An interventional study of Digital Musculoskeletal (MSK) Program and Transcutaneous Electrical Nerve Stimulation (TENS) in Back Pain Lower Back Chronic, Chronic Pain and Musculoskeletal Pain, sponsored by Hinge Health, Inc. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Hinge Health, Inc · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 196 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
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)
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)
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
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
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
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.
Time frame: 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.
Time frame: Baseline, 2, 6, and 12 weeks
Function
Function will be measured using the Roland Morris Disability Questionnaire 11-item scale (RMDQ-11), ranging from 0 to 11. Change will be measured as baseline score minus follow-up score.
Time frame: Baseline, 2, 6, and 12 weeks
Depression
Depression symptoms will be measured with the Patient Health Questionnaire 8-item scale (PHQ-8), ranging from 0 to 24. Change will be measured as baseline score minus follow-up score.
Time frame: Baseline, 2, 6, and 12 weeks
Anxiety
Anxiety symptoms will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7), ranging from 0 to 21. Change will be measured as baseline score minus follow-up score.
Time frame: Baseline, 2, 6, and 12 weeks
Healthcare Utilization and Costs
Healthcare utilization and cost data will be come from administrative claims data and prescription history. These data will be collected for the intervention and control groups and will include 12 months of retrospective healthcare utilization claims records.
Time frame: Baseline, 12 months
Plan to share: No
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