Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2022-12-14

Brief Summary

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

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Detailed Description

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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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3PDQ self-questionnaire validation

200 patients will be included for this step in 10 French Parkinson expert centers.

Group Type EXPERIMENTAL

Self-questionnaire 3PDQ

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No