Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis
Overview
- Phase
- Phase 3
- Sponsor
- Federal University of São Paulo
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Change in hand range of motion
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Group
Splint group
Intervention: Serial night time position splint (Device)
Control Group
Drug treatment
Intervention: Drug treatment (Drug)
Outcomes
Primary Outcomes
Change in hand range of motion
Time Frame: Baseline and after 3, 6, 9 and 12 months
Measured by goniometry
Secondary Outcomes
- Change in pain(Baseline, after 10, 20 and 40 weeks)
- Change in functional capacity(Baseline, after 10, 20 and 40 weeks)
- Change in quality of life(Basline, after 10, 20 and 40 weeks)
- Change in upper limb function(Baseline, after 10, 20 and 40 weeks)
- Change in dexterity(Baseline, after 3, 6, 9 and 12 months)
Investigators
Fernanda Pontes Cardoso
Principal Investigator
Federal University of São Paulo