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

Cubital Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02995382
• Other study ID #: 2016-2361
• Status: Withdrawn
• Phase: N/A
• Start date: April 2023
• Est. completion date: June 2023

Study information

• Verified date: September 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Anterior Intramuscular Transposition
Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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