Diffuse Systemic Sclerosis
Conditions
Keywords
Diffuse Systemic Sclerosis, Hand, Range of motion, Splint
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.
Interventions
DEVICESerial night time position splint
This group will use a serial night time position splint, adjusted monthly, during three months.
DRUGDrug treatment
This patients will keep there drug treatment and will receive their splints on the end of the study.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hand range of motion | Baseline and after 3, 6, 9 and 12 months | Measured by goniometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dexterity | Baseline, after 3, 6, 9 and 12 months | Measured by SODA test |
| 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 |
Countries
Brazil
Contacts
Primary ContactFernanda P Cardoso, OT
Outcome results
None listed