Clinical trial NCT02610842: Hands on - a Hand Care Guide in Systemic Sclerosis
Official title: Hands on - a Hand Care Guide in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cochin Hand Functional Scale
timeFrame: 08 weeks
measure: Visual Analogue Pain Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Delta Finger-to-palm
timeFrame: 8 weeks
measure: Scleroderma Health Assessment Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Clinical Hospital of University of Campinas
state: São Paulo
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas
name: Bertolo B Manoel, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003 May;29(2):239-54. doi: 10.1016/s0889-857x(03)00022-x.
citation: 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.
citation: 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.