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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adjusted rate of spinal imaging during 18-month follow-up
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Sutter Institute for Medical ResearchUNKNOWN
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,523 Total Patients Enrolled
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,822,288 Total Patients Enrolled

Media Library

Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04255199 — N/A
Lower Back Pain Clinical Trial 2023: Intervention Highlights & Side Effects. Trial Name: NCT04255199 — N/A
Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04255199 — N/A
Lower Back Pain Research Study Groups: Intervention, Control

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research still feasible for participants?

"As indicated by the clinicaltrials.gov database, this trial is not presently accepting patients. This research was initially posted on October 21st 2020 and recently revised on January 13th 2022. However, there are 286 other studies searching for participants at this time."

Answered by AI
~13 spots leftby Apr 2025