ACTRN12624001062516尚未招募Unknown
The clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain: FusiOn veRsus bEst coNServatIve Care (the FORENSIC-Australia trial)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •A patient will be eligible for inclusion if ALL of the following criteria apply:
- •Adults aged 18-65 years old. Patients over 65 years old are excluded given the increasing prevalence of spinal stenosis seen in older adults i.e. a change in pathology involving neurological compression requiring a different surgery.
- •Episode of low back pain (lasting 6 months or longer)
- •Low back pain severity is more than or equal to 6 on a 0-10 numeric rating scale (NRS)
- •With or without previous discectomy/decompression
- •Have undergone one or more of the following previous treatment for LBP recommended in guidelines/standards:
- •ostructured and supervised exercise therapy with or without manual therapy, with a healthcare professional
- •ostructured and supervised psychological programme
- •ostructured and supervised combined physical and psychological programme (CPPP)
- •ostructured and supervised programme of treatment led by a pain service
- •oradiofrequency denervation
- •(Previous recommended treatment(s) may have been delivered virtually, face to face, individually or in a group.)
- •Recent evidence of lumbar spine degenerative changes using appropriate imaging (Magnetic Resonance Imaging (within the last 12 months) [MRI] +/- Single Photon Emission Computed Tomography-Computed Tomography [SPECT-CT]).
- •Assessed as suitable for both LFS at 1 or 2 lumbar spine levels and BCC by a participating surgeon
- •Able to give full informed consent
排除标准
- •A patient will not be eligible for the study if ANY of the following apply:
- •Has low back-related leg pain more severe than their low back pain
- •Has pain in other body regions that is more severe than their low back pain
- •Radiculopathy or claudication or clinical signs of nerve compression where the treatment plan includes offering direct or indirect spinal decompression along with the fusion
- •Other reasons indicated for LFS (e.g. lumbar spine deformity, infection, tumours, instability due to spondylolisthesis of grade 2 or above, spinal fracture, systemic inflammatory disease)
- •Previous (or attempted) LFS
- •Psychiatric conditions (e.g., diagnosed personality disorders, post-traumatic stress disorder, drug or alcohol abuse/addictions, diagnosis of severe depression)
- •Is pregnant
研究者
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