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

McMaster University

Status: Withdrawn

Conditions: Cubital Tunnel Syndrome

Treatments: Procedure: Anterior Intramuscular Transposition

Study type: Interventional

Funder types: Other

Identifiers

NCT02995382

2016-2361

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Anterior Intramuscular Transposition

Experimental group

Description:

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.

Treatment:

Procedure: Anterior Intramuscular Transposition