Serial Night Time Position Splint on Systemic Sclerosis

Diffuse Systemic Sclerosis Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

• NCT number: NCT01586663
• Study type: Interventional
• Source: Federal University of São Paulo
• Contact: Fernanda P Cardoso, OT
• Phone: 551155764239
• Email: anamajones@gmail.com
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2010
• Completion date: December 2012