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

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ClinicalTrials.gov Identifier: NCT02995382
Recruitment Status : Not yet recruiting
First Posted : December 16, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Procedure: Anterior Intramuscular Transposition Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


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




Primary Outcome Measures :
  1. Is there improvement in Health Related Quality of Life? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]
    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 :
  1. Which Domains of Health Related Quality of Life Improve? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]
    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)

  2. Is there improvement in physical performance? [ Time Frame: 1 week and 1 day pre-op & 3, 6, 12 months post op ]
    This will be measured by using grip strength and moving 2-point discrimination



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995382


Contacts
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Contact: Matthew McRae, MD 905-522-1155 ext 36092 matthewcmcrae@gmail.com
Contact: Achilles Thooma, MD 905-523-0019 athoma@mcmaster.ca

Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Matthew McRae, MD McMaster University

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02995382     History of Changes
Other Study ID Numbers: 2016-2361
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared to other researchers

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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

Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Syndrome
Cubital Tunnel Syndrome
Disease
Pathologic Processes
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries