Ultrasound-guided Thoracic Spinal Level Identification

Myofascial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04223700
• Other study ID #: 1911-063-1078
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: January 2020
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Myofascial Pain
• Thoracic Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Outcome

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