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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03940872
Acronym
3PDQ
Enrollment
227
Registered
2019-05-07
Start date
2019-04-23
Completion date
2022-12-14
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

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

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

Interventions

DIAGNOSTIC_TESTSelf-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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)4 monthsDevelop 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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORChristine BREFEL COURBON, MCU PH

Service de Pharmacologie Clinique et Service de Neurologie B8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026