Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

NCT05622578 | Completed

• 2 other identifiers: APHP2206642022-A01357-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Keywords

scleroderma; phenotyping

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Assessment of quality of life by questionnaire EQ5D

  at baseline

• Assessment of quality of life by questionnaire HAQ.

  at baseline

• SSc-SAQ questionnaire development

  through study completion, an average of 2 years

Study Arms (2)

scleroderma with pain

OTHER

systemic sclerosis (SSc) with chronic pain

Other: QST, CPM and Paisudoscan

scleroderma without pain

OTHER

systemic sclerosis patients without chronic pain

Other: QST, CPM and Paisudoscan

Interventions

QST, CPM and Paisudoscan OTHER

Quantified pain tests

scleroderma with pain; scleroderma without pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association de patients : association sclérodermies de France: collaborator

Study Sites (1)

Center of evaluation and treatment of pain - Cochin hospital - APHP

Paris, 75014, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Interventions

carboxypeptidase M

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Serge PERROT, MD, PhD

  Center of evaluation and treatment of pain - Cochin hospital - APHP

  PRINCIPAL INVESTIGATOR

• Anne Priscille TROUVIN, MD

  Center of evaluation and treatment of pain - Cochin hospital - APHP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: November 18, 2022
• Study Start: October 19, 2022
• Primary Completion: December 19, 2023
• Study Completion: October 4, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

FR (1)