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Ultrasound-guided Thoracic Spinal Level Identification

Primary Purpose

Thoracic Diseases, Myofascial Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound imaging & fluoroscopic confirmation
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Diseases focused on measuring Ultrasound guided intervention, Rhomboid muscle, Thoracic spine

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing thoracic nerve root block due to herpes zoster, postherpetic neuralgia, complex regional pain syndrome, post traumatic pain syndrome, or compression fracture of vertebra.

Exclusion Criteria:

  1. Previous T-spine surgery
  2. Patient refusal
  3. Coagulopathy
  4. Generalized infection or localized infection at injection site
  5. Anatomical abnormality of T-spine
  6. Allergic reaction to local anesthetics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group 1

    Arm Description

    Ultrasound scanning of the rhomboid muscle

    Outcomes

    Primary Outcome Measures

    Ultrasound-guided Thoracic Spinal Level
    Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm

    Secondary Outcome Measures

    1. Changes in marker position when raised the arm above the head and in a relaxed position
    2. Rhomboid muscle variation
    The presence of rhomboid muscle fusion
    3. Visibility grade of muscle fascia using Ultrasound (I - IV)
    A. Grade I: Definitely visible B. Grade II: Somewhat visible C. Grade III: Barely visible D. Grade IV: Not visible
    4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine
    5. Difference between left and right sides
    The distance between left and right inferior thoracic spine attachment site of rhomboid muscle

    Full Information

    First Posted
    December 16, 2019
    Last Updated
    January 8, 2020
    Sponsor
    Seoul National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04223700
    Brief Title
    Ultrasound-guided Thoracic Spinal Level Identification
    Official Title
    Ultrasound-guided Thoracic Spinal Level Identification Using Rhomboid Muscle as a Reference Landmark
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 13, 2020 (Anticipated)
    Primary Completion Date
    December 15, 2021 (Anticipated)
    Study Completion Date
    December 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National 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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Typically, the rhomboid minor muscles rise from the C7-T1 spinous process and run downward to touch the upper inner corner of the scapula, and the rhomboid major muscles rise from the T2-T5 spinous process and run downward to reach the lower middle inner corner of the scapula. In anatomical research articles, it has been reported that the rhomboid muscle's anatomical variations are rare. Considering the characteristics of these rhomboid muscles, the investigators planned a study on the utility of rhomboid muscles as a landmark for identifying thoracic spine levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Diseases, Myofascial Pain
    Keywords
    Ultrasound guided intervention, Rhomboid muscle, Thoracic spine

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Ultrasound scanning of the rhomboid muscle
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound imaging & fluoroscopic confirmation
    Intervention Description
    The researchers use ultrasound to scan the left and right sides of the paravertebral sagittal imaging to identify trapezius, semispinalis, erector spinae muscle, transverse process and rhomboid muscle. The radiopaque marker is attached respectively to the skin of the inferior margin of the rhomboid muscle on the left and right thoracic spinal spines. Then, as the first step for the scheduled nerve block to the patient, thoracic vertebra level verification using C-arm is performed. At this time, left and right level of the transverse process of thoracic spine marked with the radiopaque marker are confirmed and recorded.
    Primary Outcome Measure Information:
    Title
    Ultrasound-guided Thoracic Spinal Level
    Description
    Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm
    Time Frame
    during the procedure
    Secondary Outcome Measure Information:
    Title
    1. Changes in marker position when raised the arm above the head and in a relaxed position
    Time Frame
    during the procedure
    Title
    2. Rhomboid muscle variation
    Description
    The presence of rhomboid muscle fusion
    Time Frame
    during the procedure
    Title
    3. Visibility grade of muscle fascia using Ultrasound (I - IV)
    Description
    A. Grade I: Definitely visible B. Grade II: Somewhat visible C. Grade III: Barely visible D. Grade IV: Not visible
    Time Frame
    during the procedure
    Title
    4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine
    Time Frame
    during the procedure
    Title
    5. Difference between left and right sides
    Description
    The distance between left and right inferior thoracic spine attachment site of rhomboid muscle
    Time Frame
    during the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing thoracic nerve root block due to herpes zoster, postherpetic neuralgia, complex regional pain syndrome, post traumatic pain syndrome, or compression fracture of vertebra. Exclusion Criteria: Previous T-spine surgery Patient refusal Coagulopathy Generalized infection or localized infection at injection site Anatomical abnormality of T-spine Allergic reaction to local anesthetics

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35289904
    Citation
    Jung H, Bae J, Kim J, Yoo Y, Lee HJ, Rho H, Han AH, Moon JY. Can the Rhomboid Major Muscle Be Used to Identify the Thoracic Spinal Segment on Ultrasonography? A Prospective Observational Study. Pain Med. 2022 Sep 30;23(10):1670-1678. doi: 10.1093/pm/pnac043.
    Results Reference
    derived

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