Serial Night Time Position Splint on Systemic Sclerosis

Diffuse Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01586663
• Other study ID #: CEP 1070/09
• Status: Recruiting
• Phase: Phase 3
• First received: April 25, 2012
• Last updated: April 27, 2012
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Federal University of São Paulo
• Contact: Fernanda P Cardoso, OT
• Phone: 551155764239
• Email: anamajones[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Device:
• Serial night time position splint
This group will use a serial night time position splint, adjusted monthly, during three months.

Drug:
• Drug treatment
This patients will keep there drug treatment and will receive their splints on the end of the study.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hand range of motion	Measured by goniometry	Baseline and after 3, 6, 9 and 12 months	No
Secondary	Change in pain	Measured by a visual analogue scale	Baseline, after 10, 20 and 40 weeks	No
Secondary	Change in functional capacity	Measured by HAQ questionnaire	Baseline, after 10, 20 and 40 weeks	No
Secondary	Change in quality of life	Measured by SF-36 questionnaire	Basline, after 10, 20 and 40 weeks	No
Secondary	Change in upper limb function	Measured by DASH questionnaire	Baseline, after 10, 20 and 40 weeks	No
Secondary	Change in dexterity	Measured by SODA test	Baseline, after 3, 6, 9 and 12 months	No