Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No night splint.
- Who it may be relevant to
- Registry conditions: Dupuytren Contracture, Dupuytren's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
Overview
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.
Interventions
- Other 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.
Primary outcome measures
- Reduction of finger joint contracture [Time frame: at 1 year follow up]
Secondary outcome measures (7)
- Change of active finger flexion [Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up]
- Change of grip strength [Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up]
- Pain assessed by a numeric rating scale (NRS) [Time frame: before treatment, at 3, 12 and 36 months follow-up]
- Quality of life assessed by EQ-5D [Time frame: before treatment, at 3, 12 and 36 months follow-up]
- Dupuytren-disease-associated disability assessed by URAM [Time frame: before treatment, at 3, 12 and 36 months follow-up]
- Semmes-Weinstein monofilament test [Time frame: before treatment, at 3, 12 and 36 months follow-up]
- Study specific questionnaire concerning the patient's medical history [Time frame: before treatment, at 3, 12 and 36 months follow-up]
Eligibility criteria
Inclusion criteria
- 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, 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 3 centers
- Falu Lasarett — Falun
- Akademiska Sjukhuset — Uppsala
- Universitetssjukhuset Örebro — Örebro
Identifiers
NCT: NCT05300893 · 2021-01331