Trial Outcomes & Findings for Flares of Low Back Pain With Activity Research Study (NCT NCT04828330)

Last Updated: 2025-11-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

416 participants

Primary outcome timeframe

Flares over 1-year follow-up

Results posted on

2025-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Observational Cohort This is a case-crossover study nested within a cohort study.
Overall Study STARTED	416
Overall Study COMPLETED	416
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

6 participants had missing data for sex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational Cohort n=416 Participants This is a case-crossover study nested within a cohort study.
Age, Continuous	47.5 years STANDARD_DEVIATION 10.9 • n=416 Participants
Sex: Female, Male Female	306 Participants n=410 Participants • 6 participants had missing data for sex
Sex: Female, Male Male	104 Participants n=410 Participants • 6 participants had missing data for sex
Ethnicity (NIH/OMB) Hispanic or Latino	52 Participants n=416 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	328 Participants n=416 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	36 Participants n=416 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=416 Participants
Race (NIH/OMB) Asian	21 Participants n=416 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=416 Participants
Race (NIH/OMB) Black or African American	54 Participants n=416 Participants
Race (NIH/OMB) White	279 Participants n=416 Participants
Race (NIH/OMB) More than one race	35 Participants n=416 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=416 Participants
Roland-Morris Disability Questionnaire	12.2 units on a scale STANDARD_DEVIATION 5.8 • n=416 Participants

PRIMARY outcome

Timeframe: Flares over 1-year follow-up

Outcome measures

Outcome measures
Measure	Observational Cohort n=416 Participants This is a case-crossover study nested within a cohort study.
Participant-reported "Flares" of Low Back Pain (Aim 1)	7.3 Mean flares per year Standard Deviation 7.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Observational Cohort n=416 Participants This is a case-crossover study nested within a cohort study.
Roland-Morris Disability Questionnaire (Aim 2)	10.0 Units on a scale Standard Deviation 6.3

Adverse Events

Observational Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pradeep Suri

VA Puget Sound Health Care System

Phone: 207-762-1010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place