Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Ba… (NCT07011537) | Clinical Trial Compass
By InvitationNot Applicable
Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain
United States196 participantsStarted 2026-01-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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 surg…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.