Ultrasound-guided Thoracic Spinal Level Identification

Ultrasound-guided Thoracic Spinal Level Identification Using Rhomboid Muscle as a Reference Landmark

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.

Study Overview

• Status: Unknown
• Conditions: Myofascial Pain; Thoracic Diseases
• Intervention / Treatment: Procedure: Ultrasound imaging & fluoroscopic confirmation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Group 1; Ultrasound scanning of the rhomboid muscle

Procedure: Ultrasound imaging & fluoroscopic confirmation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound-guided Thoracic Spinal Level	Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Changes in marker position when raised the arm above the head and in a relaxed position		during the procedure
2. Rhomboid muscle variation	The presence of rhomboid muscle fusion	during the procedure
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	during the procedure
4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine		during the procedure
5. Difference between left and right sides	The distance between left and right inferior thoracic spine attachment site of rhomboid muscle	during the procedure

Collaborators and Investigators

• Sponsor: Seoul National University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 13, 2020
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): December 15, 2021

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (ACTUAL): January 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Thoracic spine; Ultrasound guided intervention; Rhomboid muscle
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases
• Other Study ID Numbers: 1911-063-1078

Drug and device information, study documents

• 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