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

Dupuytren Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02301078
• Other study ID #: Pain and Function - PNA vs CCH
• Status: Recruiting
• Phase: N/A
• First received: July 11, 2014
• Last updated: December 5, 2016
• Start date: July 2014
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren Disease

Intervention

Procedure:
• Percutaneous Needle Aponeurotomy
single procedure (day 0)

Drug:
• Collagenase clostridium histolyticum
Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Brief Michigan Hand Questionnaire (brief MHQ)		Day 7	No
Primary	Brief Michigan Hand Questionnaire (brief MHQ)		Day 14	No
Primary	Brief Michigan Hand Questionnaire (brief MHQ)		Day 21	No
Primary	Brief Michigan Hand Questionnaire (brief MHQ)		Day 28	No
Primary	Unite Rhumatologique des Affections de la Main (URAM) scale		Day 7	No
Primary	Unite Rhumatologique des Affections de la Main (URAM) scale		Day 14	No
Primary	Unite Rhumatologique des Affections de la Main (URAM) scale		Day 21	No
Primary	Unite Rhumatologique des Affections de la Main (URAM) scale		Day 28	No
Primary	Daily Pain and Function Scales		Day 1	No
Primary	Daily Pain and Function Scales		Day 2	No
Primary	Daily Pain and Function Scales		Day 3	No
Primary	Daily Pain and Function Scales		Day 4	No
Primary	Daily Pain and Function Scales		Day 5	No
Primary	Daily Pain and Function Scales		Day 6	No
Primary	Daily Pain and Function Scales		Day 7	No
Primary	Daily Pain and Function Scales		Day 14	No
Primary	Daily Pain and Function Scales		Day 21	No
Primary	Daily Pain and Function Scales		Day 28	No