Serial Night Time Position Splint on Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis

Conditions
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Diffuse Systemic Sclerosis

Intervention / Treatment
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* Device: Serial night time position splint
* Drug: Drug treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Splint group | Device: Serial night time position splint<br>* This group will use a serial night time position splint, adjusted monthly, during three months.<br>|
| Active Comparator: Control Group<br>Drug treatment | Drug: Drug treatment<br>* This patients will keep there drug treatment and will receive their splints on the end of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hand range of motion | Measured by goniometry | Baseline and after 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Measured by a visual analogue scale | Baseline, after 10, 20 and 40 weeks | 
| Change in functional capacity | Measured by HAQ questionnaire | Baseline, after 10, 20 and 40 weeks | 
| Change in quality of life | Measured by SF-36 questionnaire | Basline, after 10, 20 and 40 weeks | 
| Change in upper limb function | Measured by DASH questionnaire | Baseline, after 10, 20 and 40 weeks | 
| Change in dexterity | Measured by SODA test | Baseline, after 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse Systemic Sclerosis, Hand, Range of motion, Splint