Clinical Trial: Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome

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

Official Title: Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study

Brief Summary: This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.

Detailed Summary:

As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL will be used to determine if anterior intramuscular transposition provides patients with positive outcomes. To measure HRQOL 3 specific scales will be administered:

  1. A generic scale, the Short Form-36
  2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
  3. A utility scale, the EuroQOL, five dimension questionnaire

These scales are widely reported in the literature, are valid, reliable and easy to fill out. Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which, allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.

Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2 performance tests (grip strength, and a moving 2-point discrimination test) at the following time points:

  1. 1 week prior to surgery
  2. 1 day prior to surgery
  3. 3 months post surgery
  4. 6 months post surgery
  5. 12 months post surgery

Sponsor: McMaster University

Current Primary Outcome: Is there improvement in Health Related Quality of Life? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]

HRQOL will be determined using 3 questionnaires: a generic widely reported scale (SF-36), a condition specific valid and reliable scale (The PRUNE), and a utility scale EuroQol-5D)


Original Primary Outcome: Is there improvement in Health Related Quality of Life? [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Which Domains of Health Related Quality of Life Improve? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]
    There are different domains listed in the questionnaires, depending on the response from the patients we will determine where the improvement was seen (physical, mental, emotional, etc)
  • Is there improvement in physical performance? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]
    This will be measured by using grip strength and moving 2-point discrimination


Original Secondary Outcome:

  • Which Domains of Health Related Quality of Life Improve? [ Time Frame: 1 year ]
  • Is there improvement in physical performance? [ Time Frame: 1 year ]


Information By: McMaster University

Dates:
Date Received: December 14, 2016
Date Started: February 2017
Date Completion: February 2019
Last Updated: January 18, 2017
Last Verified: January 2017