Prospective, Randomized, Single Blind Trial on the Effects of Paravertebral Intramuscular Oxygen-ozone Therapy on Back Pain in Subjects Aged 65 or Older
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index(ODI)
研究概览
简要总结
This study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back pain in subjects aged 65 or older. In particular, the intramuscular injection technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to intradiscal infiltration/intraforaminal technique, will be used.
详细描述
Back pain is a leading cause of disability, including impairment in activities of daily living. In particular, the persistence of low back pain is more frequent in the elderly, associated with functional limitations and difficulties to perform tasks in everyday life. In addition to pharmacological treatments, various non-surgical interventional procedures are used for the treatment of low back pain. Some recent studies have evaluated the interventional oxygen-ozone (O2-O3) therapy in the treatment of back pain. However, these results are based on the technique of intradiscal infiltration / intraforaminal of O2-O3, while the intramuscular injection technique / paravertebral is the most widely used in clinical practice in Italy. In general, minimally invasive treatments such as percutaneous infiltration, are well tolerated and have been shown to produce clinical results, although the number of controlled studies is still scarce and the studies are often not comparable. Taking into account the above considerations, it seems appropriate to try to broaden the knowledge on the use of O2-O3 in the treatment of low back pain, using the technique of intramuscular injection / paravertebral, with particular reference to the elderly population.
The primary objective of this trial is therefore to evaluate the effects of O2-O3 therapy in the treatment of back pain associated with lumbar disc disease using the technique of intramuscular injection/paravertebral. These effects will be evaluated after a 6 weeks treatment period and after a 3 months follow-up period.
The project will include 130 subjects aged 65 or older who will be randomly enrolled in two different types of intervention:
- Oxygen-ozone therapy
- Simulated treatment
fully described below in the section: Interventions
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 65 or older
- •intervertebral disc degeneration
- •back pain persistent for at least 6 weeks
- •painkillers and anti-inflammatory drugs
- •ODI score at baseline between 30 and 80%
排除标准
- •heart failure
- •clinically hyperthyroidism
- •cancer and concomitant chemo-or radio-therapy
- •life expectancy of 6 months or less
- •psychotic drugs
- •clinical signs of radiculopathy
- •polyradiculopathy
- •progressive neurological deficit
- •lumbar stenosis
- •spondylolisthesis
- •diabetic neuropathy
研究组 & 干预措施
Intramuscular/paravertebral injections of Oxygen-Ozone
This group will be treated with "Intramuscular/paravertebral injections of Oxygen-Ozone" twice a week for six weeks
干预措施: Intramuscular/paravertebral injections of Oxygen-Ozone (Drug)
Simulated treatment
The "Simulated intramuscular/paravertebral injections" will mimic the Oxygen-Ozone injections in the area to be treated by pricking the skin with the needle without drilling. These simulated injections will be performed twice a week for six weeks.
干预措施: Simulated intramuscular/paravertebral injections (Other)
结局指标
主要结局
Oswestry Disability Index(ODI)
时间窗: 6 weeks
The Oswestry Disability Index (ODI) is used to investigate the functional impairment in activities of daily living related to low back pain. The ODI is one of the main measuring instruments necessary for the evaluation of disability from pain and is considered the gold standard for evaluation of disability in low back pain. It consists of 10 questions with multiple answers in which the patient chooses the answer that comes closest to its current state or to that of the last 2 weeks. Response to treatment is considered as a binary classification: "success" if the Oswestry Disability Index is between 0 and 20% (minimal disability) and "failure" in the other cases.
次要结局
- Oswestry Disability Index (ODI)(3 months follow-up)
- Comprehensive geriatric assessment by INTERRAI-MDS-HC/VAOR-ADI instrument(6 weeks)
- intake of paracetamol(6 weeks)
- oxidative stress(6 weeks)