Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome

Study Overview
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Brief Summary
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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
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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: A generic scale, the Short Form-36 A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE) 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 week prior to surgery 1 day prior to surgery 3 months post surgery 6 months post surgery 12 months post surgery

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

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Procedure: Anterior Intramuscular Transposition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior Intramuscular Transposition<br>This is the only arm in our study, patients with cubital tunnel syndrome will undergo anterior intramuscular transposition, one of many surgical techniques utilized on patients with Cubital Tunnel Syndrome to alleviate symptoms. | Procedure: Anterior Intramuscular Transposition<br>* Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there improvement in Health Related Quality of Life? | 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) | 1 week and 1 day pre-op & 3, 6, 12 months post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Which Domains of Health Related Quality of Life Improve? | 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) | 1 week and 1 day pre-op & 3, 6, 12 months post op | 
| Is there improvement in physical performance? | This will be measured by using grip strength and moving 2-point discrimination | 1 week and 1 day pre-op & 3, 6, 12 months post op |