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

NCT05300893 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-05-31

No results posted yet for this 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.

Conditions

  • Dupuytren Contracture
  • Dupuytren's Disease

Interventions

OTHER

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.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Stephan Wilbrand, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300893 on ClinicalTrials.gov