3PDQ: Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
Study Details
Study Description
Brief Summary
Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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design of the self-questionnaire
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appearance validity study
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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:
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Appearance validity study : 6 months
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Validity study : 20 months
Duration of participation for each patient:
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Appearance validity study : about 30 min
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Validity study : 3 days maximum Total duration of the study: (with results analysis): 3 years
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with Parkinson Disease (PD)
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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
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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
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Patients who have stable analgesic medication during the study
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Patients who understand and speak fluently French
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Patients with health insurance
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Patients who signed the written informed consent form
Exclusion Criteria:
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Patients with severe depression according to Diagnostic and Statistical Manual (DSM) V criteria
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Analgesic medication modified recently (less than 1month)
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Patients with psycho-actives substances or alcohol abused
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Patients with cognitive impairment (MoCA score < 25)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neurology service | Clermont-Ferrand | France | ||
| 2 | Neurology service | Lille | France | ||
| 3 | Neurology service | Lyon | France | ||
| 4 | Neurology service | Marseille | France | ||
| 5 | Neurology Service | Montpellier | France | ||
| 6 | Neurolgoy service | Nancy | France | ||
| 7 | Neurology service | Nantes | France | ||
| 8 | Neurology service | Rouen | France | ||
| 9 | Neurology service | Strasbourg | France | ||
| 10 | Neurology service | Toulouse | France | 31059 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Christine BREFEL COURBON, MCU PH, Service de Pharmacologie Clinique et Service de Neurologie B8
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC 31/18/0034