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Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)

T

Toulouse University Hospital

Status

Completed

Conditions

Parkinson Disease

Treatments

Diagnostic Test: Self-questionnaire 3PDQ

Study type

Interventional

Funder types

Other

Identifiers

NCT03940872
RC 31/18/0034

Details and patient eligibility

About

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

Full 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

Enrollment

227 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

227 participants in 1 patient group

3PDQ self-questionnaire validation
Experimental group
Description:
200 patients will be included for this step in 10 French Parkinson expert centers.
Treatment:
Diagnostic Test: Self-questionnaire 3PDQ

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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