Hands on - a Hand Care Guide in Systemic Sclerosis

NCT ID: NCT02610842

Last Updated: 2018-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.

Detailed Description

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Introduction: Hands are commonly affected in Systemic sclerosis (SS). Skin thickening, Raynaud phenomenon, digital ulcers and cutaneous calcinosis may result in pain, disability and claw deformity. Strategies to improve hand function are recommended since its diagnosis and throughout the treatment. Unfortunately hand care assistance is not often available. The objective of this study was to developed a brief guide about hand care and home-based exercises to be applied in our outpatient clinic.

Methods: A brief program , with instructions about the disease and home-based exercises will be applied in a group patients with Systemic Sclerosis (SS) during the period of 12 weeks. Hand function (Cochin Hand and Functional Scale), disability (HAQ-Scleroderma), quality of life (SF-36 hand pain (visual analogue scale), grip and pinch strength, hand mobility (delta finger) will be assessed in the first appointment and after twelve weeks.

Conditions

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Scleroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Handbook group

Patients will receive a home based program named "Hands on" - a hand care guide in Systemic Sclerosis" which includes a handbook with instructions about the disease and hand exercises. Patients will be asked to follow the program instructions and carry out the exercises daily during the following 12 weeks.

Group Type EXPERIMENTAL

Handbook

Intervention Type OTHER

The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.

Interventions

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Handbook

The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Systemic Scleroderma according to the American College of Rheumatology (Criteria Committee, Arthritis Rheum. 2013).
* Involvement of hands with skin thickening.
* Interest in participating in the investigation
* Ability to read and to answer the the proposed questionnaires

Exclusion Criteria

* Upper limb commitment due other reasons other than Systemic Sclerosis.
* Presence of digital ulcers, hand deformities or conditins that impede the realization of the proposed exercises
* Clinical manifestations that impede the performance of the proposed exercises
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Eduardo de Paiva Magalhães

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bertolo B Manoel, MD,PhD

Role: STUDY_DIRECTOR

University of Campinas

Locations

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Clinical Hospital of University of Campinas

Campinas, São Paulo, Brazil

Site Status

University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003 May;29(2):239-54. doi: 10.1016/s0889-857x(03)00022-x.

Reference Type BACKGROUND
PMID: 12841293 (View on PubMed)

Skare TL, Toebe BL, Boros C. Hand dysfunction in scleroderma patients. Sao Paulo Med J. 2011;129(5):357-60. doi: 10.1590/s1516-31802011000500012. No abstract available.

Reference Type BACKGROUND
PMID: 22069136 (View on PubMed)

Torok KS, Baker NA, Lucas M, Domsic RT, Boudreau R, Medsger TA Jr. Reliability and validity of the delta finger-to-palm (FTP), a new measure of finger range of motion in systemic sclerosis. Clin Exp Rheumatol. 2010 Mar-Apr;28(2 Suppl 58):S28-36. Epub 2010 Jun 10.

Reference Type BACKGROUND
PMID: 20576211 (View on PubMed)

Other Identifiers

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UOP01

Identifier Type: -

Identifier Source: org_study_id

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