RecruitingNot ApplicableNCT06080464

Clinician Satisfaction With the VERABAND™

A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™


Sponsor

University of Michigan

Enrollment

360 participants

Start Date

Jun 9, 2025

Study Type

INTERVENTIONAL

Conditions

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-developed, disposable, wearable activity monitor, across multiple clinical sites in the chronic low back pain (cLBP) population.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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.

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Interventions

OTHERVERABAND information

The device, VERABAND™, activity data reports (including a summary broken down by week) will be provided to treating clinicians prior to each patient's follow-up clinic visit.


Locations(3)

Altman Clinical and Translational Research Institute

La Jolla, California, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

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NCT06080464


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