Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain and Cognition in Relation to Micro RNA-155 Serum Level
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Assessment of verbal fluency and executive function.
研究概览
简要总结
Chronic pain could be considered a brain disease as it can affect multiple aspects of brain function, chemistry, neural networks and structure. Pain is associated with impaired cognitive function (1). Around 45-50% of these patients report cognitive deficits such as forgetfulness (23.4%), minor accidents (23.1%), difficulty finishing tasks (20.5%), and difficulty maintaining attention (18.7%) (2,3). Many studies emphasised an impairment in the cognitive tests assessing executive functioning, attention abilities, processing speed, and memory in patients with chronic pain (4,5). Studies of community-dwelling older adults found that pain, particularly widespread or severe pain, was associated with mobility Limitations in physical performance (e.g., walking speed, stair climbing, and activities of daily living) (6-9) in individuals with chronic pain and correspond to the pain level (10,11). Finally, both pain and impaired cognition affect mobility status in older adults, and mobility is affected to a greater extent when both are present (12).
Recent data indicate that miR-155 has a typical multifunctional miRNA and plays a crucial role in various physiological and pathological processes such as immunity, inflammation, cognitive dysfunction and neuropathies (13). The available experimental evidence indicating that miR-155 is up-regulated in neuropathies allows us to include this miRNA in the list of genes of paramount importance in chronic low back pain diagnosis and prognosis. Exogenous molecular control in vivo of miR-155 expression could open up new ways to restore cognitive outcome or attenuate the pain intensity (14).
No study searched the role of intervention (epidural steroid injection) on cognitive function reserve, whether it is a better substitution or not for the conservative medical treatment. Since exogenous steroid is a part of epidural injection, the systemic effect of a single dose of steroids does not affect cognitive function, giving superiority to the intervention modality on the conservative medical therapy approach (15).
Aim ot the work This work aims to study the impact of transforaminal epidural steroid injection in lumbar disc prolapse on pain intensity and cognitive function in relation to Micro RNA-155 serum level.
详细描述
Study design and Participants:
The study will be conducted in two stages:
Stage (1): It will be a case control study that will include 44 patients diagnosed as having symptomatic lumbar disc prolapse and 44 age and sex matched healthy controls. Both patients and control groups will be subjected to measurement of baseline miR-155 expression level.
Stage (2): It will be an interventional non-experimental study that will include only the 44 patients who had symptomatic lumbar disc prolapse. Those patients will be subjected to transforaminal epidural steroid injection. Assessment of pain intensity, functional disability, cognitive function, depression, and miR-155 expression level will be done for the included patients before and 1 month after transforaminal epidural steroid injection to clarify the effect steroid injection on these variables.
The included patients will be recruited from the neurology and pain clinics of Beni-Suef University Hospital, in the period from December 2022 to September 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
lumbar disc prolapse group
44 patients diagnosed as having symptomatic lumbar disc prolapse
干预措施: transforaminal epidural injection. (Drug)
lumbar disc prolapse group
44 patients diagnosed as having symptomatic lumbar disc prolapse
干预措施: micro RNA-155 serum level (Other)
Control
44 age and sex matched healthy controls
干预措施: micro RNA-155 serum level (Other)
结局指标
主要结局
Assessment of verbal fluency and executive function.
时间窗: 1 month
Change in Controlled Oral Word Association Test following transforaminal epidural steroid injection: The subject was inquired to generate words that begin with a specified letter in one minute, eliminating proper nouns.
Memory assessment
时间窗: 1 month
Change in Paired Associate Learning test following transforaminal epidural steroid injection: The test was conducted on three trials. A score of 0.5 is given for each true well-matched pair, while a score of 1 is given for each true mismatched pair, with a total score ranging between 0 and 21.
Assessment of miR-155 expression level
时间窗: 1 month
Change in miR-155 expression level following transforaminal epidural steroid injection.
Assessment of pain intensity
时间窗: 1 month
Change in Numeric Rating Scale following transforaminal epidural steroid injection: It is an 11-point numeric scale for pain intensity evaluation, ranging from 0 to 10, where higher scores denote more intense pain.
Attention assessment
时间窗: 1 month
Change in Paced Auditory Serial Addition Test following transforaminal epidural steroid injection: A set of single digits is audio recorded at a rate of one every 3 seconds and then introduced to the subject. The subject was requested to add each digit to the one just heard before. The number of correct answers was summed to gain the total score (0 to 60).
Assessment of functional disability
时间窗: 1 month
Change in Functional rating index following transforaminal epidural steroid injection: The scale consists of 10 items scored on a scale of 0-4 for each, where higher scores denote more disability.
次要结局
- The relationship between pain intensity and functional disability, cognitive function, and miRNA-155 serum level in patients with lumbar disc prolapse.(At the same time point before intervention)
研究者
Mona Hussein
Associate professor of Neurology
Beni-Suef University