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Abstract Background Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. Methods We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10–12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients’ intervention assignment. Discussion By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. Trial registration ClinicalTrials.gov Identifier: NCT03581123.

OBJECTIVES/GOALS: Chronic low back pain (cLBP) is associated with gait impairments. Gait may serve as an important biomarker for improvement following therapy interventions; however, gait has not been sufficiently studied in relationship to pain and function in cLBP. METHODS/STUDY POPULATION: Adults with cLBP completed a two-minute-walk-test around a 37.5 m oval track while wearing an inertial measurement unit (IMU—Lifeware LLC, Pittsburgh, PA) over the L5 spinous process. Step time average, step time variability, step length, and symmetry (harmonic ratio) were calculated based on linear trunk accelerations, and gait speed was calculated based on distance walked. Participants completed the PEG tool (Pain, Enjoyment, General activity; scores closer to 10 indicate worse pain) to quantify pain intensity/interference and the PROMIS Physical Function SF-6b tool (mean t-scores=50 +/- 10; higher scores indicate better function) to quantify physical function. Pearson correlation coefficient (r) was used to determine strength of associations between gait and pain/physical function. RESULTS/ANTICIPATED RESULTS: Eleven adults (8 female, age 40 +/- 17, pain duration≥3 months) with cLPB participated in this study after completing an informed consent process approved by the University of Pittsburgh Institutional Review Board. Participants with a history of cancer, spinal cord compression, discitis, or activity restrictions prohibiting them from protocol completion were excluded. The mean PEG scores and PROMIS Physical Function t-scores were 2.8 +/- 1.8 and 47.8 +/- 8.2 respectively. There was a moderate-strong correlation between step time average and PEG (r=0.67, p=0.02), and a moderate-strong correlation between gait speed and PROMIS Physical Function (r=0.62, p=0.04). There were no other significant associations. DISCUSSION/SIGNIFICANCE: Gait speed and step time may be important movement biomarkers to consider when evaluating patients with cLBP. Generalizability of results are limited by the small study cohort and this cohort's relatively low pain burden and high level of physical function.