Ultrasound-guided Thoracic Spinal Level Identification

Sponsor

Seoul National University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04223700

Collaborator

(none)

100

Enrollment

Arm

23.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Diseases Myofascial Pain	Procedure: Ultrasound imaging & fluoroscopic confirmation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 13, 2020

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ultrasound-guided Thoracic Spinal Level [during the procedure]
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 [during the procedure]
2. Rhomboid muscle variation [during the procedure]
The presence of rhomboid muscle fusion
3. Visibility grade of muscle fascia using Ultrasound (I - IV) [during the procedure]
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 [during the procedure]
5. Difference between left and right sides [during the procedure]
The distance between left and right inferior thoracic spine attachment site of rhomboid muscle

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeeyoun Moon, Associate Professor, Seoul National University

ClinicalTrials.gov Identifier:

NCT04223700

Other Study ID Numbers:

1911-063-1078

First Posted:

Jan 10, 2020

Last Update Posted:

Jan 10, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Jeeyoun Moon, Associate Professor, Seoul National University

Ultrasound guided intervention

Rhomboid muscle

Thoracic spine

Additional relevant MeSH terms:

Thoracic Diseases

Study Results

No Results Posted as of Jan 10, 2020