EUCTR2014-003187-20-GB进行中（未招募）1 期
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 - Facet-joint feasibility study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain (clinical indicators for pain of facet-joint origin include tenderness over the facet-joints, referred leg pain above the knees, and worsening pain on extension, flexion and rotation).
- •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 (NICE recommends providing patients with advice and information to promote self-management of their low back pain, and offering one of the following treatments, taking into account patient preference: an exercise programme, a course of manual therapy, or a course of acupuncture).
- •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 (Dworkin et al. 2005).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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 (Dworkin et al. 2005)
- •4. ‘Red flag’ signs (‘red flag’ signs are possible indicators of serious spinal pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel dysfunction, progressive neurological deficit, and saddle anaesthesia).
- •5. Hypersensitivity to study medications or X-ray contrast medium.
- •6. Radicular pain (radicular pain is defined as pain perceived as arising in a limb or the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality and travels along a narrow band).
- •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 thirty days.
- •17. Patients unable to commit to the six-month study duration.
- •18. Patients involved in legal actions or employment or benefit tribunals related to their low back pain.
- •19. Patients with a history of substance abuse.
研究者
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