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

Not Applicable

Withdrawn

• Conditions: Cubital Tunnel Syndrome
• Interventions: Procedure: Anterior Intramuscular Transposition

• Registration Number: NCT02995382
• Lead Sponsor: McMaster University

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-16
• Status Verified: 2021-09
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21
• Study Start: 2023-04
• Primary Completion: 2023-04
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anterior Intramuscular Transposition	Anterior Intramuscular Transposition	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.

Primary Outcome Measures

Name	Time	Method
Is there improvement in Health Related Quality of Life?	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 Outcome Measures

Name	Time	Method
Which Domains of Health Related Quality of Life Improve?	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?	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