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

NCT03940872 | Completed

• 1 other identifier: RC 31/18/0034
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Parkinsonian central pain; Diagnosis; Primary Parkinsonian Pain Diagnostic Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

3PDQ self-questionnaire validation

EXPERIMENTAL

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

Diagnostic Test: Self-questionnaire 3PDQ

Interventions

Self-questionnaire 3PDQ 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.

3PDQ self-questionnaire validation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (10)

Neurology service

Clermont-Ferrand, France

Location

Neurology service

Lille, France

Location

Neurology service

Lyon, France

Location

Neurology service

Marseille, France

Location

Neurology Service

Montpellier, France

Location

Neurolgoy service

Nancy, France

Location

Neurology service

Nantes, France

Location

Neurology service

Rouen, France

Location

Neurology service

Strasbourg, France

Location

Neurology service

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson Disease; Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine BREFEL COURBON, MCU PH

  Service de Pharmacologie Clinique et Service de Neurologie B8

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 7, 2019
• Study Start: April 23, 2019
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (10)