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

December 5, 2016 updated by: Sunnybrook Health Sciences Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery
        • Contact:
        • Principal Investigator:
          • Paul A. Binhammer, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at Sunnybrook Health Sciences Centre choosing either percutaneous needle aponeurotomy or Xiaflex injection for treatment of Dupuytren's disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percutaneous Needle Aponeurotomy
Patients who choose to undergo percutaneous needle aponeurotomy (PNA) for primary treatment of Dupuytren's disease
Procedure: Percutaneous Needle Aponeurotomy
single procedure (day 0)
Other Names:
  • needle aponeurotomy
  • fasciotomy
Xiaflex
Patients who choose to receive Collagenase clostridium histolyticum injection (drug name Xiaflex) for primary treatment of Dupuytren's disease.
Drug: Collagenase clostridium histolyticum
Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)
Other Names:
  • Xiaflex

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

July 11, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pain and Function - PNA vs CCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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