Serial Night Time Position Splint on Systemic Sclerosis
Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 1, 2012
April 1, 2012
2.9 years
April 25, 2012
April 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in hand range of motion
Measured by goniometry
Baseline and after 3, 6, 9 and 12 months
Secondary Outcomes (5)
Change in pain
Baseline, after 10, 20 and 40 weeks
Change in functional capacity
Baseline, after 10, 20 and 40 weeks
Change in quality of life
Basline, after 10, 20 and 40 weeks
Change in upper limb function
Baseline, after 10, 20 and 40 weeks
Change in dexterity
Baseline, after 3, 6, 9 and 12 months
Study Arms (2)
Experimental Group
EXPERIMENTALSplint group
Control Group
ACTIVE COMPARATORDrug treatment
Interventions
This group will use a serial night time position splint, adjusted monthly, during three months.
This patients will keep there drug treatment and will receive their splints on the end of the study.
Eligibility Criteria
You may qualify if:
- Diffuse Systemic scleroses diagnosed following the ACR criteria
- Older than 18 years old
- Sclerodactyly
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04023-062, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jamil Natour, PhD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 27, 2012
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 1, 2012
Record last verified: 2012-04