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Serial Night Time Position Splint on Systemic Sclerosis

NCT01586663 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-05-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Jamil Natour, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586663 on ClinicalTrials.gov