Flares of Low Back Pain With Activity Research Study

NCT04828330 | Completed Results

• 2 other identifiers: F3248-RI01RX003248
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Participant-reported "Flares" of Low Back Pain (Aim 1)

  At each study assessment, participants are presented with the flare definition used in this study, which was derived from a previously validated flare definition by Costa et al (2000). The definition is: "A 'flare' of low back pain is a worsening of your low back pain that lasts from hours to weeks". Participants are then asked to self-report whether a flare of low back pain is currently ongoing, by responding to the question "According to the definition above, are you currently experiencing a flare of your low back pain?", with response options of "yes" or "no". These response options define participant-reported flares.

  Flares over 1-year follow-up

• Roland-Morris Disability Questionnaire (Aim 2)

  Roland-Morris Disability Questionnaire (RMDQ) is a back-specific measure of functional limitations ranging from 0 to 24, where 0 reflects no disability and 24 reflects severe disability.

  1-year follow-up

Study Arms (1)

Observational cohort

This is a case-crossover study nested within a cohort study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans age 18-65 years seen in VA primary care for LBP

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

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

• Suri P, Tanus AD, Torres N, Timmons A, Irimia B, Friedly JL, Korpak A, Daniels C, Morelli D, Hodges PW, Costa N, Day MA, Heagerty PJ, Jensen MP. The Flares of Low back pain with Activity Research Study (FLAReS): study protocol for a case-crossover study nested within a cohort study. BMC Musculoskelet Disord. 2022 Apr 21;23(1):376. doi: 10.1186/s12891-022-05281-1.

  PMID: 35449043 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a purely observational study. It was not a randomized trial. Due to the purely observational nature of the study, no adverse event data is provided, as no adverse event monitoring was conducted.

Results Point of Contact

• Title: Dr. Pradeep Suri
• Organization: VA Puget Sound Health Care System

pradeep.suri@va.gov

207-762-1010

Study Officials

• Pradeep Suri, MD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: March 25, 2021
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will endeavor to be able to share IPD when requested by 6 months after the time of publication of the main study findings and publication of longer-term results of the study, provided that appropriate enterprise-level procedures permit this and are in place at the time of.
• Access Criteria: The study team and PI will review each request for IPD, with involvement of local administrative officials or ORD officials as appropriate. Requests will be evaluated for criteria including data safety, the purpose of analyses warranting potential risks of transferring data, security of the transfer. An agreement will specify the duration of time for data to be held before

Locations

US (1)