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

NCT06503835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-07-19

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Ibn Sina Hospital

    lead OTHER_GOV

Principal Investigators

  • İbrahim Aşık, Prof. Dr · Ankara University Faculty of Medicine, Department of Pain Medicine

  • Derya Bayram, M.D · Ankara University Faculty of Medicine, Department of Pain Medicine

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503835 on ClinicalTrials.gov