Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

Scleroderma, Systemic Clinical Trial

— PAIN SSc  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622578
• Other study ID #: APHP220664
• Secondary ID: 2022-A01357-36
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Other:
• QST, CPM and Paisudoscan
Quantified pain tests

Locations

Country	Name	City	State
France	Center of evaluation and treatment of pain - Cochin hospital - APHP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association de patients : association sclérodermies de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assessment of pain by NRS	Pain will be evaluated by the numerical pain rating scale (NRS).	at baseline
Primary	Assessment of pain by BPI	Pain will be evaluated by the Brief Pain Inventory (BPI)	at baseline
Primary	Assessment of pain by DN4	Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.	at baseline
Primary	Assessment of pain by Pain Detect Questionnaires	Pain will be evaluated by the painDETECT questionnaire.	at baseline
Primary	Assessment of pain by FiRST	Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).	at baseline
Secondary	Assessment of quality of life by questionnaire EQ5D	By questionnaire EQ5D.	at baseline
Secondary	Assessment of quality of life by questionnaire HAQ.	By questionnaire HAQ.	at baseline
Secondary	SSc-SAQ questionnaire development	Questionnaire of symptoms associated with SSc.	through study completion, an average of 2 years