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NCT Number: NCT05300893

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

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.

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Key information

Conditions

Dupuytren Contracture Connective Tissue Diseases Contracture Dupuytren's Disease Fibroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falu Lasarett, Falun, Dalarna County, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reduction of finger joint contracture

    Time frame: 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 outcomes

  1. Change of active finger flexion

    Time frame: 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.

  2. Change of grip strength

    Time frame: 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.

  3. Pain assessed by a numeric rating scale (NRS)

    Time frame: 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.

  4. Quality of life assessed by EQ-5D

    Time frame: 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.

  5. Dupuytren-disease-associated disability assessed by URAM

    Time frame: 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.

  6. Semmes-Weinstein monofilament test

    Time frame: 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.

  7. Study specific questionnaire concerning the patient's medical history

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antje Straatmann, MD

CONTACT

[email protected]

0046-18-6110000

Daniel Muder, MD

CONTACT

[email protected]

0046-23-490000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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