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Behavioral Intervention
Educational Video for Musculoskeletal Pain (PIVOT Trial)
N/A
Recruiting
Led By Michelle Meyer, PhD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Average pain score ≥4 (0-10 scale) since pain onset
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
PIVOT Trial Summary
This trial will test a brief video to help educate patients about treatment options for musculoskeletal pain, with the aim of improving pain recovery and reducing opioid use.
Who is the study for?
This trial is for adults over 18 with acute musculoskeletal pain who score their pain at least a 4 out of 10. They must be expecting to go home after an emergency or urgent care visit, have a working phone, and speak English. It's not for those critically ill, in long-term care or without homes, pregnant women, prisoners, or if the pain is from non-MSP causes.Check my eligibility
What is being tested?
The study compares two groups: one watches an educational video on managing musculoskeletal pain safely and effectively; the other receives usual care. The goal is to see if the video helps improve recovery and prevents long-term opioid use by following up with patients after 1 and 3 months.See study design
What are the potential side effects?
Since this intervention involves watching an educational video rather than taking medication or undergoing surgery, there are no direct medical side effects associated with it.
PIVOT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My average pain level is 4 or higher on a scale of 0 to 10.
Select...
I am currently experiencing severe muscle pain.
PIVOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined Pain Severity and Interference Scores
Secondary outcome measures
Healthcare Utilization, Number of Visits to ED/urgent care
Healthcare Utilization, Number of Visits to non-ED or Urgent Care Physicians
Opioid Use During the Past Week
+4 morePIVOT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention (video)Experimental Treatment1 Intervention
Educational Video: Participants in this arm will watch an interactive pain management video, sent as a link to their email. Participants will send back answers to the multiple-choice questions posed during the video and/or confirm having watched the video within 5 days (at most) of their acute care visit or discharge from the ED.
Group II: Usual CareActive Control1 Intervention
Participants will receive the typical care provided by medical personnel for their acute pain.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Educational video
2014
Completed Phase 3
~3650
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,521 Previous Clinical Trials
4,196,434 Total Patients Enrolled
1 Trials studying Acute Musculoskeletal Pain
330 Patients Enrolled for Acute Musculoskeletal Pain
Elon UniversityUNKNOWN
1 Previous Clinical Trials
330 Total Patients Enrolled
1 Trials studying Acute Musculoskeletal Pain
330 Patients Enrolled for Acute Musculoskeletal Pain
Centers for Disease Control and PreventionFED
878 Previous Clinical Trials
22,479,056 Total Patients Enrolled
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