Serial Night Time Position Splint on Systemic Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fernanda Pontes Cardoso, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01586663
First received: April 25, 2012
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Diffuse Systemic Sclerosis
Device: Serial night time position splint
Drug: Drug treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Change in hand range of motion [ Time Frame: Baseline and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Measured by goniometry


Secondary Outcome Measures:
  • Change in pain [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Measured by a visual analogue scale

  • Change in functional capacity [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Measured by HAQ questionnaire

  • Change in quality of life [ Time Frame: Basline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Measured by SF-36 questionnaire

  • Change in upper limb function [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]
    Measured by DASH questionnaire

  • Change in dexterity [ Time Frame: Baseline, after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
    Measured by SODA test


Estimated Enrollment: 76
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586663

Contacts
Contact: Fernanda P Cardoso, OT 551155764239 anamajones@gmail.com

Locations
Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04023-062
Contact: Fernanda P Cardosos, OT    551155764239    anamajones@gmail.com   
Sub-Investigator: Jamil Natour, PhD         
Sub-Investigator: Paula G Silva, MsC         
Sub-Investigator: Anamaria Jones, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Jamil Natour, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Fernanda Pontes Cardoso, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01586663     History of Changes
Other Study ID Numbers: CEP 1070/09
Study First Received: April 25, 2012
Last Updated: April 27, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Diffuse Systemic Sclerosis
Hand
Range of motion
Splint

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014