NL-OMON51773招募中不适用
State-of-the-art nuclear neuroimaging in failed back surgery syndrome: can we predict the outcome? - FDG PET brain in FBSS prior to SCS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Aged between 18 and 75 years
- •Diagnosed with FBSS with low back pain radiating in lumbar segments L4, L5
- •and S1 with or without pain in the lower limbs
- •Experienced chronic pain for >= six months with a pain score >= 5 for the
- •weighted Visual Analogue Scale (VAS)
- •No option for further surgical intervention
- •Previous pain treatments have been unsuccessful (insufficient pain relief or
- •unacceptable side effects)
- •Psychologically screened
- •Willing to provide informed consent
- •Scheduled to receive neurostimulation treatment (i.e., SCS)
排除标准
- •participation in this study:
- •Younger than 18 years old
- •Presence of clinically significant (e.g., Alzheimer*s disease, frontotemporal
- •dementia, Parkinson*s disease) or disabling chronic pain condition as this will
- •limit the validity of PET-CT imaging and the outcome of SCS treatment. To test
- •for neurodegenerative disorders, well-validated, Dutch versions of the
- •mini-mental state examination (MMSE) and the frontal assessment battery (FAB)
- •tests will be used
- •Patients with diabetes mellitus (either type I or type II)
- •The expected inability of the patients to properly operate the
- •neurostimulation system
- •A previous SCS procedure
- •Addiction to drugs, alcohol (>= 5 E / day) or medication
- •Insufficient cooperation (lack of motivation, understanding)
- •History of coagulation disorders, lupus erythematosus, diabetes mellitus,
- •rheumatoid arthritis or Morbus Bechterew
- •Current use of medication affecting coagulation which cannot be temporarily
- •Medication usage that could interfere with biodistribution of F18-FDG tracer
- •(e.g., benzodiazepines, barbiturates)
- •An inability to speak or understand the Dutch language
- •Life expectancy < 1 year
- •Patients with a pacemaker
- •Local infection or other skin problems in the operation area
- •Existing or planned pregnancy
研究者
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