Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
NCT ID: NCT06267469
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-07-06
2026-09-30
Brief Summary
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The main questions it aims to answer are:
1\. 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
1. 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.
2. 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.
4\. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Grip strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Thermoplastic orthosis
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.
DASH Questionnaire
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.
Thermoplastic orthosis
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.
Likert scale
Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis
Thermoplastic orthosis
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.
Kapandji score
Is a tool useful for assessing the opposition of the thumb
Thermoplastic orthosis
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.
NRS scale
Requires the patient to rate their pain on a defined scale
Thermoplastic orthosis
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.
Pinch strength
Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Thermoplastic orthosis
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.
Interventions
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Thermoplastic orthosis
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.
Eligibility Criteria
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Inclusion Criteria
* diagnosed thumb deformity: butonier finger, type I or II
* female
* age 18 - 65 years
* patient's consent to the study
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
NETWORK
Magdalena Kolasińska
OTHER
Responsible Party
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Magdalena Kolasińska
Principal Investigator
Principal Investigators
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Magdalena Kolasińska, Msc
Role: STUDY_DIRECTOR
University of Physical Education in Warsaw
Locations
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Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Boutonniere deformity
Identifier Type: -
Identifier Source: org_study_id
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