NCT04075487: MEPS-Pain

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

Completed NA Results posted Last updated 31 July 2025

What this trial tests

NA trial testing Web-module for patient education and planning in Chronic Low Back Pain in 20 participants. Completed in 31 July 2023.

Timeline

21 June 2022

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	21 June 2022
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Web-module for patient education and planning

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Use of Tablet-based Application (App) for Creation of Pain Self-management Plan Primary · 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

Group	Value	95% CI
User Experiences With MEPS-Pain	19

Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale Primary · 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).

Group	Value	95% CI
User Experiences With MEPS-Pain	39	± 2.0

Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed Primary · 6 weeks

Total days with plan accessed in the App Maximum score 42 (good outcome), minimum score 0 (bad outcome).

Group	Value	95% CI
User Experiences With MEPS-Pain	20	0 – 38

Pain Intensity Completion Secondary · 6 weeks

DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome).

Group	Value	95% CI
User Experiences With MEPS-Pain	5.1	± .57

Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities Secondary · 5 weeks

Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome).

Group	Value	95% CI
User Experiences With MEPS-Pain	7.2	± 3.7

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

Group	Value	95% CI
User Experiences With MEPS-Pain	59.0	± 7.4

Actigraph Sleep-time Percentage Secondary · 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)

Group	Value	95% CI
User Experiences With MEPS-Pain	22.3	± 8.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.