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Completed

NCT Number: NCT05171114

Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Measurement of joint amplitudes

Diagnostic Test

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 outcomes

  1. Measurement of joint amplitudes

    Time frame: at inclusion

    Measurement of joint amplitudes by goniometry

Secondary outcomes

  1. Digital skin score

    Time frame: at inclusion

    Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).

  2. Digital pressure

    Time frame: at inclusion

    use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.

  3. Number of digital ulcers

    Time frame: at inclusion

  4. Number of subcutaneous calcifications

    Time frame: at inclusion

  5. Visual Analog Score for pain

    Time frame: at inclusion

    Score varie from 0 (no pain) to 10 (worst pain possible)

  6. number of painful joints

    Time frame: at inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: SCLERO-HAND

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2021
Registry last updated
Mar 27, 2026

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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