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
About this trial
This is an interventional diagnostic trial for Thoracic Diseases focused on measuring Ultrasound guided intervention, Rhomboid muscle, Thoracic spine
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
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
NCT ID
NCT04223700
First Posted
December 16, 2019
Last Updated
January 8, 2020
Sponsor
Seoul National University
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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Ultrasound-guided Thoracic Spinal Level Identification
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