Evaluating night splinting after needle fasciotomy for Dupuytren's contracture
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
This study is testing if wearing a night splint after a needle procedure for Dupuytren's contracture can help prevent the condition from coming back compared to just physical therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 3 sites (Falun, Dalarna County and 2 other locations) |
| Trial ID | NCT05300893 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of night splinting following percutaneous needle fasciotomy (PNF) in patients with Dupuytren's contracture. Patients will be randomized into two groups: one receiving standard physical therapy and night splinting, and the other receiving physical therapy without splinting. The primary goal is to determine if night splinting reduces the recurrence rate of Dupuytren's contracture after PNF. This approach aims to provide insights into optimizing post-treatment care for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific Dupuytren's contracture characteristics as defined by the Tubiana classification.
Not a fit: Patients with advanced Dupuytren's contracture or those who have previously undergone treatment for the same digit may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies that reduce the recurrence of Dupuytren's contracture after treatment.
How similar studies have performed: While the effectiveness of night splinting is debated, this study aims to provide new insights, as similar approaches have not been extensively validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Falun, Dalarna County and 2 other locations
- Falu Lasarett — Falun, Dalarna County, Sweden (Recruiting)
- Akademiska Sjukhuset — Uppsala, Uppsala County, Sweden (Recruiting)
- Universitetssjukhuset Örebro — Örebro, Örebro County, Sweden (Recruiting)
Study contacts
- Principal investigator: Stephan Wilbrand, MD, PhD — Uppsala University
- Study coordinator: Daniel Muder, MD
- Email: daniel.muder@surgsci.uu.se
- Phone: 0046-23-490000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.