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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 below

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I am 18 years old or older.

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My average pain level is 4 or higher on a scale of 0 to 10.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

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 more

PIVOT 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

~3610

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,842 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

875 Previous Clinical Trials

22,477,202 Total Patients Enrolled

Frequently Asked Questions

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

Is the cutoff for this experiment limited to those under sixty years of age?

"Adhering to the criteria set forth for inclusion, those wishing to be part of this medical experiment must fall between 18 and 99 years old."

Answered by AI

Are there any vacancies available for this clinical trial?

"According to the clinicaltrials.gov registry, this study is not presently looking for participants as of September 6th 2023. However, there are 448 other active trials that could benefit from your involvement."

Answered by AI

Is it possible to join in this research initiative?

"To be accepted into this research project, individuals must suffer from chronic pain and be between 18 to 99 years old. The total patient recruitment goal is 200 people."

Answered by AI

Recent research and studies

TrialsJournal

Randomized Controlled Pilot Study of an Educational Video Plus Telecare for the Early Outpatient Management of Musculoskeletal Pain Among Older Emergency Department Patients

Platts-Mills, Timothy F., Allison G. Hollowell, Gary F. Burke, Sheryl Zimmerman, Joseph A. Dayaa, Benjamin R. Quigley, Montika Bush, Morris Weinberger, and Mark A. Weaver. 2018. “Randomized Controlled Pilot Study of an Educational Video Plus Telecare for the Early Outpatient Management of Musculoskeletal Pain Among Older Emergency Department Patients”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-017-2403-8.

TrialsJournal

Brief Educational Video Plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: An Update to the Study Protocol for a Randomized Controlled Trial

Hurka-Richardson, Karen, Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Eugenia Quackenbush, et al.. 2022. “Brief Educational Video Plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: An Update to the Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06310-z.

clinicaltrials.govStudy

The Pain Intervention Via Video Optimization Trial

2023. "The Pain Intervention Via Video Optimization Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06035575.