A Prospective Clinical Series followed by A Multicenter Double-blind Randomised Placebo-Controlled Clinical Trial - Intradiscal Methylene Blue for discogenic low back pain

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 84 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Axial low back pain of presumed discogenic origin of at least 6 months duration and non responsive to treatment of at least 6 months conservative medical management.;History consistent with discogenic low back pain ( e.g. predominant axial pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) A neurological exam without marked motor deficit. Age between18 and 65 years and painintensity should be NRS 5 or higher. In provocative discography Modified Dallas classification grade 1 to 4 and a provoked pain of at least NRS 7 or >=70% of worst pain.

•Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.;- Extruded or sequestered herniated nucleus pulposus at the affected level(s).;- Body Mass Index BMI of >= 35;- Mean pain with NRS below 5;- Previous lumbar back surgery ( e.g. Laminectomy, discectomy or fusion);- Invasive intradiscal procedure previously performed at the same level.;- Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT, provided stenosis is the cause of pain.;- Moderate to severe endplate degenerative changes at the affected levels;- Grate 1-2 spondylolisthesis;- Pregnancy;- Coagulopathy or oral anti-coagulant therapy;- Infection;- Patients incapable of following verbal or written instructions or with psychiatric problems potentially interfering with cooperation in the study;- Discography: ;That shows a posterior annular disruption to extend into the outer annulus or beyond the confines of the outer annulus.;-;Discography without pain reproduction at the affected level( s), or with discordant pain at adjacent unaffected levels at up to 50 Psi above opening pressure.;-;Pain provocation in disc at pressures >50 Psi above opening pressure;-;In provocative discography Modified Dallas classification grade 0 and 5.

发起方

Medisch Universitair Ziekenhuis Maastricht