Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy

Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy

This retrospective study aimed to assess the clinical effectiveness and safety of transforaminal epidural injections of steroid and ozone mixture versus steroid alone in low back and radicular leg pain related to disk herniation.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Hernia; Disk Herniated Lumbar; Radiculopathy Lumbar
• Intervention / Treatment: Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection; Procedure: Fluoroscopy Guided Transforaminal Epidural Ozone Injection

Detailed Description

Low back and radicular leg pain due to radiculopathy are the common presenting symptoms in the field of pain medicine.For patients with chronic low back and radicular leg pain, pain relief can be achieved through minimally invasive interventional procedures under fluoroscopic guidance. Since some patients may experience persistent pain and the potential development risk of failed back surgery syndrome, minimally invasive procedures are preferred as a pre-surgical intervention.

Interlaminar or transforaminal epidural steroid injections are the most commonly used nonsurgical interventions for disc herniation. Ozone therapy has also started to be used as frequently as steroids. Previous studies have shown that ozone can be given through intradiscally, epidural space, and paravertebral muscles. Ozone gase is thought to modulate levels of cytokines and prostaglandins, minimize reactive oxidant species levels, and improve local periganglionic circulation.

The objective of this study was to assess the short- and long-term clinical efficacy of transforaminal epidural steroid and steroid plus ozone injection in patients presenting with low back and radicular leg pain and to analyze which treatment method is most beneficial in reducing pain relief.

This was a retrospective study of 120 patients who underwent transforaminal epidural steroid or combination of steroid and ozone injection between June and December 2020 in the Ankara University Faculty of Medicine, Department of Pain Medicine.

Demographic information, pain intensity, localization, pattern (neuropathic/nonneuropathic/mix), and patients' quality of life and the treated level (the innervation territories of L2 (Lomber), L3, L4, L5, or S1 (Sacral)) were analyzed. Pain intensity was assessed with the Visual Analog Scale (VAS), and patient disability was evaluated with the Oswestry Disability Questionnaire (ODI).

One group included patients who underwent transforaminal epidural steroid and ozone injection, and another group included patients who underwent transforaminal epidural steroid injection alone. In both groups, two mL of dexamethasone (8 mg) and 3 mL of saline were used for each transforaminal epidural injection level. Patients who received combination therapy were injected 5ml of ozone at a concentration of 28 g/ml in addition to steroids for each level.

The investigators evaluated the patients' records of VAS and ODI scores on the day of the procedure and at the 24th hours (for VAS only) 1st, 3rd, 6th, and 12th months after the procedure. Patients' satisfaction was assessed using modified MacNab scale scores after the 1st and 12th months. The post-treatment results of the patients were compared between the two groups and with the baseline.

• Study Type: Observational
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Ankara University Faculty of Medicine, Ibni Sina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

120 patients (age range, 18-72 years) who underwent transforaminal epidural steroid or combination of steroid and ozone injection between June and December 2020 in the Ankara University Faculty of Medicine, Department of Pain Medicine.

Description

Inclusion Criteria:

• Files of patients underwent transforaminal epidural steroid or combination of steroid and ozone injection
• Age between 18-75 years
• Body mass index (BMI) <35,
• VAS score ≥ 4
• Radicular pain not responding to conservative therapy related to lumbar disk herniation on magnetic resonance imaging
• Duration of pain of >3 months

Exclusion Criteria:

• Pregnancy
• Major progressive neurologic deficits
• Infective or inflammatory diseases
• Uncontrolled diabetes or other severe internal comorbidities
• Malignancy
• international normalized ratio (INR) > 1.2
• Glucose-6-phosphate dehydrogenase deficiency

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The patients who underwent transforaminal epidural steroid and ozone injection; Patients who received combination therapy were injected 5ml of ozone at a concentration of 28 g/ml and two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level under fluoroscopy guidance	Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection; All procedures were performed under light sedation in a sterile operating room.Appropriate diffusion of the non-ionic contrast agent into the periradicular and epidural area was verified through anteroposterior and lateral fluoroscopic images and the injections were then safely performed. Patients who underwent transforaminal epidural steroid injection received two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level; Procedure: Fluoroscopy Guided Transforaminal Epidural Ozone Injection; All procedures were performed under light sedation in a sterile operating room. Ozone was created by an ozone generator (Dr. J. Hänsler Ozonosan, Iffezheim, Germany). Appropriate diffusion of the non-ionic contrast agent into the periradicular and epidural area was verified through anteroposterior and lateral fluoroscopic images and the injections were then safely performed. Patients who underwent transforaminal epidural steroid plus ozone injection received additionally 5ml of ozone at a concentration of 28 g/ml for each transforaminal epidural injection level.
The patients who underwent transforaminal epidural steroid injection alone; Patients who received transforaminal epidural steroid injection were injected two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level.	Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection; All procedures were performed under light sedation in a sterile operating room.Appropriate diffusion of the non-ionic contrast agent into the periradicular and epidural area was verified through anteroposterior and lateral fluoroscopic images and the injections were then safely performed. Patients who underwent transforaminal epidural steroid injection received two mL of dexamethasone (8 mg) and 3 mL of saline for each transforaminal epidural injection level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain).	24th hours, 1st, 3rd, 6th, and 12th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Questionnaire (ODI)	ODI is a questionnaire in which the level of disability increases as the total score increases. Total scores vary between 0 and 50.	1st, 3rd, 6th, and 12th months
MacNab Scale Scores	The MacNab scale scores were used for success in pain decrease and include excellent, good, fair, and poor. The "excellent" and "good" results were accepted as favorable outcomes, and the "fair" and "poor" results were considered unsatisfactory	1st and 12th months

Collaborators and Investigators

• Sponsor: Ibn Sina Hospital
• Investigators: Principal Investigator: Derya Bayram, M.D, Ankara University Faculty of Medicine, Department of Pain Medicine; Principal Investigator: İbrahim Aşık, Prof. Dr, Ankara University Faculty of Medicine, Department of Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Low back pain; Injections; Steroids; Ozone; Disk Herniated Lumbar
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Radiculopathy
• Other Study ID Numbers: IbnSinaH-PM-DB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No