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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05622578
Other study ID # APHP220664
Secondary ID 2022-A01357-36
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2022
Est. completion date December 19, 2023

Study information

Verified date January 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 19, 2023
Est. primary completion date December 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
QST, CPM and Paisudoscan
Quantified pain tests

Locations

Country Name City State
France Center of evaluation and treatment of pain - Cochin hospital - APHP Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Association de patients : association sclérodermies de France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of pain McGill Pain Questionnaire (MPQ) will be used.
McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
at baseline
Primary Assessment of pain by NRS Pain will be evaluated by the numerical pain rating scale (NRS). at baseline
Primary Assessment of pain by BPI Pain will be evaluated by the Brief Pain Inventory (BPI) at baseline
Primary Assessment of pain by DN4 Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool. at baseline
Primary Assessment of pain by Pain Detect Questionnaires Pain will be evaluated by the painDETECT questionnaire. at baseline
Primary Assessment of pain by FiRST Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST). at baseline
Secondary Assessment of quality of life by questionnaire EQ5D By questionnaire EQ5D. at baseline
Secondary Assessment of quality of life by questionnaire HAQ. By questionnaire HAQ. at baseline
Secondary SSc-SAQ questionnaire development Questionnaire of symptoms associated with SSc. through study completion, an average of 2 years
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