Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

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.

Study Overview

• Status: Recruiting
• Conditions: Orthotic Devices
• Intervention / Treatment: Device: Thermoplastic orthosis

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdalena Kolasińska, Msc; Phone Number: +48609219822; Email: magdalena.kolasinska@awf.edu.pl
• Study Contact Backup: Name: Teresa Sadura-Sieklucka, Phd; Email: teresa.sadura@awf.edu.pl

Study Locations

• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 01-494
      • Recruiting
      • Terapia Ręki Magda Kolasińska
      • Contact: Magdalena Kolasińska, Msc; Phone Number: +48609219822; Email: magdalena.kolasinska@awf.edu.pl
    • Warsaw, Masovian Voivodeship, Poland, 02-637
      • Recruiting
      • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
      • Contact: Magdalena Kolasińska, Msc; Phone Number: +48609219822; Email: magdalena.kolasinska@awf.edu.pl
      • Contact: Teresa Sadura-Sieklucka, Phd; Email: teresa.sadura@awf.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
pinch strength	pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.	6 month

Collaborators and Investigators

• Sponsor: Magdalena Kolasińska
• Collaborators: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• Investigators: Study Director: Magdalena Kolasińska, Msc, University of Physical Education in Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Boutonniere deformity; thermoplastic orthosis
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Boutonniere deformity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No