Clinician Satisfaction With the VERABAND™

ConditionChronic Low-back Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorUniversity of Michigan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

VERABAND information
Other intervention
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.

Treatment groups

360 Participants

are divided into 1 treatment group

Group A: VERABAND informationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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™

Time frame

approximately 7 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Arbor Medical Innovations, LLC

Collaborator

Source ClinicalTrials.gov

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