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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Withdrawn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
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cubital Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    December 14, 2016
    Last Updated
    July 18, 2022
    Sponsor
    McMaster University
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    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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