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NCT Number: NCT05713500

Comparative Study of Personality in Parkinson's Disease Patients With Other Chronic Pain

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Pain Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TCI

Other

Temperament and character inventory

BPI

Other

Brief Pain Inventory

CPAQ-8

Other

Chronic Pain Acceptance Questionnaire-8

SF-MPQ

Other

short-form McGill Pain Questionnaire

King's Parkinson's Disease Pain Scale (KPPS)

Other

King's Parkinson's Disease Pain Scale

Hospital Anxiety and Depression scale (HAD) questionary

Other

Hospital Anxiety and Depression scale

PCS

Other

Pain Catastrophism Scale

ORT

Other

Opioid Risk Tool

Social Support Questionnaire (SSQ6)

Other

Social Support Questionnaire (SSQ6) (score of availability and score of satisfaction)

IPQ-R

Other

Illness Perception Questionnaire Revised

WCC-R

Other

Ways of Coping Checklist Revised

Primary outcomes

  1. 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

Secondary outcomes

  1. 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:

    • 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

  2. 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).

  3. 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)

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PSYCHO-PAIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2023
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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