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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pain and Function - PNA vs CCH

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