N/A N=416

Flares of Low Back Pain With Activity Research Study

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT04828330 ↗

Enrolled (actual)

416

Serious AEs

—

Results posted

Nov 2025

Primary outcome: Primary: Participant-reported "Flares" of Low Back Pain (Aim 1) — 7.3 Mean flares per year

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Participant-reported "Flares" of Low Back Pain (Aim 1)	7.3	—
PRIMARY Roland-Morris Disability Questionnaire (Aim 2)	10.0	—

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.

Eligibility Criteria

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

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04828330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.