Scleroderma, Diffuse, Scleroderma, Systemic
Conditions
Keywords
scleroderma, phenotyping
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.
Interventions
OTHERQST, CPM and Paisudoscan
Quantified pain tests
Sponsors
Association de patients : association sclérodermies de France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pain by FiRST | at baseline | Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST). |
| Assessment of pain by DN4 | at baseline | Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool. |
| Assessment of pain | at baseline | McGill Pain Questionnaire (MPQ) will be used. McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain. |
| Assessment of pain by NRS | at baseline | Pain will be evaluated by the numerical pain rating scale (NRS). |
| Assessment of pain by Pain Detect Questionnaires | at baseline | Pain will be evaluated by the painDETECT questionnaire. |
| Assessment of pain by BPI | at baseline | Pain will be evaluated by the Brief Pain Inventory (BPI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of quality of life by questionnaire HAQ. | at baseline | By questionnaire HAQ. |
| SSc-SAQ questionnaire development | through study completion, an average of 2 years | Questionnaire of symptoms associated with SSc. |
| Assessment of quality of life by questionnaire EQ5D | at baseline | By questionnaire EQ5D. |
Countries
France
Outcome results
None listed