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Status unknownNCT04223700Updated Jan 10, 2020

Ultrasound-guided Thoracic Spinal Level Identification

An interventional study of Ultrasound imaging & fluoroscopic confirmation in Thoracic Diseases and Myofascial Pain, sponsored by Seoul National University. Status unknown. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Seoul National University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
19 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Thoracic Diseases
  • Myofascial Pain

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Keywords

  • Ultrasound guided intervention
  • Rhomboid muscle
  • Thoracic spine
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In context

Thoracic Diseases

68 studies on the registry are indexed under Thoracic Diseases; 14 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 50 interventional studies indexed under Thoracic Diseases.

Browse Thoracic Diseases studies →

Lead sponsor

Seoul National University is the lead sponsor of 30 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group 1

    Ultrasound scanning of the rhomboid muscle

    Procedure: Ultrasound imaging & fluoroscopic confirmation

Interventions

  • ProcedureUltrasound 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.

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What researchers measure

Primary outcomes

  1. Ultrasound-guided Thoracic Spinal Level

    Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm

    Time frame: during the procedure

Secondary outcomes

  1. 1. Changes in marker position when raised the arm above the head and in a relaxed position

    Time frame: during the procedure

  2. 2. Rhomboid muscle variation

    The presence of rhomboid muscle fusion

    Time frame: during the procedure

  3. 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

    Time frame: during the procedure

  4. 4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine

    Time frame: during the procedure

  5. 5. Difference between left and right sides

    The distance between left and right inferior thoracic spine attachment site of rhomboid muscle

    Time frame: during the procedure

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 35289904 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04223700
Lead sponsor
Seoul National University
Responsible party
Jeeyoun Moon (Associate Professor, Seoul National University) — Principal investigator
First posted
Jan 10, 2020
Start date
Jan 13, 2020 (estimated)
Primary completion
Dec 15, 2021 (estimated)
Completion
Dec 15, 2021 (estimated)
Last update
Jan 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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