The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain

NCT ID: NCT05586633

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-11-01

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.

Conditions

Low Back Pain, Posterior Compartment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

deep paravertebral- periforaminal ozone injection

Group Type: ACTIVE_COMPARATOR

deep paravertebral periforaminal ozone injeciton

Intervention Type: PROCEDURE

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.

Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.

transforaminal steroid injeciton

Group Type: ACTIVE_COMPARATOR

transforaminal steroid injeciton

Intervention Type: PROCEDURE

Transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy.

Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.

Interventions

deep paravertebral periforaminal ozone injeciton

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.

Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.

Intervention Type: PROCEDURE

transforaminal steroid injeciton

Transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy.

Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Back and leg pain lasting longer than 3 months
• Diagnosis of lumbar disc herniation with advanced imaging techniques after anamnesis, - physical examination and laboratory examinations
• Continuation of complaints despite conservative treatment before
• Regular participation in the study voluntarily

Exclusion Criteria

• Being pregnant and breastfeeding
• History of lomber surgery
• Peripheral neuropathy (diabetes, alcoholism...)
• Cauda equina syndrome or progressive neurologic deficit in the lower extremity
• Neurogenic bladder/bowel syndrome
• Arterial vascular disease-Vascular claudication
• Spinal stenosis, spondylolysis, spondylolisthesis
• Local infection at the injection site
• Presence of bleeding diathesis
• Neuro-degenerative diseases
• Uncontrolled diabetes, hypertension
• History of malignancy
• Uncontrolled psychiatric illness
• BMI over 40
• Allergy to injection substances

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sefa Gümrük Aslan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

esra ülgen kıratlıoğlu

Role: CONTACT

esraulgen@gmail.com

+905079614194

Facility Contacts

esra ülgen kıratlıoğlu

Role: primary

esraulgen@gmail.com

+905079614194

Other Identifiers

32

Identifier Type: -

Identifier Source: org_study_id