Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thermoplastic orthosis.
- Who it may be relevant to
- Registry conditions: Orthotic Devices. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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: 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.
Interventions
- Device 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.
Primary outcome measures
- Grip strength [Time frame: 6 month]
- DASH -Disabilities of the Arm, Shoulder and Hand [Time frame: 6 month]
- Likert scale [Time frame: 6 month]
- Kapandji score [Time frame: 6 month]
- NRS - Numerical Rating Scale [Time frame: 6 month]
- pinch strength [Time frame: 6 month]
Eligibility criteria
Inclusion criteria
- diagnosed with RA
- diagnosed thumb deformity: butonier finger, type I or II
- female
- age 18 - 65 years
- patient's consent to the study
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Poland · 2 centers
- Terapia Ręki Magda Kolasińska — Warsaw
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory — Warsaw
Identifiers
NCT: NCT06267469 · Boutonniere deformity