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Completed

NCT Number: NCT06503835

Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine, İbni Sina Hospital

Ankara, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 24th hours, 1st, 3rd, 6th, and 12th months

    The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain).

Secondary outcomes

  1. Oswestry Disability Questionnaire (ODI)

    Time frame: 1st, 3rd, 6th, and 12th months

    ODI is a questionnaire in which the level of disability increases as the total score increases. Total scores vary between 0 and 50.

  2. MacNab Scale Scores

    Time frame: 1st and 12th months

    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

Sponsors and collaborators

Lead sponsor

Ibn Sina Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 16, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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