Comparative Study of Personality in Parkinson's Disease Patients With Other Chronic Pain (PSYCHO-PAIN)

April 5, 2024 updated by: University Hospital, Toulouse

Personality and Chronic Pain: a Comparative Study in Parkinson's Disease and Other Chronic Pain Conditions

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.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31059
        • Toulouse University Hospital (CHU de Toulouse)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Parkinsonian patients with and without chronic pain and non-parkinsonian patients with chronic pain such as fibromyalgia and headache

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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
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:

  • 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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christine BREFEL-COURBON, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

April 3, 2024

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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