NCT05713500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

November 3, 2022

Last Update Submit

April 5, 2024

Conditions

Keywords

Chronic painpersonality

Outcome Measures

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

    24 months

Secondary Outcomes (5)

  • personality dimensions of the TCI and two-by-two analyses

    24 months

  • association between personality the seven TCI and scores

    24 months

  • association between personality the seven TCI personality dimensions and different pain

    24 months

  • association of personality dimensions of the TCI and in other patients with chronic pain etiology

    24 months

  • exploratory objective

    24 months

Study Arms (3)

PD patients with chronic pain

Parkinsonian patient with pain

Other: TCIOther: BPIOther: CPAQ-8Other: SF-MPQOther: King's Parkinson's Disease Pain Scale (KPPS)Other: Hospital Anxiety and Depression scale (HAD) questionaryOther: PCSOther: ORTOther: Social Support Questionnaire (SSQ6)Other: IPQ-ROther: WCC-R

PD patients without pain

Parkinsonian patient without pain

Other: TCIOther: Hospital Anxiety and Depression scale (HAD) questionaryOther: ORTOther: Social Support Questionnaire (SSQ6)

non-PD patients with chronic pain

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

Other: TCIOther: BPIOther: CPAQ-8Other: SF-MPQOther: Hospital Anxiety and Depression scale (HAD) questionaryOther: PCSOther: ORT

Interventions

TCIOTHER

Temperament and character inventory

PD patients with chronic painPD patients without painnon-PD patients with chronic pain
BPIOTHER

Brief Pain Inventory

PD patients with chronic painnon-PD patients with chronic pain
CPAQ-8OTHER

Chronic Pain Acceptance Questionnaire-8

PD patients with chronic painnon-PD patients with chronic pain
SF-MPQOTHER

short-form McGill Pain Questionnaire

PD patients with chronic painnon-PD patients with chronic pain

King's Parkinson's Disease Pain Scale

PD patients with chronic pain

Hospital Anxiety and Depression scale

PD patients with chronic painPD patients without painnon-PD patients with chronic pain
PCSOTHER

Pain Catastrophism Scale

PD patients with chronic painnon-PD patients with chronic pain
ORTOTHER

Opioid Risk Tool

PD patients with chronic painPD patients without painnon-PD patients with chronic pain

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

PD patients with chronic painPD patients without pain
IPQ-ROTHER

Illness Perception Questionnaire Revised

PD patients with chronic pain
WCC-ROTHER

Ways of Coping Checklist Revised

PD patients with chronic pain

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson DiseaseChronic Pain

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine BREFEL-COURBON, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

February 6, 2023

Study Start

February 16, 2023

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations