Dupuytren ContractureNCT05300893
Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture
A study testing No night splint in people with Dupuytren Contracture and Dupuytren's Disease, run by Uppsala University at 3 sites in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dupuytren Contracture, Dupuytren's Disease
- What is being tested?
- No night splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesSweden
- Study dates
- 14 Sep 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Falu Lasarett
Falun, Dalarna County, 79182
Daniel Muder, MD, 0046-23-490000, daniel.muder@surgsci.uu.se
Anna-Karin Tibell, MD, 0046-23-490000, anna-karin.tibell@regiondalarna.se
- Recruiting
Universitetssjukhuset Örebro
Örebro, Örebro County, 70185
Madeleine Harryson, MD, 0046-19-6023656, madeleine.harryson@regionorebrolan.se
- Recruiting
Akademiska Sjukhuset
Uppsala, Uppsala County, 75185
Antje Straatmann, MD, 0046-18-6110000, antje.straatmann@akademiska.se
About this study
Official title: 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.
- Conditions
- Dupuytren Contracture, Dupuytren's Disease
- Being tested
- No night splint
- Keywords
- Percutaneous needle fasciotomy, Splint
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No night splintOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with night splint after percutaneous needle fasciotomy | No intervention | Not described |
| No treatment with night splint after percutaneous needle fasciotomy | Experimental | Not described Receives: Other: No night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of finger joint contracture
Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.
Measured: at 1 year follow up
Secondary outcomes (7)
Change of active finger flexion
Finger joint movement in order to flex the finger measured in degrees with a goniometer before and after treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before treatment, at 3, 12 and 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start14 Sep 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Wilbrand, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300893
- Sponsor's protocol ID
- 2021-01331
- Status last verified
- May 2024
- First submitted
- 28 Feb 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT05300893
- Acronym / sponsor ID
- 2021-01331
- Conditions
- Dupuytren Contracture, Dupuytren's Disease
- Keywords
- Percutaneous needle fasciotomy, Splint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with night splint after percutaneous needle fasciotomy | No intervention | – |
| No treatment with night splint after percutaneous needle fasciotomy | Experimental | Other: No night splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No night splintInstead of the usual treatment with a night splint for three months after percutaneous needle fasciotomy patients do not receive treatment with a night splint. | Other | No treatment with night splint after percutaneous needle fasciotomy |
Primary outcome
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.
7 secondary outcomes
Change of active finger flexion
Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
Change of grip strength
Time frame: before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up
Pain assessed by a numeric rating scale (NRS)
Time frame: before treatment, at 3, 12 and 36 months follow-up
Quality of life assessed by EQ-5D
Time frame: before treatment, at 3, 12 and 36 months follow-up
Dupuytren-disease-associated disability assessed by URAM
Time frame: before treatment, at 3, 12 and 36 months follow-up
Semmes-Weinstein monofilament test
Time frame: before treatment, at 3, 12 and 36 months follow-up
Study specific questionnaire concerning the patient's medical history
Time frame: before treatment, at 3, 12 and 36 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Wilbrand, MD, PhD principal investigator
Uppsala University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No night splint in people with Dupuytren Contracture and Dupuytren's Disease, run by Uppsala University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Muder, MD (0046-23-490000, daniel.muder@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of finger joint contracture (time frame: at 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.