Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06080464

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VERABAND information

Study Details

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

Study ID

NCT06080464

Start date

Jun 9, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: VERABAND information

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.

Interventions

VERABAND 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.

Primary outcome measure

  • Measure clinician satisfaction of the usability of the VERABAND™ using the System Usability Scale (SUS) [ Time Frame: approximately 7 weeks ]
  • Measure the likelihood of clinical adoption of the VERABAND™ using Item 1 of the System Usability Scale (SUS) [ Time Frame: approximately 7 weeks ]

Central Contacts and Locations

Central contacts

Kristi Pickup, MSW

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

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Miranda McMillan

913-588-7630facelab@kumc.edu

Principal Investigator:

Andrea Chadwick, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kristi Pickup, MSW

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

Daniel Whibley, PhD

dwhib@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-03.