ACTRN12617000239369尚未招募未知
The long-term effects of spinal cord stimulation on neural function in chronic low back pain – a pilot study
orthern Sydney Local Health District0 个研究点目标入组 30 人开始时间: 2017年2月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 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
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Have a primary diagnosis of chronic low back pain (lumbo-sacral) with or without leg pain.
- •2. Be a candidate for a commercial spinal cord stimulation system.
- •3. Have responded inadequately to at least 6 months of conservative treatment (pharmacological, physical therapy +/- spinal injections including radiofrequency lesioning).
- •4. Pain intensity >= 3/10 (NRS11) over previous month.
- •5. Patients may have had previous spinal surgery.
- •6. Patients with a known condition that may potentially result in neuropathy will not be excluded (e.g. diabetes, multiple sclerosis).
- •7. Patients with a significant neuropathy demonstrated on clinical examination (e.g. reflex depression, focal sensory changes or focal muscle weakness, especially lower limbs) will not be excluded.
- •8. May have undertaken a cognitive behavioural therapy pain program.
- •9. Be able to consent.
- •10. Be 18 years or older at the time of enrolment.
- •11. Be able to comply with study procedures.
排除标准
- •1. Have mechanical spinal instability (diagnosed with radiological imaging).
- •2. Have malignancy with life expectancy <1year.
- •3. Have a systemic infection.
- •4. Have other implantable devices.
- •5. Are participating in another clinical trial.
- •6. Have unstable major psychiatric comorbidities.
- •7. Are pregnant/lactating or not using adequate birth control.
- •8. Have bleeding or coagulopathy issues.
- •9. Are immunocompromised and at risk of infection.
- •10. Have uncontrolled insulin-dependent diabetes mellitus despite treatment.
研究者
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