The Effect of Ultrasound Guidance on Radiation Dose and Procedure Time in Lumbar Transforaminal Epidural Injection

March 20, 2023 updated by: Marmara University

Low back pain is one of the leading causes of disability, and its social burden and economic cost are quite high. Although there are many causes that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernias, is one of the most common pathologies. Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods.

For fluoroscopy-guided epidural injections; transforaminal, interlaminar and caudal approaches may be preferred. It is accepted as the superiority of the transforaminal approach that it allows access to the area of pathology, thus to the anterior epidural area where inflammatory mediators are more concentrated, and that it can spread to the target specifically around the inflamed nerve roots.

In transforaminal epidural injections, the use of ultrasound as the sole imaging tool throughout the entire procedure is still not appropriate, as subbony structures cannot be visualized. However, ultrasound can be integrated at any stage of the process. Thus, the relatively inexpensive cost, portability, and ability to show non-osseous tissues of ultrasonography are utilized, particularly in terms of reducing radiation exposure.

Gofeld et al. claimed that ultrasound-guided transforaminal epidural injection could be performed by targeting the posterior part of the vertebral body. However, in cases where the lamina is wide and covers the posterior of the vertebral body, it may not be possible to sonographically view the vertebral body. In addition, although the intervertebral disc is differentiated from the corpus, loss of fluid content in the elderly can cause acoustic shadowing in the disc. This may result in accidental intra-disc injections. Finally, even if the target point is reached, it is not possible to show intravascular spread at this level ultrasonographically. Therefore, in our opinion, this method is unreliable for transforaminal epidural injections. Another study used ultrasound and fluoroscopy together for transforaminal epidural injections. After imaging the lamina of the relevant vertebral level sonographically, the needle is directed to the lateral edge of the lamina, then fluoroscopic imaging is performed after it passes under the lamina with the loss of resistance technique. However, it should be known that the loss of resistance technique is not a suitable and reliable method in transforaminal injections. In addition, since it is not known how far the lamina has progressed after it has passed under the bone, in other words, imaging guidance is disabled in this part of the process.

In our clinic, we use ultrasonography and fluoroscopy methods in an integrated way (hybrid method) for transforaminal epidural injections. For this purpose, we proceed to fluoroscopic imaging immediately after the spinal needle is advanced to the lateral edge of the lamina at the vertebral level where there is pathology with ultrasound. We think that with this method, we continue to stay in the safe window and reduce the radiation dose and procedure time. Based on this, we determined the aim of this study as the effect of including ultrasonography guidance in transforaminal epidural injections on radiation dose and procedure time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study group will consist of patients who are planned to receive transforaminal epidural steroid injection or erector spina plane block treatment by the clinician, and who want to participate in the study.

Description

Inclusion Criteria:

  • Being between the ages of 18-70
  • Radicular low back pain
  • Failure to respond to conservative treatments
  • Pain intensity NRS >3/10
  • Lumbar nerve root compression due to disc herniation in lumbar MRI
  • Agree to participate in the research

Exclusion Criteria:

  • Patients younger than 18 years old and over 70 years old
  • Patients describing only localized pain in the lower back without radiating to the lower extremities
  • Those with nerve root compression due to reasons other than disc herniation
  • Those with spondylolisthesis
  • Those with transitional vertebrae
  • Pregnancy
  • Patients with a body mass index over 30
  • Patients with bleeding diathesis
  • Having a known psychiatric illness diagnosis
  • History of allergy to any of the injection substances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Those who had lumbar radicular pain
Patients with lumbar radicular pain identified by inclusion and exclusion criteria
Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection
The patients are positioned prone. The injection site is cleaned with povidone-iodine 3 times and a sterile drape was applied. Short-acting local anesthesia (3 mL of 2% prilocaine) is applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle is inserted just below the pedicle. It is advanced into the subpedicular space using the coaxial technique under the intermittent guidance of fluoroscopy. The needle position is confirmed through a lateral view. Using lateral views, the needle is placed at the posterior one-third of the foramen. Using the anteroposterior view, one to 2 mL of the contrast agent (300 mg/50 mL iohexol) is given and the distribution pattern is visualized. Once the epidural distribution of the contrast agent is confirmed without vascular flow, a mixture of 8 mg (two mL) of dexamethasone, 1 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride is injected.
Procedure: Ultrasound Guided Transforaminal Epidural Steroid Injection
The patients are positioned prone placed. Following the provision of aseptic conditions, the spinous process of the vertebral midline is visualized using a low-frequency convex ultrasound probe. The lateral edge of the relevant vertebral lamina is visualized by sonographic scanning in the horizontal plane. Local anesthesia is applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle is advanced to the lateral edge of the relevant vertebral lamina under ultrasound image guidance. Then, anteroposterior imaging is performed with fluoroscopy to confirm needle localization when the lamina margin is reached, and the needle is guided into the foramen under the guidance of fluoroscopy. The contrast agent is given and the distribution pattern is visualized. Once the epidural distribution of the contrast agent is confirmed without vascular flow, a mixture of 2 mL of dexamethasone, 1 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride is injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NRS (Numeric Rating Scale)
Time Frame: at first hour
≥50% reduction in the NRS scores at first hour relative to the initial NRS scores.
at first hour
Radiation Dose
Time Frame: at first hour
Radiation dose during the TFESI
at first hour
Radiation Time
Time Frame: at first hour
Radiation time during the TFESI
at first hour
Procedure Time
Time Frame: at first hour
Procedure time during the TFESI
at first hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-SK-YO-20.03.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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