Osteoarthritis of Trapeziometacarpal JointNCT02635932
Effectiveness of Trapeziometacarpal Splint
A study testing Day Splint and Night Splint in people with Osteoarthritis of Trapeziometacarpal Joint, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of Trapeziometacarpal Joint
- What is being tested?
- Day Splint and Night Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Mar 2017
- Phase
- Interventional
- 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
- Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm
Who cannot join
- Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
- Deformity of the distal interphalangeal joint (IFD) of the thumb
- Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
- Allergy to the material of the splint
- Inability to respond to the questionnaire and perform the tests
- Geographic inaccessibility
Show all 10Show fewer
- Infiltration in hand in the previous 3 months
- Changes in the use of anti-inflammatory and analgesic past 3 months
- Physiotherapy in hand over the last 3 months
- Have the following related diseases: carpal tunnel syndrome, carpal fractures of DeQuervain syndrome, tendonitis, fibromyalgia and chronic inflammatory arthropathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Rheumatology Division
São Paulo, São Paulo, 04023-900
About this study
The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function
Read the detailed description
Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.
- Being tested
- Day Splint, Night Splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day SplintDevice
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the daily life activities.
Night SplintDevice
A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the night.
| Study group | Role | What they receive |
|---|---|---|
| Functional Splint group | Experimental | Patient will be using the functional splint during their activity daily life Receives: Device: Day Splint |
| Night Splint group | Active comparator | Patients will use the night splint during the sleep time Receives: Device: Night Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scale
Measured: baseline, after 45, 90 and 180 days
Secondary outcomes (2)
Change in Functional capacity using the Cochin Hand Functional Scale questionnaire
Measured: baseline, after 45, 90 and 180 days
Change in pinch and grip strength
Measured: baseline, after 45, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of Trapeziometacarpal JointStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiana de Carvalho Silva, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635932
- Sponsor's protocol ID
- CEP_UNIFESP_269.012
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2015
- Last updated
- 15 Dec 2022
- Results posted
- No
Publications
Silva FC, da Silva RVT, Meireles SM, Fernandes ADRC, Natour J. Daytime Functional Usage Versus Night-Time Wearing: Identifying the Optimal Wearing Regimen for a Custom-Made Orthosis in the Treatment of Trapeziometacarpal Osteoarthritis. Arch Phys Med Rehabil. 2024 Oct;105(10):1837-1845. doi: 10.1016/j.apmr.2024.06.013. Epub 2024 Jul 4.
PubMed 38971487
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trapeziometacarpal Splint
- ClinicalTrials.gov ID
- NCT02635932
- Acronym / sponsor ID
- CEP_UNIFESP_269.012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Dec 2015 (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.
The trapeziometacarpal osteoarthritis is a degenerative or inflammatory joint that affects the trapeziometacarpal joint (TMC) of the thumb. Its main symptom is pain that leads to difficulty in manual function and decrease the patient's quality of life. Immobilization of TMC thumb joint by bracing has been effective in reducing pain and improving function. Objective: To compare the effectiveness between day and night functional splint for patients with trapeziometacarpal osteoarthritis in improving pain and function
Detailed description
Randomized clinical trial, and blind where selected 60 patients diagnosed with trapeziometacarpal osteoarthritis.Os patients were assessed by a blinded evaluator at the beginning of treatment and after 45, 90 and 180 days in relation to pain, thumb range of motion, strength hold, tweezers, dexterity, function and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Splint group | Experimental | Device: Day SplintPatient will be using the functional splint during their activity daily life |
| Night Splint group | Active comparator | Device: Night SplintPatients will use the night splint during the sleep time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with osteoarthritis in accordance with the American College of Rheumatology classification criteria (ACR); of both genders and age above 18 years; Pain in TMC articulation between 3 and 8 cm in numerical pain scale (END) 10cm
Key exclusion criteria (10 listed)
- Patients with severe deformities in hand with trapeziometacarpal osteoarthritis not possible to achieve pincer movement between the first, second and third fingers
- Deformity of the distal interphalangeal joint (IFD) of the thumb
- Use of splint the thumb in the last six months; Have surgery scheduled on hand for the next six months
- Allergy to the material of the splint
- Inability to respond to the questionnaire and perform the tests
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 |
|---|---|---|
| Day SplintA thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the daily life activities. | Device | Functional Splint group |
| Night SplintA thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the night. | Device | Night Splint group |
Primary outcome
Change in pain scale
Time frame: baseline, after 45, 90 and 180 days
2 secondary outcomes
Change in Functional capacity using the Cochin Hand Functional Scale questionnaire
Time frame: baseline, after 45, 90 and 180 days
Change in pinch and grip strength
Time frame: baseline, after 45, 90 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 38971487Silva FC, da Silva RVT, Meireles SM, Fernandes ADRC, Natour J. Daytime Functional Usage Versus Night-Time Wearing: Identifying the Optimal Wearing Regimen for a Custom-Made Orthosis in the Treatment of Trapeziometacarpal Osteoarthritis. Arch Phys Med Rehabil. 2024 Oct;105(10):1837-1845. doi: 10.1016/j.apmr.2024.06.013. Epub 2024 Jul 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day Splint and Night Splint in people with Osteoarthritis of Trapeziometacarpal Joint, 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 15 Dec 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scale (time frame: baseline, after 45, 90 and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635932, which also lists 1 linked publication.
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 15 Dec 2022.