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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
This group will use a serial night time position splint, adjusted monthly, during three months.
This patients will keep there drug treatment and will receive their splints on the end of the study.
Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
RECRUITINGChange in hand range of motion
Measured by goniometry
Time frame: Baseline and after 3, 6, 9 and 12 months
Change in pain
Measured by a visual analogue scale
Time frame: Baseline, after 10, 20 and 40 weeks
Change in functional capacity
Measured by HAQ questionnaire
Time frame: Baseline, after 10, 20 and 40 weeks
Change in quality of life
Measured by SF-36 questionnaire
Time frame: Basline, after 10, 20 and 40 weeks
Change in upper limb function
Measured by DASH questionnaire
Time frame: Baseline, after 10, 20 and 40 weeks
Change in dexterity
Measured by SODA test
Time frame: Baseline, after 3, 6, 9 and 12 months
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