Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

Orthotic Devices Clinical Trial

Official title:

Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267469
• Other study ID #: Boutonniere deformity
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Józef Pilsudski University of Physical Education
• Contact: Magdalena Kolasinska, MSc
• Phone: +48609219822
• Email: magdalena.kolasinska[@]awf.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Orthotic Devices

Intervention

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.

Locations

Country	Name	City	State
Poland	Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher	Warsaw	Mazowieckie
Poland	Terapia Reki Magda Kolasinska	Warszawa	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Magdalena Kolasinska	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength	Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.	6 month
Primary	DASH -Disabilities of the Arm, Shoulder and Hand	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)	6 month
Primary	Likert scale	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	6 month
Primary	Kapandji score	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.	6 month
Primary	NRS - Numerical Rating Scale	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.	6 month
Primary	pinch strength	pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.	6 month