Thoracic DiseasesNCT04223700
Ultrasound-guided Thoracic Spinal Level Identification
A study testing Ultrasound imaging & fluoroscopic confirmation in people with Thoracic Diseases and Myofascial Pain, run by Seoul National University.
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Thoracic Diseases, Myofascial Pain
- What is being tested?
- Ultrasound imaging & fluoroscopic confirmation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Thoracic Diseases, Myofascial Pain
- Being tested
- Ultrasound imaging & fluoroscopic confirmation
- Keywords
- Ultrasound guided intervention, Rhomboid muscle, Thoracic spine
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound imaging & fluoroscopic confirmationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Ultrasound scanning of the rhomboid muscle Receives: Procedure: Ultrasound imaging & fluoroscopic confirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-guided Thoracic Spinal Level
Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm
Measured: during the procedure
Secondary outcomes (5)
1. Changes in marker position when raised the arm above the head and in a relaxed position
Measured: during the procedure
2. Rhomboid muscle variation
The presence of rhomboid muscle fusion
Measured: during the procedure
3. Visibility grade of muscle fascia using Ultrasound (I - IV)
- Grade I: Definitely visible B. Grade II: Somewhat visible C. Grade III: Barely visible D. Grade IV: Not visible
Measured: during the procedure
4. Depth: The distance from the skin where the marker is attached to the transverse process of thoracic spine
Measured: during the procedure
5. Difference between left and right sides
The distance between left and right inferior thoracic spine attachment site of rhomboid muscle
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start13 Jan 2020 (estimated)
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223700
- Sponsor's protocol ID
- 1911-063-1078
- Status last verified
- Jan 2020
- First submitted
- 16 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Thoracic Spinal Level Identification Using Rhomboid Muscle as a Reference Landmark
- ClinicalTrials.gov ID
- NCT04223700
- Acronym / sponsor ID
- 1911-063-1078
- Conditions
- Thoracic Diseases, Myofascial Pain
- Keywords
- Ultrasound guided intervention, Rhomboid muscle, Thoracic spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (estimated)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Ultrasound imaging & fluoroscopic confirmationUltrasound scanning of the rhomboid muscle |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous T-spine surgery
- Patient refusal
- Coagulopathy
- Generalized infection or localized infection at injection site
- Anatomical abnormality of T-spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound imaging & fluoroscopic confirmationThe 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. | Procedure or surgery | Group 1 |
Primary outcome
Ultrasound-guided Thoracic Spinal Level
Time frame: during the procedure
Thoracic vertebra level of radiopaque marker labeled on the rhomboid muscle inferior margin on C-arm
5 secondary outcomes
1. Changes in marker position when raised the arm above the head and in a relaxed position
Time frame: during the procedure
2. Rhomboid muscle variation
Time frame: during the procedure
3. Visibility grade of muscle fascia using Ultrasound (I - IV)
Time frame: during the procedure
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. Difference between left and right sides
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 35289904Jung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound imaging & fluoroscopic confirmation in people with Thoracic Diseases and Myofascial Pain, run by Seoul National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound-guided Thoracic Spinal Level (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.