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 range18 Years
SexALL
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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…