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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05713500
Other study ID # RC31/22/0372
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 16, 2023
Est. completion date April 3, 2024

Study information

Verified date April 2024
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The present study would like to compare personality dimensions from the Temperament and character inventory (TCI) in four groups of patients: PD patients with chronic pain related to PD, PD patients without pain and non-PD patients with chronic pain such as fibromyalgia or chronic headache. Our aim is to evaluate if PD patients with chronic pain related to PD have a different personality than PD patients without pain and to see if this personality is specific to PD.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TCI
Temperament and character inventory
BPI
Brief Pain Inventory
CPAQ-8
Chronic Pain Acceptance Questionnaire-8
SF-MPQ
short-form McGill Pain Questionnaire
King's Parkinson's Disease Pain Scale (KPPS)
King's Parkinson's Disease Pain Scale
Hospital Anxiety and Depression scale (HAD) questionary
Hospital Anxiety and Depression scale
PCS
Pain Catastrophism Scale
ORT
Opioid Risk Tool
Social Support Questionnaire (SSQ6)
Social Support Questionnaire (SSQ6) (score of availability and score of satisfaction)
IPQ-R
Illness Perception Questionnaire Revised
WCC-R
Ways of Coping Checklist Revised

Locations

Country Name City State
France Toulouse University Hospital (CHU de Toulouse) Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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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