Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

Not Applicable

Not yet recruiting

• Conditions: Orthotic Devices
• Interventions: Device: Thermoplastic orthosis

• Registration Number: NCT06267469
• Lead Sponsor: Magdalena Kolasińska

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-03
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Start: 2024-05-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kapandji score	Thermoplastic orthosis	Is a tool useful for assessing the opposition of the thumb
DASH Questionnaire	Thermoplastic orthosis	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.
NRS scale	Thermoplastic orthosis	Requires the patient to rate their pain on a defined scale
Pinch strength	Thermoplastic orthosis	Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Grip strength	Thermoplastic orthosis	Using a hydraulic handgrip dynamometer by Saehan according to the procedure to measure grip strength
Likert scale	Thermoplastic orthosis	Measurement strategy, used in surveys to gain knowledge about the degree of acceptance of the orthosis

Primary Outcome Measures

Name	Time	Method
Grip strength	6 month	Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.
Likert scale	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	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	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.
DASH -Disabilities of the Arm, Shoulder and Hand	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)
pinch strength	6 month	pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.

Trial Locations

Locations (2)

Terapia Ręki Magda Kolasińska; 🇵🇱 Warszawa, Mazowieckie, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher; 🇵🇱 Warsaw, Mazowieckie, Poland