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Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire (3PDQ)
| 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 |
|---|---|
|
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 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
| 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)
| 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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 25, 2019 | ||||||||
| First Posted Date ICMJE | May 7, 2019 | ||||||||
| Last Update Posted Date | November 20, 2020 | ||||||||
| Actual Study Start Date ICMJE | April 23, 2019 | ||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
|
||||||||
| Original Primary Outcome Measures ICMJE |
3PDQ questionnaire [ Time Frame: 4 months ] Development and validation of the 3PDQ questionnaire
|
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire | ||||||||
| Official Title ICMJE | Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ 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:
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:
Duration of participation for each patient:
|
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||||
| Condition ICMJE | Parkinson Disease | ||||||||
| Intervention ICMJE | 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. |
||||||||
| Study Arms ICMJE | Experimental: 3PDQ self-questionnaire validation
200 patients will be included for this step in 10 French Parkinson expert centers.
Intervention: Diagnostic Test: Self-questionnaire 3PDQ
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | May 2021 | ||||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03940872 | ||||||||
| Other Study ID Numbers ICMJE | RC 31/18/0034 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University Hospital, Toulouse | ||||||||
| Study Sponsor ICMJE | University Hospital, Toulouse | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | University Hospital, Toulouse | ||||||||
| Verification Date | November 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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