Hands on - a Hand Care Guide in Systemic Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Other: Handbook

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-888
      • Clinical Hospital of University of Campinas
    • Campinas, São Paulo, Brazil, 13603027
      • University of Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Handbook; The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cochin Hand Functional Scale	The purpose of this self-report scale is to measure functional ability in the hand. The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0-90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty.	08 weeks
Visual Analogue Pain Scale	Hand pain (pain-VAS) was assessed using a 10 cm horizontal pain scale. Pain severity was rated from 0-10, where 0 = no pain and 10 = very severe pain	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta Finger-to-palm	The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimeters)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP.	8 weeks
Scleroderma Health Assessment Questionnaire	The Health Assessment Questionnaire, is a self-administered 20-questionnaire that assesses functional ability in eight domains. Questions in each domain are scored in a four-point scale, from 0 ("without difficulty") to 3 ("unable to do"). The maximum score from each domain is added together and divided by the number of categories completed (score ranging from 0 -better to 3 - worse). The Scleroderma Health Assessment Questionnaire (SHAQ) consists of the 20 items from the HAQ and has five additional questions that assess symptoms caused by Systemic Sclerosis (Raynaud Phemonomenon, digital tip ulcers, gastrointestinal and lung symptoms, as well as overall disease symptoms) using visual analogue scales (VAS). Scores on the VAS range from 0 (does not interfere with activities) to 3 (very severe limitations with activities). The overall score is the sum of each of the five VAS sub scores and the scores for the eight HAQ domains divided by 13. The SHAQ index ranges from 0 to 3.	8 weeks

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Investigators: Study Director: Bertolo B Manoel, MD,PhD, University of Campinas

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: UOP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Subjects baseline characteristics are shown in results (age,