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

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ClinicalTrials.gov Identifier: NCT02301078
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment
Dupuytren Disease Procedure: Percutaneous Needle Aponeurotomy Drug: Collagenase clostridium histolyticum

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
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparing Short-term Function and Pain After Treatment With Collagenase Clostridium Histolyticum or Percutaneous Needle Aponeurotomy for Dupuytren's Disease
Study Start Date : July 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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 Name: Xiaflex




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 7 ]
  5. Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 14 ]
  6. Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 21 ]
  7. Brief Michigan Hand Questionnaire (brief MHQ) [ Time Frame: Day 28 ]
  8. Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 7 ]
  9. Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 14 ]
  10. Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 21 ]
  11. Unite Rhumatologique des Affections de la Main (URAM) scale [ Time Frame: Day 28 ]
  12. Daily Pain and Function Scales [ Time Frame: Day 1 ]
  13. Daily Pain and Function Scales [ Time Frame: Day 2 ]
  14. Daily Pain and Function Scales [ Time Frame: Day 3 ]
  15. Daily Pain and Function Scales [ Time Frame: Day 4 ]
  16. Daily Pain and Function Scales [ Time Frame: Day 5 ]
  17. Daily Pain and Function Scales [ Time Frame: Day 6 ]
  18. Daily Pain and Function Scales [ Time Frame: Day 7 ]
  19. Daily Pain and Function Scales [ Time Frame: Day 14 ]
  20. Daily Pain and Function Scales [ Time Frame: Day 21 ]
  21. Daily Pain and Function Scales [ Time Frame: Day 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301078


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Catherine McMillan, MSc       catherine.mcmillan@sunnybrook.ca   
Principal Investigator: Paul A. Binhammer, MD, MSc         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02301078     History of Changes
Other Study ID Numbers: Pain and Function - PNA vs CCH
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by Sunnybrook Health Sciences Centre:
Dupuytren disease
needle aponeurotomy
collagenase

Additional relevant MeSH terms:
Dupuytren Contracture
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Contracture
Muscular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases