Ultrasound-guided Thoracic Spinal Level Identification

NCT ID: NCT04223700

Last Updated: 2020-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2021-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Diseases Myofascial Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Ultrasound scanning of the rhomboid muscle

Group Type EXPERIMENTAL

Ultrasound imaging & fluoroscopic confirmation

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeeyoun Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35289904 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1911-063-1078

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.