Clinical trial NCT05300893: Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
Official title: Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dupuytren Contracture
Dupuytren's Disease
Keywords: Percutaneous needle fasciotomy
Splint
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Reduction of finger joint contracture
timeFrame: at 1 year follow up
Secondary outcomes:
measure: Change of active finger flexion
timeFrame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
measure: Change of grip strength
timeFrame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
measure: Pain assessed by a numeric rating scale (NRS)
timeFrame: before treatment, at 3, 12 and 36 months follow-up
measure: Quality of life assessed by EQ-5D
timeFrame: before treatment, at 3, 12 and 36 months follow-up
measure: Dupuytren-disease-associated disability assessed by URAM
timeFrame: before treatment, at 3, 12 and 36 months follow-up
measure: Semmes-Weinstein monofilament test
timeFrame: before treatment, at 3, 12 and 36 months follow-up
measure: Study specific questionnaire concerning the patient's medical history
timeFrame: before treatment, at 3, 12 and 36 months follow-up
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu Lasarett
state: Dalarna
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
state: Uppsala Län
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro
state: Örebro Län
Study officials:
affiliation: Uppsala University
name: Stephan Wilbrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: