Actively Recruiting
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
Led by Uppsala University · Updated on 2024-05-31
154
Participants Needed
3
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery. After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated. This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.
CONDITIONS
Official 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 according to stadium 1 and 2 of the classification of Tubiana in one or two fingers excluding the thumb
- Extension deficit defined as at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint and a maximum 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 localization in the digit only
- Digital nerve injury
- Any former treatment for Dupuytren's contracture in the same digit
- Thumb contracture
- Stadium 3 and 4 according to the classification of Tubiana
AI-Screening
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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
CONTACT
A
Antje Straatmann, MD
CONTACT
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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