Serial Night Time Position Splint on Systemic Sclerosis

April 27, 2012 updated by: Fernanda Pontes Cardoso, Federal University of São Paulo

Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis

This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during the study. Patients will be evaluated at baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time position splint who will be adjusted monthly, while the control group will remain the drug treatment. The outcomes assessed will be: pain, hand range of motion, quality of life, functional capacity, upper limb function and dexterity. Our hypothesis is that the serial night time position splint will improve the hand range of motion in diffuse systemic sclerosis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04023-062
        • Recruiting
        • Universidade Federal de São Paulo
        • Contact:
        • Sub-Investigator:
          • Paula G Silva, MsC
        • Sub-Investigator:
          • Anamaria Jones, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diffuse Systemic scleroses diagnosed following the ACR criteria
  • Older than 18 years old
  • Sclerodactyly

Exclusion Criteria:

  • Neurological, psychiatric diseases and other rheumatic disease (including overlapping)
  • Previous use of splints or allergy to splint material
  • Surgery schedule to the next 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Splint group
Device: Serial night time position splint
This group will use a serial night time position splint, adjusted monthly, during three months.
Active Comparator: Control Group
Drug treatment
Drug: Drug treatment
This patients will keep there drug treatment and will receive their splints on the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hand range of motion
Time Frame: Baseline and after 3, 6, 9 and 12 months
Measured by goniometry
Baseline and after 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: Baseline, after 10, 20 and 40 weeks
Measured by a visual analogue scale
Baseline, after 10, 20 and 40 weeks
Change in functional capacity
Time Frame: Baseline, after 10, 20 and 40 weeks
Measured by HAQ questionnaire
Baseline, after 10, 20 and 40 weeks
Change in quality of life
Time Frame: Basline, after 10, 20 and 40 weeks
Measured by SF-36 questionnaire
Basline, after 10, 20 and 40 weeks
Change in upper limb function
Time Frame: Baseline, after 10, 20 and 40 weeks
Measured by DASH questionnaire
Baseline, after 10, 20 and 40 weeks
Change in dexterity
Time Frame: Baseline, after 3, 6, 9 and 12 months
Measured by SODA test
Baseline, after 3, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Jamil Natour, PHD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 1070/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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