Actively Recruiting
Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses
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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a thermoplastic orthosis designed to improve hand mobility, grip strength, and reduce pain by correcting the anatomical alignment of finger joints.
Regular visits to assess orthosis effects and hand function
Trial Site Locations
Total: 2 locations
1
Terapia Ręki Magda Kolasińska
Warsaw, Masovian Voivodeship, Poland, 01-494
Actively Recruiting
2
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
M
Magdalena Kolasińska, MSc
T
Teresa Sadura-Sieklucka, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
6
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