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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
English literate patients with chronic non-malignant pain > 3 months > 3/10 > 50% of the time, with no foreseeable or planned surgical solution
Must not have
Non-English speaking patients
Practitioners not able to fully answer questionnaires and participate in training and evaluations in the research study
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
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chronic pain for over 3 months, with no surgery planned.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I am unable to complete questionnaires or participate in study training and evaluations.
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I am unable to complete questionnaires due to a condition like stroke or dementia.
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I have sickle cell disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
714 Previous Clinical Trials
22,887,207 Total Patients Enrolled
4 Trials studying Chronic Pain
3,921 Patients Enrolled for Chronic Pain
Medical College of WisconsinOTHER
628 Previous Clinical Trials
1,178,688 Total Patients Enrolled
1 Trials studying Chronic Pain
39 Patients Enrolled for Chronic Pain
Case Western Reserve UniversityOTHER
307 Previous Clinical Trials
249,445 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
~396 spots leftby Oct 2025