Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 4 of 53157 for:    questionnaire

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940872
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Diagnostic Test: Self-questionnaire 3PDQ Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3PDQ self-questionnaire validation
200 patients will be included for this step in 10 French Parkinson expert centers.
Diagnostic Test: Self-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.





Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940872


Contacts
Layout table for location contacts
Contact: Christine BREFEL COURBON, MCU PH +33 5 61 74 59 76 ext 33 christine.brefel-courbon@univ-tlse3.fr
Contact: Estelle HARROCH, Coordinator +33 5 61 77 55 41 ext 33 harroch.e@chu-toulouse.fr

Locations
Layout table for location information
France
Neurology service Recruiting
Toulouse, France, 31059
Contact: Audrey TOMASIK, PM/DRI    +33 5 61 77 85 97 ext 33    tomasik.a@chu-toulouse.fr   
Contact: Estelle HARROCH, Coordinator    +33 5 61 77 55 41 ext 33    harroch.e@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Christine BREFEL COURBON, MCU PH Service de Pharmacologie Clinique et Service de Neurologie B8

Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03940872    
Other Study ID Numbers: RC 31/18/0034
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Parkinson Disease
Parkinsonian central pain
Diagnosis
Primary Parkinsonian Pain Diagnostic Questionnaire
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases