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

NCT05300893 | Recruiting

• 1 other identifier: 2021-01331
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 3

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.

Conditions

Dupuytren Contracture; Dupuytren's Disease

Keywords

Percutaneous needle fasciotomy; Splint

Outcome Measures

Primary Outcomes (1)

• Reduction of finger joint contracture

  Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.

  at 1 year follow up

Secondary Outcomes (7)

• Change of active finger flexion

  before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up

• Change of grip strength

  before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up

• Pain assessed by a numeric rating scale (NRS)

  before treatment, at 3, 12 and 36 months follow-up

• Quality of life assessed by EQ-5D

  before treatment, at 3, 12 and 36 months follow-up

• Dupuytren-disease-associated disability assessed by URAM

  before treatment, at 3, 12 and 36 months follow-up

Study Arms (2)

Treatment with night splint after percutaneous needle fasciotomy

NO INTERVENTION

No treatment with night splint after percutaneous needle fasciotomy

EXPERIMENTAL

Other: No night splint

Interventions

No night splint OTHER

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.

No treatment with night splint after percutaneous needle fasciotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (3)

Falu Lasarett

Falun, Dalarna County, 79182, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, Uppsala County, 75185, Sweden

RECRUITING

Universitetssjukhuset Örebro

Örebro, Örebro County, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephan Wilbrand, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Muder, MD

CONTACT

0046-23-490000; daniel.muder@surgsci.uu.se

Antje Straatmann, MD

CONTACT

0046-18-6110000; antje.straatmann@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 29, 2022
• Study Start: September 14, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)