NCT01586663

Serial Night Time Position Splint on Systemic Sclerosis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Systemic Sclerosis

Interventions

Type	Name	Description
DEVICE	Serial night time position splint	This group will use a serial night time position splint, adjusted monthly, during three months.
DRUG	Drug treatment	This patients will keep there drug treatment and will receive their splints on the end of the study.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-04-27
• Last updated: 2012-05-01

Locations

1 site across 1 country: Brazil