Chronic Low-back PainNCT06080464
Clinician Satisfaction With the VERABAND™
A study testing VERABAND information in people with Chronic Low-back Pain, run by University of Michigan at 3 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- VERABAND information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Kristi Pickup, MSW, 734-764-4072, knpicku@med.umich.edu
Daniel Whibley, PhD, dwhib@med.umich.edu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Miranda McMillan, 913-588-7630, facelab@kumc.edu
Andrea Chadwick, MD
- Not yet recruiting
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Yasmeen Esshaki, 619-786-0375, yesshaki@health.ucsd.edu
Fadel Zeidan, PhD
About this study
Official title: A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™
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.
Read the 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 distributed across multiple tertiary pain clinics. 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 primary outcome will be clinician satisfaction with usability of the VERABAND™ system to support clinical cLBP management, regardless of the specific treatment(s) implemented or their analgesic effectiveness. Each clinician will complete a usability satisfaction survey at the end of each patient's episode of care, which allows for exploratory analyses to identify whether the VERABAND™ system is perceived to be more useful for specific patient phenotypes (e.g., those with higher levels of pain and/or disability or specific psychological characteristics).
- Conditions
- Chronic Low-back Pain
- Being tested
- VERABAND information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERABAND informationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: VERABAND information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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™
Measured: approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start9 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Arbor Medical Innovations, LLC
- Responsible party
- Principal investigator, Daniel Whibley, University of Michigan
- Investigators
- Daniel Whibley, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080464
- Sponsor's protocol ID
- HUM00235976
- Other IDs
- 1U44NS122002
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Clinician Satisfaction and Likelihood of Clinical Adoption of the VERABAND™
- ClinicalTrials.gov ID
- NCT06080464
- Acronym / sponsor ID
- HUM00235976
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Arbor Medical Innovations, LLC
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 distributed across multiple tertiary pain clinics. 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 primary outcome will be clinician satisfaction with usability of the VERABAND™ system to support clinical cLBP management, regardless of the specific treatment(s) implemented or their analgesic effectiveness. Each clinician will complete a usability satisfaction survey at the end of each patient's episode of care, which allows for exploratory analyses to identify whether the VERABAND™ system is perceived to be more useful for specific patient phenotypes (e.g., those with higher levels of pain and/or disability or specific psychological characteristics).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VERABAND information | Experimental | Other: VERABAND informationConsented 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERABAND informationThe 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. | Other | VERABAND information |
Primary outcome
Measure clinician satisfaction of the usability of the VERABAND™ using the System Usability Scale (SUS)
Time frame: approximately 7 weeks
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.
Measure the likelihood of clinical adoption of the VERABAND™ using Item 1 of the System Usability Scale (SUS)
Time frame: approximately 7 weeks
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™
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Whibley, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERABAND information in people with Chronic Low-back Pain, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristi Pickup, MSW (734-764-4072, knpicku@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure clinician satisfaction of the usability of the VERABAND™ using the System Usability Scale (SUS) (time frame: approximately 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.