Clinical trial NCT05622578: Phenotyping of Chronic Pain in Diffused Systemic Scleroderma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma, Systemic
Scleroderma, Diffuse
Keywords: scleroderma
phenotyping
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association de patients : association sclérodermies de France
First posted: 2022-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Assessment of pain
timeFrame: at baseline
measure: Assessment of pain by NRS
timeFrame: at baseline
measure: Assessment of pain by BPI
timeFrame: at baseline
measure: Assessment of pain by DN4
timeFrame: at baseline
measure: Assessment of pain by Pain Detect Questionnaires
timeFrame: at baseline
measure: Assessment of pain by FiRST
timeFrame: at baseline
Secondary outcomes:
measure: Assessment of quality of life by questionnaire EQ5D
timeFrame: at baseline
measure: Assessment of quality of life by questionnaire HAQ.
timeFrame: at baseline
measure: SSc-SAQ questionnaire development
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Center of evaluation and treatment of pain - Cochin hospital - APHP
Study officials:
affiliation: Center of evaluation and treatment of pain - Cochin hospital - APHP
name: Serge PERROT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center of evaluation and treatment of pain - Cochin hospital - APHP
name: Anne Priscille TROUVIN, MD
role: STUDY_DIRECTOR
References: