NCT07632508已完成不适用
F-18 Sodium Fluoride PET/CT Guided Pain Palliation in Chronic Low Backache : Comparing the Efficacy of Ultrasound - Guided Vs PET/CT Guided Intra-articular Injections of Corticosteroid and Local Anesthetic.
Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The goal of this open-label randomized controlled trial explored the efficacy of ultrasound guided versus F-18 Sodium Fluoride PET/CT guided local anesthetic and steroid injections in managing chronic low back pain caused by lumbar facet and sacroiliac joint arthritis.. The main questions it aims to answer are:
- To Compare the reduction in pain intensity between PET/CT guided and Ultrasound Guided facet joint injections using the Visual Analog Scale (VAS) at predefined follow up intervals.
- To compare functional improvement and disability outcomes between two study arms using Oswestry Disability Index (ODI) and Low Back Outcome Score (LBOS).
- To compare association of PET/CT associated parameters with post intervention clinical response associated parameters.
Patients fulfilling the inclusion criteria will be randomly allocated to one of two groups. Randomization will be conducted using a computer-generated random sequence, ensuring a 1:1 allocation ratio between the two treatment groups
- Group A: Patients receiving F-18 sodium fluoride PET/CT-guided corticosteroid plus local anesthetic injection.
- Group B: Patients receiving Ultrasound-guided corticosteroid plus local anesthetic injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a chronic nociceptive low backache attending the orthopaedic department who do not get adequate relief with conservative treatments for more than three months will be recruited in the study.
- •Patients who are ready to give informed consent
排除标准
- •Pregnant and lactating females
- •Patients with active infection and febrile illness
- •Patients with acute spine trauma
- •Spinal pathologies requiring surgical interventions such as significant spinal stenosis , spondylolisthesis or disc herniation.
- •Patients with corticosteroid injection within six weeks before the study
- •Patients who refused to give written informed consent
- •MRI showing the neuropathic cause or nerve root compression
- •Patients with deranged coagulation profile
- •Systemic conditions affecting joints (eg ankylosing spondylitis , rheumatoid arthritis)
- •Uncontrolled diabetes
研究者
Rajender Kumar
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh
研究点 (1)
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