An interventional study of No night splint in Dupuytren Contracture and Dupuytren's Disease, sponsored by Uppsala University. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
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.
81 studies on the registry are indexed under Dupuytren Contracture; 17 are open to participants now.
This study's planned enrollment of 154 is above the median of 72 across 60 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Reduction of finger joint contracture
Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.
Time frame: at 1 year follow up
Change of active finger flexion
Finger joint movement in order to flex the finger measured in degrees with a goniometer before and after treatment.
Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
Change of grip strength
The ability to grip with the hand measured with the Jamar hand dynamometer in kg before and after treatment.
Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
Pain assessed by a numeric rating scale (NRS)
Report of pain in the treated finger using a numeric rating scale from 0 to 10, where 0 is equivalent to no pain at all and 10 is equivalent to the highest thinkable pain level.
Time frame: before treatment, at 3, 12 and 36 months follow-up
Quality of life assessed by EQ-5D
Quality of life is measured by the EQ-5D questionnaire. This questionnaire is developed by the EuroQuol Group and measures 5 health dimensions: mobility, self care, usual activities, pain and discomfort, as well as anxiety and depression. The answers are transferred into an EQ-5D index from 0 to 1, where 0 is equivalent with the worst health state and 1 is equivalent with the best health state.
Time frame: before treatment, at 3, 12 and 36 months follow-up
Dupuytren-disease-associated disability assessed by URAM
The URAM (Unité Rhumatologique des Affections de la Main) scale is a 9-item questionnaire for functional assessment in Dupuytren's disease with a range from 0-45 points, where 0 is equivalent with the best functional outcome and 45 is equivalent with the worst functional outcome.
Time frame: before treatment, at 3, 12 and 36 months follow-up
Semmes-Weinstein monofilament test
Semmes-Weinstein monofilament test is a semi-quantitative test for sensory loss. Filaments in different sizes are used to put a different amount of pressure onto the skin. Depending on which filament size the patient is able to detect sensory loss can be investigated.
Time frame: before treatment, at 3, 12 and 36 months follow-up
Study specific questionnaire concerning the patient's medical history
In this questionnaire the patient answers questions about present conditions such as diabetes and smoking, therapy with pain medication for the hand, how long the patient has been diagnosed with Dupuytren'd disease, if both hands are affected and if there is a positive family history.
Time frame: before treatment, at 3, 12 and 36 months follow-up
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Sep 2022 (actual). Primary completion is estimated for Jan 2026, 40 months after the start.
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