Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
NCT ID: NCT05300893
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
154 participants
INTERVENTIONAL
2022-09-14
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment with night splint after percutaneous needle fasciotomy
No interventions assigned to this group
No treatment with night splint after percutaneous needle fasciotomy
No night splint
Instead of the usual treatment with a night splint for three months after percutaneous needle fasciotomy patients do not receive treatment with a night splint.
Interventions
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No night splint
Instead of the usual treatment with a night splint for three months after percutaneous needle fasciotomy patients do not receive treatment with a night splint.
Eligibility Criteria
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Inclusion Criteria
* 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, 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Stephan Wilbrand, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Falu Lasarett
Falun, Dalarna County, Sweden
Akademiska Sjukhuset
Uppsala, Uppsala County, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2021-01331
Identifier Type: -
Identifier Source: org_study_id
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