PAIN SSc: Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05622578

Collaborator

Association de patients : association sclérodermies de France (Other)

100

Enrollment

Location

Arms

23.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scleroderma, Systemic Scleroderma, Diffuse	Other: QST, CPM and Paisudoscan	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Oct 19, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Assessment of pain [at baseline]
McGill Pain Questionnaire (MPQ) will be used. McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Assessment of pain by NRS [at baseline]
Pain will be evaluated by the numerical pain rating scale (NRS).
Assessment of pain by BPI [at baseline]
Pain will be evaluated by the Brief Pain Inventory (BPI)
Assessment of pain by DN4 [at baseline]
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
Assessment of pain by Pain Detect Questionnaires [at baseline]
Pain will be evaluated by the painDETECT questionnaire.
Assessment of pain by FiRST [at baseline]
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of evaluation and treatment of pain - Cochin hospital - APHP	Paris		France	75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
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