The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 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.
Physical examination-femoral nerve stretch test
时间窗: 2nd week, 4th week, 8th week examination change
femoral nerve stretch test - It is recorded whether there is normal or abnormal
Physical examination-straight leg raise test
时间窗: 2nd week, 4th week, 8th week examination change
straight leg raise test- It is recorded whether there is normal or abnormal
Quality of life - Short Form-36 (SF-36)
时间窗: 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.
Physical examination-Lumbar joint range of motion examination
时间窗: 2nd week, 4th week, 8th week examination change
Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Physical examination-Walleix palpation
时间窗: 2nd week, 4th week, 8th week examination change
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
PAİN-Visual Analog Scala (VAS)
时间窗: 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.
次要结局
未报告次要终点
研究者
Sefa Gümrük Aslan
Principal Investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital