The Effect of Comorbid Psychiatric Disorders and Information Leaflet on Results of Transforaminal Epidural Steroid Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 主要终点
- Numeric rating scale
研究概览
简要总结
Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years.
The assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone TFESI could affect the result of the treatment in a good way. The pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.
详细描述
Although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. A detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral TFESI.
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 (Investigator)
盲法说明
The study was designed as prospective, single blinded, randomized controlled study. Patients were randomized into two groups. The enrollment of the participants was carried out by an independent researcher. Pre and post-injection evaluation was performed by the investigators who had no knowledge about the groups
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lumbar radiculopathy due to lumbar disc herniation,
- •unresponsive to conservative treatments,
- •duration of pain is less than 3 months,
- •patients scheduled for the first time with TFESI.
排除标准
- •the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...),
- •underwent epidural injection in the last 6 months,
- •to have a history of lumbar spinal surgery,
- •inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),
- •spinal infection or malignancy,
- •to benefit from six-week medical treatment,
- •be reluctant to participate in the work and follow up,
- •who are illiterate,
- •the patients with psychiatric disease
研究组 & 干预措施
Control Group
The control group was given verbal information
Leaflet Group
The second group was given verbal information and a detailed information leaflet with written and visual content
干预措施: Information leaflet (Other)
结局指标
主要结局
Numeric rating scale
时间窗: 3 months
The patient is asked to give a score between 1 and 10 to explain the pain level.
Oswestry disability index
时间窗: 3 months
The oswestry disability index is a survey designed to investigate how lumbar and leg pain affects their daily lives. It consists of 10 questions investigating the general life activity of the patient. The patient receives at least 0 points and at most 5 points from each question. The higher scores indicate that increased disability.
次要结局
- Hospital Anxiety and Depression Scale(3 months)
- Somatosensory Amplification Scale(3 months)
研究者
Yeliz Bahar Ozdemir
Principal Investigator
Hitit University