Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain

Enrolling by invitation · Not applicable

Conditions studied: Back Pain Lower Back Chronic, Chronic Pain, Musculoskeletal Pain

In brief

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.

Key facts

Study ID

NCT07011537

Run by

Hinge Health, Inc

People needed

196

Starts

2026-01-16

Expected to finish

2026-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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

Where it is running

• Optum Labs — Eden Prairie, Minnesota, United States

Full record on ClinicalTrials.gov

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