OsteoarthritisPhase 2NCT00612248
Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint
A Phase 2 study testing Splint in people with Osteoarthritis, run by Federal University of São Paulo.
Trial summary
Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Dec 2007
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
- either gender;
- over 40 years of age;
- pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.
Who cannot join
- severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
- deformities of distal interphalangeal joint;
- use of a splint on the thumb in the previous six months;
- surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
- allergy to the splint material;
- incapacity to respond to the questionnaire and perform the tests;
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- geographic inaccessibility;
- injections in the hand under study in the previous six months;
- other associated diseases such as carpal tunnel syndrome, fractures in the carpus, tendonitis, chronic inflammatory arthropathy;
- alterations in the use of anti-inflammatory medication and analgesics in the previous three months.
About this study
Official title: Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study
Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.
Read the detailed description
Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
- Conditions
- Osteoarthritis
- Being tested
- Splint
- Keywords
- Osteoarthritis, Thumb, Splint, Pain, Function, Osteoarthritis of the trapeziometacarpal (TMC) joint
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintOther
Patients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations
| Study group | Role | What they receive |
|---|---|---|
| SG | Experimental | Study group Receives: Other: Splint |
| CG | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
Measured: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Secondary outcomes (3)
Function (DASH)
Measured: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Grip and pinch strength (dynamometer)
Measured: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Dexterity (O'Connor test)
Measured: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJul 2005
- Primary completionJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Jamil Natour, MD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612248
- Sponsor's protocol ID
- UNIFESP0108
- Other IDs
- CEP1090/03
- Status last verified
- Jan 2008
- First submitted
- 29 Jan 2008
- Last updated
- 11 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of a Functional Splint for Osteoarthritis of the Trapeziometacarpal Joint on the Dominant Hand: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00612248
- Acronym / sponsor ID
- UNIFESP0108
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Thumb, Splint, Pain, Function, Osteoarthritis of the trapeziometacarpal (TMC) joint
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Feb 2008 (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.
Forty participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of a functional thumb splint for trapeziometacarpal OA in the dominant hand.
Detailed description
Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SG | Experimental | Other: SplintStudy group |
| CG | No intervention | –Control group |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical and radiological diagnosis of idiopathic Grade II and III OA of the TMC joint on the dominant hand;
- either gender;
- over 40 years of age;
- pain in the base of the thumb of the dominant hand greater than three and less than or equal to seven on the 0 to 10-cm visual analogue scale (VAS) for pain.
Key exclusion criteria (10 listed)
- severe deformities of the dominant hand that did not allow gripping between the first, second and third fingers;
- deformities of distal interphalangeal joint;
- use of a splint on the thumb in the previous six months;
- surgery on the hand under study in the previous six months or scheduled in the upcoming six months;
- allergy to the splint material;
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 |
|---|---|---|
| SplintPatients in the study group received the splint on the day of the first evaluation and took it with them for use during activities of daily living and patients in the control group only used the splint during the evaluations | Other | SG |
Primary outcome
Pain (VAS)
Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
3 secondary outcomes
Function (DASH)
Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Grip and pinch strength (dynamometer)
Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
Dexterity (O'Connor test)
Time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)
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 11 Feb 2008.
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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, MD study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Splint in people with Osteoarthritis, run by Federal University of São Paulo.
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 4 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 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain (VAS) (time frame: baseline (T0), after 45 days (T45), after 90 dias (T90) and after 180 dias (T180)). 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 11 Feb 2008.