Clinical Trial: BOND Study: the Benefit Of Night Splinting in Dupuytrens'

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture

Brief Summary: The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.

Detailed Summary: This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.
Sponsor: Royal Liverpool and Broadgreen University Hospitals NHS Trust

Current Primary Outcome: Range of motion [ Time Frame: At 0 weeks, 12 weeks and 52 weeks ]

To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PEM Questionnaire [ Time Frame: At 0 weeks, 12 weeks and 52 weeks ]
    Patient Evaluation Measure to give disability score
  • URAM Questionnaire [ Time Frame: At 0 weeks, 12 weeks and 52 weeks ]
    Hand specific outcome questionnaire to assess quality of life outcomes


Original Secondary Outcome: Same as current

Information By: Royal Liverpool and Broadgreen University Hospitals NHS Trust

Dates:
Date Received: January 23, 2017
Date Started: March 1, 2017
Date Completion: June 30, 2019
Last Updated: January 23, 2017
Last Verified: January 2017