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

Sunnybrook Health Sciences Centre60 enrolled

Overview

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.

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

Conditions

Dupuytren Disease

Interventions

Percutaneous Needle AponeurotomyPROCEDURE

single procedure (day 0)

Collagenase clostridium histolyticumDRUG

Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: Baseline

Brief Michigan Hand Questionnaire (brief MHQ)

Time frame: Day 7

Brief Michigan Hand Questionnaire (brief MHQ)

Time frame: Day 14

Brief Michigan Hand Questionnaire (brief MHQ)

Time frame: Day 21

Brief Michigan Hand Questionnaire (brief MHQ)

Time frame: Day 28

Unite Rhumatologique des Affections de la Main (URAM) scale

Time frame: Day 7

Unite Rhumatologique des Affections de la Main (URAM) scale

Time frame: Day 14

Data from ClinicalTrials.gov

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