Status:
COMPLETED
Flares of Low Back Pain With Activity Research Study
Lead Sponsor:
VA Office of Research and Development
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Brief Summary
Low back pain (LBP) is the most common cause of disability worldwide. Although general activity is encouraged in the treatment of LBP, there is limited empirical information available on the specific ...
Detailed Description
This research will use a novel approach to distinguish the short-term effects on LBP of physical activities from the long-term effects of such activities, by conducting a longitudinal case-crossover s...
Eligibility Criteria
Inclusion
- Veterans age 18-65 years seen in VA primary care for LBP
- Must have regular access (every day, during most hours of the day) to a computer, tablet, or smartphone with internet access at home or at work
- Basic computer literacy
- Having a mobile phone capable of receiving alerts using text messages
- Must be able to understand and read English, sufficient to provide informed consent and validly complete the study assessments.
- Participants must complete basic requirements during a 2-week run-in period, such as completing e-Questionnaires
- After approval by the study sponsor and IRB, an additional inclusion criterion was added beginning on 3/10/2023, to also allow the inclusion of other patients with low back pain. The inclusion criteria were broadened to include other patients seen for low back pain in the health care system, including three "specific" subgroups of Veterans with low back pain: (1) Veterans with lumbosacral facet-mediated low back pain; (2) Veterans with sacroiliac joint-mediated low back pain; and (3) Veterans with spondylolytic spondylolistheses.
Exclusion
- Red flag' spine conditions (spinal cord injury, infection, malignancy, fracture) or spondyloarthropathy
- Pregnancy
- Prisoners or incarcerated
- Severe active medical or psychiatric comorbidities likely to be a barrier to study participation including completing frequent, serial assessments (e.g., metastatic cancer).
- Thoracolumbar spine surgery in the past 1 year
- Other major orthopedic surgery potentially impeding normal physical activities (such as surgeries involving the hip, knee, ankle, shoulder, elbow, wrist joints) within the past 6 months, or major abdominal or chest surgery within the past 6 months.\*
- Planned major orthopedic, abdominal, or chest surgery in the next 2 months.
Key Trial Info
Start Date :
March 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT04828330
Start Date
March 25 2021
End Date
October 24 2024
Last Update
November 19 2025
Active Locations (1)
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1
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532