Phenotyping of Chronic Pain in Diffused Systemic Scleroderma (PAIN SSc)

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

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma, Systemic; Scleroderma, Diffuse
• Intervention / Treatment: Other: QST, CPM and Paisudoscan

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Center of evaluation and treatment of pain - Cochin hospital - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: scleroderma with pain; systemic sclerosis (SSc) with chronic pain	Other: QST, CPM and Paisudoscan; Quantified pain tests
Other: scleroderma without pain; systemic sclerosis patients without chronic pain	Other: QST, CPM and Paisudoscan; Quantified pain tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Assessment of pain by NRS	Pain will be evaluated by the numerical pain rating scale (NRS).	at baseline
Assessment of pain by BPI	Pain will be evaluated by the Brief Pain Inventory (BPI)	at baseline
Assessment of pain by DN4	Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.	at baseline
Assessment of pain by Pain Detect Questionnaires	Pain will be evaluated by the painDETECT questionnaire.	at baseline
Assessment of pain by FiRST	Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of quality of life by questionnaire EQ5D	By questionnaire EQ5D.	at baseline
Assessment of quality of life by questionnaire HAQ.	By questionnaire HAQ.	at baseline
SSc-SAQ questionnaire development	Questionnaire of symptoms associated with SSc.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association de patients : association sclérodermies de France
• Investigators: Principal Investigator: Serge PERROT, MD, PhD, Center of evaluation and treatment of pain - Cochin hospital - APHP; Study Director: Anne Priscille TROUVIN, MD, Center of evaluation and treatment of pain - Cochin hospital - APHP

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: scleroderma; phenotyping
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Connective Tissue Diseases; Skin Diseases; Chronic Pain; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: APHP220664; 2022-A01357-36 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No