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

NCT ID: NCT06503835

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-12-31

Brief Summary

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.

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.

Conditions

Low Back Pain; Radiculopathy Lumbar; Hernia; Disk Herniated Lumbar

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Fluoroscopy Guided Transforaminal Epidural Ozone Injection

Intervention Type: PROCEDURE

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.

Fluoroscopy Guided Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

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

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.

Fluoroscopy Guided Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ibn Sina Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Derya Bayram

Medical Doctor, Pain Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya Bayram, M.D

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine, Department of Pain Medicine

İbrahim Aşık, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Ankara University Faculty of Medicine, Department of Pain Medicine

Locations

Ankara University Faculty of Medicine, İbni Sina Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IbnSinaH-PM-DB-01

Identifier Type: -

Identifier Source: org_study_id