Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)

February 10, 2023 updated by: University Hospital, Toulouse

Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire

Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to develop and validate a French self-questionnaire to diagnose parkinsonian primary : the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ). It will allow clinicians to distinguish this pain from the other pain of the parkinsonian patient (whether or not related to Parkinson's disease).

The development and validation of the 3PDQ self-questionnaire will take place in 3 sequential steps:

  1. design of the self-questionnaire
  2. appearance validity study
  3. validation of the self-questionnaire

Participants :

Appearance validity study: 40 painful parkinsonian patients Validation study: 200 painful parkinsonian patients (10 patients per item)

Duration of the study :

Duration of the inclusion period:

  • Appearance validity study : 6 months
  • Validity study : 20 months

Duration of participation for each patient:

  • Appearance validity study : about 30 min
  • Validity study : 3 days maximum Total duration of the study: (with results analysis): 3 years

Study Type

Interventional

Enrollment (Actual)

227

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 Locations

  • France
      • Clermont-Ferrand, France
        • Neurology service
      • Lille, France
        • Neurology service
      • Lyon, France
        • Neurology service
      • Marseille, France
        • Neurology service
      • Montpellier, France
        • Neurology service
      • Nancy, France
        • Neurolgoy service
      • Nantes, France
        • Neurology service
      • Rouen, France
        • Neurology service
      • Strasbourg, France
        • Neurology service
      • Toulouse, France, 31059
        • Neurology service

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Parkinson Disease (PD)
  • Patients who have chronic pain (for at least 3months) moderate to severe (intensity ≥ 4/10 on visual analogue scale from 0 to 10) specific or unspecific to PD
  • Patients who have one type of pain or different type of pain: in this case, patients should suffered from one predominant pain and be able to identify it
  • Patients who have stable analgesic medication during the study
  • Patients who understand and speak fluently French
  • Patients with health insurance
  • Patients who signed the written informed consent form

Exclusion Criteria:

  • Patients with severe depression according to Diagnostic and Statistical Manual (DSM) V criteria
  • Analgesic medication modified recently (less than 1month)
  • Patients with psycho-actives substances or alcohol abused
  • Patients with cognitive impairment (MoCA score < 25)

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3PDQ self-questionnaire validation
200 patients will be included for this step in 10 French Parkinson expert centers.
Diagnostic test: Self-questionnaire 3PDQ

Visit 1 : - The patient will have to complete the 3PDQ self-questionnaire. - The investigator will conduct an interrogation and a neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.

Visit 2 : - The patient will have to complete the 3PDQ self-questionnaire.

- An investigator, obligatorily different from the investigator of the visit 1, will conduct to the same interrogation and the same neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.

Visits 1 and 2 can be made on the same day. In this case the patient will fill the 3PDQ self questionnaire only once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
Time Frame: 4 months

Develop and validate a French self-questionnaire to diagnose parkinsonian primary pain, this symptom questionnaire will be called 3PDQ for Primary Parkinsonian Pain Questionnaire. This questionnaire present 5 items: Location of the most embarrassing pain, Characteristics of pain, if the pain is associated in the same area with one or more of the symptoms, by what is the pain caused or increased, what criteria does the pain correspond to.

It is sufficient for each item to check the corresponding boxes
4 months

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Christine BREFEL COURBON, MCU PH, Service de Pharmacologie Clinique et Service de Neurologie B8

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)

April 23, 2019

Primary Completion (ACTUAL)

December 14, 2022

Study Completion (ACTUAL)

December 14, 2022

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 31/18/0034

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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