Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)
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|ClinicalTrials.gov Identifier: NCT03940872|
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Diagnostic Test: Self-questionnaire 3PDQ||Not Applicable|
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
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire|
|Actual Study Start Date :||April 23, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940872
|Contact: Christine BREFEL COURBON, MCU PH||+33 5 61 74 59 76 ext firstname.lastname@example.org|
|Contact: Estelle HARROCH, Coordinator||+33 5 61 77 55 41 ext email@example.com|
|Principal Investigator:||Christine BREFEL COURBON, MCU PH||Service de Pharmacologie Clinique et Service de Neurologie B8|