Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
研究概览
简要总结
The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation.
详细描述
A cohort study (patients on the waiting list for surgery due to herniated disc) will be carried out, to which the treatment with ozone will be offered, without giving up the planned surgical intervention.
The main objective of this prospective, post-authorization follow-up study is to estimate the cost-effectiveness of ozone therapy (compared to standard care) in patients with disc herniation waiting for surgery (by microdiscectomy). Besides utilities of patients with disc herniation on a waiting list for surgery will be estimated, social/economic burden of disc herniation will be quantified and a decision aid will be developed and applied.
The main outcome measures are "Direct hospital cost", "Percentage of executed surgeries" and "Change in sciatic pain". In addition, data on health-related quality of life and resource utilization will be collected which will permit to estimate the incremental cost-effectiveness ratio (ICER), comparing incremental costs and quality adjusted life years (QALY).
The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.
The results of the study will allow a better understanding of the value of ozone therapy in the management of patients on the waiting list for herniated disc surgery. In addition, it will contribute to the development of a more patient-centered health system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a herniated and not calcified lumbar disc that presents as: not migrated protrusion and/or extrusion.
- •Evaluated and diagnosed by the Neurosurgery Department, having been chosen as an appropriate candidate for surgery consisting in discectomy or microdiscectomy, after meeting the following two criteria: 1) Sciatic pain, with a visual analogue scale (VAS) intensity ≥ 5, despite 6 weeks of conservative management, wether it exists lumbar pain or not and 2) Radiating pain that matches the MRI image showing one or more herniated discs (not to be considered those patients with two herniated discs and symptoms attributable to only one of the herniated discs).
- •Included in the surgery waiting list for a discectomy or microdiscectomy.
- •Patients who have signed and dated the study 's specific informed consent.
排除标准
- •Patients who do not meet all the inclusion criteria.
- •Calcified and/or migrated herniated disc, and/or with a severe neurological deficits (cauda equine syndrome).
- •Herniated disc with surgical indication of laminectomy and/or arthrodesis (massive extrusion, sign of instability or other conditions under the neurosurgeon judgment).
- •Relevant clinical paresis that does not improve despite 6 weeks of full conservative management (patients with severe pain and mild paresis that only shows up in the physical exam are not to be excluded, but those who present with paresis as the main symptom -"clinically relevant"- must be).
- •Simultaneous symptomatic cervical or dorsal herniated discs.
- •Previous lumbar spine surgery.
- •Concomitant spine conditions that may be causing symptoms or have indication for surgery (such as fractures or tumors).
- •Known allergy to ozone.
- •Those who are uncapable to fill in the scales used to measure variables in the study, like the visual analogue scale (VAS), Roland-Morris and SF-12 questionnaires.
- •Those who are unable or do not wish to fulfill the study 's protocol (answer questions to collect the data).
结局指标
主要结局
Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
时间窗: 24 months
Euros
Percentage of surgeries finally performed.
时间窗: 24 months
Percentage of surgeries performed after enrollment
Change from Baseline in sciatic pain at 12 months
时间窗: 12 months
Visual Analogic Scale (VAS)
Change from Baseline in sciatic pain at 24 months
时间窗: 24 months
Visual Analogic Scale (VAS)
次要结局
- Adverse effects(24 months)
- Quality of life by 12-Item Short Form Survey (SF-12)(24 months)
- Quality of life by the five-level version of the EuroQol five-dimensional (EQ-5D-5L) questionnaire(24 months)
- Time from inclusion on waiting list for surgery to completion of the procedure.(24 months)
- Change from Baseline in sciatic pain at 6 months(6 months)
- Change from Baseline in lumbar pain at 6 months(6 months)
- Change from Baseline in lumbar pain at 12 months(12 months)
- Number of hospital stay days(24 months)
- Restriction of everyday activities(24 months)
- Loss of labour productivity(24 months)
- Time to resume normal activity(24 months)
- Change from Baseline in lumbar pain at 24 months(24 months)
- Direct sanitary and non-sanitary costs incurred out of hospital.(24 months)
研究者
Bernardino Clavo, MD, PhD
MD. PhD
Dr. Negrin University Hospital