Low Back PainFLAReSNCT04828330
Flares of Low Back Pain With Activity Research Study
An observational study of Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 24 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans age 18-65 years seen in VA primary care for LBP
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain
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.
Read the 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 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | This is a case-crossover study nested within a cohort study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start25 Mar 2021
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Pradeep Suri, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828330
- Sponsor's protocol ID
- F3248-R
- Other IDs
- I01RX003248
- Acronym
- FLAReS
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2021
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only completely deidentified/anonymized versions of datasets would be shared, provided that appropriate VA enterprise-level procedures permit this and are in place at the time of. These procedures do not currently exist but are expected in the future. Sharing would only take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset, and would require a properly submitted FOIA request. Due to the project's waiver of HIPAA authorization, a subset of the data cannot be disclosed to a non-Federal entity. Electronic versions of final data sets will be maintained locally in a secure manner until enterprise-level resources become available for long-term storage.
Publications
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.
PubMed 35449043
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activities on Pain and Functional Recovery in Low Back Pain
- ClinicalTrials.gov ID
- NCT04828330
- Acronym / sponsor ID
- FLAReS / F3248-R
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | –This is a case-crossover study nested within a cohort study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans age 18-65 years seen in VA primary care for LBP
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant-reported "Flares" of Low Back Pain (Aim 1)
Time frame: Flares over 1-year follow-up
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.
Roland-Morris Disability Questionnaire (Aim 2)
Time frame: 1-year follow-up
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35449043Suri 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.
- Individual participant dataSharing planned: Yes. Only completely deidentified/anonymized versions of datasets would be shared, provided that appropriate VA enterprise-level procedures permit this and are in place at the time of. These procedures do not currently exist but are expected in the future. Sharing would only take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset, and would require a properly submitted FOIA request. Due to the project's waiver of HIPAA authorization, a subset of the data cannot be disclosed to a non-Federal entity. Electronic versions of final data sets will be maintained locally in a secure manner until enterprise-level resources become available for long-term storage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Suri, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-reported "Flares" of Low Back Pain (Aim 1) (time frame: Flares over 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04828330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.