Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

Magdalena Kolasińska

Status: Not yet enrolling

Conditions: Orthotic Devices

Treatments: Device: Thermoplastic orthosis

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06267469

Boutonniere deformity

Details and patient eligibility

About

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

2. 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.

3. 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 6 patient groups

Grip strength

Other group

Description:

Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength

Treatment:

Device: Thermoplastic orthosis

DASH Questionnaire

Other group

Description:

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.

Treatment:

Device: Thermoplastic orthosis

Likert scale

Other group

Description:

Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis

Treatment:

Device: Thermoplastic orthosis

Kapandji score

Other group

Description:

Is a tool useful for assessing the opposition of the thumb

Treatment:

Device: Thermoplastic orthosis

NRS scale

Other group

Description:

Requires the patient to rate their pain on a defined scale

Treatment:

Device: Thermoplastic orthosis

Pinch strength

Other group

Description:

Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength

Treatment:

Device: Thermoplastic orthosis