Serial Night Time Position Splint on Systemic Sclerosis

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of São Paulo

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