Clinical trial NCT05586633: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Posterior Compartment
Keywords: Low Back Pain
periforaminal ozon injection
transforaminal steroid injection
ultrasound guided injection
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39; 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.

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

Primary outcomes:
measure: PAİN-Visual Analog Scala (VAS)
timeFrame: 2nd week, 4th week, 8th week pain change
measure: Quality of life - Short Form-36 (SF-36)
timeFrame: 2nd week, 4th week, 8th week quality of life change
measure: Oswestry Disability Index (ODI)
timeFrame: 2nd week, 4th week, 8th week pain change
measure: Physical examination-Lumbar joint range of motion examination
timeFrame: 2nd week, 4th week, 8th week examination change
measure: Physical examination-straight leg raise test
timeFrame: 2nd week, 4th week, 8th week examination change
measure: Physical examination-femoral nerve stretch test
timeFrame: 2nd week, 4th week, 8th week examination change
measure: Physical examination-Walleix palpation
timeFrame: 2nd week, 4th week, 8th week examination change
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
References: