Flares of Low Back Pain With Activity Research Study

Completed

Conditions studied: Low Back Pain

In brief

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 types of activities that are beneficial or harmful for patients seen in primary care for LBP. This study will identify those physical activities with short-term (transient) effects on LBP exacerbations (or "flares" of LBP), as well as identifying the long-term (cumulative) effects of such activities on functional recovery.

Key facts

Study ID

NCT04828330

Run by

VA Office of Research and Development

People needed

416

Starts

2021-03-25

Expected to finish

2024-10-24

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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