Chronic Low Back PainMEPS-PainNCT04075487
MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study
A study testing Web-module for patient education and planning in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic low back pain is the #1 cause of disability and low quality of life in Veterans. Pain is a huge burden- stealing enjoyment, fulfillment, and time. Sometimes surgery, injections, or medications can help but sometimes not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Web-module for patient education and planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans receiving care at the VAMHCS
- frequent or persistent low back pain (> 3 months)
- pain >4 on a 0-10 numeric rating scale
- willing to participate in trial of non-pharmacological therapies for pain
- ability to speak, read, and write as needed for study
- stable treatment
Who cannot join
- Veterans with cognitive or visual impairment limiting the ability to engage in self-directed self-management planning
- anticipated surgery or pain procedure during the expected study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
Chronic low back pain is the #1 cause of disability and low quality of life in Veterans. Pain is a huge burden- stealing enjoyment, fulfillment, and time. Sometimes surgery, injections, or medications can help but sometimes not. Although no one solution fixes chronic low back pain, there are many treatments that can reduce pain impact and restore quality of life. These treatments involve: movement, psychology, mind-and-body therapies, sleep, and environmental factors. The challenge is how to best coordinate these treatments for chronic low back pain. The investigators have built a prototype mobile application that delivers the latest information to Veterans so they can work with healthcare providers to build their own pain self-management plans. With this new tool, the Veteran has data at hand and chooses their preferred pain self-management activities, making a coordinated plan that can be shared with their healthcare team. The investigators' goal is giving Veterans the knowledge and power to 'plan the work and work the plan' for chronic low back pain: restoring value, fulfillment, and meaning.
Read the detailed description
Chronic low back pain is highly prevalent in Veterans, and is often resistant to pharmacological management so that non-pharmacological management is required. For many patients, the most effective approach is comprehensive pain management incorporating multiple therapies addressing: physical, mental, mind-body, sleep, safety, and environmental needs. The ultimate outcome is the development of a coordinated multidimensional evidence-based plan for pain self-management (C-MEPPS) tailored to each patient. This approach, while effective, is highly resource intensive and severely constrained by cost and health system factors.
The investigators' goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan. This will represent a novel, scalable, Veteran-driven solution to chronic low back pain aligned with VA strategic objectives 'online navigator tools.empowers Veterans to make decisions.' The investigators are focused on transferring knowledge about evidence-base practices into the primary care context to help Veterans and their healthcare providers manage pain effectively- before it gets worse. The investigators have already developed the App prototype utilizing User-Centered Design principles to optimize the user experience. Our first aim is to develop and pilot test a web-based App for Veterans, including older Veterans and women Veterans, designed to empower each in pain self-management planning: providing access and data-driven guidance about evidence-based multidimensional behavior change. The investigators' second aim is to gather pilot data targeting patient-centered and rehabilitative outcomes such as: increased activity, more sleep time, decreased pain interference and better quality of life; through use of the App and engagement in pain self-management planning.
This project brings together the expertise of skilled exercise physiologists, experienced pain and sleep clinical psychologists, pain specialists, clinical educators, geriatricians, women's health providers, and technology design experts to create a powerful new pipeline for knowledge transfer to patients and providers. Grounded in whole health and integrative approaches, nursing principles, pharmacy practices, physical therapy, and nutrition are also included in the App. The investigators are working as an interprofessional pain-focused team to put the best-available information about non-pharmacological treatments for pain into the hands of Veterans and their primary care providers. The investigators' vision is to improve the lives of Veterans with chronic low back pain, improving access to knowledge and resources and giving Veterans the power to plan their own path to better, more fulfilling living despite chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Web-module for patient education and planning
- Keywords
- Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-module for patient education and planningOther
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan
| Study group | Role | What they receive |
|---|---|---|
| User experiences with MEPS-Pain | Experimental | This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. Receives: Other: Web-module for patient education and planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Tablet-based Application (App) for Creation of Pain Self-management Plan
The investigators will assess user experience with the App, assessing actual use to create a pain self-management plan. Investigators will assess whether participants used the App to create a pain self-management plan on the tablet. The outcome will be the number of participants creating at least one pain self-management plan
Measured: 6 weeks
Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale
The investigators will assess user experience with the App, usability with SUS, modified for App.
Maximum score 50 (good outcome), minimum score 10 (poor outcome).
Measured: 6 weeks
Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed
Total days with plan accessed in the App
Maximum score 42 (good outcome), minimum score 0 (bad outcome).
Measured: 6 weeks
Secondary outcomes (1)
Pain Intensity Completion
DOD-VA Pain instrument
Maximum score 10 (bad outcome), minimum score 1 (good outcome).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start21 Jun 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Maryland Health Care System
- Responsible party
- Sponsor
- Investigators
- Beth B. Hogans, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075487
- Sponsor's protocol ID
- A3169-P
- Other IDs
- I21RX003169-01A1
- Acronym
- MEPS-Pain
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2019
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
- ClinicalTrials.gov ID
- NCT04075487
- Acronym / sponsor ID
- MEPS-Pain / A3169-P
- Conditions
- Chronic Low Back Pain
- Keywords
- Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Maryland Health Care System
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain is the #1 cause of disability and low quality of life in Veterans. Pain is a huge burden- stealing enjoyment, fulfillment, and time. Sometimes surgery, injections, or medications can help but sometimes not. Although no one solution fixes chronic low back pain, there are many treatments that can reduce pain impact and restore quality of life. These treatments involve: movement, psychology, mind-and-body therapies, sleep, and environmental factors. The challenge is how to best coordinate these treatments for chronic low back pain. The investigators have built a prototype mobile application that delivers the latest information to Veterans so they can work with healthcare providers to build their own pain self-management plans. With this new tool, the Veteran has data at hand and chooses their preferred pain self-management activities, making a coordinated plan that can be shared with their healthcare team. The investigators' goal is giving Veterans the knowledge and power to 'plan the work and work the plan' for chronic low back pain: restoring value, fulfillment, and meaning.
Detailed description
Chronic low back pain is highly prevalent in Veterans, and is often resistant to pharmacological management so that non-pharmacological management is required. For many patients, the most effective approach is comprehensive pain management incorporating multiple therapies addressing: physical, mental, mind-body, sleep, safety, and environmental needs. The ultimate outcome is the development of a coordinated multidimensional evidence-based plan for pain self-management (C-MEPPS) tailored to each patient. This approach, while effective, is highly resource intensive and severely constrained by cost and health system factors.
The investigators' goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan. This will represent a novel, scalable, Veteran-driven solution to chronic low back pain aligned with VA strategic objectives 'online navigator tools.empowers Veterans to make decisions.' The investigators are focused on transferring knowledge about evidence-base practices into the primary care context to help Veterans and their healthcare providers manage pain effectively- before it gets worse. The investigators have already developed the App prototype utilizing User-Centered Design principles to optimize the user experience. Our first aim is to develop and pilot test a web-based App for Veterans, including older Veterans and women Veterans, designed to empower each in pain self-management planning: providing access and data-driven guidance about evidence-based multidimensional behavior change. The investigators' second aim is to gather pilot data targeting patient-centered and rehabilitative outcomes such as: increased activity, more sleep time, decreased pain interference and better quality of life; through use of the App and engagement in pain self-management planning.
This project brings together the expertise of skilled exercise physiologists, experienced pain and sleep clinical psychologists, pain specialists, clinical educators, geriatricians, women's health providers, and technology design experts to create a powerful new pipeline for knowledge transfer to patients and providers. Grounded in whole health and integrative approaches, nursing principles, pharmacy practices, physical therapy, and nutrition are also included in the App. The investigators are working as an interprofessional pain-focused team to put the best-available information about non-pharmacological treatments for pain into the hands of Veterans and their primary care providers. The investigators' vision is to improve the lives of Veterans with chronic low back pain, improving access to knowledge and resources and giving Veterans the power to plan their own path to better, more fulfilling living despite chronic low back pain.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
| Arm | Type | Receives |
|---|---|---|
| User experiences with MEPS-Pain | Experimental | Other: Web-module for patient education and planningThis is a pilot study to assess user experience with MEPS-Pain App, there is only one arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans receiving care at the VAMHCS
- frequent or persistent low back pain (> 3 months)
- pain >4 on a 0-10 numeric rating scale
- willing to participate in trial of non-pharmacological therapies for pain
- ability to speak, read, and write as needed for study
Key exclusion criteria (2 listed)
- Veterans with cognitive or visual impairment limiting the ability to engage in self-directed self-management planning
- anticipated surgery or pain procedure during the expected study period
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 |
|---|---|---|
| Web-module for patient education and planningOur goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan | Other | User experiences with MEPS-Pain |
Primary outcome
Use of Tablet-based Application (App) for Creation of Pain Self-management Plan
Time frame: 6 weeks
The investigators will assess user experience with the App, assessing actual use to create a pain self-management plan. Investigators will assess whether participants used the App to create a pain self-management plan on the tablet. The outcome will be the number of participants creating at least one pain self-management plan
Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale
Time frame: 6 weeks
The investigators will assess user experience with the App, usability with SUS, modified for App. Maximum score 50 (good outcome), minimum score 10 (poor outcome).
Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed
Time frame: 6 weeks
Total days with plan accessed in the App Maximum score 42 (good outcome), minimum score 0 (bad outcome).
1 secondary outcome
Pain Intensity Completion
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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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. This study is not recruiting at the moment.
Beth B. Hogans, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-module for patient education and planning in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Tablet-based Application (App) for Creation of Pain Self-management Plan (time frame: 6 weeks). The study lists 3 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 31 Jul 2025.