Serial Night Time Position Splint on Systemic Sclerosis
This study is currently recruiting participants.
Verified April 2012 by Federal University of São Paulo
Sponsor:
Federal University of São Paulo
Information provided by (Responsible Party):
Fernanda Pontes Cardoso, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01586663
First received: April 25, 2012
Last updated: April 27, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Systemic Sclerosis |
Device: Serial night time position splint Drug: Drug treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic scleroderma
MedlinePlus related topics:
Scleroderma
U.S. FDA Resources
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Change in hand range of motion [ Time Frame: Baseline and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]Measured by goniometry
Secondary Outcome Measures:
- Change in pain [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]Measured by a visual analogue scale
- Change in functional capacity [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]Measured by HAQ questionnaire
- Change in quality of life [ Time Frame: Basline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]Measured by SF-36 questionnaire
- Change in upper limb function [ Time Frame: Baseline, after 10, 20 and 40 weeks ] [ Designated as safety issue: No ]Measured by DASH questionnaire
- Change in dexterity [ Time Frame: Baseline, after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]Measured by SODA test
| Estimated Enrollment: | 76 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Group
Splint group
|
Device: Serial night time position splint
This group will use a serial night time position splint, adjusted monthly, during three months.
|
|
Active Comparator: Control Group
Drug treatment
|
Drug: Drug treatment
This patients will keep there drug treatment and will receive their splints on the end of the study.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586663
Contacts
| Contact: Fernanda P Cardoso, OT | 551155764239 | anamajones@gmail.com |
Locations
| Brazil | |
| Universidade Federal de Sao Paulo | Recruiting |
| Sao Paulo, SP, Brazil, 04023-062 | |
| Contact: Fernanda P Cardosos, OT 551155764239 anamajones@gmail.com | |
| Sub-Investigator: Jamil Natour, PhD | |
| Sub-Investigator: Paula G Silva, MsC | |
| Sub-Investigator: Anamaria Jones, PhD | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Study Chair: | Jamil Natour, PhD | Federal University of São Paulo |
More Information
No publications provided
| Responsible Party: | Fernanda Pontes Cardoso, Principal Investigator, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01586663 History of Changes |
| Other Study ID Numbers: | CEP 1070/09 |
| Study First Received: | April 25, 2012 |
| Last Updated: | April 27, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
Diffuse Systemic Sclerosis Hand Range of motion Splint |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Connective Tissue Diseases Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013