Neuropathic PainNCT06092749
Chronic Unilateral Lumbar Radicular Pain
A study testing Transgrade technique (TG) and Interlaminar technique (IL) in people with Neuropathic Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Transgrade technique (TG) and Interlaminar technique (IL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 27 Oct 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 6-month history of persistent pain in one leg with back pain.
- Capable of giving informed consent.
- Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.
Who cannot join
- Previous lumbar spinal surgery.
- Myelopathy.
- Rheumatoid disorders.
- Psychiatric disorders
- Bleeding or coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain
Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.
- Conditions
- Neuropathic Pain
- Being tested
- Transgrade technique (TG), Interlaminar technique (IL)
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transgrade technique (TG)Other
Transgrade (TG) Epidural Steroid Injection technique
Interlaminar technique (IL)Other
Interlaminar (IL) Epidural Steroid Injection technique
| Study group | Role | What they receive |
|---|---|---|
| Transgrade technique (TG) | Active comparator | Not described Receives: Other: Transgrade technique (TG) |
| Interlaminar technique (IL) | Active comparator | Not described Receives: Other: Interlaminar technique (IL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experienced successful pain relief at 3 month post-intervention
Number of patients who experienced successful pain relief at 3 month post-intervention, which is defined as ≥ 50% reduction of numeric rating scale (NRS-11) from pre-intervention level.
Measured: 6 month post intervention (study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Nov 2023
- Primary completion27 Oct 2026
- Study completion27 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092749
- Sponsor's protocol ID
- FMASU MD 286/ 2023
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT06092749
- Acronym / sponsor ID
- FMASU MD 286/ 2023
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 27 Oct 2026 (actual)
- Study completion
- 27 Oct 2026 (actual)
- First posted
- 23 Oct 2023 (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.
Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgrade technique (TG) | Active comparator | Other: Transgrade technique (TG) |
| Interlaminar technique (IL) | Active comparator | Other: Interlaminar technique (IL) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 6-month history of persistent pain in one leg with back pain.
- Capable of giving informed consent.
- Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.
Key exclusion criteria (5 listed)
- Previous lumbar spinal surgery.
- Myelopathy.
- Rheumatoid disorders.
- Psychiatric disorders
- Bleeding or coagulation 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 |
|---|---|---|
| Transgrade technique (TG)Transgrade (TG) Epidural Steroid Injection technique | Other | Transgrade technique (TG) |
| Interlaminar technique (IL)Interlaminar (IL) Epidural Steroid Injection technique | Other | Interlaminar technique (IL) |
Primary outcome
Number of patients who experienced successful pain relief at 3 month post-intervention
Time frame: 6 month post intervention (study period)
Number of patients who experienced successful pain relief at 3 month post-intervention, which is defined as ≥ 50% reduction of numeric rating scale (NRS-11) from pre-intervention level.
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 study testing Transgrade technique (TG) and Interlaminar technique (IL) in people with Neuropathic Pain, run by Ain Shams 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 3 inclusion and 5 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 2 Nov 2026. 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.
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?
Number of patients who experienced successful pain relief at 3 month post-intervention (time frame: 6 month post intervention (study period)). 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 2 Nov 2026.