Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
NCT Number: NCT04075487
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own 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
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).
Time frame: 6 weeks
Total days with plan accessed in the App
Maximum score 42 (good outcome), minimum score 0 (bad outcome).
Time frame: 6 weeks
DOD-VA Pain instrument
Maximum score 10 (bad outcome), minimum score 1 (good outcome).
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).
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).
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)
VA Office of Research and Development
Fed
Evidence-Based Multidimensional Pain Self-Management Planning: Personalized by and for Veterans Via Web-Based Application
Acronym: MEPS-Pain
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.
Published trials that share one or more normalized conditions with this study.
NCT07727525
Back Pain, Chronic Low Back Pain
Rawalpindi, Punjab Province, Pakistan
View Trial DetailsNCT07694219
Back Pain, Chronic Low Back Pain
Lahore, Pakistan
View Trial DetailsNCT06810245
Agnosia, Arthritis
Phoenix, Arizona, United States
View Trial DetailsNCT04747314
Anxiety Disorders, Back Pain
Chestnut Hill, Massachusetts, United States
View Trial Details