Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503835
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Efficacy of Transforaminal Epidural Steroid and Its Combination With Ozone in Lumbar Radiculopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Fluoroscopy Guided Transforaminal Epidural Steroid and Steroid Plus Ozone Injection in Patients With Lumbar Radiculopathy
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 medicineFor 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 neuropathicnonneuropathicmix 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 gml 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
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 neuropathicnonneuropathicmix 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 gml 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None