Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)
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| ClinicalTrials.gov Identifier: NCT03940872 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2019
Last Update Posted : November 20, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Diagnostic Test: Self-questionnaire 3PDQ | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 3PDQ self-questionnaire validation
200 patients will be included for this step in 10 French Parkinson expert centers.
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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 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
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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)
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
| 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 |
| France | |
| Neurology service | Recruiting |
| Clermont-Ferrand, France | |
| Contact: Ana Marques 05 61 14 59 62 | |
| Principal Investigator: Ana Marques | |
| Neurology service | Recruiting |
| Lille, France | |
| Contact: Luc Defebvre | |
| Principal Investigator: Luc Defebvre | |
| Neurology service | Recruiting |
| Lyon, France | |
| Contact: Isabelle Roullet Solignac 4 72 35 76 62 ext +33 isabelle.roullet-solignac@chu-lyon.fr | |
| Neurology service | Recruiting |
| Marseille, France | |
| Contact: Frédérique FLUCHERE Frederique.FLUCHERE@ap-hm.fr | |
| Neurology Service | Recruiting |
| Montpellier, France | |
| Contact: Christian GENY 3 20 44 67 30 ext +33 c-geny@chu-montpellier.fr | |
| Principal Investigator: Christian GENY | |
| Neurolgoy service | Recruiting |
| Nancy, France | |
| Contact: Solène FRISMAND 3 83 85 23 77 ext +33 s.frismand@chru-nancy.fr | |
| Neurology service | Recruiting |
| Nantes, France | |
| Contact: Tiphaine Rouaud 2 40 16 52 12 ext +33 Tiphaine.Rouaud@chu-nantes.fr | |
| Neurology service | Recruiting |
| Rouen, France | |
| Contact: David MALTETE 2 32 95 10 31 ext +33 David.Maltete@chu-rouen.fr | |
| Neurology service | Recruiting |
| Strasbourg, France | |
| Contact: Christine Tranchant 3 88 12 87 11 ext +33 Christine.Tranchant@chru-strasbourg.fr | |
| 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 | |
| Principal Investigator: Christine Brefel-Courbon | |
| Principal Investigator: | Christine BREFEL COURBON, MCU PH | Service de Pharmacologie Clinique et Service de Neurologie B8 |
| 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: | November 20, 2020 |
| Last Verified: | November 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Parkinson Disease Parkinsonian central pain Diagnosis Primary Parkinsonian Pain Diagnostic Questionnaire |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |