Status:
RECRUITING
Clinician Satisfaction With the VERABAND™
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Arbor Medical Innovations, LLC
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The VERABAND™ is a newly-developed, disposable, wearable activity monitor. The researchers will assess clinician satisfaction with the usability and likelihood of clinical adoption of the newly-develo...
Detailed Description
A total of 340 cLBP patients (estimating n=300 completers) will be recruited and evaluated under an approved institutional review board (IRB) protocol by a total of 20 clinician participants distribut...
Eligibility Criteria
Inclusion
- Any treating clinician at a recruiting tertiary pain clinic will be eligible to participate.
- Patient participants must meet the following 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
- 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.
Key Trial Info
Start Date :
June 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06080464
Start Date
June 9 2025
End Date
June 1 2027
Last Update
July 14 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109