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

Last updated: May 30, 2024
Sponsor: Uppsala University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dupuytren's Disease

Treatment

No night splint

Clinical Study ID

NCT05300893
2021-01331
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 thePIP joint and a maximum of 75 degrees in the MCP or PIP joint

Exclusion

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

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: No night splint
Phase:
Study Start date:
September 14, 2022
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Falu Lasarett

    Falun, Dalarna 79182
    Sweden

    Active - Recruiting

  • Akademiska Sjukhuset

    Uppsala, Uppsala Län 75185
    Sweden

    Active - Recruiting

  • Universitetssjukhuset Örebro

    Örebro, Örebro Län 70185
    Sweden

    Active - Recruiting

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