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Completed

NCT Number: NCT05622578

Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QST, CPM and Paisudoscan

Other

Quantified pain tests

Primary outcomes

  1. Assessment of pain

    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.

  2. Assessment of pain by NRS

    Time frame: at baseline

    Pain will be evaluated by the numerical pain rating scale (NRS).

  3. Assessment of pain by BPI

    Time frame: at baseline

    Pain will be evaluated by the Brief Pain Inventory (BPI)

  4. Assessment of pain by DN4

    Time frame: at baseline

    Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.

  5. Assessment of pain by Pain Detect Questionnaires

    Time frame: at baseline

    Pain will be evaluated by the painDETECT questionnaire.

  6. Assessment of pain by FiRST

    Time frame: at baseline

    Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).

Secondary outcomes

  1. Assessment of quality of life by questionnaire EQ5D

    Time frame: at baseline

    By questionnaire EQ5D.

  2. Assessment of quality of life by questionnaire HAQ.

    Time frame: at baseline

    By questionnaire HAQ.

  3. SSc-SAQ questionnaire development

    Time frame: through study completion, an average of 2 years

    Questionnaire of symptoms associated with SSc.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association de patients : association sclérodermies de France

Registry information

Official study 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

Acronym: PAIN SSc

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 18, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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