Digital Health Program + TENS for Chronic Low Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a digital health program called Hinge Health and a wearable device named Enso to determine their effectiveness in reducing pain and improving function for people with chronic lower back pain. Researchers aim to assess whether these tools provide significant benefits compared to standard medical care. Participants who have experienced lower back pain for at least three months and have United Healthcare as their primary insurance may be suitable candidates. As an unphased trial, this study offers participants the chance to explore innovative pain management solutions beyond standard care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this digital health program and TENS device are safe for chronic low back pain?
Research has shown that digital programs for muscle and joint health are generally safe for treating back pain. One study found that these programs can reduce pain and improve mobility without causing serious side effects. This is encouraging for those considering this type of treatment.
For the Enso device, which uses a method called TENS to relieve pain, evidence also suggests safety. Studies have demonstrated that TENS can reduce pain levels without causing serious problems. It has been widely used and is considered well-tolerated for pain relief.
Overall, both the digital muscle and joint program and the TENS device are safe options for managing long-term low back pain.12345Why are researchers excited about this trial?
Researchers are excited about the combination of the Hinge Health program and the Enso device for chronic low back pain because it integrates digital and physical approaches. Unlike standard treatments that often rely on medications or physical therapy alone, this digital health program offers personalized, remote support to guide users through exercises and pain management strategies. Additionally, the Enso device provides Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive way to relieve pain by sending electrical impulses to the nerves. This dual approach not only makes pain management more accessible but also offers a promising, drug-free alternative that could reduce dependency on traditional pain medications.
What evidence suggests that this trial's treatments could be effective for chronic low back pain?
Research has shown that digital programs for muscle and joint health, such as the Digital Musculoskeletal (MSK) Program used in this trial, can help manage long-term pain. These programs improve pain levels and movement, often reducing the need for surgeries. Over 60% of users report managing pain in several areas of their body. Participants in this trial may receive the Hinge Health program as part of the intervention group.
Regarding the Enso device, which uses transcutaneous electrical nerve stimulation (TENS) and is also part of the intervention group, results are less encouraging. Some studies suggest that TENS may not provide much more relief than a placebo for ongoing lower back pain. However, it is generally safe and might reduce pain for some people immediately after use.12467Who Is on the Research Team?
Ken Cohen, MD, FACP
Principal Investigator
Optum, Inc.
Jeff Krauss, MD
Principal Investigator
Hinge Health
Cynthia Castro Sweet, PhD
Principal Investigator
Hinge Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic lower back pain, primarily around the spine, lasting at least 6 months. Participants must have a minimal radicular component of pain, be able to use email, understand and consent to the study, and have United Healthcare as their primary health plan.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Hinge Health digital program and Enso device for chronic low back pain management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digital Musculoskeletal (MSK) Program
- Transcutaneous Electrical Nerve Stimulation (TENS)
Trial Overview
The study tests if Hinge Health's digital program and Enso's wearable TENS device can significantly reduce pain and improve function in patients with chronic low back pain compared to standard care alone.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The control group will continue to receive access to traditional medical care for their musculoskeletal needs through their healthcare provider.
The intervention group will receive access to the Hinge Health program and an Enso device.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hinge Health, Inc
Lead Sponsor
Optum, Inc.
Industry Sponsor
Citations
Digital Care for Chronic Musculoskeletal Pain - PMC - NIH
This study aimed to evaluate the efficacy of a 12-week digital care program (DCP) in a large population of patients with chronic knee and back pain.
The New Era of Musculoskeletal Health — Happening Now
The report shows that over 60% of Hinge Health members use the platform to manage chronic pain in multiple body areas.² This adaptability ...
Clinical Outcomes After a Digital Musculoskeletal Program for ...
A digital MSK program may help to improve pain and function in the short term among those with acute and subacute MSK pain.
4.
hingehealth.com
hingehealth.com/resources/articles/how-digital-msk-is-delivering-outcomes-that-matter/How digital MSK is delivering outcomes that matter
Hinge Health's 2025 State of Musculoskeletal Care Report reveals how digital solutions are preventing avoidable surgeries and more.
Real-World Effect of a Digitally Delivered Conservative ...
Conservative, noninvasive musculoskeletal treatment delivered digitally has demonstrated similar or better effectiveness in managing and ...
Virtual Physical Therapy and More: Personalized Pain Care
Our FDA-cleared device uses patented waveforms to deliver drug-free pain relief. It's quick, safe, and exclusive to Hinge Health. Learn more →. Carousel ...
Effects of a Digital Musculoskeletal Acute Care Program on ...
The odds of achieving chronic pain prevention by 12 weeks was higher for the intervention (OR: 4.41, 95% CI: [2.10, 9.76]) versus the ...
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