Serial Night Time Position Splint on Systemic Sclerosis | NCT01586663

Studies
Serial Night Time Position Splint on Systemic Sclerosis

NCT01586663

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

May 1, 2012Estimated

Enrollment

76Estimated

Phase

Phase 3

Conditions

Diffuse Systemic Sclerosis

Interventions

Serial night time position splint
Drug treatment

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Apr 25, 2012

First Submission Date that Met QC Criteria

Apr 26, 2012

First Posted Date

Apr 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2012

Last Update Posted Date

May 1, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fernanda Pontes Cardoso, Principal Investigator, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental	Splint group	Device: Serial night time position splint
Control Group	Active Comparator	Drug treatment	Drug: Drug treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serial night time position splint	Device	This group will use a serial night time position splint, adjusted monthly, during three months.	Experimental Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fernanda P Cardoso, OT	Contact	551155764239		anamajones@gmail.com

Overall Officials

Name	Affiliation	Role
Jamil Natour, PhD	Federal University of São Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal de Sao Paulo	Recruiting	São Paulo	São Paulo	04023-062	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided