Ultrasound-guided Versus Combined Ultrasound and Fluoroscopy-guided Cervical Selective Nerve Root Block for Lower Cervical Radiculopathy: Non-inferiority Randomized Controlled Study

NCT05521373 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-09-09

No results posted yet for this study

Summary

Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root .The compression can occur as a result of disc herniation, spondylosis, instability, trauma, or rarely, tumors. Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. The clinical overlap between cervical radiculopathy and peripheral nerve entrapment syndromes and their nearly ubiquitous nature makes understanding of and identification of these entities mandatory for all practitioners The cervical spinal nerves exit the spinal cord and are oriented obliquely toward their respective neural foramen .The neural foramen is made up of the facet joint posteriorly and the intervertebral disc anteriorly. The superior and inferior borders are comprised of the pedicles of the vertebral bodies above and below, respectively. The foramina are largest in the upper cervical spine and gradually narrow distally, with the C7/T1 foramina being the narrowest. The most common causes of nerve root compression are spondylosis of the facet joint and herniation of the intervertebral disc.Hypermobility of the facet joint leads to ligamentous hypertrophy as well as bony hypertrophy. An increase in the size of the superior articulating process from the distal vertebra causes compression of the nerve. Intervertebral disc herniations can also cause nerve root compression from the anterior aspect of the foramen. Disc herniations can either be acute or chronic.

Imaging modalities and electrophysiologic testing (EMG \& NCV) play an important role in the diagnosis and localization of cervical radiculopathy. The first test that is typically done is plain x-ray. Computed tomography is the most sensitive test for examination of the bony structures of the spine.

Initial strategies in the treatment of cervical radiculopathy are typically Conservative therapies including multiple pharmacologic agents, immobilization, physical therapy, manipulation, traction, and TENS .

Traditionally, cervical spine injection performed under fluoroscopy or computed tomography guidance. However, these imaging tools are not able to visualize small vessels, and incidences such as brainstem or spinal cord infarction may occur. These complications are believed to be caused by inadvertent injection of therapeutic agents into the vertebral or radicular arteries. Therefore, accidental puncture of vessels must be prevented when performing neck injection procedures.

Recently, high-resolution musculoskeletal ultrasound (US) can be used to identify the target root and the nearby vessels. The advantage of using US as a guidance tool is that it does not expose patients or medical personnel to radiation such as fluoroscopy or computed tomography guidance. Ultrasound allows good visualization of the soft tissue such as abnormal blood vessels in the foramen and around the nerve root, which further enables accurate needle placement and avoids the risk of intravascular injections. In addition, US-guided procedures have a shorter duration compared to those guided by fluoroscopy and do not result in contrast medium-related allergic reactions . As a result, US-guided cervical nerve root block (US-CRB) is a safe alternative treatment technique that can be used in the treatment of upper extremity radicular pain.

Conditions

  • Cervical Pain

Interventions

DEVICE

ultrasound cervical selective nerve root block

A (7-12) MHz linear transducer will be applied to the symptomatic side of the neck in the transverse plane. The targeted nerve root of each patient will be identified by moving the transducer cranially from the C7 transverse process as a reference point. After the targeted nerve root identified, a needle will be gently introduced toward the dorsal aspect of the nerve root under real-time US guidance with an in-plane approach. The needle tip will be placed between the nerve root and posterior tubercle outside of the intervertebral foramen and the vessels will be around the nerve root with color Doppler. On confirmation of the absence of abnormal findings and careful aspiration, 3 cc of the treatment drug composed of dexamethasone (10 mg) and 0.2% lidocaine, will be injected under real-time US guidance

DEVICE

ultrasound and fluoroscopy-guided cervical selective nerve root block

The targeted transverse process was identified by slowly moving the probe in all directions with the 7th cervical spine transverse process as the reference point. a spinal needle 22 G was inserted. First, 1 ml of the contrast media was injected. The antero-posterior images were obtained to confirm the distribution or spread pattern of the injected contrast media with C-arm fluoroscopy. The following steps were initiated after confirming for proper shadowed contrast of the nerve root and absence of intravascular injection of the contrast media. Three cc of the treatment drug, composed of dexamethasone (10 mg) and 0.5 % lidocaine will be injected after confirming the absence of abnormal findings.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-05-01
Completion
2023-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521373 on ClinicalTrials.gov