Clinician Satisfaction With the VERABAND™

NCT06080464 | Recruiting FDA Device

• 2 other identifiers: HUM002359761U44NS122002
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (2)

• Measure clinician satisfaction of the usability of the VERABAND™ using the System Usability Scale (SUS)

  The SUS is comprised of 10 statements: Each statement is accompanied by a five-point scale Likert response option. The SUS ranges from 10-50 and the higher scores indicate higher clinician satisfaction with usability.

  approximately 7 weeks

• Measure the likelihood of clinical adoption of the VERABAND™ using Item 1 of the System Usability Scale (SUS)

  The SUS item is a five-point scale Likert response ranging from 1-5. Higher scores indicate increase likelihood of clinical adoption of the VERABAND™

  approximately 7 weeks

Study Arms (1)

VERABAND information

EXPERIMENTAL

Consented patient participants will be given a VERABAND™ activity monitor during an initial clinic visit (baseline) and will then be tracked longitudinally after beginning a new pain treatment regime as part of their normal ongoing care. VERABAND™ activity data reports (including a summary broken down by week) will subsequently be provided to treating clinicians prior to each patient's follow-up clinic visit. The arm is all of the clinicians of the participants.

Other: VERABAND information

Interventions

VERABAND information OTHER

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.

VERABAND information

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Individuals receiving disability or compensation or involved in litigation.
• Scheduled surgery before follow-up.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Arbor Medical Innovations, LLC: collaborator

Study Sites (3)

Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

NOT YET RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Daniel Whibley, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristi Pickup, MSW

CONTACT

734-764-4072; knpicku@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physical Medicine and Rehabilitation, Medical School

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: June 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)