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Behavioral Intervention

Usual ED Care plus Health Coaching for Lower Back Pain

N/A
Recruiting
Led By Rogelio Coronado, PT, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years of age or older
Chief complaint of musculoskeletal LBP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after ed discharge
Awards & highlights

Study Summary

This trial aims to see if remote health coaching, offered along with regular care, is helpful for patients with severe lower back pain who come to the emergency room. They want to find out if this type

Who is the study for?
This trial is for patients who have had an acute episode of chronic low back pain and visited the emergency department. Participants should be willing to receive health coaching or education after discharge, and able to complete follow-ups at 3 and 6 months. Specific inclusion or exclusion criteria are not provided.Check my eligibility
What is being tested?
The study is testing if a remotely-delivered health coaching program, along with usual care from the ED, can help people with chronic low back pain. It compares this approach to just getting educational materials plus usual care. The success will be measured by how feasible and acceptable these methods are.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like health coaching and education, there aren't typical side effects as seen in drug trials. However, participants may experience varying levels of satisfaction or changes in their perception of back pain management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am experiencing lower back pain.
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I have had lower back pain for more than 3 months, with pain on most days in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after ed discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after ed discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability - Acceptability of Intervention Measure (AIM)
Acceptability - Intervention Appropriateness Measure (IAM)
Feasibility - Feasibility of Intervention Measure (FIM)
+4 more
Secondary outcome measures
Disability - Oswestry Disability Index
Pain Intensity - Patient-Reported Outcomes Measurement Information System
Pain Interference - Patient-Reported Outcomes Measurement Information System
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Usual ED Care plus Health CoachingExperimental Treatment1 Intervention
Group II: Usual ED Care plus EducationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
866 Previous Clinical Trials
672,635 Total Patients Enrolled
Rogelio Coronado, PT, PhDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Kristin Archer, PhD, DPTStudy DirectorVanderbilt University Medical Center
2 Previous Clinical Trials
102 Total Patients Enrolled
~27 spots leftby Sep 2025
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