A Randomized Controlled Trial to Compare the Efficacy of Medicine Conservative Treatment and Surgical Treatment for Symptomatic Sacral Perineurial Cysts (Tarlov Cysts) and the Applied Value of Resting State Functional Magnetic Resonance Imaging (rfMRI).
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Visual analog scale(VAS)
研究概览
简要总结
There are very few data and analysis in the literature regarding the symptomatic sacral perineurial cysts. Most studies are case reports or small retrospective sample, which rarely more than 20 cases. There is no an consensus on the choice of treatment (medicine conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical treatment for symptomatic sacral perineurial cysts by a randomized controlled trial. Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes at pain related brain areas, which will be develop an objective method to evaluate the clinical curative effect of the two treatment options.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with symptomatic sacral perineurial cysts(e.g., lumbosacral or perineal pain, fecal or urinary functions change, sexual function change, lower limb radiation pain, muscle abate, paresthesia, etc)
- •Visual analog scale more than or equal to 4
- •Signed the informed consent
- •Years, range 18-60
- •Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores < 50
- •No Congenital,Mental and other Nervous system diseases
- •No Serious Cardiac,Pulmonary,Hepatic and Nephritic disease
- •No history of drug allergy
- •No pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month
- •MRI finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group
- •MRI finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group
排除标准
- •Patients with lumbar common diseases(e.g., Lumbar disc, Lumbar spinal stenosis, Lumbar slippage, etc)
- •Researchers think that Patients with disease may be interference results(e.g., Spinal deformity, spine fracture, ankylosing spondylitis, spinal tuberculosis and spinal infection, spinal tumor, pelvic inflammatory disease and other disease of department of gynaecology, etc)
- •Patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc)
- •Patients with Magnetic resonance imaging contraindication ,including claustrophobic syndrome patients
- •Patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems
- •In the past 2 months involved in other drugs or devices clinical trials
研究组 & 干预措施
surgery group
sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)
干预措施: sacral canal cyst microscopic tamponade (Procedure)
surgery group
sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)
干预措施: resting state functional magnetic resonance imaging (rfMRI) (Device)
drug group
gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)
干预措施: gabapentin + tramadol (Drug)
drug group
gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)
干预措施: resting state functional magnetic resonance imaging (rfMRI) (Device)
control group
resting state functional magnetic resonance imaging (rfMRI)
干预措施: resting state functional magnetic resonance imaging (rfMRI) (Device)
结局指标
主要结局
Visual analog scale(VAS)
时间窗: 3year
Structure and Function connection change(e.g., increase or decrease the thickness of the cortex, or gray matter;function connection increase or decrease) at somatosensory area
时间窗: 1year
次要结局
- Modify Japanese orthopedic association low back pain score (M-JOA)(3year)
- MacNab curative effect evaluation(3year)
- Oswestry Disability Index score (DOI)(3year)
研究者
Jiangkai Lin
Vice chief of Neurosurgery Department
Southwest Hospital, China