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Hands on - a Hand Care Guide in Systemic Sclerosis

Primary Purpose

Scleroderma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Handbook
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Hospital of University of Campinas
  • University of Campinas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Handbook group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 12, 2015
Last Updated
January 18, 2018
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02610842
Brief Title
Hands on - a Hand Care Guide in Systemic Sclerosis
Official Title
Hands on - a Hand Care Guide in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Handbook group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Handbook
Intervention Description
The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.
Primary Outcome Measure Information:
Title
Cochin Hand Functional Scale
Description
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.
Time Frame
08 weeks
Title
Visual Analogue Pain Scale
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Delta Finger-to-palm
Description
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.
Time Frame
8 weeks
Title
Scleroderma Health Assessment Questionnaire
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertolo B Manoel, MD,PhD
Organizational Affiliation
University of Campinas
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Hospital of University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-888
Country
Brazil
Facility Name
University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13603027
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Subjects baseline characteristics are shown in results (age,
Citations:
PubMed Identifier
12841293
Citation
Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003 May;29(2):239-54. doi: 10.1016/s0889-857x(03)00022-x.
Results Reference
background
PubMed Identifier
22069136
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.
Results Reference
background
PubMed Identifier
20576211
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.
Results Reference
background

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Hands on - a Hand Care Guide in Systemic Sclerosis

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