Comparison of Unilateral and Bilateral Transforaminal Epidural Steroid Injection
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Lumbar radicular pain affects the person's quality of life. The most common cause of lumbar
      radicular pain is disc herniation. In radicular pain due to lumbar disc herniation, epidural
      steroid injections are frequently applied to patients who do not benefit from medical
      treatment and physical medicine modalities. Epidural steroid injection inhibits the synthesis
      and release of pro-inflammatory substances that develop as a result of mechanical
      compression.In the transforaminal epidural technique, the solution is administered to the
      anterior epidural space and spreads to the ipsilateral periradicular area. The applied
      solution does not cross the midline and there is no contralateral drug spread. Although
      bilateral transforaminal epidural steroid injection is recommended in unilateral lumbosacral
      disc herniation because the inflammation is bilateral, unilateral transforaminal steroid
      injection has been applied in most studies. We aimed to to evaluate the effects of unilateral
      and bilateral transforaminal epidural steroid injection on pain intensity, functionality and
      medication use in unilateral lumbosacral disc herniation
    

Detailed description: 
      Lumbar radicular pain is a condition that is very common The lifetime incidence of lumbar
      radicular pain is up to 43%. The most common cause of lumbar radicular pain is disc
      herniation. Other reasons; spinal stenosis, tumor, infection, spondylosis, spondylolisthesis,
      ligamentum flavum hypertrophy and synovial cyst. Lumbar disc herniation is most commonly
      located at L4-5 and L5-S1. Nerve compression due to disc herniation can occur in the spinal
      canal, lateral recess, neuroforaminal or extraforaminal region.

      Inflammatory and mechanical reactions between the intervertebral disc, posterior longitudinal
      ligament and nerve roots play a role in the development of radicular pain. Chemical mediators
      released from the herniated disc increase the inflammatory response, and prostaglandin is
      released due to phospholipase A2 production. This situation results in radicular pain.
      Epidural steroid injections are frequently applied to patients in the treatment of radicular
      pain who do not benefit from medical treatment (non-steroidal anti-inflammatory analgesic,
      opioid, gabapentin, pregabalin) and physical medicine modalities. Epidural steroid injections
      can be administered via interlaminar, transforaminal or caudal routes. Epidural steroid
      injection inhibits the synthesis and release of pro-inflammatory substances that develop as a
      result of mechanical compression. In the transforaminal technique, the solution is
      administered to the anterior epidural space and spreads to the ipsilateral periradicular
      area. The applied solution does not cross the midline and there is no contralateral drug
      spread. In interlaminar epidural steroid injection, the solution crosses the midline and
      spreads bilaterally; but it remains in the posterior epidural area. Injection applied to the
      anterior epidural area adjacent to the nerve root via the transforaminal route is
      target-specific and a more effective form of treatment. In a study researchers reported that
      there was a greater decrease in pain intensity in patients with spinal stenosis with
      bilateral transforaminal epidural injection compared to interlaminar epidural injection. In
      another study, transforaminal injection was found to be superior in pain palliation compared
      to interlaminar injection in symptomatic lumbar disc herniation. Although there are studies
      in the literature comparing the advantages of epidural injection methods in lumbar disc
      herniation, there are no studies comparing the clinical effect of unilateral and bilateral
      transforaminal injection. Although bilateral transforaminal epidural steroid injection is
      recommended in unilateral lumbosacral disc herniation because the inflammation is bilateral,
      unilateral transforaminal steroid injection has been applied in most studies. (9- This study
      aims to evaluate the effects of unilateral and bilateral transforaminal epidural steroid
      injection on pain intensity, functionality and medication use in unilateral lumbosacral disc
      herniation and to observe whether they are superior to each other.

      A single-center, prospective randomized controlled study will be conducted at Ankara
      University Faculty of Medicine, Department of Algology. Within the scope of the study,
      patients with radicular pain radiating to the unilateral lower extremities due to lumbosacral
      disc herniation will be evaluated with Magnetic Resonance Imaging (MRI) and physical
      examination between 1.6.2023 and 1.10.2023. The study included patients between the ages of
      18 and 65, who had unilateral lumbosacral radicular pain for at least 3 months, whose MRI and
      physical examination confirmed lumbosacral disc herniation, who developed pain secondary to
      unilateral lumbosacral disc herniation, who did not respond to conservative treatment
      (medical and physical medicine modalities), and 128 patients with pain intensity of 4 and
      above measured using Numeric Rating Scala (NRS) will be included. Patients with previous
      lumbar surgery, patients with psychiatric illnesses who are unstable/not controlled by
      medical treatment, pregnant patients, patients with bleeding diathesis, patients who have
      received epidural steroid injection within the last year, patients who are exposed to
      substances given during the procedure (local anesthetic, steroid, contrast material).
      Patients with known allergies, scoliosis, spondylolisthesis, central canal stenosis,
      compression fracture, previous discitis, sequestered disc, and bilateral disc herniation will
      be excluded from the study.

      Patients will receive epidural steroid injection through a unilateral or bilateral
      transforaminal approach. Within the scope of the study, patients with unilateral lumbosacral
      disc herniation and who are deemed suitable for transforaminal epidural steroid injection
      will be numbered in the order they are included in the study. Patients given an odd number
      will receive unilateral transforaminal epidural steroid injection, and patients given an even
      number will receive bilateral transforaminal epidural steroid injection. Transforaminal
      epidural steroid injections will be administered by Hanzade Aybüke Ünal. Pre-procedure and
      post-procedure evaluations of the patients will be recorded by Ahmet Basari, who is blind to
      the procedure performed. Demographic information of the patients, including age, gender,
      comorbidities, pain duration, and disc herniation level, will be recorded before the
      procedure. Before the procedure, pain intensity will be evaluated using the NRS 11 scale, and
      functionality will be evaluated using the ODI. The amount of medication used by the patients
      (non-steroidal anti-inflammatory analgesics, opioids, gabapentin, pregabalin) will also be
      noted. Patients will be contacted by phone at 1st week, 1st month and 3rd month to obtain
      information about NRS and ODI. During the specified time periods, pain intensity will be
      recorded using the NRS 11 scale, functionality will be recorded using the ODI, and medication
      use (non-steroidal anti-inflammatory analgesic, opioid, gabapentin, pregabalin) will be
      recorded. Additionally, possible complications in patients will also be recorded. A 50% or
      more reduction in pain intensity will be considered a response to treatment.
    

Intervention name(s): unilateral transforaminal epidural steroid block; bilateral transforaminal epidural steroid block
Intervention type(s): Procedure; Procedure
Intervention description(s): unilateral transforaminal epidural steroid block; bilateral transforaminal epidural steroid block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain