ISRCTN12191542已完成不适用
A multicentre double-blind randomised controlled trial to assess the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain: a feasibility study
IHR Health Technology Assessment Programme - HTA (UK)0 个研究点目标入组 150 人开始时间: 2014年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29231159
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of nonspecific low back pain
- •2. Low back pain of greater than three months? duration
- •3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment despite NICE-recommended treatment
- •4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels
- •5. At least two components of NICE-recommended best non-invasive care completed, including education and one of a physical exercise programme, acupuncture and manual therapy
排除标准
- •1. Patient refusal
- •2. More than four painful lumbar facet-joints
- •3. Patient has not completed at least two components of NICE-recommended best non-invasive care
- •4. 'Red flag' signs
- •5. Hypersensitivity to study medications or X-ray contrast medium
- •6. Radicular pain
- •7. Dominantly midline tenderness over the lumbar spine
- •8. Any other dominant pain
- •9. Any major systemic disease or mental health illness that may affect the patient?s pain, disability and/or their ability to exercise and rehabilitate
- •10. Any active neoplastic disease, including primary or secondary neoplasm
- •11. Pregnant or breastfeeding patients
- •12. Previous lumbar facet-joint injections
- •13. Previous lumbar spinal surgery
- •14. Patients with morbid obesity (body mass index of 35 or greater)
- •15. Major trauma or infection to the lumbar spine
- •16. Participation in another clinical trial in the past 30 days
- •17. Patients unable to commit to the six-month study duration
- •18. Patients involved in legal actions or employment tribunals related to their low back pain
- •19. Patients with a history of substance abuse
研究者
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