Clinical trial NCT06267469: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Official title: Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orthotic Devices
Keywords: Boutonniere deformity
thermoplastic orthosis
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
Collaborators: name: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
First posted: 2024-02-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


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

Primary outcomes:
measure: Grip strength
timeFrame: 6 month
measure: DASH -Disabilities of the Arm, Shoulder and Hand
timeFrame: 6 month
measure: Likert scale
timeFrame: 6 month
measure: Kapandji score
timeFrame: 6 month
measure: NRS - Numerical Rating Scale
timeFrame: 6 month
measure: pinch strength
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
state: Mazowieckie
city: Warszawa
country: Poland
facility: Terapia Ręki Magda Kolasińska
state: Mazowieckie
Study officials:
affiliation: University of Physical Education in Warsaw
name: Magdalena Kolasińska, Msc
role: STUDY_DIRECTOR
References: