Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545812
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Concentrations of Pro-inflammatory and Anti-inflammatory Cytokines and Metallopeptidases in the Serum During the Treatment of Pain Caused by Bulging of the Intervertebral Disc in the Lumbar Spine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Concentrations of Pro-inflammatory and Anti-inflammatory Cytokines and Metallopeptidases in the Serum During the Treatment of Pain Caused by Bulging of the Intervertebral Disc in the Lumbar Spine During the Application of Physical Therapy and Epidural Steroid Injection
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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 patients 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
Detailed Description:
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
The first and control examinations will be performed by a competent doctor specialist Blood sampling will be performed according to control at the Osijek Clinical Hospital Center if the control is not scheduled and for research purposes it will be performed at the Mursa Medical Center From the laboratory findings leukocytes C-reactive protein CRP and differential blood count DKS and cytokine levels will be measured
Blood samples for analysis will be collected in test tubes with red caps which will be stored at 4 until centrifugation in the Translational Medicine Laboratory of the Faculty of Dental Medicine and Health Osijek The sample will be centrifuged at 1000 rcf10min and then the serum will be aliquoted into separate sterile test tubes and stored in a refrigerator at -80C until laboratory analysis For multicomplex quantitative analysis of anti-inflammatory cytokines interferon gamma tumor necrosis factor alpha chemokine ligand and matrix metalloproteinases will be used customized ProcartaPlex Multiplex tests eBioscience Affymetrix whose principle is based on beads for protein quantification according to the principle of the Sedwich ELISA test with the use of Luminex xMAP multi -analyte profiling The entire protocol will be carried out according to the manufacturers eBioscience instructions The plate will be read in the Luminex xMAP device The level of the tested analytes will be determined using the ProcartaPlex Analyst v10 software eBioscience Affymetrix
To calculate the appropriate number of respondents statistical methods will be applied as follows - to observe a medium effect f 025 in the difference of continuous variables between three measurements in two groups of subjects the total minimum required sample size is 44 subjects - to observe a medium effect d 05 in the difference of continuous variables between two groups of subjects with a significance level of 005 and a power of 080 the minimum required sample size is 128 subjects In conclusion the minimum sample size in the research is 128 respondents GPower 312
Numerical data will be described by the arithmetic mean and standard deviation and in the case of distributions that do not follow a normal distribution by the median and interquartile range Differences between two independent groups of normally distributed numerical data will be tested by Students T-test in case the variables do not follow a normal distribution a non-parametric analogue Man-Whitney U test will be used Statistical analysis will be performed with the Statistica 100 program StatSoft Tulsa OK USA with a selected significance level of α005
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
The first and control examinations will be performed by a competent doctor specialist Blood sampling will be performed according to control at the Osijek Clinical Hospital Center if the control is not scheduled and for research purposes it will be performed at the Mursa Medical Center From the laboratory findings leukocytes C-reactive protein CRP and differential blood count DKS and cytokine levels will be measured
Blood samples for analysis will be collected in test tubes with red caps which will be stored at 4 until centrifugation in the Translational Medicine Laboratory of the Faculty of Dental Medicine and Health Osijek The sample will be centrifuged at 1000 rcf10min and then the serum will be aliquoted into separate sterile test tubes and stored in a refrigerator at -80C until laboratory analysis For multicomplex quantitative analysis of anti-inflammatory cytokines interferon gamma tumor necrosis factor alpha chemokine ligand and matrix metalloproteinases will be used customized ProcartaPlex Multiplex tests eBioscience Affymetrix whose principle is based on beads for protein quantification according to the principle of the Sedwich ELISA test with the use of Luminex xMAP multi -analyte profiling The entire protocol will be carried out according to the manufacturers eBioscience instructions The plate will be read in the Luminex xMAP device The level of the tested analytes will be determined using the ProcartaPlex Analyst v10 software eBioscience Affymetrix
To calculate the appropriate number of respondents statistical methods will be applied as follows - to observe a medium effect f 025 in the difference of continuous variables between three measurements in two groups of subjects the total minimum required sample size is 44 subjects - to observe a medium effect d 05 in the difference of continuous variables between two groups of subjects with a significance level of 005 and a power of 080 the minimum required sample size is 128 subjects In conclusion the minimum sample size in the research is 128 respondents GPower 312
Numerical data will be described by the arithmetic mean and standard deviation and in the case of distributions that do not follow a normal distribution by the median and interquartile range Differences between two independent groups of normally distributed numerical data will be tested by Students T-test in case the variables do not follow a normal distribution a non-parametric analogue Man-Whitney U test will be used Statistical analysis will be performed with the Statistica 100 program StatSoft Tulsa OK USA with a selected significance level of α005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None