Phenotyping of Chronic Pain in Diffused Systemic Scleroderma
- Conditions
- Scleroderma, DiffuseScleroderma, Systemic
- Interventions
- Other: QST, CPM and Paisudoscan
- Registration Number
- NCT05622578
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description scleroderma with pain QST, CPM and Paisudoscan systemic sclerosis (SSc) with chronic pain scleroderma without pain QST, CPM and Paisudoscan systemic sclerosis patients without chronic pain
- Primary Outcome Measures
Name Time Method Assessment of pain by BPI at baseline Pain will be evaluated by the Brief Pain Inventory (BPI)
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 FiRST at baseline Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
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 DN4 at baseline Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
- Secondary Outcome Measures
Name Time Method Assessment of quality of life by questionnaire EQ5D at baseline By questionnaire EQ5D.
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.
Trial Locations
- Locations (1)
Center of evaluation and treatment of pain - Cochin hospital - APHP
🇫🇷Paris, France