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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05586633
Enrollment
50
Registered
2022-10-19
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Posterior Compartment

Keywords

Low Back Pain, periforaminal ozon injection, transforaminal steroid injection, ultrasound guided injection

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.

Interventions

PROCEDUREdeep 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.

PROCEDUREtransforaminal 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.

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
PAİN-Visual Analog Scala (VAS)2nd week, 4th week, 8th week pain changeVisual 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)2nd week, 4th week, 8th week quality of life changeSatisfaction 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)2nd week, 4th week, 8th week pain changeIn 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 examination2nd week, 4th week, 8th week examination changeLumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Physical examination-straight leg raise test2nd week, 4th week, 8th week examination changestraight leg raise test- It is recorded whether there is normal or abnormal
Physical examination-femoral nerve stretch test2nd week, 4th week, 8th week examination changefemoral nerve stretch test - It is recorded whether there is normal or abnormal
Physical examination-Walleix palpation2nd week, 4th week, 8th week examination changeWalleix palpation- It is recorded whether there is tenderness in Walleix palpation.

Countries

Turkey (Türkiye)

Contacts

Primary Contactesra ülgen kıratlıoğlu
esraulgen@gmail.com+905079614194

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026