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

NCT06503835 | Completed

• 1 other identifier: IbnSinaH-PM-DB-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Low back pain; Injections; Steroids; Ozone; Disk Herniated Lumbar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oswestry Disability Questionnaire (ODI)

  1st, 3rd, 6th, and 12th months

• MacNab Scale Scores

  1st and 12th months

Study Arms (2)

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 Ozone Injection; Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection

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

Interventions

Fluoroscopy Guided Transforaminal Epidural Ozone Injection 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.

The patients who underwent transforaminal epidural steroid and ozone injection

Fluoroscopy Guided Transforaminal Epidural Steroid Injection 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 and ozone injection; The patients who underwent transforaminal epidural steroid injection alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ibn Sina Hospital: lead

Study Sites (1)

Ankara University Faculty of Medicine, İbni Sina Hospital

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Hernia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Pain Specialist

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)