Orthotic DevicesNCT06267469
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
A study testing Thermoplastic orthosis in people with Orthotic Devices, run by Magdalena Kolasińska at 2 sites in Poland.
Trial summary
The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthotic Devices
- What is being tested?
- Thermoplastic orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPoland
- Study dates
- 6 Jul 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed with RA
- diagnosed thumb deformity: butonier finger, type I or II
- female
- age 18 - 65 years
- patient's consent to the study
Who cannot join
- other deformity of the thumb
- less than 1 year since surgical intervention in the hand
- less than 6 months since delivery injections within the thumb
- change in treatment during the study and 3 months before the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Teresa Sadura-Sieklucka, Phd contact
Poland2 sites, 2 recruiting
- Recruiting
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, 01-494
Magdalena Kolasińska, Msc, +48609219822, magdalena.kolasinska@awf.edu.pl
- Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Masovian Voivodeship, 02-637
Magdalena Kolasińska, Msc, +48609219822, magdalena.kolasinska@awf.edu.pl
Teresa Sadura-Sieklucka, Phd, teresa.sadura@awf.edu.pl
About this study
The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)
The main questions it aims to answer are:
- How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will
- measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
- measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.
- completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional.
- Conditions
- Orthotic Devices
- Being tested
- Thermoplastic orthosis
- Keywords
- Boutonniere deformity, thermoplastic orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoplastic orthosisDevice
The use of the author's orthosis is aimed at correcting the anatomical alignment of the MP (metacarpophalangeal) joints, IP (interphalangeal) by properly tensioning the central extensor band and the lateral bands of the thumb's extensor apparatus. It should significantly increase the mobility of the hand in connection with improving hand grip and reducing pain.
| Study group | Role | What they receive |
|---|---|---|
| Grip strength | Other | Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength Receives: Device: Thermoplastic orthosis |
| DASH Questionnaire | Other | The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status. Receives: Device: Thermoplastic orthosis |
| Likert scale | Other | Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis Receives: Device: Thermoplastic orthosis |
| Kapandji score | Other | Is a tool useful for assessing the opposition of the thumb Receives: Device: Thermoplastic orthosis |
| NRS scale | Other | Requires the patient to rate their pain on a defined scale Receives: Device: Thermoplastic orthosis |
| Pinch strength | Other | Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength Receives: Device: Thermoplastic orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.
Measured: 6 month
DASH -Disabilities of the Arm, Shoulder and Hand
The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. In the DASH a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on test ranges from 0 (no disability) to 100 (most severe disability)
Measured: 6 month
Likert scale
Measurement strategy, used surveys through which knowledge about the degree of acceptance of the product can be obtained. Participants provide data using a four-point strongly disagree, disagree, agree, strongly agree
Measured: 6 month
Kapandji score
Is a tool useful for assessing the opposition of the thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
Measured: 6 month
NRS - Numerical Rating Scale
Requires the patient to rate their pain on a defined scale. Ranges from 0 to 10. zero being an example of someone with no pain and ten being the worst pain possible.
Measured: 6 month
pinch strength
pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start6 Jul 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthotic DevicesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magdalena Kolasińska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Responsible party
- Sponsor-investigator, Magdalena Kolasińska, Józef Piłsudski University of Physical Education
- Investigators
- Magdalena Kolasińska, Msc, Study director, University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267469
- Sponsor's protocol ID
- Boutonniere deformity
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
- ClinicalTrials.gov ID
- NCT06267469
- Acronym / sponsor ID
- Boutonniere deformity
- Conditions
- Orthotic Devices
- Keywords
- Boutonniere deformity, thermoplastic orthosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Magdalena KolasińskaUniversity, hospital or other
- Collaborators
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- 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 goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)
The main questions it aims to answer are:
- How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will
- measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.
- measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.
- completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Grip strength | Other | Device: Thermoplastic orthosisUsing a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength |
| DASH Questionnaire | Other | Device: Thermoplastic orthosisThe DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. Assess symptoms and the inability to perform certain activities based on health status. |
| Likert scale | Other | Device: Thermoplastic orthosisMeasurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis |
| Kapandji score | Other | Device: Thermoplastic orthosisIs a tool useful for assessing the opposition of the thumb |
| NRS scale | Other | Device: Thermoplastic orthosisRequires the patient to rate their pain on a defined scale |
| Pinch strength | Other | Device: Thermoplastic orthosisUsing a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with RA
- diagnosed thumb deformity: butonier finger, type I or II
- female
- age 18 - 65 years
- patient's consent to the study
Key exclusion criteria (4 listed)
- other deformity of the thumb
- less than 1 year since surgical intervention in the hand
- less than 6 months since delivery injections within the thumb
- change in treatment during the study and 3 months before the study
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 |
|---|---|---|
| Thermoplastic orthosisThe use of the author's orthosis is aimed at correcting the anatomical alignment of the MP (metacarpophalangeal) joints, IP (interphalangeal) by properly tensioning the central extensor band and the lateral bands of the thumb's extensor apparatus. It should significantly increase the mobility of the hand in connection with improving hand grip and reducing pain. | Device | DASH Questionnaire, Grip strength, Kapandji score, Likert scale, NRS scale, Pinch strength |
Primary outcome
Grip strength
Time frame: 6 month
Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.
DASH -Disabilities of the Arm, Shoulder and Hand
Time frame: 6 month
The DASH questionnaire assesses upper limb disability and consists of 30 questions in the general section and an additional work module with 4 questions and a sport/instrument playing module with 4 questions. In the DASH a higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on test ranges from 0 (no disability) to 100 (most severe disability)
Likert scale
Time frame: 6 month
Measurement strategy, used surveys through which knowledge about the degree of acceptance of the product can be obtained. Participants provide data using a four-point strongly disagree, disagree, agree, strongly agree
Kapandji score
Time frame: 6 month
Is a tool useful for assessing the opposition of the thumb. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.
NRS - Numerical Rating Scale
Time frame: 6 month
Requires the patient to rate their pain on a defined scale. Ranges from 0 to 10. zero being an example of someone with no pain and ten being the worst pain possible.
pinch strength
Time frame: 6 month
pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Teresa Sadura-Sieklucka, Phd contact
Magdalena Kolasińska, Msc study director
University of Physical Education in Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoplastic orthosis in people with Orthotic Devices, run by Magdalena Kolasińska at 2 sites in Poland.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Kolasińska, MSc (+48609219822, magdalena.kolasinska@awf.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: 6 month). The study lists 6 primary outcomes in all. 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 3 Sep 2025.