Diffuse Systemic SclerosisPhase 3NCT01586663
Serial Night Time Position Splint on Systemic Sclerosis
A Phase 3 study testing Serial night time position splint and Drug treatment in people with Diffuse Systemic Sclerosis, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Systemic Sclerosis
- What is being tested?
- Serial night time position splint and Drug treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diffuse Systemic scleroses diagnosed following the ACR criteria
- Older than 18 years old
- Sclerodactyly
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04023-062
Fernanda P Cardosos, OT, 551155764239, anamajones@gmail.com
Jamil Natour, PhD
About this study
Official title: Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis
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.
- Conditions
- Diffuse Systemic Sclerosis
- Being tested
- Serial night time position splint, Drug treatment
- Keywords
- Diffuse Systemic Sclerosis, Hand, Range of motion, Splint
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial night time position splintDevice
This group will use a serial night time position splint, adjusted monthly, during three months.
Drug treatmentDrug
This patients will keep there drug treatment and will receive their splints on the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Splint group Receives: Device: Serial night time position splint |
| Control Group | Active comparator | Drug treatment Receives: Drug: Drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand range of motion
Measured by goniometry
Measured: Baseline and after 3, 6, 9 and 12 months
Secondary outcomes (5)
Change in pain
Measured by a visual analogue scale
Measured: Baseline, after 10, 20 and 40 weeks
Change in functional capacity
Measured by HAQ questionnaire
Measured: Baseline, after 10, 20 and 40 weeks
Change in quality of life
Measured by SF-36 questionnaire
Measured: Basline, after 10, 20 and 40 weeks
Change in upper limb function
Measured by DASH questionnaire
Measured: Baseline, after 10, 20 and 40 weeks
Change in dexterity
Measured by SODA test
Measured: Baseline, after 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Pontes Cardoso, Federal University of São Paulo
- Investigators
- Jamil Natour, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586663
- Sponsor's protocol ID
- CEP 1070/09
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serial Night Time Position Splint on Range of Motion for Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01586663
- Acronym / sponsor ID
- CEP 1070/09
- Conditions
- Diffuse Systemic Sclerosis
- Keywords
- Diffuse Systemic Sclerosis, Hand, Range of motion, Splint
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Serial night time position splintSplint group |
| Control Group | Active comparator | Drug: Drug treatmentDrug treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diffuse Systemic scleroses diagnosed following the ACR criteria
- Older than 18 years old
- Sclerodactyly
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial night time position splintThis group will use a serial night time position splint, adjusted monthly, during three months. | Device | Experimental Group |
| Drug treatmentThis patients will keep there drug treatment and will receive their splints on the end of the study. | Drug | Control Group |
Primary outcome
Change in hand range of motion
Time frame: Baseline and after 3, 6, 9 and 12 months
Measured by goniometry
5 secondary outcomes
Change in pain
Time frame: Baseline, after 10, 20 and 40 weeks
Change in functional capacity
Time frame: Baseline, after 10, 20 and 40 weeks
Change in quality of life
Time frame: Basline, after 10, 20 and 40 weeks
Change in upper limb function
Time frame: Baseline, after 10, 20 and 40 weeks
Change in dexterity
Time frame: Baseline, after 3, 6, 9 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamil Natour, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serial night time position splint and Drug treatment in people with Diffuse Systemic Sclerosis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda P Cardoso, OT (551155764239, anamajones@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand range of motion (time frame: Baseline and after 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.