Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-questionnaire 3PDQ
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson Disease, Parkinsonian central pain, Diagnosis, Primary Parkinsonian Pain Diagnostic Questionnaire
Eligibility Criteria
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)
Sites / Locations
- Neurology service
- Neurology service
- Neurology service
- Neurology service
- Neurology Service
- Neurolgoy service
- Neurology service
- Neurology service
- Neurology service
- Neurology service
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3PDQ self-questionnaire validation
Arm Description
200 patients will be included for this step in 10 French Parkinson expert centers.
Outcomes
Primary Outcome Measures
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03940872
First Posted
April 25, 2019
Last Updated
February 10, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03940872
Brief Title
Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
Acronym
3PDQ
Official Title
Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)
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:
design of the self-questionnaire
appearance validity study
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Parkinsonian central pain, Diagnosis, Primary Parkinsonian Pain Diagnostic Questionnaire
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3PDQ self-questionnaire validation
Arm Type
Experimental
Arm Description
200 patients will be included for this step in 10 French Parkinson expert centers.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-questionnaire 3PDQ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
Description
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
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL COURBON, MCU PH
Organizational Affiliation
Service de Pharmacologie Clinique et Service de Neurologie B8
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology service
City
Clermont-Ferrand
Country
France
Facility Name
Neurology service
City
Lille
Country
France
Facility Name
Neurology service
City
Lyon
Country
France
Facility Name
Neurology service
City
Marseille
Country
France
Facility Name
Neurology Service
City
Montpellier
Country
France
Facility Name
Neurolgoy service
City
Nancy
Country
France
Facility Name
Neurology service
City
Nantes
Country
France
Facility Name
Neurology service
City
Rouen
Country
France
Facility Name
Neurology service
City
Strasbourg
Country
France
Facility Name
Neurology service
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
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