Ireland
--:--IST
Recruiting Not applicable

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture

NCT05300893 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2022-09-14
Last updated
2024-05-31

Condition(s) studied

Dupuytren ContractureDupuytren's Disease

Investigational drug(s) / intervention(s)

No night splint

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Reduction of finger joint contracture — at 1 year follow up
    Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.

Trial sites (3)

FacilityCityRegionStatus
Falu Lasarett Falun Dalarna County Recruiting
Akademiska Sjukhuset Uppsala Uppsala County Recruiting
Universitetssjukhuset Örebro Örebro Örebro County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05300893 on ClinicalTrials.gov ↗ ← All trials in Sweden