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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Posterior Compartment
• Intervention / Treatment: Procedure: deep paravertebral periforaminal ozone injeciton; Procedure: transforaminal steroid injeciton

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: esra ülgen kıratlıoğlu; Phone Number: +905079614194; Email: esraulgen@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    • Contact: esra ülgen kıratlıoğlu; Phone Number: +905079614194; Email: esraulgen@gmail.com
    • Principal Investigator: kutay tezel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: deep paravertebral- periforaminal ozone injection	Procedure: 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.
Active Comparator: transforaminal steroid injeciton	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAİN-Visual Analog Scala (VAS)	Visual Analog Scala (VAS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Severity of pain was assessed VAS using the standard 10 cm (back pain and leg pain) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.	2nd week, 4th week, 8th week pain change
Quality of life - Short Form-36 (SF-36)	Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.	2nd week, 4th week, 8th week quality of life change
Oswestry Disability Index (ODI)	In the ODI questionnaire, the effect of low back pain on activities of daily living is questioned. In the test, which consists of 10 questions in total, the patient's pain intensity, the effects of pain on personal care, walking, lifting weights, standing, sitting, sleeping, sexual life, social life and traveling are questioned. The patient can get a minimum of 0 and a maximum of 5 points from each question. The maximum score to be taken from the test is 50. The patient's score is found by dividing the total score of the patient by 50, which is the maximum score, and calculating the percentage. (Patient's score ÷ maximum score × 100). Accordingly, it is calculated how much the patient's life activities are affected.	2nd week, 4th week, 8th week pain change
Physical examination-Lumbar joint range of motion examination	Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)	2nd week, 4th week, 8th week examination change
Physical examination-straight leg raise test	straight leg raise test- It is recorded whether there is normal or abnormal	2nd week, 4th week, 8th week examination change
Physical examination-femoral nerve stretch test	femoral nerve stretch test - It is recorded whether there is normal or abnormal	2nd week, 4th week, 8th week examination change
Physical examination-Walleix palpation	Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.	2nd week, 4th week, 8th week examination change

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Low Back Pain; periforaminal ozon injection; transforaminal steroid injection; ultrasound guided injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No