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Behavioral Intervention
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
Must not have
Requires hospitalization for an acute medical condition or active comorbidity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months after ed discharge, 6 months after ed discharge
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am 18 years old or older.
Select...
I am experiencing lower back pain.
Select...
I have had lower back pain for more than 3 months, with pain on most days in the last 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently hospitalized for a serious health issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after ed discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after ed discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability - Acceptability of Intervention Measure (AIM)
Acceptability - Intervention Appropriateness Measure (IAM)
Feasibility - Feasibility of Intervention Measure (FIM)
+4 moreSecondary study objectives
Disability - Oswestry Disability Index
Pain Intensity - Patient-Reported Outcomes Measurement Information System
Pain Interference - Patient-Reported Outcomes Measurement Information System
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
906 Previous Clinical Trials
934,529 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
Sean Collins, MDStudy DirectorVanderbilt University Medical Center
3 Previous Clinical Trials
541 Total Patients Enrolled