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

NCT ID: NCT02995382

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-06-30

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

Conditions

Cubital Tunnel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Anterior Intramuscular Transposition

Intervention Type: PROCEDURE

Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

Interventions

Anterior Intramuscular Transposition

Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew McRae, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Other Identifiers

2016-2361

Identifier Type: -

Identifier Source: org_study_id