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NCT Number: NCT06267469

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.

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Key information

Conditions

Orthotic Devices

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Warsaw, Masovian Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermoplastic orthosis

Device

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.

Primary outcomes

  1. Grip strength

    Time frame: 6 month

    Measurement of grip strength and of the right and left hands with a dynamometer in an orthosis and without an orthosis.

  2. DASH -Disabilities of the Arm, Shoulder and Hand

    Time frame: 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)

  3. Likert scale

    Time frame: 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

  4. Kapandji score

    Time frame: 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.

  5. NRS - Numerical Rating Scale

    Time frame: 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.

  6. pinch strength

    Time frame: 6 month

    pincer grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Kolasińska, MSc

CONTACT

[email protected]

+48609219822

Teresa Sadura-Sieklucka, Phd

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Magdalena Kolasińska

Other

Collaborators

  • National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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