Serial Night Time Position Splint on Systemic Sclerosis

Phase 3

• Conditions: Diffuse Systemic Sclerosis
• Interventions: Device: Serial night time position splint; Drug: Drug treatment

• Registration Number: NCT01586663
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-27
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-05-01
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Serial night time position splint	Splint group
Control Group	Drug treatment	Drug treatment

Primary Outcome Measures

Name	Time	Method
Change in hand range of motion	Baseline and after 3, 6, 9 and 12 months	Measured by goniometry

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidade Federal de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil