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CompletedNCT05713500PSYCHO-PAINUpdated Apr 9, 2024

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

An observational study in Parkinson Disease, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

Keywords

  • Chronic pain
  • personality
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 100 is close to the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • PD patients with chronic pain

    Parkinsonian patient with pain

    Other: TCI · Other: BPI · Other: CPAQ-8 · Other: SF-MPQ · Other: King's Parkinson's Disease Pain Scale (KPPS) · Other: Hospital Anxiety and Depression scale (HAD) questionary · Other: PCS · Other: ORT · Other: Social Support Questionnaire (SSQ6) · Other: IPQ-R · Other: WCC-R

  • PD patients without pain

    Parkinsonian patient without pain

    Other: TCI · Other: Hospital Anxiety and Depression scale (HAD) questionary · Other: ORT · Other: Social Support Questionnaire (SSQ6)

  • non-PD patients with chronic pain

    Non-PD with fibromyalgia and non-PD with chronic headache

    Other: TCI · Other: BPI · Other: CPAQ-8 · Other: SF-MPQ · Other: Hospital Anxiety and Depression scale (HAD) questionary · Other: PCS · Other: ORT

Interventions

  • OtherTCI

    Temperament and character inventory

  • OtherBPI

    Brief Pain Inventory

  • OtherCPAQ-8

    Chronic Pain Acceptance Questionnaire-8

  • OtherSF-MPQ

    short-form McGill Pain Questionnaire

  • OtherKing's Parkinson's Disease Pain Scale (KPPS)

    King's Parkinson's Disease Pain Scale

  • OtherHospital Anxiety and Depression scale (HAD) questionary

    Hospital Anxiety and Depression scale

  • OtherPCS

    Pain Catastrophism Scale

  • OtherORT

    Opioid Risk Tool

  • OtherSocial Support Questionnaire (SSQ6)

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

  • OtherIPQ-R

    Illness Perception Questionnaire Revised

  • OtherWCC-R

    Ways of Coping Checklist Revised

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

Secondary outcomes

  1. 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

    Time frame: 24 months

  2. 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).

    Time frame: 24 months

  3. 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)

    Time frame: 24 months

  4. 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

    Time frame: 24 months

  5. 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)

    Time frame: 24 months

07

Study locations

1 site
  • Toulouse University Hospital (CHU de Toulouse)
    Toulouse, 31059, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05713500
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 6, 2023
Start date
Feb 16, 2023
Primary completion
Apr 3, 2024
Completion
Apr 3, 2024
Last update
Apr 9, 2024

Study contacts

Christine BREFEL-COURBON, MD PhD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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