Clinician satisfaction with the VERABAND wearable activity monitor
A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™
This study will test whether giving wearable VERABAND activity monitors to people with chronic low back pain helps clinicians find the device usable and likely to use in patient care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 3 sites (La Jolla, California and 2 other locations) |
| Trial ID | NCT06080464 on ClinicalTrials.gov |
What this trial studies
Up to 340 ambulatory patients with chronic low back pain will receive a disposable VERABAND activity monitor at baseline and begin a new non-surgical treatment as part of routine care. Activity data and weekly summary reports will be sent to the treating clinician before each follow-up visit across multiple tertiary pain clinics. Twenty clinicians will complete a usability satisfaction survey at the end of each patient's episode of care, and the primary outcome is clinician-reported usability and likelihood of clinical adoption. Exploratory analyses will examine whether clinician perceptions differ by patient phenotype such as pain severity, disability, or psychological characteristics.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults with chronic low back pain that interferes with mobility who are starting a new non-surgical treatment and are willing to wear and return a disposable VERABAND until their next clinic visit.
Not a fit: Patients who are non-ambulatory, have signs of systemic disease, are not starting a new non-surgical treatment, or are unwilling to wear or return the device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, clinicians might use VERABAND to monitor patient activity between visits and better tailor treatments for chronic low back pain.
How similar studies have performed: Wearable activity monitors have been used successfully to track mobility in musculoskeletal conditions, but clinician satisfaction and adoption of a new disposable device like VERABAND remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Any treating clinician at a recruiting tertiary pain clinic will be eligible to participate. Patient participants must meet the following criteria: Inclusion Criteria: * Ambulatory * Diagnosis of chronic low back pain (cLBP) according to the criteria of National Institute of Health (NIH) Task Force on Research Standards for cLBP * Answering 'Yes' to the question: Does your low back pain interfere with your mobility? * Starting any new non-surgical treatment or combination of treatments for cLBP as part of their normal ongoing care, including medications; physical therapy/exercise; integrated therapies (e.g., massage, acupuncture, yoga); cognitive- behavioral therapy; and/or interventional procedures (e.g., epidural steroid or facet joint injections) * Willingness to wear a VERABAND™ continuously until their next clinic visit and return used devices in the mail. Exclusion Criteria: * Clinical findings suggesting the presence of ongoing systemic disease, including fever, weight loss, initiation of pain following major trauma, immunosuppression, intravenous drug use, recent bacterial infection, severe or persistent sensory or motor involvement of bowel, bladder, or lower extremity; or any condition that would greatly limit physical activity not due to pain. * Inability to speak and write English. * Visual or hearing difficulties that would preclude participation. * Severe psychiatric disorders that in the opinion of the investigative team would interfere with participation in the study. This includes any active suicidal ideations or history of suicide attempts. Exclusions will be based on self-reported medical history or chart review and in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. * Individuals receiving disability or compensation or involved in litigation. * Scheduled surgery before follow-up.
Where this trial is running
La Jolla, California and 2 other locations
- Altman Clinical and Translational Research Institute — La Jolla, California, United States (Not_yet_recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Not_yet_recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Whibley, PhD — University of Michigan
- Study coordinator: Kristi Pickup, MSW
- Email: knpicku@med.umich.edu
- Phone: 734-764-4072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.