Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT05300893

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

Led by Uppsala University · Updated on 2024-05-31

154

Participants Needed

3

Research Sites

224 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Extension deficit 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Falu Lasarett

Falun, Dalarna County, Sweden, 79182

Actively Recruiting

2

Akademiska Sjukhuset

Uppsala, Uppsala County, Sweden, 75185

Actively Recruiting

3

Universitetssjukhuset Örebro

Örebro, Örebro County, Sweden, 70185

Actively Recruiting

Loading map...

Research Team

D

Daniel Muder, MD

CONTACT

A

Antje Straatmann, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here