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Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05171114
Acronym
SCLERO-HAND
Enrollment
30
Registered
2021-12-28
Start date
2021-12-28
Completion date
2022-04-22
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma, Systemic

Keywords

scleroderma, dermatology

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.

Interventions

DIAGNOSTIC_TESTMeasurement of joint amplitudes

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, descriptive and comparative, monocentric pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of joint amplitudesat inclusionMeasurement of joint amplitudes by goniometry

Secondary

MeasureTime frameDescription
Digital skin scoreat inclusionMeasure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
Digital pressureat inclusionuse of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
Number of digital ulcersat inclusion
Number of subcutaneous calcificationsat inclusion
Visual Analog Score for painat inclusionScore varie from 0 (no pain) to 10 (worst pain possible)
number of painful jointsat inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026