Primary Parkinsonian Pain Diagnostic Qu… | Clinical Trial

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology service, Clermont-Ferrand, France

About this study

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:

design of the self-questionnaire
appearance validity study
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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: 3PDQ

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: May 7, 2019
Registry last updated: Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed