Hands on - a Hand Care Guide in Systemic Sclerosis

• ClinicalTrials.gov Identifier: NCT02610842
• Recruitment Status: Completed
• First Posted: November 20, 2015
• Results First Posted: October 26, 2018
• Last Update Posted: October 26, 2018
• Sponsor: University of Campinas, Brazil
• Information provided by (Responsible Party): Eduardo de Paiva Magalhães, University of Campinas, Brazil

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Scleroderma	Other: Handbook	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hands on - a Hand Care Guide in Systemic Sclerosis
• Study Start Date: January 2015
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Cochin Hand Functional Scale [ Time Frame: 08 weeks ]

   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.

2. Visual Analogue Pain Scale [ Time Frame: 8 weeks ]
   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

Secondary Outcome Measures :

1. Delta Finger-to-palm [ Time Frame: 8 weeks ]
   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.
2. Scleroderma Health Assessment Questionnaire [ Time Frame: 8 weeks ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Brazil

Clinical Hospital of University of Campinas

Campinas, São Paulo, Brazil, 13083-888

University of Campinas

Campinas, São Paulo, Brazil, 13603027

Sponsors and Collaborators

University of Campinas, Brazil

Investigators

• Study Director: Bertolo B Manoel, MD,PhD; University of Campinas

More Information

Publications:

Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003 May;29(2):239-54. Review.

Skare TL, Toebe BL, Boros C. Hand dysfunction in scleroderma patients. Sao Paulo Med J. 2011;129(5):357-60.

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.

• Responsible Party: Eduardo de Paiva Magalhães, MD, PhD, University of Campinas, Brazil
• ClinicalTrials.gov Identifier: NCT02610842
• Other Study ID Numbers: UOP01
• First Posted: November 20, 2015
• Results First Posted: October 26, 2018
• Last Update Posted: October 26, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Subjects baseline characteristics are shown in results (age,

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Skin Diseases