Back to resultsThe Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Primary Purpose
Low Back Pain, Posterior Compartment
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
deep paravertebral periforaminal ozone injeciton
transforaminal steroid injeciton
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Posterior Compartment focused on measuring Low Back Pain, periforaminal ozon injection, transforaminal steroid injection, ultrasound guided injection
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
Sites / Locations
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
deep paravertebral- periforaminal ozone injection
transforaminal steroid injeciton
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Physical examination-Lumbar joint range of motion examination
Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Physical examination-straight leg raise test
straight leg raise test- It is recorded whether there is normal or abnormal
Physical examination-femoral nerve stretch test
femoral nerve stretch test - It is recorded whether there is normal or abnormal
Physical examination-Walleix palpation
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
Secondary Outcome Measures
Full Information
NCT ID
NCT05586633
First Posted
August 14, 2022
Last Updated
October 15, 2022
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05586633
Brief Title
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Official Title
The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Posterior Compartment
Keywords
Low Back Pain, periforaminal ozon injection, transforaminal steroid injection, ultrasound guided injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
deep paravertebral- periforaminal ozone injection
Arm Type
Active Comparator
Arm Title
transforaminal steroid injeciton
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
deep paravertebral periforaminal ozone injeciton
Intervention Description
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
Intervention Name(s)
transforaminal steroid injeciton
Intervention Description
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.
Primary Outcome Measure Information:
Title
PAİN-Visual Analog Scala (VAS)
Description
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.
Time Frame
2nd week, 4th week, 8th week pain change
Title
Quality of life - Short Form-36 (SF-36)
Description
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.
Time Frame
2nd week, 4th week, 8th week quality of life change
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
2nd week, 4th week, 8th week pain change
Title
Physical examination-Lumbar joint range of motion examination
Description
Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Time Frame
2nd week, 4th week, 8th week examination change
Title
Physical examination-straight leg raise test
Description
straight leg raise test- It is recorded whether there is normal or abnormal
Time Frame
2nd week, 4th week, 8th week examination change
Title
Physical examination-femoral nerve stretch test
Description
femoral nerve stretch test - It is recorded whether there is normal or abnormal
Time Frame
2nd week, 4th week, 8th week examination change
Title
Physical examination-Walleix palpation
Description
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
Time Frame
2nd week, 4th week, 8th week examination change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
esra ülgen kıratlıoğlu
Phone
+905079614194
Email
esraulgen@gmail.com
Facility Information:
Facility Name
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
esra ülgen kıratlıoğlu
Phone
+905079614194
Email
esraulgen@gmail.com
First Name & Middle Initial & Last Name & Degree
kutay tezel
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
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