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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01357-36 | Registry Identifier | IDRCB |
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| Name | Class |
|---|---|
| Association de patients : association sclérodermies de France | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scleroderma with pain | Other | systemic sclerosis (SSc) with chronic pain |
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| scleroderma without pain | Other | systemic sclerosis patients without chronic pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QST, CPM and Paisudoscan | Other | Quantified pain tests |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge PERROT, MD, PhD | Center of evaluation and treatment of pain - Cochin hospital - APHP | Principal Investigator |
| Anne Priscille TROUVIN, MD | Center of evaluation and treatment of pain - Cochin hospital - APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of evaluation and treatment of pain - Cochin hospital - APHP | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C058479 | carboxypeptidase M |
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| at baseline |
| SSc-SAQ questionnaire development | Questionnaire of symptoms associated with SSc. | through study completion, an average of 2 years |