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

Uppsala University154 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

154

Conditions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Falu Lasarett

Falun, Dalarna County, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, Uppsala County, Sweden

RECRUITING

Universitetssjukhuset Örebro

Örebro, Örebro County, Sweden

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.