Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. (PPPCARE II)

February 5, 2026 updated by: University Hospital, Rouen

Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study

The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • Recruiting
        • CHU de Lille
        • Contact:
          • Chloé DELANNOY-ROUSSELIERE, Dr
      • Nîmes, France
        • Recruiting
        • Chu de Nimes
        • Contact:
          • Clarisse ROUX MARSON, Dr
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
          • Catherine CHENAILLER, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient hospitalized in the rheumatology department
  • Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
  • Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion

Exclusion Criteria:

  • Patient with cancer or fibromyalgia already diagnosed at inclusion
  • Patient with poor French language skills
  • Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
  • Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
  • Patient already included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional group
benefiting from a multi-professional intervention around the strong opioid treatment with the aim of setting up a personalized pharmaceutical plan
Other: personalized pharmaceutical plan
multi-professional intervention around strong opioid treatment with targeted pharmaceutical interview
No Intervention: control group
routine management, including medication reconciliation at entry and exit and pharmaceutical analysis of prescriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total duration of treatment in days with strong opioids from day of inclusion
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)
Time Frame: 3 months
3 months
pain assessment (numerical scale) at first patient call after stopping strong opioids
Time Frame: 6 months
6 months
number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Catherine CHENAILLER, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

July 18, 2028

Study Completion (Estimated)

July 18, 2028

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/0426/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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