Ultrasound-guided Versus Combined Ultrasound and Fluoroscopy-guided Cervical Selective Nerve Root Block for Lower Cervical Radiculopathy: Non-inferiority Randomized Controlled Study
1 other identifier
interventional
68
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 13, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedSeptember 9, 2022
September 1, 2022
1 year
August 13, 2022
September 6, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
Numerical rating scale
0=no pain , 10=sever pain
immediately before Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
after 2 weeks from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
after 1 month from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
after 2 months from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
after 3 months from Cervical Selective Nerve Root Block
neck disability index questionnaire
it is a questionnaire composed of 10 items: pain, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, Recreation. each item ranges from 0= do not affect to 5= worst affect and the total score of the 10 items will be summed. if the total score will be 4 or lower, no disability; 5 to 14, mild disability; 15 to 24, moderate disability; 25 to 34, severe disability; 35 or over, complete disability.
immediately before Cervical Selective Nerve Root Block
neck disability index questionnaire
it is a questionnaire composed of 10 items: pain, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, Recreation. each item ranges from 0= do not affect to 5= worst affect and the total score of the 10 items will be summed. if the total score will be 4 or lower, no disability; 5 to 14, mild disability; 15 to 24, moderate disability; 25 to 34, severe disability; 35 or over, complete disability.
after 1 month from Cervical Selective Nerve Root Block
neck disability index questionnaire
it is a questionnaire composed of 10 items: pain, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, Recreation. each item ranges from 0= do not affect to 5= worst affect and the total score of the 10 items will be summed. if the total score will be 4 or lower, no disability; 5 to 14, mild disability; 15 to 24, moderate disability; 25 to 34, severe disability; 35 or over, complete disability.
after 2 months from Cervical Selective Nerve Root Block
neck disability index questionnaire
it is a questionnaire composed of 10 items: pain, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, Recreation. each item ranges from 0= do not affect to 5= worst affect and the total score of the 10 items will be summed. if the total score will be 4 or lower, no disability; 5 to 14, mild disability; 15 to 24, moderate disability; 25 to 34, severe disability; 35 or over, complete disability.
after 3 months from Cervical Selective Nerve Root Block
Secondary Outcomes (3)
time of the procedure by minutes
during the injection procedure
patient satisfaction from 0 to 10
after two months from Cervical Selective Nerve Root Block
complication
during the performance of the procedure
Study Arms (2)
ultrasound cervical selective nerve root block
ACTIVE COMPARATORA (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
ultrasound and fluoroscopy-guided cervical selective nerve root block
ACTIVE COMPARATORThe 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Patients between 18-80 years old
- Both sexes.
- Single level cervical radiculopathy C6 or C7.
- Cervical radicular pain was diagnosed on the basis of clinical profiles, medical examinations
- Radiologic finding via cervical computed tomography or magnetic resonance imaging was consistent with the clinical diagnosis.
- Patients presenting with acute and sever symptoms with verbal numeric scale (VNS) at least 5 points for at least 3 months prior to study entry (day 0)
- Pain relief not achieved with conservative treatments administered for at least 4 weeks, including analgesic use (nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids) and physical therapy.
You may not qualify if:
- Patients younger than 18 years or older than 80 years.
- Patient refusal.
- Pregnant or lactating women.
- Psychiatric disorders affecting co-operation of the patient.
- Bleeding or coagulation disorders
- Local skin infection or current other problem in the affected extremity.
- Prior allergic reaction to any of the study medications; contrast media, steroid or local anaesthetic.
- Laboratory result suggestive of systemic inflammatory disease or rheumatoid disorder.
- Cervical radiculopathy at multiple levels.
- Cervical myelopathy.
- Patient presenting with motor power less than Medical Research Council MRC grade 4.
- Injections within prior 3 months.
- Recent cervical spinal surgery.
- Previous chronic opioid use.
- Any condition that could interfere with the interpretation of the outcome assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yahya Wahba
Al Mansurah, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assist. prof. of anesthesia and pain management
Study Record Dates
First Submitted
August 13, 2022
First Posted
August 30, 2022
Study Start
May 1, 2022
Primary Completion
May 1, 2023
Study Completion
September 1, 2023
Last Updated
September 9, 2022
Record last verified: 2022-09