Serum Concentrations of Cytokines and Metallopeptidases During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Using standard biochemical analyses, measure the concentrations of pro-inflammatory and anti-inflammatory cytokines and metallopeptidases in the serum before physical therapy, i.e. ESI, and two weeks and three months after the start of said therapies.
研究概览
简要总结
Bulging of the intervertebral disc in the lumbar part of the spine is one of the most common degenerative changes of the spine in the elderly population, which causes various symptoms such as radicular pain. Possible mechanisms of radicular pain are mechanical compression of the intervertebral disc on the nerve and sterile local inflammation caused by proinflammatory factors. Depending on the degree of diagnosis, if conservative treatment is not successful, then treatment is focused on minimally invasive methods such as epidural steroid injection (ESI). The achieved neural blockade is believed to alter or interrupt nociceptive input, reflex mechanisms induced by afferent fibers, self-sustaining neuronal activity, and central neuronal activity. On the other hand, corticosteroids reduce inflammation by inhibiting pro-inflammatory mediators and causing a reversible local anesthetic effect. The aim of the research is to measure the concentrations of pro-inflammatory and anti-inflammatory cytokines and metallopeptidases in the serum before physical therapy, i.e. ESI, and two weeks and three months after the start of said therapies, then to examine the clinical status, intensity of pain and limitations of movement associated with pain in all three time points in order to determine the treatment outcomes after the mentioned therapies and examine the possible association of cytokine concentrations with the treatment outcomes and, last but not least, to determine the degree of the patient's psychophysical condition and quality of life before the mentioned therapies, two weeks and three months after the start of the therapies in order to examined possible associations with treatment outcomes and changes in cytokine and metallopeptidases concentrations.
详细描述
The location of the research is the Institute for Pain Management at the Clinic for Anesthesiology, Reanimatology and Intensive Care, Clinical Hospital Center Osijek, then the Translational Medicine Laboratory of the Faculty of Dental Medicine and Health Osijek. The research is designed as a non-randomized controlled experiment, and the duration of the research will depend on the available number of patients who meet the inclusion criteria for the mentioned research, and considering the expected influx of patients, the planned duration is 18 months.
All patients will receive written informed consent and the procedure will be explained orally. After signing the informed consent, the patients will be divided into two groups. One group of patients will undergo epidural administration of steroids and local anesthetic through a transforaminal approach, and the other group of patients will undergo a conservative pain management method. All subjects will be selected at the Institute for Pain Management of KBC Osijek. Below are the criteria for inclusion and exclusion of patients in this study.
By inspecting the medical documentation, all the ethical and moral rights of the respondents will be respected, with special reference to the personal data of the respondents, which will be anonymous. The subjects will be collected at the Osijek Clinical Hospital Center - Clinic for Anesthesiology, Reanimation and Intensive Care at the Institute for Pain Management. Patients who meet the criteria for inclusion in the research will be asked to participate in it and will be explained to them verbally and in writing using the information form for the subjects. After signing the informed consent, patients will be encrypted for data and identity protection.
On the specified day, they will be asked to fill out a questionnaire (ODI, PSQI, SF-36, MCGill short, HAQ, painDETECT), then allow blood sampling, and a physiotherapeutic assessment - mobility range (goniometry), circularity measurements, and Time up and go tests. Sit up test, Adams Forward Bend test, Lasegue test, walk on toes test, walk on heel test and toe-floor distance test. The above physiotherapeutic tests are used in the standard assessment of patients.
Patients will be asked to fill out a questionnaire at the follow-up examination, at the end of therapy and at the next follow-up examination, after 3 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes; age 18-70 years;
- •unilateral radicular pain of the lumbar segment;
- •diagnosis: intervertebral disc herniation;
- •confirmed diagnosis by clinical picture;
- •consent to participate in the study, which is confirmed by signing the informed consent;
- •unilateral lumbar radicular pain;
- •duration of pain up to six months;
- •symptomatic disc herniation at one level;
- •pain intensity measured by the VAS scale from 0 to 10, which is equal to or greater than 5;
- •pain intensity along the leg
排除标准
- •patients younger than 18 or older than 70 years;
- •refusal of patients to participate in research;
- •patients with systemic, local infections in the area of the lumbar spine;
- •dermatological diseases in the area of the lumbar spine;
- •pregnancy;
- •central stenosis of the lumbar canal;
- •patients with bilateral radicular pain;
- •lumbar radicular pain caused by causes other than a herniated disc;
- •allergy to steroids, local anesthetics, fentanyl, midazolam and contrast media;
- •positive history of prolonged bleeding;
- •local or systemic infection; previous lumbar spine surgery;
- •abuse of opioids;
- •proven inflammatory rheumatic disease;
- •proven inflammatory bowel disease;
- •other infections.
研究组 & 干预措施
Epidural steroid injection (ESI)
Minimally invasive methods such as epidural steroid injection (ESI). Blood samples for analysis for multicomplex quantitative analysis of anti-inflammatory cytokines (interleukin 1β (IL-1β), interleukin 6 (IL-6), interleukin 8 (IL-8), interferon gamma (INF-γ), tumor necrosis factor alpha or gamma (TNF-α), chemokine ligand 3 (CCL3) and matrix metalloproteinases MMP-3 and MMP-9
干预措施: Transforaminal epidural steroid injection (Drug)
Physical therapy for disc herniation
Conservative treatment in the form of physical therapy consists of several physical factors, namely laser therapy, ultrasound and transcutaneous electroneurostimulation (TENS). Blood samples for analysis for multicomplex quantitative analysis of anti-inflammatory cytokines (interleukin 1β (IL-1β), interleukin 6 (IL-6), interleukin 8 (IL-8), interferon gamma (INF-γ), tumor necrosis factor alpha or gamma (TNF-α), chemokine ligand 3 (CCL3) and matrix metalloproteinases MMP-3 and MMP-9
干预措施: Physical therapy for disc herniation (Device)
结局指标
主要结局
Using standard biochemical analyses, measure the concentrations of pro-inflammatory and anti-inflammatory cytokines and metallopeptidases in the serum before physical therapy, i.e. ESI, and two weeks and three months after the start of said therapies.
时间窗: Up to 3 months
There will be changes in the concentrations of pro-inflammatory and anti-inflammatory cytokines and matopeptidases in the serum, like interleukin 1β (IL-1β), interleukin 6 (IL-6), interleukin 8 (IL-8), interferon gamma (INF-γ), tumor necrosis factor alpha or gamma (TNF-α), chemokine ligand 3 (CCL3) and matrix metalloproteinases MMP-3 and MMP-9, during physical therapy, that is, the minimally invasive application of epidural steroid injection therapy in patients with pain caused by the bulging of the intervertebral disc in the lumbar part of the spine, and whether these changes are expressed when using both methods.
次要结局
- Determine the degree of the patient's psychophysical condition and quality of life(Up to 3 months)
研究者
Karla Rožac
researcher in the doctoral study of Molecular Biosciences, Faculty of dental medicine and health Osijek
Josip Juraj Strossmayer University of Osijek