Flares of Low Back Pain With Activity Research Study (FLAReS)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    550
  • sponsor
    VA Office of Research and Development
Updated on 27 April 2022
back pain
low back pain

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 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.

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 study nested within a cohort study. This design accounts for measured and unmeasured confounds by using each case as his/her own control- an entirely observational study that is analogous to a crossover experiment- capitalizing on modern mobile health and actigraphy technology. The primary exposures of interest are 10 self-reported physical activities commonly performed during work and activities of daily living, and actigraphy-assessed physical activity. Other exposures of interest include psychological factors, social factors, lifestyle-related factors, and work-related factors. The primary outcomes are participant-reported "flares" of low back pain (Aim 1) and participant-reported back-related functional limitations (mobility and activities of daily living [ADLs]) at 1-year follow-up, as measured by the Roland-Morris Disability Questionnaire. This observational study will include up to 550 Veterans with LBP aged 18 and older recruited from the VA Puget Sound Health Care System (VAPSHCS). The study will not affect participants' medical care in any way. After informed consent, recruitment, and baseline data collection, study participants will complete frequent, serial electronic "e-Questionnaires" using their own personal electronic devices (personal computer [PC], tablet, or smartphone) over the 1-year period of follow-up. Participants may also wear ActiGraph units for the 1st 4 weeks of follow-up. Long-term outcomes will be assessed by extended e-Questionnaires completed at 1-year follow-up. Aim 1 analyses will examine the short-term effects of 10 specific activity categories on participant-reported flares across all study assessments over 1-year follow-up. Aim 2 analyses will examine associations between the frequency of exposure to 10 specific activity categories over weeks 1-4 of follow-up, and long-term functional recovery at 12 months as defined by the RMDQ. All analyses will use a biopsychosocial framework accounting for potential confounders (sociodemographics, psychological factors, etc.) and effect modifiers, and will include sensitivity analyses to examine the robustness of findings and important study assumptions. This study was registered prior to the start of enrollment.

Details
Condition Low Back Pain
Clinical Study IdentifierNCT04828330
SponsorVA Office of Research and Development
Last Modified on27 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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