Lumbar RadiculopathyNCT05290779
Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection
A study testing selective lumbar nerve root injection in people with Lumbar Radiculopathy, run by Minia University at 1 site in Egypt.
Trial summary
The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- selective lumbar nerve root injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2021to 16 May 2022
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients aged 18-60 years .
- Both sexes .
- With unilateral chronic lumbar radicular pain for more than 3 months.
- Cooperative and oriented patients.
- All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI).
Who cannot join
- Uncontrolled diabetes.
- Infection at the site of injection.
- Spine fractures.
- Previous back surgery.
- Progressive neurologic disorders.
- Fever.
Show all 11Show fewer
- Peripheral neuropathy.
- Presence of motor or sphencteric disturbance.
- Bilateral radicular pain.
- Allergy to substance of injection.
- Patients with body mass index (BMI) more than 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain
The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance
Read the detailed description
Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure.
- Conditions
- Lumbar Radiculopathy
- Being tested
- selective lumbar nerve root injection
- Keywords
- lumbar radicular pain, selective nerve root injection, ultrasound selective lumbar nerve root injection
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective lumbar nerve root injectionProcedure or surgery
selective lumbar nerve root steroid injection for treatment of radicular pain.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Active comparator | selective lumbar nerve root steroid injection under ultrasound guidance. Receives: Procedure: selective lumbar nerve root injection |
| fluoroscopy | Sham comparator | selective lumbar nerve root steroid injection under fluoroscopy guidance. Receives: Procedure: selective lumbar nerve root injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of visual analogue score of pain
evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome
Measured: 3 months
improvement of Oswestry disability index score for back pain
evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.
Measured: 3 months
Secondary outcomes (2)
safety of technique
comparing rate of complications
Measured: 3 months
radiation exposure
time of x-ray radiation exposure during procedure.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start6 Apr 2021
- Primary completion12 Apr 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Minia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Ahmed Bakr Mohammed, Minia University
- Investigators
- Amany K Abu Elhusein, PhD, Study chair, Professor of Anesthesia and intensive care, MiniaU.Abd ELraheem M Mohamed, MD, Study director, Assistant professor of Anesthesia and intensive care, AsuitU..
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290779
- Sponsor's protocol ID
- US vs. FL SNRB injection
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2022
- Last updated
- 27 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain
- ClinicalTrials.gov ID
- NCT05290779
- Acronym / sponsor ID
- US vs. FL SNRB injection
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radicular pain, selective nerve root injection, ultrasound selective lumbar nerve root injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 22 Mar 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.
The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance
Detailed description
Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Active comparator | Procedure: selective lumbar nerve root injectionselective lumbar nerve root steroid injection under ultrasound guidance. |
| fluoroscopy | Sham comparator | Procedure: selective lumbar nerve root injectionselective lumbar nerve root steroid injection under fluoroscopy guidance. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- adult patients aged 18-60 years .
- Both sexes .
- With unilateral chronic lumbar radicular pain for more than 3 months.
- Cooperative and oriented patients.
- All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI).
Key exclusion criteria (11 listed)
- Uncontrolled diabetes.
- Infection at the site of injection.
- Spine fractures.
- Previous back surgery.
- Progressive neurologic disorders.
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 |
|---|---|---|
| selective lumbar nerve root injectionselective lumbar nerve root steroid injection for treatment of radicular pain. | Procedure or surgery | fluoroscopy, ultrasound |
Primary outcome
improvement of visual analogue score of pain
Time frame: 3 months
evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome
improvement of Oswestry disability index score for back pain
Time frame: 3 months
evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.
2 secondary outcomes
safety of technique
Time frame: 3 months
radiation exposure
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Amany K Abu Elhusein, PhD study chair
Professor of Anesthesia and intensive care, MiniaU.
Abd ELraheem M Mohamed, MD study director
Assistant professor of Anesthesia and intensive care, AsuitU..
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective lumbar nerve root injection in people with Lumbar Radiculopathy, run by Minia 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 27 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of visual analogue score of pain (time frame: 3 months). The study lists 2 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 27 Sep 2022.