Clinical trial NCT07011537: Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Hinge Health, Inc
Sponsor class: INDUSTRY
Collaborators: name: Optum, Inc.
First posted: 2025-06-08
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Digital health approaches are a way to deliver conservative therapy through interactive methods. These approaches may expand access to care due to the convenience of digital health, as participants can access care services at all hours and locations. Research has shown that participants of digital health programs show significant improvements in pain.

Hinge Health is a digital musculoskeletal (MSK) program that aims to help people manage their MSK pain through exercise, education, and personal coaching. In previous research, Hinge Health has shown improvements in pain, functional, and health care use outcomes. Enso is a portable device for the treatment of chronic and acute types of MSK pain. The electrical pulses delivered by Enso incorporate neuromodulation at high frequency (0.1 to 10 MHz) in addition to the low frequency (0 to 1 KHz) pulses transmitted by more traditional transcutaneous electrical nerve stimulation (TENS) units. The result is a unique mechanism of action compared to the paresthesia resulting from the electrical pulses delivered by traditional TENS devices. Furthermore, Enso has shown promising clinical outcomes in a small, pilot RCT.

While the pilot study provided preliminary results demonstrating clinical improvements in the short term, there is a need for evidence about medium to long term outcomes, impact on mood, and the effect on healthcare utilization. Therefore, the purpose of this study is to examine the extent to which Hinge Health, with Enso, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for their chronic lower back pain in the medium and long term.

Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* United Healthcare (UHC) is primary health plan
* Mechanical (myofascial), axial back pain (focused around the spine)
* 60/100 or greater level of pain on the Numerical Pain Rating Scale of 0-100.
* Radicular component of pain is minimal (\<25% of pain)
* Radicular component of pain has minimal effect on functionality, medication, quality of life
* 80% or greater of disability is due to pain in the low back (as opposed to other areas)
* Experiencing chronic pain for at least 6 months
* Subject able to understand and provide informed consent
* 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 or other lower extremity symptoms
* 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
* Source of pain is a prior spinal fusion surgery
* Has a cardiac pacemaker, implanted defibrillator, or other implanted electronic device
* 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 6 months
* Is scheduled for upcoming surgery to solve pain related to the study indication
* Patients with history of opioid, alcohol, or drug abuse in the last 5 years, per investigator discretion
* 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)
* Have severe epilepsy
* Have severe form of cardiovascular disease
* 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
* Participants who met with an orthopedic or neurosurgeon in the 3 months prior to the index month

Primary outcomes:
measure: Change in Pain
timeFrame: Baseline, 1, 2, 6, and 12 weeks
measure: Change in Pain
timeFrame: Baseline, 1, 2, 6, and 12 weeks
Secondary outcomes:
measure: Function
timeFrame: Baseline, 1, 2, 6, and 12 weeks
measure: Depression
timeFrame: Baseline, 1, 2, 6, and 12 weeks
measure: Anxiety
timeFrame: Baseline, 1, 2, 6, and 12 weeks
Other outcomes:
measure: Healthcare Utilization and Costs
timeFrame: Baseline, 12 months
Locations:
Study officials:
affiliation: Optum, Inc.
name: Ken Cohen, MD, FACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Hinge Health
name: Jeff Krauss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hinge Health
name: Cynthia Castro Sweet, PhD
role: PRINCIPAL_INVESTIGATOR
References: