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Enrolling by Invitation

NCT Number: NCT06795542

The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with 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

Enrolling by Invitation

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurossurgery Department of Sohag university

Sohag, Sohag Governorate, 11511, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina

Procedure

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

Primary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Amr Mohamed Sedik

Other

Registry information

Official study title

Predictive Factors for the Success of Transforaminal Epidural Injection in Lumbosacral Radiculopathy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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