Center of evaluation and treatment of pain - Cochin hospital - APHP
Paris, 75014, France
NCT Number: NCT05622578
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quantified pain tests
Time frame: at baseline
McGill Pain Questionnaire (MPQ) will be used.
McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Time frame: at baseline
Pain will be evaluated by the numerical pain rating scale (NRS).
Time frame: at baseline
Pain will be evaluated by the Brief Pain Inventory (BPI)
Time frame: at baseline
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
Time frame: at baseline
Pain will be evaluated by the painDETECT questionnaire.
Time frame: at baseline
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
Time frame: at baseline
By questionnaire EQ5D.
Time frame: at baseline
By questionnaire HAQ.
Time frame: through study completion, an average of 2 years
Questionnaire of symptoms associated with SSc.
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: PAIN SSc
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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