Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cubital Tunnel Syndrome
- Sponsor
- McMaster University
- Primary Endpoint
- Is there improvement in Health Related Quality of Life?
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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 Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging
- •Ability to comprehend English and complete health related quality of life questionnaires
- •Willing to provide informed consent
- •Age \> 18 years
- •Not pregnant
Exclusion Criteria
- •Prior ipsilateral cubital tunnel release
- •Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS)
- •Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Which Domains of Health Related Quality of Life Improve?(1 week and 1 day pre-op & 3, 6, 12 months post op)
- Is there improvement in physical performance?(1 week and 1 day pre-op & 3, 6, 12 months post op)