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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cubital Tunnel Syndrome
• Intervention / Treatment: Procedure: Anterior Intramuscular Transposition

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Anterior Intramuscular Transposition; Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Matthew McRae, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Nerve Compression Syndromes; Ulnar Neuropathies; Syndrome; Cubital Tunnel Syndrome
• Other Study ID Numbers: 2016-2361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes