Clinical trial NCT06503835: Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy
Official title: Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Radiculopathy Lumbar
Hernia
Disk Herniated Lumbar
Keywords: Low back pain
Injections
Steroids
Ozone
Disk Herniated Lumbar
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 24th hours, 1st, 3rd, 6th, and 12th months
Secondary outcomes:
measure: Oswestry Disability Questionnaire (ODI)
timeFrame: 1st, 3rd, 6th, and 12th months
measure: MacNab Scale Scores
timeFrame: 1st and 12th months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, İbni Sina Hospital
Study officials:
affiliation: Ankara University Faculty of Medicine, Department of Pain Medicine
name: Derya Bayram, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Faculty of Medicine, Department of Pain Medicine
name: İbrahim Aşık, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: