Chronic Low Back Pain
Conditions
Keywords
Low back pain
Brief 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. 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.
Interventions
OTHERWeb-module for patient education and planning
Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan
Sponsors
VA Maryland Health Care System
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study of feasibility and user experience of minimal risk App for pain self-management intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of Tablet-based Application (App) for Creation of Pain Self-management Plan | 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) Use for Pain Self-management Planning: Total Days With Plan Accessed | 6 weeks | Total days with plan accessed in the App Maximum score 42 (good outcome), minimum score 0 (bad outcome). |
| Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Completion | 6 weeks | DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities | 5 weeks | Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome). |
| Actigraph Sleep-time Percentage | 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) |
| Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure | 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). |
Countries
United States
Participant flow
Recruitment details
6/21/2022-7/15/2023; recruitment from medical center through clinic outreach and advertisement on research bulletin board
Participants by arm
| Arm | Count |
|---|---|
| User Experiences With MEPS-Pain This is a pilot study to assess user experience with MEPS-Pain App, there is only one arm.
Web-module for patient education and planning: Our goal is a mobile web-based application (App) that provides immediate feedback to Veterans seeking to develop their own pain self-management plan | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | User Experiences With MEPS-Pain |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 61.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
| Veteran | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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).
Time frame: 6 weeks
Population: Completed system usability scale for the App
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| User Experiences With MEPS-Pain | Tablet-based Application (App) for Pain Self-management Planning: Patient Experience Via System Usability Scale | 39 sum score | Standard Error 2 |
Primary
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).
Time frame: 6 weeks
Population: Tablet-based application (App) use for pain self-management planning: total days with plan accessed
| Arm | Measure | Value (MEAN) |
|---|---|---|
| User Experiences With MEPS-Pain | Tablet-based Application (App) Use for Pain Self-management Planning: Total Days With Plan Accessed | 20 Days plan accessed |
Primary
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
Time frame: 6 weeks
Population: Completed creation of a pain plan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| User Experiences With MEPS-Pain | Use of Tablet-based Application (App) for Creation of Pain Self-management Plan | 19 Participants |
Secondary
Pain Intensity Completion
DOD-VA Pain instrument Maximum score 10 (bad outcome), minimum score 1 (good outcome).
Time frame: 6 weeks
Population: Pain intensity
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| User Experiences With MEPS-Pain | Pain Intensity Completion | 5.1 score on a scale | Standard Error 0.57 |
Other Pre-specified
Actigraph Sleep-time Percentage
Actigraph sleep-time percentage - percent of time spent in sleep per adjudicated Actigraph recording 25-30% (good outcome), \<20% or \>40% (bad outcome)
Time frame: 6 weeks
Population: Week 6, final visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| User Experiences With MEPS-Pain | Actigraph Sleep-time Percentage | 22.3 percent time in sleep | Standard Deviation 8.7 |
Other Pre-specified
Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure
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
Population: Participants initiating the study and not withdrawing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| User Experiences With MEPS-Pain | Pain Interference as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Measure | 59.0 score on a scale | Standard Deviation 7.4 |
Other Pre-specified
Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities
Average number activities logged per day in the App during week 5 Maximum score 12 (good outcome), minimum score 0 (bad outcome).
Time frame: 5 weeks
Population: Average number activities logged per day in the App during week 5 on the days used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| User Experiences With MEPS-Pain | Tablet-based Application (App) Use for Pain Self-management Planning: Daily Logging of Activities | 7.2 number activities logged per day of use | Standard Deviation 3.7 |