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Watchful Waiting Strategy for Lower Back Pain

N/A

Waitlist Available

Led By Joshua J Fenton, MD, MPH

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months following date of first spi visit

Summary

This trial will test whether using actors to portray patients can help doctors learn how to better offer watchful waiting as a means of avoiding low-value spinal imaging for patients with acute low back pain.

Who is the study for?

This trial is for full-time or part-time primary care and urgent care clinicians with at least two years of experience in the health system. It includes nurse practitioners and physician assistants practicing as such clinicians who plan to continue their practice throughout the trial.

What is being tested?

The study tests if standardized patients (actors) can train clinicians to use 'watchful waiting' instead of immediately turning to spinal imaging for acute low back pain, aiming to reduce unnecessary testing while preserving patient-doctor relationships.

What are the potential side effects?

Since this trial involves communication strategies rather than medical treatments, there are no direct side effects like those associated with drugs or surgical interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months following date of first spi visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months following date of first spi visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months following date of first spi visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adjusted rate of spinal imaging during 18-month follow-up

Secondary study objectives

Adjusted rate of advanced spinal imaging during 18-month follow-up

Adjusted rate of diagnostic test ordering during 18-month follow-up

Adjusted rate of lumbar x-ray imaging during 18-month follow-up

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Primary care and urgent care clinicians randomized to the intervention arm will receive two to three visits with a standardized patient instructor who will physicians how to facilitate patient acceptance of a watchful waiting strategy with regard to spinal imaging in the context of acute low back pain.

Group II: ControlPlacebo Group1 Intervention

Primary care and urgent care clinicians randomized to the control arm will receive a single visit with a standardized patient who simulates a visit with patient with acute low back pain but will deliver no instruction on patient communication or other content.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention

2011

Completed Phase 4

~73780

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