NL-OMON55329招募中不适用
My spine is on fire: neuroinflammation in spinal radiculopathy and physiotherapy on it. - NOTICE (NeurOinflammaTion In Cervical radiculopathy)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
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 至 99（—）
入选标准
- •Cervical radiculopathy patients
- •Age between 30-65 years.
- •Minimal score of 4 on the Numeric Pain Rating Scale (0-10).
- •Cervical radiculopathy based on the clinical diagnosis confirmed by the
- •Magnetic Resonance Imaging (MRI through a medical specialist). The compression
- •must be caused by a discus protrusion or herniation.
- •Written informed consent of the patient.
- •Referral by a medical specialist
- •High and mixed affinity binders for second generation TSPO radiotracers
- •Evident [11C]-DPA713 binding in the neuroforamina and/or spinal cord. Only
- •applicable for research question 2 and 3.
- •Healthy control
- •Age between 30-65 years.
- •Asymptomatic for neck or shoulder pain and other musculoskeletal conditions
- •in the past 3 months.
- •Written informed consent of the healthy control.
- •Referral by a medical specialist
- •High and mixed affinity binders for second generation TSPO radiotracers
排除标准
- •Cervical radiculopathy patients and healthy control
- •A potential participant who meets any of the following criteria will be
- •excluded from participation in this study:
- •Pregnancy or postpartum for 9 months
- •Contra-indications for venipuncture (e.g. phlebitis)
- •Underwent treatment for current complaints for the last 2 weeks (e.g.
- •physiotherapy, manual therapy, general practitioner etc.)
- •Taken one of the following medications for the last 6 weeks: corticosteroids
- •(e.g. prednisone), immunomodulatory medication (e.g. methotrexate, infliximab
- •etc.) and the use of botox for the last 3 months.
- •Taken one of the following medication: NSAID*s (e.g. diclofenac, ibuprofen,
- •naproxen etc.), Aspirin, Simvastatin (29) for the last week.
- •Benzodiazepine (30) use for the last six weeks.
- •MRI contraindications, (e.g. claustrophobia, inability to lie still in the
- •scanner or metal objects in or around the body)
- •Inability to undergo PET-CT with administration of radioligand [¹¹C]-R-DP713.
- •Significant radiation exposure such that inclusion in this study will take
- •the total dose >10mSv within the preceding 12 months.
- •Current participation in another clinical trial.
- •Previous participation in a PET-CT study in the last 12 months.
- •Having a medical disease with immune system involvement (e.g. MS, Spondylitis
- •Ankylpoetica)
研究者
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