Lumbar RadiculopathyPhase 2NCT06795542
The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with Lumbosacral Radiculopathy
A Phase 2 study testing lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina in people with Lumbar Radiculopathy, run by Amr Mohamed Sedik at 1 site in Egypt.
Trial summary
the aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy 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?
- lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 1.Patients who underwent lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina 2.Patients age 18 to 60 years 3.Patients had been symptomatic longer than 6 Weeks with Leg pain more than back pain with failure conservative treatment.
- 4.Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse
Who cannot join
- 1- Patients had previous lumbar surgery 2- Patients had a large herniated disc with severe central or foraminal stenosis on magnetic resonance imaging 3- Patients had Scoliosis , spondylolisthesis or malignancy 4- patients with neurological deficit. 5-Patients had a blood coagulation disorder, or had experienced an allergic reaction to local anesthetics or corticosteroids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Neurossurgery Department of Sohag university
Sohag, Sohag Governorate, 11511
About this study
Official title: Predictive Factors for the Success of Transforaminal Epidural Injection in Lumbosacral Radiculopathy
the aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy
Read the detailed description
Lumbar radicular pain (known as sciatica) represents a prevalent medical and socioeconomic problem.
More than half of the patients with sciatica report a decline in their activities of daily living and ability to work.
Mixed Pathologies as foraminal stenosis, spondylolisthesis, and space-occupying lesions in the lumbar spine can cause Sciatica but the most common cause is lumbar disc herniation. (1) Overall, the vast majority of patients with lumbosacral radiculopathy recover with conservative care as trial of bed rest, oral medications, lumbar corsets and physiotherapy. (2) The involvement of inflammation has attracted the use of steroids (corticosteroids) to reduce the inflammation and, thereby, relieve the pain. Injections of steroids, by various routes, have been used as an alternative to surgery, and as an alternative or complement to conservative therapy, for the treatment of lumbar radicular pain. (3) Steroids are believed to have a therapeutic effect due to their anti inflammatory properties.
This belief is supported by evidence from in vitro studies that show that steroids have a role in decreasing inflammatory mediators such as cytokines and chemokines another study suggests that steroids may provide a stabilizing effect on nociceptive signaling in C-fibers and suppression of ectopic neural discharges. (4) The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids (5) Transforaminal epidural injection may be by autologous Platelet Rich Plasma (PRP) as a novel pharmaceutical agent that has strongly emerged in recent years to treat patients of lumbar disc herniation.(6)
- Conditions
- Lumbar Radiculopathy
- Being tested
- lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina
- Keywords
- predictive factors, transforaminal, epidural, injection
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foraminaProcedure or surgery
The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids
| Study group | Role | What they receive |
|---|---|---|
| lumbosacral transforaminal epidural injection | Experimental | Transforaminal Epidural Injections using C-arm imaging with or without Fluoroscopic Guidance Receives: Procedure: lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transformainal Epidural Injection
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing Visual Analogue Pain Scale (VAS)
Measured: 3 months
Transformainal Epidural Injection
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing
-Roland \& Morris Disability Questionnaire
Measured: 3 months
Transformainal Epidural Injection
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing modified oswestry disability index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- steroid
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amr Mohamed Sedik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr Mohamed Sedik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795542
- Sponsor's protocol ID
- Soh-Med--25-1-05MS
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for the Success of Transforaminal Epidural Injection in Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06795542
- Acronym / sponsor ID
- Soh-Med--25-1-05MS
- Conditions
- Lumbar Radiculopathy
- Keywords
- predictive factors, transforaminal, epidural, injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amr Mohamed SedikUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Jan 2025 (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 aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy
Detailed description
Lumbar radicular pain (known as sciatica) represents a prevalent medical and socioeconomic problem.
More than half of the patients with sciatica report a decline in their activities of daily living and ability to work.
Mixed Pathologies as foraminal stenosis, spondylolisthesis, and space-occupying lesions in the lumbar spine can cause Sciatica but the most common cause is lumbar disc herniation. (1) Overall, the vast majority of patients with lumbosacral radiculopathy recover with conservative care as trial of bed rest, oral medications, lumbar corsets and physiotherapy. (2) The involvement of inflammation has attracted the use of steroids (corticosteroids) to reduce the inflammation and, thereby, relieve the pain. Injections of steroids, by various routes, have been used as an alternative to surgery, and as an alternative or complement to conservative therapy, for the treatment of lumbar radicular pain. (3) Steroids are believed to have a therapeutic effect due to their anti inflammatory properties.
This belief is supported by evidence from in vitro studies that show that steroids have a role in decreasing inflammatory mediators such as cytokines and chemokines another study suggests that steroids may provide a stabilizing effect on nociceptive signaling in C-fibers and suppression of ectopic neural discharges. (4) The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids (5) Transforaminal epidural injection may be by autologous Platelet Rich Plasma (PRP) as a novel pharmaceutical agent that has strongly emerged in recent years to treat patients of lumbar disc herniation.(6)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- steroid
| Arm | Type | Receives |
|---|---|---|
| lumbosacral transforaminal epidural injection | Experimental | Procedure: lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foraminaTransforaminal Epidural Injections using C-arm imaging with or without Fluoroscopic Guidance |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1.Patients who underwent lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina 2.Patients age 18 to 60 years 3.Patients had been symptomatic longer than 6 Weeks with Leg pain more than back pain with failure conservative treatment.
- 4.Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse
Key exclusion criteria (1 listed)
- 1- Patients had previous lumbar surgery 2- Patients had a large herniated disc with severe central or foraminal stenosis on magnetic resonance imaging 3- Patients had Scoliosis , spondylolisthesis or malignancy 4- patients with neurological deficit. 5-Patients had a blood coagulation disorder, or had experienced an allergic reaction to local anesthetics or corticosteroids.
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 |
|---|---|---|
| lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foraminaThe most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids | Procedure or surgery | lumbosacral transforaminal epidural injection |
Primary outcome
Transformainal Epidural Injection
Time frame: 3 months
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing Visual Analogue Pain Scale (VAS)
Transformainal Epidural Injection
Time frame: 3 months
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing -Roland \& Morris Disability Questionnaire
Transformainal Epidural Injection
Time frame: 3 months
All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing modified oswestry disability index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina in people with Lumbar Radiculopathy, run by Amr Mohamed Sedik 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 28 Jan 2025. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Transformainal Epidural Injection (time frame: 3 months). The study lists 3 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 28 Jan 2025.