- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713500
Comparative Study of Personality in Parkinson's Disease Patients With Other Chronic Pain (PSYCHO-PAIN)
Personality and Chronic Pain: a Comparative Study in Parkinson's Disease and Other Chronic Pain Conditions
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- Toulouse University Hospital (CHU de Toulouse)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PD patients with chronic pain
Parkinsonian patient with pain
|
Temperament and character inventory
Brief Pain Inventory
Chronic Pain Acceptance Questionnaire-8
short-form McGill Pain Questionnaire
Pain Catastrophism Scale
Opioid Risk Tool
Illness Perception Questionnaire Revised
Ways of Coping Checklist Revised
King's Parkinson's Disease Pain Scale
Hospital Anxiety and Depression scale
Social Support Questionnaire (SSQ6) (score of availability and score of satisfaction)
|
|
PD patients without pain
Parkinsonian patient without pain
|
Temperament and character inventory
Opioid Risk Tool
Hospital Anxiety and Depression scale
Social Support Questionnaire (SSQ6) (score of availability and score of satisfaction)
|
|
non-PD patients with chronic pain
Non-PD with fibromyalgia and non-PD with chronic headache
|
Temperament and character inventory
Brief Pain Inventory
Chronic Pain Acceptance Questionnaire-8
short-form McGill Pain Questionnaire
Pain Catastrophism Scale
Opioid Risk Tool
Hospital Anxiety and Depression scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TCI personality dimensions between the two groups of patients
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
personality dimensions of the TCI and two-by-two analyses
Time Frame: 24 months
|
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
|
|
association between personality the seven TCI personality dimensions and different pain
Time Frame: 24 months
|
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:
|
24 months
|
|
association between personality the seven TCI and scores
Time Frame: 24 months
|
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:
|
24 months
|
|
association of personality dimensions of the TCI and in other patients with chronic pain etiology
Time Frame: 24 months
|
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
|
|
exploratory objective
Time Frame: 24 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine BREFEL-COURBON, MD PhD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/22/0372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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