Parkinson Disease3PDQNCT03940872
Primary Parkinsonian Pain Diagnostic Questionnaire: Development and Validation of This Questionnaire
A study testing Self-questionnaire 3PDQ in people with Parkinson Disease, run by University Hospital, Toulouse at 10 sites in France.
Trial summary
Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Self-questionnaire 3PDQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 10 sitesFrance
- Study dates
- 23 Apr 2019to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Neurology service
Clermont-Ferrand
Neurology service
Lille
Neurology service
Lyon
Neurology service
Marseille
Neurology Service
Montpellier
Neurolgoy service
Nancy
Neurology service
Nantes
Neurology service
Rouen
Neurology service
Strasbourg
Neurology service
Toulouse, 31059
About this study
Official title: Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)
Read the 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:
- 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
- Conditions
- Parkinson Disease
- Being tested
- Self-questionnaire 3PDQ
- Keywords
- Parkinson Disease, Parkinsonian central pain, Diagnosis, Primary Parkinsonian Pain Diagnostic Questionnaire
- Medical subject headings
- Parkinson Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaire 3PDQDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 3PDQ self-questionnaire validation | Experimental | 200 patients will be included for this step in 10 French Parkinson expert centers. Receives: Diagnostic Test: Self-questionnaire 3PDQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire)
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start23 Apr 2019
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BREFEL COURBON, MCU PH, Principal investigator, Service de Pharmacologie Clinique et Service de Neurologie B8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940872
- Sponsor's protocol ID
- RC 31/18/0034
- Acronym
- 3PDQ
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire
- ClinicalTrials.gov ID
- NCT03940872
- Acronym / sponsor ID
- 3PDQ / RC 31/18/0034
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Parkinsonian central pain, Diagnosis, Primary Parkinsonian Pain Diagnostic Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3PDQ self-questionnaire validation | Experimental | Diagnostic Test: Self-questionnaire 3PDQ200 patients will be included for this step in 10 French Parkinson expert centers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaire 3PDQVisit 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. | Diagnostic test | 3PDQ self-questionnaire validation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine BREFEL COURBON, MCU PH principal investigator
Service de Pharmacologie Clinique et Service de Neurologie B8
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-questionnaire 3PDQ in people with Parkinson Disease, run by University Hospital, Toulouse at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Parkinsonian Pain Questionnaire (3PDQ questionnaire) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.