Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
Primary Purpose
Cubital Tunnel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anterior Intramuscular Transposition
Sponsored by
About this trial
This is an interventional treatment trial for Cubital Tunnel Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anterior Intramuscular Transposition
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Is there improvement in physical performance?
This will be measured by using grip strength and moving 2-point discrimination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02995382
Brief Title
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
Official Title
Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was not received and the study could not proceed without this support.
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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:
A generic scale, the Short Form-36
A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
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 week prior to surgery
1 day prior to surgery
3 months post surgery
6 months post surgery
12 months post surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cubital Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior Intramuscular Transposition
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Anterior Intramuscular Transposition
Intervention Description
Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow
Primary Outcome Measure Information:
Title
Is there improvement in Health Related Quality of Life?
Description
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)
Time Frame
1 week and 1 day pre-op & 3, 6, 12 months post op
Secondary Outcome Measure Information:
Title
Which Domains of Health Related Quality of Life Improve?
Description
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)
Time Frame
1 week and 1 day pre-op & 3, 6, 12 months post op
Title
Is there improvement in physical performance?
Description
This will be measured by using grip strength and moving 2-point discrimination
Time Frame
1 week and 1 day pre-op & 3, 6, 12 months post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew McRae, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared to other researchers
Learn more about this trial
Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
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