Short-term Function and Pain After Treatment for Dupuytren's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease

Conditions
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Dupuytren Disease

Intervention / Treatment
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* Procedure: Percutaneous Needle Aponeurotomy
* Drug: Collagenase clostridium histolyticum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous Needle Aponeurotomy<br>Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease | Procedure: Percutaneous Needle Aponeurotomy<br>* single procedure (day 0)<br>* Other names: fasciotomy;|
| Xiaflex<br>Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease. | Drug: Collagenase clostridium histolyticum<br>* Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)<br>* Other names: Xiaflex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | Baseline | 
| Brief Michigan Hand Questionnaire (brief MHQ) |  | Day 7 | 
| Brief Michigan Hand Questionnaire (brief MHQ) |  | Day 14 | 
| Brief Michigan Hand Questionnaire (brief MHQ) |  | Day 21 | 
| Brief Michigan Hand Questionnaire (brief MHQ) |  | Day 28 | 
| Unite Rhumatologique des Affections de la Main (URAM) scale |  | Day 7 | 
| Unite Rhumatologique des Affections de la Main (URAM) scale |  | Day 14 | 
| Unite Rhumatologique des Affections de la Main (URAM) scale |  | Day 21 | 
| Unite Rhumatologique des Affections de la Main (URAM) scale |  | Day 28 | 
| Daily Pain and Function Scales |  | Day 1 | 
| Daily Pain and Function Scales |  | Day 2 | 
| Daily Pain and Function Scales |  | Day 3 | 
| Daily Pain and Function Scales |  | Day 4 | 
| Daily Pain and Function Scales |  | Day 5 | 
| Daily Pain and Function Scales |  | Day 6 | 
| Daily Pain and Function Scales |  | Day 7 | 
| Daily Pain and Function Scales |  | Day 14 | 
| Daily Pain and Function Scales |  | Day 21 | 
| Daily Pain and Function Scales |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupuytren disease, needle aponeurotomy, collagenase