Comparison of Unilateral and Bilateral Transforaminal Epidural Steroid Injection

NCT06240793 | Completed

• 1 other identifier: 2023/267
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pain, Chronic

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• pain severity

  In patients who received unilateral and bilateral transforaminal steroid injection, pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.

  3 months

Secondary Outcomes (3)

• functionality

  3 months

• medication use

  3 months

• Complication

  3 months

Study Arms (2)

Unilateral transforaminal epidural block

OTHER

The necessary oblique and cranio-caudal angles will be provided in fluoroscopy for the patients' designated procedure area. Skin and subcutaneous tissue anesthesia will be applied to the injection site with 3 ml of 2% prilocaine. The neural foramen will be entered using a blunt-tipped sympathetic block needle and a guiding needle. After needle localization is confirmed with antero-posterior and lateral fluoroscopic images, 1-2 ml of contrast material will be injected following negative aspiration. After confirming the contrast material spread in the anterior epidural area and periradicular area, 8 mg dexamethasone will be injected. If the application will be performed bilaterally, the specified techniques will be applied in half the same way on the bilateral side. Patients will be observed for one hour after the procedure for possible complications.

Procedure: unilateral transforaminal epidural steroid block

bilateral transforaminal epidural block

ACTIVE COMPARATOR

The necessary oblique and cranio-caudal angles will be provided in fluoroscopy for the patients' designated procedure area. Skin and subcutaneous tissue anesthesia will be applied to the injection site with 3 ml of 2% prilocaine. The neural foramen will be entered using a blunt-tipped sympathetic block needle and a guiding needle. After needle localization is confirmed with antero-posterior and lateral fluoroscopic images, 1-2 ml of contrast material will be injected following negative aspiration. After confirming the contrast material spread in the anterior epidural area and periradicular area, 8 mg dexamethasone will be injected. If the application will be performed bilaterally, the specified techniques will be applied in half the same way on the bilateral side. Patients will be observed for one hour after the procedure for possible complications.

Procedure: bilateral transforaminal epidural steroid block

Interventions

unilateral transforaminal epidural steroid block PROCEDURE

unilateral transforaminal epidural steroid block

Unilateral transforaminal epidural block

bilateral transforaminal epidural steroid block PROCEDURE

bilateral transforaminal epidural steroid block

bilateral transforaminal epidural block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65
• Patients with unilateral lumbosacral radicular pain for at least 3 months
• Lumbosacral radicular pain is confirmed by Magnetic Resonance Imaging (MRI) and physical examination and the pain is secondary to unilateral lumbosacral disc herniation.
• Patients who did not respond to conservative treatment (medical and physical medicine modalities)
• Pain intensity measured using Numeric Rating Scala (NRS) is 4 or more

You may not qualify if:

• Patients with previous lumbar surgery
• Presence of psychiatric disease that is unstable/not controlled by medical treatment
• Pregnant patients
• Those with bleeding diathesis
• Patients who received epidural steroid injection within the last year
• Patients with known allergies to the substances administered during the procedure (local anesthetic, steroid, contrast material)
• Patients with scoliosis, spondylolisthesis, central canal stenosis, compression fracture, previous discitis, sequestered disc, bilateral disc herniation

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (7)

• Germann C, Gotschi T, Sutter R. Predictive value of immediate pain relief after lumbar transforaminal epidural injection with local anesthetics and steroids for single level radiculopathy. Skeletal Radiol. 2022 Oct;51(10):1975-1985. doi: 10.1007/s00256-022-04051-3. Epub 2022 Apr 8.

  PMID: 35394165 BACKGROUND

• Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.

  PMID: 18923325 BACKGROUND

• Lee JH, An JH, Lee SH. Comparison of the effectiveness of interlaminar and bilateral transforaminal epidural steroid injections in treatment of patients with lumbosacral disc herniation and spinal stenosis. Clin J Pain. 2009 Mar-Apr;25(3):206-10. doi: 10.1097/AJP.0b013e3181878f9e.

  PMID: 19333170 BACKGROUND

• Liu J, Zhou H, Lu L, Li X, Jia J, Shi Z, Yao X, Wu Q, Feng S. The Effectiveness of Transforaminal Versus Caudal Routes for Epidural Steroid Injections in Managing Lumbosacral Radicular Pain: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 May;95(18):e3373. doi: 10.1097/MD.0000000000003373.

  PMID: 27149443 BACKGROUND

• Makkar JK, Gourav KKP, Jain K, Singh PM, Dhatt SS, Sachdeva N, Bhadada S. Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized Double-Blind Trial. Pain Physician. 2019 Nov;22(6):561-573.

  PMID: 31775403 BACKGROUND

• Schaufele MK, Hatch L, Jones W. Interlaminar versus transforaminal epidural injections for the treatment of symptomatic lumbar intervertebral disc herniations. Pain Physician. 2006 Oct;9(4):361-6.

  PMID: 17066121 BACKGROUND

• Unal HA, Basari A, Ozgencil BK, Ozgencil GE, Erkoc SK. Comparison of Unilateral and Bilateral Transforaminal Epidural Steroid Injections in Unilateral Lumbar Disc Herniation: A Randomized Controlled Trial. J Clin Med. 2024 Dec 30;14(1):147. doi: 10.3390/jcm14010147.

  PMID: 39797230 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanzade A Unal, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 5, 2024
• Study Start: June 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)