Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Phenotyping of Chronic Pain in Diffused Systemic Scleroderma: Characteristics and Perturbations of Mechanisms of Pain, Impact on the Quality of Life and Correlations of Fatigue, Sleeping Disorders and Mood or Anxiety Disorders

Conditions
-----------------
Scleroderma, Systemic, Scleroderma, Diffuse

Intervention / Treatment
-----------------
* Other: QST, CPM and Paisudoscan


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: scleroderma with pain<br>systemic sclerosis (SSc) with chronic pain | Other: QST, CPM and Paisudoscan<br>* Quantified pain tests<br>|
| Other: scleroderma without pain<br>systemic sclerosis patients without chronic pain | Other: QST, CPM and Paisudoscan<br>* Quantified pain tests<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Assessment of pain by NRS | Pain will be evaluated by the numerical pain rating scale (NRS). | at baseline | 
| Assessment of pain by BPI | Pain will be evaluated by the Brief Pain Inventory (BPI) | at baseline | 
| Assessment of pain by DN4 | Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool. | at baseline | 
| Assessment of pain by Pain Detect Questionnaires | Pain will be evaluated by the painDETECT questionnaire. | at baseline | 
| Assessment of pain by FiRST | Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST). | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of quality of life by questionnaire EQ5D | By questionnaire EQ5D. | at baseline | 
| Assessment of quality of life by questionnaire HAQ. | By questionnaire HAQ. | at baseline | 
| SSc-SAQ questionnaire development | Questionnaire of symptoms associated with SSc. | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleroderma, phenotyping