Actively Recruiting
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
Led by Uppsala University · Updated on 2024-05-31
154
Participants Needed
3
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Dupuytren's contracture is a condition causing progressive finger stiffness due to fibrosis in the palm and fingers. This trial investigates whether using a night splint after a minimally invasive procedure called percutaneous needle fasciotomy (PNF) reduces the chance of the contracture coming back. The study compares two groups of patients receiving PNF treatment to see if night splinting adds benefit beyond physical therapy alone. Participants are randomly assigned to one of two groups: one group will receive usual care including physical therapy and night splinting for three months after PNF, while the other group will have physical therapy without night splinting. Those in the no splint group will have an additional check three weeks after PNF to monitor finger extension. Follow-up visits occur at 2 weeks, then 3, 12, and 36 months after treatment. During the study, patients will undergo physical exams assessing finger motion, sensation, and grip strength. They will also complete questionnaires about hand function, pain, and quality of life at several timepoints including the day of procedure and months 3, 12, and 36. The main outcome measured is reduction in finger joint contracture at 1 year. Researchers will also evaluate changes in finger flexion, grip strength, pain levels, disability, sensation, and medical history over the follow-up period.
CONDITIONS
Brief Title
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age and older
- Palpable Dupuytren strand with passive extension deficit in one or two fingers excluding the thumb
- Extension deficit at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint
- Maximum contracture of 75 degrees in the MCP or PIP joint
You will not qualify if you...
- Multiple, invasive or wide strands in the palm
- Skin irritation
- Strand located only in the digit
- Digital nerve injury
- Any former treatment for Dupuytren's contracture in the same digit
- Thumb contracture
- Severe contracture classified as stadium 3 or 4 according to Tubiana classification
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.
Duration - 3 months
Participants receive percutaneous needle fasciotomy and are randomized to either treatment with a night splint or no night splint for three months after the procedure.
1 treatment visit and follow-up visits at 2 weeks and 3 months
Duration - Up to 36 months after treatment
Participants are followed to assess finger joint contracture, finger flexion, grip strength, pain, quality of life, disability, and sensory function.
Visits at 12 and 36 months after treatment
Trial Site Locations
Total: 3 locations
1
Falu Lasarett
Falun, Dalarna County, Sweden, 79182
Actively Recruiting
2
Akademiska Sjukhuset
Uppsala, Uppsala County, Sweden, 75185
Actively Recruiting
3
Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden, 70185
Actively Recruiting
Research Team
D
Daniel Muder, MD
A
Antje Straatmann, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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