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4PCP Training for Chronic Pain (4PCP Trial)

N/A
Recruiting
Led By Thomas Chelimsky, M.D.
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have been a patient in the practice across 2 established visits
English literate patients with chronic non-malignant pain > 3 months > 3/10 > 50% of the time, with no foreseeable or planned surgical solution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
Awards & highlights

4PCP Trial Summary

This trial seeks to improve chronic pain treatment & outcomes for all, potentially at a lower cost. A startup will provide the program & results will show if it works.

Who is the study for?
This trial is for primary care practitioners with patients suffering from chronic pain, who can complete questionnaires and engage in a training program. It's also for English-speaking patients aged 14-80 with long-term non-cancer pain that's moderate to severe most of the time, without plans for surgery. Excluded are those unable to participate fully or answer questions due to conditions like dementia.Check my eligibility
What is being tested?
The study tests a course called '4PCP' designed to reduce opioid prescriptions and improve patient outcomes in chronic pain management. The effectiveness of this potentially cost-saving approach provided by PainSTakers, LLC will be evaluated on clinical outcomes, aiming later at proving economic benefits.See study design
What are the potential side effects?
Since this intervention involves an educational course rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect effects related to changes in pain management practices.

4PCP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have visited this medical practice at least twice before.
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I have had chronic pain for over 3 months, with no surgery planned.
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I am between 14 and 80 years old and speak English.

4PCP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and upon enrollment, 1 week before practitioner course participation, up to 3 years after practitioner course participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient Participant Pain, Enjoyment of Life and General Activity (PEG-3)
Change in Practitioner Chronic Pain Physician Perspectives Questionnaire (CPPP)
Number of Patient Participants whose opioid dose tapered
Secondary outcome measures
Change in Patient Participant Generalized Anxiety Disorder (GAD-7)
Change in Patient Participant Pain Catastrophizing Scale (PCS)
Change in Patient Participant Pain Interference (PI)
+6 more

4PCP Trial Design

1Treatment groups
Experimental Treatment
Group I: 4PCP Course (for practitioners only)Experimental Treatment1 Intervention
All enrolled practitioners will be assigned to take the 4PCP course as the intervention. Patients will not be assigned to the course and will only be completing surveys before and after their practitioner completes 4PCP.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
697 Previous Clinical Trials
22,883,808 Total Patients Enrolled
4 Trials studying Chronic Pain
3,921 Patients Enrolled for Chronic Pain
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,161,395 Total Patients Enrolled
1 Trials studying Chronic Pain
39 Patients Enrolled for Chronic Pain
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
258,832 Total Patients Enrolled
4 Trials studying Chronic Pain
4,195 Patients Enrolled for Chronic Pain

Media Library

4PCP Training Clinical Trial Eligibility Overview. Trial Name: NCT05580419 — N/A
Chronic Pain Research Study Groups: 4PCP Course (for practitioners only)
Chronic Pain Clinical Trial 2023: 4PCP Training Highlights & Side Effects. Trial Name: NCT05580419 — N/A
4PCP Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580419 — N/A

Frequently Asked Questions

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

Are there any existing opportunities to join this clinical trial?

"According to clinicaltrials.gov, this medical trial is actively recruiting patients. The study was first publicized on November 9th 2022 and the most recent update came a week later on November 16th 2022."

Answered by AI

Who is eligible to join this medical research project?

"This trial is accepting 1188 individuals aged between 14 and 80 who suffer from persistent pain. Prospective participants must be physicians in primary care, have a minimum of one year's experience with the practice, understand English both orally and written, possess an identifiable patient base afflicted by chronic non-malignant pain for over three months at a rate of intensity greater than 3/10 more than half the time without any impending or scheduled surgical procedures. Furthermore, they should also demonstrate capability to answer surveys and partake in research training sessions as well as assessments."

Answered by AI

Does the protocol of this clinical investigation encompass individuals aged eighty and above?

"Consistent with the prerequisites for study participation, patients aged 14 to 80 are eligible."

Answered by AI

What aims is this trial endeavoring to accomplish?

"This trial will focus on the Participant Pain, Enjoyment of Life and General Activity (PEG-3) metric over a period spanning 6 months before to 3 years after training. Secondary objectives include changes in Practitioner Chronic pain Attitudes and Beliefs Questionnaire (PABS-PT), Participant Pain Interference (PI), and Participant Generalized Anxiety Disorder (GAD-7)."

Answered by AI

What is the cumulative tally of participants enrolled in this experiment?

"Affirmative. Clinicaltrials.gov data displays that this trial is actively enrolling patients, since November 9th 2022. A total of 1188 individuals are to be recruited across 5 clinical centers and the study was most recently updated on 16th November 2022."

Answered by AI

How many locations have been approved to execute this trial?

"Presently, 5 different sites are recruiting patients for this trial. These locations include Milwaukee, Madison and Cleveland with two additional centres available. If you decide to join the study, it is important to choose a clinic close by in order to minimize commuting needs."

Answered by AI

Who else is applying?

What site did they apply to?
Medical College of Wisconsin
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Impact of 4PCP on Practitioner and Patient Outcomes
2023. "Impact of 4PCP on Practitioner and Patient Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05580419.
All > Pcp
~673 spots leftby Oct 2025
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