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More info
You can access this
clinical trial
if you have
Diffuse Systemic Sclerosis
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Device: Serial night time position splint
  • Drug: Drug treatment

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01586663. The sponsor of the trial is Federal University of São Paulo and it is looking for 76 volunteers for the current phase.
Official trial title:
Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis