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

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

Sponsors

Lead sponsor: University Hospital, Toulouse

Source 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

Overall Status Recruiting
Start Date April 23, 2019
Completion Date May 2021
Primary Completion Date May 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
3PDQ questionnaire 4 months
Enrollment 200
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Self-questionnaire 3PDQ

Description: 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.

Arm group label: 3PDQ self-questionnaire validation

Eligibility

Criteria:

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)

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Christine BREFEL COURBON, MCU PH Principal Investigator Service de Pharmacologie Clinique et Service de Neurologie B8
Overall Contact

Last name: Christine BREFEL COURBON, MCU PH

Phone: +33 5 61 74 59 76

Phone ext: 33

Email: [email protected]

Location
facility status contact contact_backup
Neurology service Recruiting Audrey TOMASIK, PM/DRI +33 5 61 77 85 97 33 [email protected]
Location Countries

France

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: 3PDQ self-questionnaire validation

Arm group type: Experimental

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

Acronym 3PDQ
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov