Orthokine Therapy in Lumbar Degenerative Disease: Does the Route of Administration Really Matter
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in EQ-5D-5L index from baseline to 24 weeks
研究概览
简要总结
The aim of the trial is the comparison of the effectiveness of two methods of Orthokine administration (periradicular or epidural) in lumbar degenerative disc disease.
详细描述
BACKGROUND: Lumbar Degenerative Disc Disease (LDDD) is a serious, global health problem for patients from the third decade of life. It is assumed that 75-85% of the population suffer from pain in the lumbar spine at least once during their lifetime (vital morbidity), and 3-5% of the population suffer from root-type pain.
The annual prevalence of the spine complaints in the United States alone ranges from 15 to 20%, and in Europe it ranges from 25 to 45%.
In addition to the immeasurable losses associated with impaired patient activity and a significant reduction in the quality of their life, LBP is the greatest burden for the world economy, measured by the years lived with disability (YLD) index due to a significant reduction in the productivity and professional ability of patients affected by LBP.
AIM: Assessment of the effectiveness of symptomatic treatment of Lumbar Degenerative Disc Disease (LDDD) with the autologous Orthokine serum, comparison of two methods of its application - epidural or periradicular.
DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Two groups of patients (A, B) with confirmed LDDD by MRI, without gender or age limitation, meeting the health conditions according to the inclusion and exclusion criteria. There will be 50 people in each group (100 people in total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of LDDD in the lumbar region
- •LDDD confirmed by MRI
- •No contraindications to injections (hemorrhagic diathesis, anticoagulants, skin lesions)
- •An adult consenting to participate in the study
排除标准
- •Presence of severe neurological deficits requiring surgery
- •Discopathy of other origin - traumatic, spondylolisthesis, cancer, infection, inflammatory systemic diseases
- •Previous surgical treatment in the lumbar spine
- •Mental state that prevents cooperation during injection
- •Contraindications for injection (hemorrhagic diathesis, anticoagulants, skin lesions)
- •Lack of consent to participate in the study
结局指标
主要结局
Change in EQ-5D-5L index from baseline to 24 weeks
时间窗: Time Frame: Change from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L descriptive system based on Polish directly measured value set. Minimum: -0.590; Maximum: 1.0; More points means better outcome.
Change in Oswestry Disability Index from baseline to 24 weeks
时间窗: Time Frame: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
Change in Roland Morris Questionnaire score from baseline to 24 weeks
时间窗: Time Frame: Change from baseline to 24 weeks
Disease-specific questionnaire. Range: 0 (the best score) - 24 (the worst score).
次要结局
- Pain according to Numeric Rating Scale (NRS) from baseline to 4 weeks(Change from baseline to 4 weeks)
- Change in EQ-5D-5L index from baseline to 4 week(Change from baseline to 4 weeks)
- Change in Oswestry Disability Index from baseline to 4 weeks(Change from baseline to 4 weeks)
- Change in Roland Morris Questionnaire score from baseline to 4 weeks(Change from baseline to 4 weeks)
- Pain according to Numeric Rating Scale (NRS) from baseline to 12 weeks(Change from baseline to 12 weeks)
- Pain according to Numeric Rating Scale (NRS) from baseline to 24 weeks(Change from baseline to 24 weeks)
- Change in Oswestry Disability Index from baseline to 12 weeks(Change from baseline to 12 weeks)
- Change in Roland Morris Questionnaire score from baseline to 12 weeks(Change from baseline to 12 weeks)
- Change in EQ-5D-5L index from baseline to 12 week(Change from baseline to 12 weeks)
研究者
Piotr Godek
Principal Investigator
Sutherland Medical Center