Dupuytren Disease
Conditions
Keywords
Dupuytren disease, needle aponeurotomy, collagenase
Brief 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. 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.
Interventions
PROCEDUREPercutaneous Needle Aponeurotomy
single procedure (day 0)
DRUGCollagenase clostridium histolyticum
Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)
Sponsors
Sunnybrook Health Sciences Centre
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Previous treatment for Dupuytren's disease * Type 2 Diabetes Mellitus * Pre-existing hand condition, previous hand surgery or trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Michigan Hand Questionnaire (brief MHQ) | 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 | 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 | 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) |
Countries
Canada
Outcome results
None listed