Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT05586633
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Sponsor:
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Organization:
Study Overview
Official Title:
The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Conservative, pharmacological, interventional and surgical treatment options are available in its treatment. In this study, it was aimed to determine the effects of ultrasound-guided deep paravertebral periforaminal ozone injection treatment on physical examination, functional independence, quality of life and pain scores in patients with chronic low back and leg pain and to compare it with transforaminal epidural steroid injection treatment.
Detailed Description:
A total of 50 patients were included in the study. Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. In the transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. The patients in both groups were offered a home exercise program for therapeutic waist and abdominal muscles to do during the treatment follow-up period. Patients\' quality of life was evaluated with SF-36(Short Form-36), pain scores with VAS(Visüel Analog Scala) and functional evaluations with ODI(Oswestry Disability Index) at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: