NCT03346408

Brief Summary

The identification of an addiction to opioid analgesics has become strong recommendation for the purpose of improving the clinical management of the patients. However, the success of the patient's clinical management, in terms of analgesia and treatment of drug dependence, rests on the acceptance of this management by the patient himself. The main objective of this study is to evaluate the factors associated to the discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception that the patient with non-cancer chronic pain has of this dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

November 10, 2017

Last Update Submit

May 28, 2024

Conditions

Keywords

Analgesics

Outcome Measures

Primary Outcomes (1)

  • discrepancy between the assessment of dependence on analgesic drugs by the algologist and the perception of the patient

    The patients will complete a self-questionnaire and the algologist physician will fill another questionnaire.

    Baseline

Secondary Outcomes (2)

  • Consumption drugs

    Baseline

  • Anxiety

    Baseline

Study Arms (1)

Patients

data collection obtained from patient (self-questionnaire) and algologist physician (questionnaire).

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

patient (self-questionnaire) and algologist physician (questionnaire)

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Physician and patients recruited in pain consultations and treatment structures

You may qualify if:

  • suffering from chronic non-cancer pain,
  • taking at least one analgesic medication

You may not qualify if:

  • Patient minor or major protected by the law (under tutelage),
  • Patient with chronic pain of cancerous origin,
  • Opposition of the patient to be included in the study,
  • Patient not having the overall skills to complete a self-questionnaire: major difficulties in understanding the French language and / or reading / writing difficulties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital Bordeaux

Bordeaux, 33000, France

Location

University Hospital Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

University Hospital Limoges

Limoges, 87000, France

Location

University Hospital Marseille

Marseille, 13000, France

Location

University Hospital Montpellier

Montpellier, 34000, France

Location

University Hospital Nice

Nice, 06000, France

Location

University HospitalToulouse

Toulouse, 31052, France

Location

Related Publications (1)

  • Roussin A, Cisse Z, Rousseau V, Roche G, Lestrade C, Cauchie A, Delage N, Donnet A, Van Obberghen E, Wood C, Lapeyre-Mestre M, Cantagrel N. Discordance between pain specialists and patients on the perception of dependence on pain medication: A multi-centre cross-sectional study. Therapie. 2024 Sep-Oct;79(5):543-551. doi: 10.1016/j.therap.2024.01.008. Epub 2024 Apr 12.

MeSH Terms

Conditions

Chronic Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anne ROUSSIN, PharmD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

November 4, 2017

Primary Completion

November 19, 2018

Study Completion

December 18, 2018

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations