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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Diagnostic Test: Self-questionnaire 3PDQ

• Registration Number: NCT03940872
• Lead Sponsor: University Hospital, Toulouse

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

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3PDQ self-questionnaire validation	Self-questionnaire 3PDQ	200 patients will be included for this step in 10 French Parkinson expert centers.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Neurology service; 🇫🇷 Toulouse, France

Neurolgoy service; 🇫🇷 Nancy, France

Neurology Service; 🇫🇷 Montpellier, France