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

October 15, 2022 updated by: Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
        • Contact:
        • Principal Investigator:
          • kutay tezel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PAİN-Visual Analog Scala (VAS)
Time Frame: 2nd week, 4th week, 8th week pain change
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)
Time Frame: 2nd week, 4th week, 8th week quality of life change
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)
Time Frame: 2nd week, 4th week, 8th week pain change
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
Time Frame: 2nd week, 4th week, 8th week examination change
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
Time Frame: 2nd week, 4th week, 8th week examination change
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
Time Frame: 2nd week, 4th week, 8th week examination change
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
Time Frame: 2nd week, 4th week, 8th week examination change
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
2nd week, 4th week, 8th week examination change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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