Dupuytren DiseaseNCT02301078
Short-term Function and Pain After Treatment for Dupuytren's Disease
An observational study of Dupuytren Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease
- What is being tested?
- Percutaneous Needle Aponeurotomy and Collagenase clostridium histolyticum
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Sunnybrook Health Sciences Centre choosing either percutaneous needle aponeurotomy or Xiaflex injection for treatment of Dupuytren's disease.
Who may be able to join
- Adult
- Dupuytren's disease diagnosis
- Consented to either percutaneous needle aponeurotomy or Xiaflex injection (patient choice)
- Able to read/write/speak English
- Must have an email address
Who cannot join
- Previous treatment for Dupuytren's disease
- Type 2 Diabetes Mellitus
- Pre-existing hand condition, previous hand surgery or trauma
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery
Toronto, Ontario, M4N 3M5
Catherine McMillan, MSc, catherine.mcmillan@sunnybrook.ca
Paul A. Binhammer, MD, MSc
About this study
Official title: Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.
Read the detailed description
Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.
- Conditions
- Dupuytren Disease
- Being tested
- Percutaneous Needle Aponeurotomy, Collagenase clostridium histolyticum
- Keywords
- Dupuytren disease, needle aponeurotomy, collagenase
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Needle AponeurotomyProcedure or surgery
Also called needle aponeurotomy, fasciotomy
single procedure (day 0)
Collagenase clostridium histolyticumDrug
Also called Xiaflex
Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Needle Aponeurotomy | Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease Receives: Procedure: Percutaneous Needle Aponeurotomy | |
| Xiaflex | Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease. Receives: Drug: Collagenase clostridium histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Michigan Hand Questionnaire (brief MHQ)
A validated patient-reported 12-item questionnaire pertaining to several aspects of hand function that is answered on 1 through 5 Likert scales. Higher scores indicate better hand function.
Measured: Baseline
Unite Rhumatologique des Affections de la Main (URAM) scale
The URAM is a validated patient-reported 9-item functional assessment scale used clinically and for research purposes specific to patients with Dupuytren's disease. The resulting score quantifies Dupuytren's disease-related disability, with higher scores indicating higher level of disability.
Measured: Baseline
Daily Pain and Function Scales
An emailed form asking participants to rate pain and function during the past 24 hours using two 1-5 Likert scales. Two additional questions to assess night splint compliance and pain medication (yes/no)
Measured: Baseline
Brief Michigan Hand Questionnaire (brief MHQ)
Measured: Day 7
Brief Michigan Hand Questionnaire (brief MHQ)
Measured: Day 14
Brief Michigan Hand Questionnaire (brief MHQ)
Measured: Day 21
Brief Michigan Hand Questionnaire (brief MHQ)
Measured: Day 28
Unite Rhumatologique des Affections de la Main (URAM) scale
Measured: Day 7
Unite Rhumatologique des Affections de la Main (URAM) scale
Measured: Day 14
Unite Rhumatologique des Affections de la Main (URAM) scale
Measured: Day 21
Unite Rhumatologique des Affections de la Main (URAM) scale
Measured: Day 28
Daily Pain and Function Scales
Measured: Day 1
Daily Pain and Function Scales
Measured: Day 2
Daily Pain and Function Scales
Measured: Day 3
Daily Pain and Function Scales
Measured: Day 4
Daily Pain and Function Scales
Measured: Day 5
Daily Pain and Function Scales
Measured: Day 6
Daily Pain and Function Scales
Measured: Day 7
Daily Pain and Function Scales
Measured: Day 14
Daily Pain and Function Scales
Measured: Day 21
Daily Pain and Function Scales
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301078
- Sponsor's protocol ID
- Pain and Function - PNA vs CCH
- Status last verified
- Dec 2016
- First submitted
- 11 Jul 2014
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT02301078
- Acronym / sponsor ID
- Pain and Function - PNA vs CCH
- Conditions
- Dupuytren Disease
- Keywords
- Dupuytren disease, needle aponeurotomy, collagenase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 25 Nov 2014 (estimated)
- 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.
This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.
Detailed description
Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Needle Aponeurotomy | – | Procedure: Percutaneous Needle AponeurotomyPatients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease |
| Xiaflex | – | Drug: Collagenase clostridium histolyticumPatients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Sunnybrook Health Sciences Centre choosing either percutaneous needle aponeurotomy or Xiaflex injection for treatment of Dupuytren's disease.
Key inclusion criteria (5 listed)
- Adult
- Dupuytren's disease diagnosis
- Consented to either percutaneous needle aponeurotomy or Xiaflex injection (patient choice)
- Able to read/write/speak English
- Must have an email address
Key exclusion criteria (3 listed)
- Previous treatment for Dupuytren's disease
- Type 2 Diabetes Mellitus
- Pre-existing hand condition, previous hand surgery or trauma
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 |
|---|---|---|
| Percutaneous Needle AponeurotomyAlso: needle aponeurotomy, fasciotomysingle procedure (day 0) | Procedure or surgery | Percutaneous Needle Aponeurotomy |
| Collagenase clostridium histolyticumAlso: XiaflexXiaflex injection into palpable cords (day 0), physical manipulation (day 7) | Drug | Xiaflex |
Primary outcome
Brief Michigan Hand Questionnaire (brief MHQ)
Time frame: Baseline
A validated patient-reported 12-item questionnaire pertaining to several aspects of hand function that is answered on 1 through 5 Likert scales. Higher scores indicate better hand function.
Unite Rhumatologique des Affections de la Main (URAM) scale
Time frame: Baseline
The URAM is a validated patient-reported 9-item functional assessment scale used clinically and for research purposes specific to patients with Dupuytren's disease. The resulting score quantifies Dupuytren's disease-related disability, with higher scores indicating higher level of disability.
Daily Pain and Function Scales
Time frame: Baseline
An emailed form asking participants to rate pain and function during the past 24 hours using two 1-5 Likert scales. Two additional questions to assess night splint compliance and pain medication (yes/no)
Brief Michigan Hand Questionnaire (brief MHQ)
Time frame: Day 7
Brief Michigan Hand Questionnaire (brief MHQ)
Time frame: Day 14
Brief Michigan Hand Questionnaire (brief MHQ)
Time frame: Day 21
Brief Michigan Hand Questionnaire (brief MHQ)
Time frame: Day 28
Unite Rhumatologique des Affections de la Main (URAM) scale
Time frame: Day 7
Unite Rhumatologique des Affections de la Main (URAM) scale
Time frame: Day 14
Unite Rhumatologique des Affections de la Main (URAM) scale
Time frame: Day 21
Unite Rhumatologique des Affections de la Main (URAM) scale
Time frame: Day 28
Daily Pain and Function Scales
Time frame: Day 1
Daily Pain and Function Scales
Time frame: Day 2
Daily Pain and Function Scales
Time frame: Day 3
Daily Pain and Function Scales
Time frame: Day 4
Daily Pain and Function Scales
Time frame: Day 5
Daily Pain and Function Scales
Time frame: Day 6
Daily Pain and Function Scales
Time frame: Day 7
Daily Pain and Function Scales
Time frame: Day 14
Daily Pain and Function Scales
Time frame: Day 21
Daily Pain and Function Scales
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
Related trials for Dupuytren Disease
Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
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. This study is not recruiting at the moment.
Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery
Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Michigan Hand Questionnaire (brief MHQ) (time frame: Baseline). The study lists 21 primary outcomes in all. 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 6 Dec 2016.