Parkinson Disease Clinical Trial
— PSYCHO-PAINOfficial title:
Personality and Chronic Pain: a Comparative Study in Parkinson's Disease and Other Chronic Pain Conditions
Verified date | April 2024 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The present study compare personality of Parkinson's Disease (PD) patients with chronic, PD patients without pain and non-parkinsonian patients with other chronic pain condition.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 3, 2024 |
Est. primary completion date | April 3, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - PD patients: Patients having Parkinson's disease according to UNITED KINGDOM PARKINSON'S DISEASE SOCIETY BRAIN BANK (UKPDSBB) criteria PD patients with chronic pain: Patients with a pain VAS score = 4 (mean VAS for the last week) Patients with a chronic pain since at least 3 months PD patients without pain: Patients with a pain VAS score < 3 - non PD patients: Patients with chronic headache: Patients with chronic headache according to the ICHD-3 beta criteria Patients with a chronic pain since at least 3 months Patients with fibromyalgia: Patients with fibromyalgia according to the criteria of the American College of Rheumatology 2016 (Wolfe et al., 2016) Patients with a pain VAS score = 4 (mean VAS for the last week) Patients with a chronic pain since at least 3 months - All patients: Patient > 18 years old Patient able to give its free and informed consent Patient having a social security. Exclusion Criteria: - PD patients: Patients presenting atypical Parkinson's syndrome Patients having a deep brain stimulation Patients presenting a cognitive decline evaluated by a Montreal Cognitive Assessment (MoCA) score inferior to 24 - All patients: Patient having a psychiatric disease diagnosed according to the Diagnostic and Statistical Manual-V (DSM-V) criteria such as mood disorders, psychotic disorder… None ability to give its consent Patients unable to realize the tests provided in the context of this study Patients under supervision, curatorship, or legal guardian Patients non-affiliated to a social security Patients in exclusion period of another study. |
Country | Name | City | State |
---|---|---|---|
France | Toulouse University Hospital (CHU de Toulouse) | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | TCI personality dimensions between the two groups of patients | compare scores of the seven TCI personality dimensions between the two groups of parkinsonian patients with or without chronic pain related to PD. This will allow to determinate if PD patients with chronic pain related to PD have a different personality than PD patients without pain | 24 months | |
Secondary | personality dimensions of the TCI and two-by-two analyses | compare personality dimensions of the TCI through two-by-two analyses between PD patients with chronic pain related to PD and patients presenting another chronic pain etiology:
1) patients with fibromyalgia, 2) patients with chronic headache. This will allow to determinate if PD patients with chronic pain have a personality specific to their PD |
24 months | |
Secondary | association between personality the seven TCI and scores | determinate if there are some associations between the seven TCI personality dimensions of PD patients with chronic pain related to PD and different pain parameters:
the pain intensity evaluated with the Visual Analog Scale (VAS) the functional discomfort evaluated with the Brief Pain Inventory (BPI) the acceptation of pain evaluated with the Chronic Pain Acceptance questionnaire-8 (CPAQ-8) the discriminative and affective components of pain evaluated with the Short-Form McGill Pain Questionnaire (SF-MPQ) the level of catastrophism evaluated with the Pain Catastrophism Scale (PCS). |
24 months | |
Secondary | association between personality the seven TCI personality dimensions and different pain | determinate if there are some associations between the seven TCI personality dimensions of PD patients with chronic pain related to PD and different pain parameters:
the pain intensity evaluated with the VAS (Visual Analog Scale) the functional discomfort evaluated with the BPI (Brief Pain Inventory) the acceptation of pain evaluated with the CPAQ-8 (Chronic Pain Acceptance questionnaire-8) the discriminative and affective components of pain evaluated with the SF-MPQ (short-form McGill Pain Questionnaire) the level of catastrophism evaluated with the PCS (Pain Catastrophism Scale) |
24 months | |
Secondary | association of personality dimensions of the TCI and in other patients with chronic pain etiology | determinate if there are some associations between TCI personality dimensions and these same previous parameters (VAS, BPI, CPAQ-8, SF-MPQ, PCS and ORT) in other patients with chronic pain etiology: 1) first, in patients with fibromyalgia, 2) then, in patients with chronic headache | 24 months | |
Secondary | exploratory objective | determinate if there are some associations between TCI personality dimensions in PD patients with chronic pain related to PD and PD-specific pain evaluated by the King's Parkinson's Disease Pain Scale (KPPS) | 24 months |
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