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

Not Applicable

Recruiting

• Conditions: Dupuytren's Disease; Dupuytren Contracture
• Interventions: Other: No night splint

• Registration Number: NCT05300893
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-29
• Study Start: 2022-09-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No treatment with night splint after percutaneous needle fasciotomy	No night splint	-

Primary Outcome Measures

Name	Time	Method
Reduction of finger joint contracture	at 1 year follow up	Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by EQ-5D	before treatment, at 3, 12 and 36 months follow-up	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.
Dupuytren-disease-associated disability assessed by URAM	before treatment, at 3, 12 and 36 months follow-up	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.
Study specific questionnaire concerning the patient's medical history	before treatment, at 3, 12 and 36 months follow-up	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.
Pain assessed by a numeric rating scale (NRS)	before treatment, at 3, 12 and 36 months follow-up	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.
Semmes-Weinstein monofilament test	before treatment, at 3, 12 and 36 months follow-up	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.
Change of active finger flexion	before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up	Finger joint movement in order to flex the finger measured in degrees with a goniometer before and after treatment.
Change of grip strength	before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up	The ability to grip with the hand measured with the Jamar hand dynamometer in kg before and after treatment.

Trial Locations

Locations (3)

Akademiska Sjukhuset; 🇸🇪 Uppsala, Uppsala Län, Sweden

Falu Lasarett; 🇸🇪 Falun, Dalarna, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Örebro Län, Sweden