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

NCT07011537 | Enrolling By Invitation FDA Device

• 1 other identifier: 1389625
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain Lower Back Chronic; Chronic Pain; Musculoskeletal Pain

Keywords

Chronic Pain; Chronic Back Pain; Chronic Lower Back Pain; Mechanical Back Pain; Degenerative Disc Disease; Degenerative Arthritis; Disc Compression

Outcome Measures

Primary Outcomes (2)

• Change in Pain

  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.

  Baseline, 2, 6, and 12 weeks

• Change in Pain

  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.

  Baseline, 2, 6, and 12 weeks

Secondary Outcomes (3)

• Function

  Baseline, 2, 6, and 12 weeks

• Depression

  Baseline, 2, 6, and 12 weeks

• Anxiety

  Baseline, 2, 6, and 12 weeks

Other Outcomes (1)

• Healthcare Utilization and Costs

  Baseline, 12 months

Study Arms (2)

Hinge Health + Enso

EXPERIMENTAL

The intervention group will receive access to the Hinge Health program and an Enso device.

Behavioral: Digital Musculoskeletal (MSK) Program; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Standard of Care

OTHER

The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider.

Other: Standard of Care (SOC)

Interventions

Digital Musculoskeletal (MSK) Program BEHAVIORAL

Hinge Health is a digital MSK program to help participants manage chronic MSK pain through offering exercise therapy sessions, educational articles, and personal health coaching. Hinge Health delivers exercise therapy sessions and education through "playlists" accessed through the program app. Each playlist consists of three to seven exercises specific to the body region(s) the participant experiences pain in. Animations and videos, while paired with sensors and computer vision, demonstrate how to perform exercises, the number of repetitions for each exercise, and how long to hold positions. Playlists present more challenging exercises and/or more repetitions as participants progress further along in the program. After participants complete the exercises, the playlist delivers educational articles and resources focused on MSK pain-related topics, including lifestyle changes, pain neuroscience, and social support.

Also known as: Hinge Health Program

Hinge Health + Enso

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

The Enso is a strong complement/enhancement to the Hinge Health program, as it helps users to better manage their pain in order to work through their exercise sessions in the program. The Enso device is not intended to be a stand-alone solution; it provides pain relief, but exercise therapy provides important long-term benefits. Participants will use the digital MSK program (Hinge Health) in combination with a pain management device (Enso).

Also known as: ENSO Device

Hinge Health + Enso

Standard of Care (SOC) OTHER

The control group will continue to receive the access to traditional medical care for their MSK needs through their healthcare provider. Upon study completion, control group members who complete all follow-up surveys will receive Hinge Health membership and an Enso device for free for 12 months, starting at the conclusion of their participation in the study.

Also known as: Traditional Medical Care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Optum, Inc.: collaborator
• Hinge Health, Inc: lead

Study Sites (1)

Optum Labs

Eden Prairie, Minnesota, 55344, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Intervertebral Disc Degeneration; Osteoarthritis

Interventions

Masks; Transcutaneous Electric Nerve Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ken Cohen, MD, FACP

  Optum, Inc.

  PRINCIPAL INVESTIGATOR

• Jeff Krauss, MD

  Hinge Health

  PRINCIPAL INVESTIGATOR

• Cynthia Castro Sweet, PhD

  Hinge Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 8, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)