Clinical trial NCT02301078: Short-term Function and Pain After Treatment for Dupuytren's Disease
Official title: Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dupuytren Disease
Keywords: Dupuytren disease
needle aponeurotomy
collagenase
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief Michigan Hand Questionnaire (brief MHQ)
timeFrame: Baseline
measure: Unite Rhumatologique des Affections de la Main (URAM) scale
timeFrame: Baseline
measure: Daily Pain and Function Scales
timeFrame: Baseline
measure: Brief Michigan Hand Questionnaire (brief MHQ)
timeFrame: Day 7
measure: Brief Michigan Hand Questionnaire (brief MHQ)
timeFrame: Day 14
measure: Brief Michigan Hand Questionnaire (brief MHQ)
timeFrame: Day 21
measure: Brief Michigan Hand Questionnaire (brief MHQ)
timeFrame: Day 28
measure: Unite Rhumatologique des Affections de la Main (URAM) scale
timeFrame: Day 7
measure: Unite Rhumatologique des Affections de la Main (URAM) scale
timeFrame: Day 14
measure: Unite Rhumatologique des Affections de la Main (URAM) scale
timeFrame: Day 21
measure: Unite Rhumatologique des Affections de la Main (URAM) scale
timeFrame: Day 28
measure: Daily Pain and Function Scales
timeFrame: Day 1
measure: Daily Pain and Function Scales
timeFrame: Day 2
measure: Daily Pain and Function Scales
timeFrame: Day 3
measure: Daily Pain and Function Scales
timeFrame: Day 4
measure: Daily Pain and Function Scales
timeFrame: Day 5
measure: Daily Pain and Function Scales
timeFrame: Day 6
measure: Daily Pain and Function Scales
timeFrame: Day 7
measure: Daily Pain and Function Scales
timeFrame: Day 14
measure: Daily Pain and Function Scales
timeFrame: Day 21
measure: Daily Pain and Function Scales
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery
state: Ontario
Study officials:
References: