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

Primary Purpose

Scleroderma, Systemic, Scleroderma, Diffuse

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QST, CPM and Paisudoscan
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scleroderma, Systemic focused on measuring scleroderma, phenotyping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center of evaluation and treatment of pain - Cochin hospital - APHPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

scleroderma with pain

scleroderma without pain

Arm Description

systemic sclerosis (SSc) with chronic pain

systemic sclerosis patients without chronic pain

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assessment of quality of life by questionnaire EQ5D
By questionnaire EQ5D.
Assessment of quality of life by questionnaire HAQ.
By questionnaire HAQ.
SSc-SAQ questionnaire development
Questionnaire of symptoms associated with SSc.

Full Information

First Posted
September 26, 2022
Last Updated
November 14, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association de patients : association sclérodermies de France
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1. Study Identification

Unique Protocol Identification Number
NCT05622578
Brief Title
Phenotyping of Chronic Pain in Diffused Systemic Scleroderma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association de patients : association sclérodermies de France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic, Scleroderma, Diffuse
Keywords
scleroderma, phenotyping

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
scleroderma with pain
Arm Type
Other
Arm Description
systemic sclerosis (SSc) with chronic pain
Arm Title
scleroderma without pain
Arm Type
Other
Arm Description
systemic sclerosis patients without chronic pain
Intervention Type
Other
Intervention Name(s)
QST, CPM and Paisudoscan
Intervention Description
Quantified pain tests
Primary Outcome Measure Information:
Title
Assessment of pain
Description
McGill Pain Questionnaire (MPQ) will be used. McGill Pain Questionnaire is a self-report questionnaire for multidimensional pain assessment in chronic pain.
Time Frame
at baseline
Title
Assessment of pain by NRS
Description
Pain will be evaluated by the numerical pain rating scale (NRS).
Time Frame
at baseline
Title
Assessment of pain by BPI
Description
Pain will be evaluated by the Brief Pain Inventory (BPI)
Time Frame
at baseline
Title
Assessment of pain by DN4
Description
Pain will be evaluated by the Douleur Neuropathique (DN4) questionnaire as tool.
Time Frame
at baseline
Title
Assessment of pain by Pain Detect Questionnaires
Description
Pain will be evaluated by the painDETECT questionnaire.
Time Frame
at baseline
Title
Assessment of pain by FiRST
Description
Pain will be evaluated by the Fibromyalgia Rapid Screening Tool (FiRST).
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
Assessment of quality of life by questionnaire EQ5D
Description
By questionnaire EQ5D.
Time Frame
at baseline
Title
Assessment of quality of life by questionnaire HAQ.
Description
By questionnaire HAQ.
Time Frame
at baseline
Title
SSc-SAQ questionnaire development
Description
Questionnaire of symptoms associated with SSc.
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge PERROT, MD, PhD
Phone
+ 33 01 58 41 30 40
Email
Serge.perrot@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Priscille TROUVIN, MD
Phone
+ 33 01 58 41 30 40
Email
annepriscille.trouvin@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge PERROT, MD, PhD
Organizational Affiliation
Center of evaluation and treatment of pain - Cochin hospital - APHP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Priscille TROUVIN, MD
Organizational Affiliation
Center of evaluation and treatment of pain - Cochin hospital - APHP
Official's Role
Study Director
Facility Information:
Facility Name
Center of evaluation and treatment of pain - Cochin hospital - APHP
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Phenotyping of Chronic Pain in Diffused Systemic Scleroderma

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