NCT05521373

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

Status unknown Phase 2, PHASE3 Last updated 9 September 2022

What this trial tests

Phase 2, PHASE3 trial testing ultrasound cervical selective nerve root block in Cervical Pain in 68 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
1 May 2023

1 September 2023

Quick facts

Lead sponsor	Mansoura University
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	68
Start date	1 May 2022
Primary completion	1 May 2023
Estimated completion	1 September 2023
Sites	1 location across Egypt

Drugs / interventions tested

• ultrasound cervical selective nerve root block
• ultrasound and fluoroscopy-guided cervical selective nerve root block

Conditions studied

• Cervical Pain — all drugs for Cervical Pain →

Sponsor

Mansoura University

Who can join

Adults 18 to 80, any sex, with Cervical Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.