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Completed

NCT Number: NCT04075487

MEPS-Pain: Personalized Pain Self-management Planning by and for Veterans Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Web-module for patient education and planning

Other

Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan

Primary outcomes

  1. 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

  2. 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).

  3. 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).

Secondary outcomes

  1. Pain Intensity Completion

    Time frame: 6 weeks

    DOD-VA Pain instrument

    Maximum score 10 (bad outcome), minimum score 1 (good outcome).

Other outcomes

  1. Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities

    Time frame: 5 weeks

    Average number activities logged per day in the App during week 5

    Maximum score 12 (good outcome), minimum score 0 (bad outcome).

  2. Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure

    Time frame: 6 weeks

    Pain interference utilizing Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference measure Data are reported as scores in the PROMIS standardized scale derived by summing raw scores and converting this based on published conversion tables.

    100 (bad outcome), 0 (good outcome).

  3. Actigraph Sleep-time Percentage

    Time frame: 6 weeks

    Actigraph sleep-time percentage - percent of time spent in sleep per adjudicated Actigraph recording

    25-30% (good outcome), <20% or >40% (bad outcome)

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • VA Maryland Health Care System

Registry information

Official study title

Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application

Acronym: MEPS-Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2019
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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