IRCT20231127060204N1招募中Unknown
Comparison of the incidence of chronic sacroiliac joint pain (SIJP) following lumbar surgeries with and without lumbosacral spine fusion in spinal stenosis patients with low-grade lumbar degenerative spondylolisthesis using a non-randomized clinical trial study method.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Obtaining written informed consent from the patient to participate in the study
- •Age over 18 years
- •Age below 75 years
- •Patients suffering from lumbar spinal canal stenosis along with low grade degenerative spondylolisthesis of the lumbar spine which has been examined by clinical examinations and imaging methods and their disease has been confirmed by a neurosurgeon and spine specialist and a radiologist
- •Ineffectiveness of non-surgical conservative methods in controlling the patient's symptoms and pain and disability
- •No history of lumbar spine surgery
- •Presence of a clear indication for decompression with or without fusion in the patient
- •Having Iranian citizenship
- •It is possible to follow up the patient and be available to participate in routine follow-up sessions
排除标准
- •Vertebral fracture
- •tumoral or metastatic lesions of vertebrae
- •Infection in the lumbosacral spine
- •Inflammatory spondylopathy
- •Presence of SIJ disease
- •Patients who have already undergone lumbosacral spine surgery, including revision cases
- •Interior fusion indication (insertion of interbody cage)
- •Chronic pain problems, such as Fibromyalgia and other Rheumatological diseases, chronic pain associated with inflammation or irritation of the muscle or fascia around the muscle
- •Suspicion of Osteoporosis based on simple lumbosacral radiography (Bone Densitometry is performed to prove the disease in suspected cases)
- •People who have Scoliosis with a Cobb angle of more than 25 degrees
- •Sagittal Imbalance with (Sagittal Vertical Axis - SVA) more than 9 cm
- •Presence of Hip flexion contracture based on examination with Thomas test
- •Simultaneous surgical indication of lumbar canal stenosis and cervical canal stenosis
- •Pregnant women
- •Presence of contraindications for MRI
- •The patient's unwillingness to participate in the study despite explaining the benefits of the plan and the efforts of the study team to attract their participation
- •People who are unable to communicate in order to answer study questions, such as Deaf, Blind, Speech problems
- •People suffering from Mental and Psychological disorders, Mental retardation and any Psychiatric disease in the acute stage such as Psychosis, who have not been treated and are unable to cooperate
- •Sciatica pain radiating below the knee, work injury, litigation
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