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NCT07011537

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
Hinge Health, Inc
~196 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Digital Musculoskeletal (MSK) ProgramTranscutaneous Electrical Nerve Stimulation (TENS)Standard of Care (SOC)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain
Measured over Baseline, 2, 6, and 12 weeks
+1 more outcome measured

Conditions

Back Pain Lower Back Chronic
Chronic Pain
Musculoskeletal Pain

Explore related trials

Lower Back Pain

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Ken Cohen, MD, FACP · PRINCIPAL_INVESTIGATOR · Optum, Inc.
  • Jeff Krauss, MD · PRINCIPAL_INVESTIGATOR · Hinge Health
  • Cynthia Castro Sweet, PhD · PRINCIPAL_INVESTIGATOR · Hinge Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Change in PainBaseline, 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 PainBaseline, 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.