Scleroderma: Functional Disability Between the Dominant and Contralateral Hand. (SCLERO-HAND)
Primary Purpose
Scleroderma, Systemic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measurement of joint amplitudes
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma, Systemic focused on measuring scleroderma, dermatology
Eligibility Criteria
Inclusion Criteria:
- Group 1 :
- Major patient
- Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
- Cochin hand score less than or equal to 16
- Group 2 :
- Major patient
- Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
- Cochin hand score greater than 16.
Exclusion Criteria:
- Overlap syndrome (Sharp or scleromyositis 2)
- Patient with another autoimmune disease
- History of surgery or trauma to the hand with proven functional sequelae
- Presence of synovitis
- Patient with Dupuytren's disease
Sites / Locations
- CHU de Limoges
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
moderate Scleroderma
severe Scleroderma
Arm Description
Patients with Cochin hand score less than or equal to 16
Patients with Cochin hand score greater than 16
Outcomes
Primary Outcome Measures
Measurement of joint amplitudes
Measurement of joint amplitudes by goniometry
Secondary Outcome Measures
Digital skin score
Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
Digital pressure
use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
Number of digital ulcers
Number of subcutaneous calcifications
Visual Analog Score for pain
Score varie from 0 (no pain) to 10 (worst pain possible)
number of painful joints
Full Information
NCT ID
NCT05171114
First Posted
November 29, 2021
Last Updated
May 5, 2022
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT05171114
Brief Title
Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
Acronym
SCLERO-HAND
Official Title
Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
April 22, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
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
Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.
Detailed Description
Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. In case of limitation, the level of skin fibrosis, Raynaud's syndrome and its complications, the search for painful joints with or without synovitis, and the presence of calcifications must therefore be assessed. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. No study to date has compared the functionality of one hand to the other. The hypothesis is that there is a difference in range of motion limitations between the dominant hand and the contralateral hand.
Patients in the active file of the Internal Medicine A department of the Limoges University Hospital who meet the inclusion criteria will be offered the study by telephone. Patients wishing to participate will be given an appointment on a dedicated consultation slot. During this visit, Patients will be given an information note and their consent will be collected. The study examinations will be performed and the questionnaire completed. At the end of this visit, the study will be completed for the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic
Keywords
scleroderma, dermatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, descriptive and comparative, monocentric pilot study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
moderate Scleroderma
Arm Type
Experimental
Arm Description
Patients with Cochin hand score less than or equal to 16
Arm Title
severe Scleroderma
Arm Type
Experimental
Arm Description
Patients with Cochin hand score greater than 16
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of joint amplitudes
Intervention Description
Measurement of joint amplitudes by goniometry of the MCP, IPP, IPD for 2, 3, 4 and 5th radii, 1st commissure spacing and Kapandji score for the thumb
Primary Outcome Measure Information:
Title
Measurement of joint amplitudes
Description
Measurement of joint amplitudes by goniometry
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Digital skin score
Description
Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
Time Frame
at inclusion
Title
Digital pressure
Description
use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
Time Frame
at inclusion
Title
Number of digital ulcers
Time Frame
at inclusion
Title
Number of subcutaneous calcifications
Time Frame
at inclusion
Title
Visual Analog Score for pain
Description
Score varie from 0 (no pain) to 10 (worst pain possible)
Time Frame
at inclusion
Title
number of painful joints
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group 1 :
Major patient
Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
Cochin hand score less than or equal to 16
Group 2 :
Major patient
Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
Cochin hand score greater than 16.
Exclusion Criteria:
Overlap syndrome (Sharp or scleromyositis 2)
Patient with another autoimmune disease
History of surgery or trauma to the hand with proven functional sequelae
Presence of synovitis
Patient with Dupuytren's disease
Facility Information:
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
We'll reach out to this number within 24 hrs