Low Back PainNCT06503835
Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy
An observational study of Low Back Pain and Radiculopathy Lumbar, run by Ibn Sina Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain, Radiculopathy Lumbar, Hernia
- What is being tested?
- Fluoroscopy Guided Transforaminal Epidural Ozone Injection and Fluoroscopy Guided Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, İbni Sina Hospital
Ankara, 06230
About this study
Official title: Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With 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.
Read the 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
- Being tested
- Fluoroscopy Guided Transforaminal Epidural Ozone Injection, Fluoroscopy Guided Transforaminal Epidural Steroid Injection
- Keywords
- Low back pain, Injections, Steroids, Ozone, Disk Herniated Lumbar
- Medical subject headings
- Low Back Pain, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy Guided Transforaminal Epidural Ozone InjectionProcedure or surgery
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 InjectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The VAS score for pain assessment ranges between 0-10 ( (0=no pain, 5=moderate pain, 10=extremely severe pain).
Measured: 24th hours, 1st, 3rd, 6th, and 12th months
Secondary outcomes (2)
Oswestry Disability Questionnaire (ODI)
ODI is a questionnaire in which the level of disability increases as the total score increases. Total scores vary between 0 and 50.
Measured: 1st, 3rd, 6th, and 12th months
MacNab Scale Scores
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
Measured: 1st and 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Bayram, Ibn Sina Hospital
- Investigators
- Derya Bayram, M.D, Principal investigator, Ankara University Faculty of Medicine, Department of Pain Medicineİbrahim Aşık, Prof. Dr, Principal investigator, Ankara University Faculty of Medicine, Department of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503835
- Sponsor's protocol ID
- IbnSinaH-PM-DB-01
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06503835
- Acronym / sponsor ID
- IbnSinaH-PM-DB-01
- Conditions
- Low Back Pain, Radiculopathy Lumbar, Hernia, Disk Herniated Lumbar
- Keywords
- Low back pain, Injections, Steroids, Ozone, Disk Herniated Lumbar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The patients who underwent transforaminal epidural steroid and ozone injection | – | Procedure: Fluoroscopy Guided Transforaminal Epidural Ozone Injection, Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid InjectionPatients 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 |
| The patients who underwent transforaminal epidural steroid injection alone | – | Procedure: Fluoroscopy Guided Transforaminal Epidural Steroid InjectionPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Major progressive neurologic deficits
- Infective or inflammatory diseases
- Uncontrolled diabetes or other severe internal comorbidities
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoroscopy Guided Transforaminal Epidural Ozone InjectionAll 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 or surgery | The patients who underwent transforaminal epidural steroid and ozone injection |
| Fluoroscopy Guided Transforaminal Epidural Steroid InjectionAll 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 | Procedure or surgery | The patients who underwent transforaminal epidural steroid and ozone injection, The patients who underwent transforaminal epidural steroid injection alone |
Primary outcome
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).
2 secondary outcomes
Oswestry Disability Questionnaire (ODI)
Time frame: 1st, 3rd, 6th, and 12th months
MacNab Scale Scores
Time frame: 1st and 12th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Bayram, M.D principal investigator
Ankara University Faculty of Medicine, Department of Pain Medicine
İbrahim Aşık, Prof. Dr principal investigator
Ankara University Faculty of Medicine, Department of Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Radiculopathy Lumbar, run by Ibn Sina Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 24th hours, 1st, 3rd, 6th, and 12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.