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

Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial

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 Overview

• Status: Recruiting
• Conditions: Dupuytren Contracture; Dupuytren's Disease
• Intervention / Treatment: Other: No night splint

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Muder, MD; Phone Number: 0046-23-490000; Email: daniel.muder@surgsci.uu.se
• Study Contact Backup: Name: Antje Straatmann, MD; Phone Number: 0046-18-6110000; Email: antje.straatmann@akademiska.se

Study Locations

• Sweden
  • Dalarna
    • Falun, Dalarna, Sweden, 79182
      • Recruiting
      • Falu Lasarett
      • Contact: Daniel Muder, MD; Phone Number: 0046-23-490000; Email: daniel.muder@surgsci.uu.se
      • Contact: Anna-Karin Tibell, MD; Phone Number: 0046-23-490000; Email: anna-karin.tibell@regiondalarna.se
  • Uppsala Län
    • Uppsala, Uppsala Län, Sweden, 75185
      • Recruiting
      • Akademiska Sjukhuset
      • Contact: Antje Straatmann, MD; Phone Number: 0046-18-6110000; Email: antje.straatmann@akademiska.se
  • Örebro Län
    • Örebro, Örebro Län, Sweden, 70185
      • Recruiting
      • Universitetssjukhuset Örebro
      • Contact: Madeleine Harryson, MD; Phone Number: 0046-19-6023656; Email: madeleine.harryson@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment with night splint after percutaneous needle fasciotomy
Experimental: No treatment with night splint after percutaneous needle fasciotomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of active finger flexion	Finger joint movement in order to flex the finger measured in degrees with a goniometer before and after treatment.	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.	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.	before treatment, at 3, 12 and 36 months follow-up
Quality of life assessed by EQ-5D	Quality of life is measured by the EQ-5D questionnaire. This questionnaire is developed by the EuroQuol Group and measures 5 health dimensions: mobility, self care, usual activities, pain and discomfort, as well as anxiety and depression. The answers are transferred into an EQ-5D index from 0 to 1, where 0 is equivalent with the worst health state and 1 is equivalent with the best health state.	before treatment, at 3, 12 and 36 months follow-up
Dupuytren-disease-associated disability assessed by URAM	The URAM (Unité Rhumatologique des Affections de la Main) scale is a 9-item questionnaire for functional assessment in Dupuytren's disease with a range from 0-45 points, where 0 is equivalent with the best functional outcome and 45 is equivalent with the worst functional outcome.	before treatment, at 3, 12 and 36 months follow-up
Semmes-Weinstein monofilament test	Semmes-Weinstein monofilament test is a semi-quantitative test for sensory loss. Filaments in different sizes are used to put a different amount of pressure onto the skin. Depending on which filament size the patient is able to detect sensory loss can be investigated.	before treatment, at 3, 12 and 36 months follow-up
Study specific questionnaire concerning the patient's medical history	In this questionnaire the patient answers questions about present conditions such as diabetes and smoking, therapy with pain medication for the hand, how long the patient has been diagnosed with Dupuytren'd disease, if both hands are affected and if there is a positive family history.	before treatment, at 3, 12 and 36 months follow-up

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Stephan Wilbrand, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Splint; Percutaneous needle fasciotomy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: 2021-01331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No