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

Parkinson Disease Clinical Trial

— 3PDQ  

Official title:

Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940872
• Other study ID #: RC 31/18/0034
• Status: Completed
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: December 14, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	Neurology service	Clermont-Ferrand
France	Neurology service	Lille
France	Neurology service	Lyon
France	Neurology service	Marseille
France	Neurology Service	Montpellier
France	Neurolgoy service	Nancy
France	Neurology service	Nantes
France	Neurology service	Rouen
France	Neurology service	Strasbourg
France	Neurology service	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)	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	4 months