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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05713500
Collaborator
(none)
100
36

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: TCI
  • Other: BPI
  • Other: CPAQ-8
  • Other: SF-MPQ
  • Other: KPPS
  • Other: HAD
  • Other: PCS
  • Other: ORT

Detailed Description

The present study would like to compare personality dimensions from the 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Personality and Chronic Pain: a Comparative Study in Parkinson's Disease and Other Chronic Pain Conditions
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
PD patients with chronic pain

Parkinsonian patient with pain

Other: TCI
Temperament and character inventory

Other: BPI
Brief Pain Inventory

Other: CPAQ-8
Chronic Pain Acceptance Questionnaire-8

Other: SF-MPQ
short-form McGill Pain Questionnaire

Other: KPPS
King's Parkinson's Disease Pain Scale

Other: HAD
Hospital Anxiety and Depression scale

Other: PCS
Pain Catastrophism Scale

Other: ORT
Opioid Risk Tool

PD patients without pain

Parkinsonian patient without pain

Other: TCI
Temperament and character inventory

Other: HAD
Hospital Anxiety and Depression scale

Other: ORT
Opioid Risk Tool

non-PD patients with chronic pain

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

Other: TCI
Temperament and character inventory

Other: BPI
Brief Pain Inventory

Other: CPAQ-8
Chronic Pain Acceptance Questionnaire-8

Other: SF-MPQ
short-form McGill Pain Questionnaire

Other: HAD
Hospital Anxiety and Depression scale

Other: PCS
Pain Catastrophism Scale

Other: ORT
Opioid Risk Tool

Outcome Measures

Primary Outcome Measures

  1. TCI personality dimensions between the two groups of patients [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 Outcome Measures

  1. personality dimensions of the TCI and two-by-two analyses [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

  2. association between personality the seven TCI and scores [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)

  3. association between personality the seven TCI personality dimensions and different pain [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 [24 months]

    determinate if there are some associations between TCI personality dimensions and these same previous parameters (VAS, BPI, CAPQ-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 [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 KPPS (King's Parkinson's Disease Pain Scale)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • PD patients:

Patients having Parkinson's disease according to UKPDSBB criteria

PD patients with chronic pain:

Patients with a pain EVA score ≥ 4 (mean EVA for the last week) Patients with a chronic pain since at least 3 months

PD patients without pain:

Patients with a pain EVA score < 4

  • 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 EVA score ≥ 4 (mean EVA 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 MoCA (Montreal Cognitive Assessment) score inferior to 24

  • All patients:
Patient having a psychiatric disease diagnosed according to the 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Chrisitne Chrisitne, MD, University toulouse 3

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05713500
Other Study ID Numbers:
  • RC31/22/0372
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2023