Hands on - a Hand Care Guide in Systemic Sclerosis

NCT02610842 | Completed Results

• 1 other identifier: UOP01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Delta Finger-to-palm

  8 weeks

• Scleroderma Health Assessment Questionnaire

  8 weeks

Study Arms (1)

Handbook group

EXPERIMENTAL

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

Interventions

Handbook OTHER

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

Handbook group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (2)

Clinical Hospital of University of Campinas

Campinas, São Paulo, 13083-888, Brazil

Location

University of Campinas

Campinas, São Paulo, 13603027, Brazil

Location

Related Publications (3)

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

  PMID: 12841293 BACKGROUND

• 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.

  PMID: 22069136 BACKGROUND

• 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.

  PMID: 20576211 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Eduardo de Paiva Magalhaes
• Organization: Unicamp - University of Campinas

dreduardomagalhaes@gmail.com

+55 (19) 35217113

Study Officials

• Bertolo B Manoel, MD,PhD

  University of Campinas

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (2)