard of Care |
Primary outcome
Change in Pain
Time frame: Baseline, 2, 6, and 12 weeks
Pain in the last 24 hours and at its worst in the last week will be measured via a Numerical Pain Rating Score (NPRS) with 0 indicating no pain and 100 indicating worst imaginable pain.
Change in Pain
Time frame: Baseline, 2, 6, and 12 weeks
In addition to the NPRS, Patient Global Impression of Change (PGIC) in pain will be collected based on the response to the question, "Compared to before starting this study, how would you rate your back pain now?" (Much Worse, Worse, A Little Worse, No Change, A Little Better, Better, Much Better), on a 0 to 7 scale.
3 secondary outcomes
Function
Time frame: Baseline, 2, 6, and 12 weeks
Depression
Time frame: Baseline, 2, 6, and 12 weeks
Anxiety
Time frame: Baseline, 2, 6, and 12 weeks
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Ken Cohen, MD, FACP principal investigator
Optum, Inc.
Jeff Krauss, MD principal investigator
Hinge Health
Cynthia Castro Sweet, PhD principal investigator
Hinge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Musculoskeletal (MSK) Program and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Back Pain Lower Back Chronic and Chronic Pain, 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 9 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. 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?
Change in Pain (time frame: Baseline, 2, 6, and 12 weeks). The study lists 2 primary outcomes in all. 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 23 Jan 2026.