Clinical trial NCT03940872: Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
Official title: Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Parkinsonian central pain
Diagnosis
Primary Parkinsonian Pain Diagnostic Questionnaire
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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

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)

Primary outcomes:
measure: Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Neurology service
city: Lille
country: France
facility: Neurology service
city: Lyon
country: France
facility: Neurology service
city: Marseille
country: France
facility: Neurology service
city: Montpellier
country: France
facility: Neurology Service
city: Nancy
country: France
facility: Neurolgoy service
city: Nantes
country: France
facility: Neurology service
city: Rouen
country: France
facility: Neurology service
city: Strasbourg
country: France
facility: Neurology service
city: Toulouse
country: France
facility: Neurology service
Study officials:
affiliation: Service de Pharmacologie Clinique et Service de Neurologie B8
name: Christine BREFEL COURBON, MCU PH
role: PRINCIPAL_INVESTIGATOR
References: