Cervical PainPhase 2/3NCT05521373
Ultrasound-guided Versus Combined Ultrasound and Fluoroscopy-guided Cervical Selective Nerve Root Block for Lower Cervical Radiculopathy: Non-inferiority Randomized Controlled Study
A Phase 2/3 study testing ultrasound cervical selective nerve root block and ultrasound and fluoroscopy-guided cervical selective nerve root block in people with Cervical Pain, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- ultrasound cervical selective nerve root block and ultrasound and fluoroscopy-guided cervical selective nerve root block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Sep 2023
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Yahya Wahba
Al Mansurah
yahya m wahba, assist prof., 01211313554, yahyawahba@gmail.com
Amira m barakat attia, assistant lecture
About this study
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.
Read more
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.
Read the detailed description
This study will be conducted to evaluate immediate and long-term effectiveness, functional improvements, and safety of ultrasound (US)-guided selective cervical nerve root block compared with fluoroscopy-guided selective nerve root block.
Technique of ultrasound guided cervical selective nerve root block:
Basic monitoring with non-invasive arterial blood pressure, electrocardiogram and pulse oximetry will be applied before the procedure, an intravenous catheter (20 G) will be inserted in a peripheral line for crystalloid infusion. Patients will be positioned in the oblique supine decubitus position with head externally rotated at 30° to 40° away from the targeted area, the frontal cervical spine area from the clavicle to mandible was adequately disinfected with Betadine and an aseptic dressing was applied. The sternocleidomastoid muscle was first palpated from the posterior side to palpate the transverse process of the cervical spine.
A (7-12) MHz linear transducer of a US machine will be applied to the symptomatic side of the neck in the transverse plane. Initially, the cervical nerve roots will be identified on US by the shape of the transverse process. Unlike the transverse processes of the 3rd to 6th cervical spines, the transverse process of the 7th cervical spine has a rudimentary anterior tubercle and a prominent posterior tubercle. The C6 transverse process characterized by its sharp anterior tubercle. The C5 transverse process identified by the "two-humped camel" sign formed by anterior and posterior tubercles. Within the intertubercular groove of the corresponding transverse process, the nerve root of each cervical spinal level will be observed with hypoechoic texture. The targeted nerve root of each patient will be identified by moving the transducer cranially from the C7 transverse process as a reference point.
The optimal image of the nerve root, location of the radicular artery and surrounding vessels near the border of the nerve root were obtained through probe manipulation in the power and color Doppler modes After the targeted nerve root identified, a 60-mm, 23-G needle will be gently introduced toward the dorsal aspect of the nerve root under real-time US guidance. The needle will be inserted just lateral to the transducer and advanced, from postero-lateral to antero-medial, with an in-plane approach. The needle tip will be placed between the nerve root and posterior tubercle outside of the intervertebral foramen and approached close to the epineurium with care to avoid inadvertent injection to the vessel through locating the vessels around the nerve root with color Doppler. Then, 1 ml of 1% lidocaine will be injected, following which the patient monitored for the onset of clinical manifestations such as mid-neck and contralateral arm pain, metallic taste, dizziness, tachycardia, full-body paraesthesia, auditory changes, slurred speech, and motor ataxia for 1 to 2 minutes. On confirmation of the absence of abnormal findings and careful aspiration, 3 cc of the treatment drug composed of dexamethasone (10 mg) and 0.5% lidocaine, will be injected under real-time US guidance
Technique of combined ultrasound and fluoroscopy guided selective nerve root block:
With the patient's head externally rotated 30 to 40 degrees away from the targeted area in a supine position, the frontal cervical spine area from the clavicle to mandible was adequately disinfected with Betadine and an aseptic dressing was applied. The sternocleidomastoid muscle was first palpated from the posterior side to palpate the transverse process of the cervical spine. A probe was placed and a transverse scan image of the transverse process was obtained after locating the transverse process. The location of the 7th transverse process was confirmed by visualization of the adjacent transverse processes sonographically from the superior to inferior direction. Unlike the transverse processes of the 3rd to 6th cervical spines, the transverse process of the 7th cervical spine has a rudimentary anterior tubercle and a prominent posterior tubercle, a unique characteristic used to identify and differentiate the 7th transverse process.
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. The optimal image of the nerve root, the location of the radicular artery, and the surrounding vessels near the border of the nerve root were obtained through the probe manipulation. Next, a spine needle 22 G was inserted from the posterior to anterior direction, toward the nerve root and parallel to the probe. The needle end was placed on the dorsal side of the nerve by cautiously avoiding damage to the possible deep cervical artery near the insertion site and locating the area free of the radicular artery. 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. One millilitre of 1 % lidocaine was injected and monitored for the onset of clinical manifestations such as mid-neck and contralateral arm pain, metallic taste, dizziness, tachycardia, full body paraesthesia, auditory changes, slurred speech, and motor ataxia for 1-2 min. 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. The procedure will be completed after obtaining the images of the wash out spot
- Conditions
- Cervical Pain
- Being tested
- ultrasound cervical selective nerve root block, ultrasound and fluoroscopy-guided cervical selective nerve root block
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound cervical selective nerve root blockDevice
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
ultrasound and fluoroscopy-guided cervical selective nerve root blockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound cervical selective nerve root block | Active comparator | 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 Receives: Device: ultrasound cervical selective nerve root block |
| ultrasound and fluoroscopy-guided cervical selective nerve root block | Active comparator | 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. Receives: Device: ultrasound and fluoroscopy-guided cervical selective nerve root block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
0=no pain , 10=sever pain
Measured: immediately before Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
Measured: after 2 weeks from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
Measured: after 1 month from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
Measured: after 2 months from Cervical Selective Nerve Root Block
Numerical rating scale
0=no pain , 10=sever pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 3 months from Cervical Selective Nerve Root Block
Secondary outcomes (3)
time of the procedure by minutes
starting from putting the ultrasound probe until withdraw the needle after injection
Measured: during the injection procedure
patient satisfaction from 0 to 10
0 = not satisfied , 10 = maximum satisfied
Measured: after two months from Cervical Selective Nerve Root Block
complication
any complication during the procedure as intravascular injection, hypotension, bradycardia
Measured: during the performance of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 May 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521373
- Sponsor's protocol ID
- MD.22.03.627
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Versus Combined Ultrasound and Fluoroscopy-guided Cervical Selective Nerve Root Block for Lower Cervical Radiculopathy: Non-inferiority Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05521373
- Acronym / sponsor ID
- MD.22.03.627
- Conditions
- Cervical Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 30 Aug 2022 (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.
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.
Detailed description
This study will be conducted to evaluate immediate and long-term effectiveness, functional improvements, and safety of ultrasound (US)-guided selective cervical nerve root block compared with fluoroscopy-guided selective nerve root block.
Technique of ultrasound guided cervical selective nerve root block:
Basic monitoring with non-invasive arterial blood pressure, electrocardiogram and pulse oximetry will be applied before the procedure, an intravenous catheter (20 G) will be inserted in a peripheral line for crystalloid infusion. Patients will be positioned in the oblique supine decubitus position with head externally rotated at 30° to 40° away from the targeted area, the frontal cervical spine area from the clavicle to mandible was adequately disinfected with Betadine and an aseptic dressing was applied. The sternocleidomastoid muscle was first palpated from the posterior side to palpate the transverse process of the cervical spine.
A (7-12) MHz linear transducer of a US machine will be applied to the symptomatic side of the neck in the transverse plane. Initially, the cervical nerve roots will be identified on US by the shape of the transverse process. Unlike the transverse processes of the 3rd to 6th cervical spines, the transverse process of the 7th cervical spine has a rudimentary anterior tubercle and a prominent posterior tubercle. The C6 transverse process characterized by its sharp anterior tubercle. The C5 transverse process identified by the "two-humped camel" sign formed by anterior and posterior tubercles. Within the intertubercular groove of the corresponding transverse process, the nerve root of each cervical spinal level will be observed with hypoechoic texture. The targeted nerve root of each patient will be identified by moving the transducer cranially from the C7 transverse process as a reference point.
The optimal image of the nerve root, location of the radicular artery and surrounding vessels near the border of the nerve root were obtained through probe manipulation in the power and color Doppler modes After the targeted nerve root identified, a 60-mm, 23-G needle will be gently introduced toward the dorsal aspect of the nerve root under real-time US guidance. The needle will be inserted just lateral to the transducer and advanced, from postero-lateral to antero-medial, with an in-plane approach. The needle tip will be placed between the nerve root and posterior tubercle outside of the intervertebral foramen and approached close to the epineurium with care to avoid inadvertent injection to the vessel through locating the vessels around the nerve root with color Doppler. Then, 1 ml of 1% lidocaine will be injected, following which the patient monitored for the onset of clinical manifestations such as mid-neck and contralateral arm pain, metallic taste, dizziness, tachycardia, full-body paraesthesia, auditory changes, slurred speech, and motor ataxia for 1 to 2 minutes. On confirmation of the absence of abnormal findings and careful aspiration, 3 cc of the treatment drug composed of dexamethasone (10 mg) and 0.5% lidocaine, will be injected under real-time US guidance
Technique of combined ultrasound and fluoroscopy guided selective nerve root block:
With the patient's head externally rotated 30 to 40 degrees away from the targeted area in a supine position, the frontal cervical spine area from the clavicle to mandible was adequately disinfected with Betadine and an aseptic dressing was applied. The sternocleidomastoid muscle was first palpated from the posterior side to palpate the transverse process of the cervical spine. A probe was placed and a transverse scan image of the transverse process was obtained after locating the transverse process. The location of the 7th transverse process was confirmed by visualization of the adjacent transverse processes sonographically from the superior to inferior direction. Unlike the transverse processes of the 3rd to 6th cervical spines, the transverse process of the 7th cervical spine has a rudimentary anterior tubercle and a prominent posterior tubercle, a unique characteristic used to identify and differentiate the 7th transverse process.
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. The optimal image of the nerve root, the location of the radicular artery, and the surrounding vessels near the border of the nerve root were obtained through the probe manipulation. Next, a spine needle 22 G was inserted from the posterior to anterior direction, toward the nerve root and parallel to the probe. The needle end was placed on the dorsal side of the nerve by cautiously avoiding damage to the possible deep cervical artery near the insertion site and locating the area free of the radicular artery. 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. One millilitre of 1 % lidocaine was injected and monitored for the onset of clinical manifestations such as mid-neck and contralateral arm pain, metallic taste, dizziness, tachycardia, full body paraesthesia, auditory changes, slurred speech, and motor ataxia for 1-2 min. 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. The procedure will be completed after obtaining the images of the wash out spot
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound cervical selective nerve root block | Active comparator | Device: ultrasound cervical selective nerve root blockA (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 comparator | Device: ultrasound and fluoroscopy-guided cervical selective nerve root blockThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Patients between 18-80 years old
Key exclusion criteria (15 listed)
- • Patients younger than 18 years or older than 80 years.
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 cervical selective nerve root blockA (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 cervical selective nerve root block |
| ultrasound and fluoroscopy-guided cervical selective nerve root blockThe 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. | Device | ultrasound and fluoroscopy-guided cervical selective nerve root block |
Primary outcome
Numerical rating scale
Time frame: immediately before Cervical Selective Nerve Root Block
0=no pain , 10=sever pain
Numerical rating scale
Time frame: after 2 weeks from Cervical Selective Nerve Root Block
0=no pain , 10=sever pain
Numerical rating scale
Time frame: after 1 month from Cervical Selective Nerve Root Block
0=no pain , 10=sever pain
Numerical rating scale
Time frame: after 2 months from Cervical Selective Nerve Root Block
0=no pain , 10=sever pain
Numerical rating scale
Time frame: after 3 months from Cervical Selective Nerve Root Block
0=no pain , 10=sever pain
neck disability index questionnaire
Time frame: immediately before Cervical Selective Nerve Root Block
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.
neck disability index questionnaire
Time frame: after 1 month from Cervical Selective Nerve Root Block
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.
neck disability index questionnaire
Time frame: after 2 months from Cervical Selective Nerve Root Block
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.
neck disability index questionnaire
Time frame: after 3 months from Cervical Selective Nerve Root Block
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.
3 secondary outcomes
time of the procedure by minutes
Time frame: during the injection procedure
patient satisfaction from 0 to 10
Time frame: after two months from Cervical Selective Nerve Root Block
complication
Time frame: during the performance of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ultrasound cervical selective nerve root block and ultrasound and fluoroscopy-guided cervical selective nerve root block in people with Cervical Pain, run by Mansoura University at 1 site in Egypt.
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 7 inclusion and 15 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact yahya m wahba, assist professor (01211313554, yahyawahba@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (time frame: immediately before Cervical Selective Nerve Root Block). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2022.