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

Dupuytren Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300893
• Other study ID #: 2021-01331
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: January 2027

Study information

• Verified date: February 2023
• Source: Uppsala University
• Contact: Daniel Muder, MD
• Phone: 0046-23-490000
• Email: daniel.muder[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: January 2027
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Disease

Intervention

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.

Locations

Country	Name	City	State
Sweden	Falu Lasarett	Falun	Dalarna
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro Län
Sweden	Akademiska Sjukhuset	Uppsala	Uppsala Län

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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