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Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
ID06267469

Effectiveness of Thermoplastic vs Fabricated Orthoses for Female Adults with Boutonniere Thumb Deformity and Rheumatoid Arthritis

Led by Magdalena Kolasińska · Updated on 2025-09-03

60

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Magdalena Kolasińska

Lead Sponsor

N

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of a specially designed thermoplastic thumb orthosis compared with factory-made fabric orthoses in women with rheumatoid arthritis and boutonniere deformity of the thumb. The study will assess how these devices impact hand function, strength, dexterity, and pain levels over time. About 60 female participants aged 18 to 65 years will be included, with half using the thermoplastic orthosis and half using the factory-made version. Participants will be randomly assigned to wear either the thermoplastic or fabric orthosis. The thermoplastic device is designed to correct the alignment of the thumb joints by properly tensioning the extensor bands, aiming to improve hand mobility, grip strength, and reduce pain. Both groups will be monitored for changes in grip strength, pincer grip strength, pain levels, hand function, and satisfaction with the orthosis over a six-month period. During the study, participants will undergo regular measurements of grip and pincer strength using a hydraulic handgrip dynamometer, complete the Disabilities of the Arm, Shoulder and Hand DASH questionnaire to assess upper limb disability, rate their pain on a numerical scale, and evaluate thumb opposition using the Kapandji score. Satisfaction with the orthosis will also be assessed using a Likert scale. Researchers will compare the results between the two groups to determine which orthosis offers better function and pain relief.

CONDITIONS

Brief Title

Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with rheumatoid arthritis (RA)
  • Diagnosed boutonniere finger deformity, type I or II
  • Female
  • Age between 18 and 65 years
  • Patient's consent to participate in the study
Not Eligible

You will not qualify if you...

  • Other deformity of the thumb
  • Less than 1 year since surgical intervention in the hand
  • Less than 6 months since injection treatment within the thumb
  • Change in treatment during the study and 3 months before the study

Research Team

M

Magdalena Kolasińska, MSc

T

Teresa Sadura-Sieklucka, Phd

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