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Serial Night Time Position Splint on Systemic Sclerosis

Primary Purpose

Diffuse Systemic Sclerosis

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Serial night time position splint

Drug treatment

About this trial

This is an interventional treatment trial for Diffuse Systemic Sclerosis focused on measuring Diffuse Systemic Sclerosis, Hand, Range of motion, Splint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidade Federal de Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Splint group

Drug treatment

Outcomes

Primary Outcome Measures

Change in hand range of motion

Measured by goniometry

Secondary Outcome Measures

Change in pain

Measured by a visual analogue scale

Change in functional capacity

Measured by HAQ questionnaire

Change in quality of life

Measured by SF-36 questionnaire

Change in upper limb function

Measured by DASH questionnaire

Change in dexterity

Measured by SODA test

Full Information

NCT ID

NCT01586663

First Posted

April 25, 2012

Last Updated

April 27, 2012

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01586663

Brief Title

Serial Night Time Position Splint on Systemic Sclerosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Systemic Sclerosis

Keywords

Diffuse Systemic Sclerosis, Hand, Range of motion, Splint

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Splint group

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Drug treatment

Intervention Type

Device

Intervention Name(s)

Serial night time position splint

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Drug treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in hand range of motion

Description

Measured by goniometry

Time Frame

Baseline and after 3, 6, 9 and 12 months

Secondary Outcome Measure Information:

Title

Change in pain

Description

Measured by a visual analogue scale

Time Frame

Baseline, after 10, 20 and 40 weeks

Title

Change in functional capacity

Description

Measured by HAQ questionnaire

Time Frame

Baseline, after 10, 20 and 40 weeks

Title

Change in quality of life

Description

Measured by SF-36 questionnaire

Time Frame

Basline, after 10, 20 and 40 weeks

Title

Change in upper limb function

Description

Measured by DASH questionnaire

Time Frame

Baseline, after 10, 20 and 40 weeks

Title

Change in dexterity

Description

Measured by SODA test

Time Frame

Baseline, after 3, 6, 9 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fernanda P Cardoso, OT

Phone

551155764239

anamajones@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamil Natour, PhD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Study Chair

Facility Information:

Facility Name

Universidade Federal de Sao Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernanda P Cardosos, OT

Phone

551155764239

anamajones@gmail.com

First Name & Middle Initial & Last Name & Degree

Jamil Natour, PhD

First Name & Middle Initial & Last Name & Degree

Paula G Silva, MsC

First Name & Middle Initial & Last Name & Degree

Anamaria Jones, PhD

12. IPD Sharing Statement

Learn more about this trial

Serial Night Time Position Splint on Systemic Sclerosis

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