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

Enrolling by invitationNot applicableNCT07011537
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Interventions
Sponsor
Hinge Health, Inc
Collaborators
Optum, Inc.
Start date
2026-01-16
Primary completion
2026-06
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 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 an…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07011537