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Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

NCT ID: NCT05622578

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2024-10-04

Brief Summary

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The primary objective of the study is to describe the different phenotyping of pain in systemic scleroderma patients and perturbations of mechanisms of the pain.

As secondary objectives, the study aims to describe the importances of overall symptoms in alteration of quality of life and conserve the questions which will be associated in a unique questionnaire in order to evaluate the pain, the fatigue and the sleeping disorders in diffused systemic scleroderma patients.

Detailed Description

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This is a prospective, non-randomized, controlled study.

Beside the routine care, the patients will have only one visit in the study during which the informed consent will be signed, also the following will be performed: pain evaluation, blood sampling, questionnaires and Sudoscan, test QST.

100 patients will be enrolled in total with 50 in each group (scleroderma with pain vs. scleroderma without pain, 1:1 ratio), the duration of inclusion is estimated for 23 months.

2 centers will be involved in the enrollment of patients: rheumatology department and interne medicine department of Cochin hospital-APHP. One center will perform the evaluations of pain for all patients: center of pain of Cochin hospital - APHP.

Conditions

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Scleroderma, Systemic Scleroderma, Diffuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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scleroderma with pain

systemic sclerosis (SSc) with chronic pain

Group Type OTHER

QST, CPM and Paisudoscan

Intervention Type OTHER

Quantified pain tests

scleroderma without pain

systemic sclerosis patients without chronic pain

Group Type OTHER

QST, CPM and Paisudoscan

Intervention Type OTHER

Quantified pain tests

Interventions

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QST, CPM and Paisudoscan

Quantified pain tests

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years;
* Patients with diffused SSc according to ACR / EULAR Classification 2013 since at least 3 months;
* For group pain: pain intensity ≥4 of 11 points of scale (NRS);
* For group painless: pain intensity on the month before inclusion.

Exclusion Criteria

* Patients unable to understand french language;
* Patients no-affiliated to the french social security scheme;
* Patients under the french AME scheme;
* Patients under guardianship;
* Pregnant and breastfeeding patients;
* Patients with thermoalgesic neuropathy;
* Articular pain from degenerative diseases (known osteoarthritis);
* Patients under antidepressant;
* Temporary discontinuation of analgesics which are not well tolerated.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association de patients : association sclérodermies de France

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge PERROT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center of evaluation and treatment of pain - Cochin hospital - APHP

Anne Priscille TROUVIN, MD

Role: STUDY_DIRECTOR

Center of evaluation and treatment of pain - Cochin hospital - APHP

Locations

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Center of evaluation and treatment of pain - Cochin hospital - APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01357-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP220664

Identifier Type: -

Identifier Source: org_study_id