Intervertebral Disc HerniationNCT06545812
Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
A study testing Transforaminal epidural steroid injection and Physical therapy for disc herniation in people with Intervertebral Disc Herniation and Back Pain, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intervertebral Disc Herniation, Back Pain, Analgesic Nephropathy
- What is being tested?
- Transforaminal epidural steroid injection and Physical therapy for disc herniation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCroatia
- Study dates
- 2 Sep 2024to 2 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Concentrations of Cytokines and Metallopeptidases During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
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.
Read the 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 rcf/10min and then the serum will be aliquoted into separate sterile test tubes and stored in a refrigerator at -80°C 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 manufacturer's 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 v1.0 software. eBioscience, Affymetrix).
To calculate the appropriate number of respondents, statistical methods will be applied as follows: - to observe a medium effect (f = 0.25) 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 = 0.5) in the difference of continuous variables between two groups of subjects, with a significance level of 0.05 and a power of 0.80, the minimum required sample size is 128 subjects. In conclusion, the minimum sample size in the research is 128 respondents (G*Power, 3.1.2).
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 Student's 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 10.0 program (StatSoft, Tulsa, OK, USA), with a selected significance level of α=0.05.
- Being tested
- Transforaminal epidural steroid injection, Physical therapy for disc herniation
- Keywords
- Bulging of intervertebral disc;, Physical therapy;, Epidural steroid injection (ESI);, Pro-inflammatory cytokines;, Anti-inflammatory cytokines;, Metallopeptidases;
- Medical subject headings
- Intervertebral Disc Displacement, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal epidural steroid injectionDrug
Also called ESI TF
Transforaminal epidural steroid injection (ESI TF) with corticosteroids like Methylprednisolone, Levobupivacaine and Lidocaine according to the protocol of the institution. They reduce inflammation by inhibiting pro-inflammatory mediators and causing a reversible local anesthetic effect.
Physical therapy for disc herniationDevice
BTL Laser therapy, BTL ultrasound therapy and BTL Transcutaneous electrical nerve stimulation - TENS
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy for disc herniation | Active comparator | 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 Receives: Device: Physical therapy for disc herniation |
| Epidural steroid injection (ESI) | Active comparator | 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 Receives: Drug: Transforaminal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Up to 3 months
Secondary outcomes (1)
Determine the degree of the patient's psychophysical condition and quality of life
Physical therapy, i.e. therapy with epidural steroid injection on possible changes in the clinical status, psychophysical function and quality of life of patients with questionnaire: For pain-Visual Analogue Pain Scale (VAS), McGill short and painDETECT. The questionnaires for the percentage of disability, physical functioning,health status and quality of life - Oswestry low back pain disability questionnaire (ODI), 36-Item Short Form Survey (SF-36) and Health Assessment Questionnaire (HAQ). Pittsburgh Sleep Quality Index (PSQI) - for sleep quality, sleep disturbances and use of sleep medications. With these questionnaires I want to establish whether changes in these parameters are reflected in changes in the concentrations of pro-inflammatory or anti-inflammatory cytokines and metallopeptidases in order to possibly identify new biological markers that would could be used in monitoring the outcome of treatment when applying physical therapy, that is, ESI.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start2 Sep 2024
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Rožac, Josip Juraj Strossmayer University of Osijek
- Investigators
- Karla Rožac, Master's, Principal investigator, Faculty of Dental Medicine and Health Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545812
- Sponsor's protocol ID
- 2158/97-97-10-24-50
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to make IPD available to other researchers. IPDs will be administrated and stored by one person.
Publications
Budrovac D, Rados I, Hnatesen D, Harsanji-Drenjancevic I, Tot OK, Katic F, Lukic I, Skiljic S, Neskovic N, Dimitrijevic I. Effectiveness of Epidural Steroid Injection Depending on Discoradicular Contact: A Prospective Randomized Trial. Int J Environ Res Public Health. 2023 Feb 19;20(4):3672. doi: 10.3390/ijerph20043672.
PubMed 36834367Rozac K, Matic A, Budrovac D, Hnatesen D, Rados I, Kralik K, Smolic M, Kovac Lukic T. Biological Mechanisms of Pain Management in Lumbar Disk Herniation: Focus on Cytokine Correlations and Therapeutic Approaches. Int J Mol Sci. 2025 Nov 7;26(22):10830. doi: 10.3390/ijms262210830.
PubMed 41303319
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentrations of Cytokines and Metallopeptidases During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06545812
- Acronym / sponsor ID
- 2158/97-97-10-24-50
- Keywords
- Bulging of intervertebral disc;, Physical therapy;, Epidural steroid injection (ESI);, Pro-inflammatory cytokines;, Anti-inflammatory cytokines;, Metallopeptidases;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 rcf/10min and then the serum will be aliquoted into separate sterile test tubes and stored in a refrigerator at -80°C 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 manufacturer's 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 v1.0 software. eBioscience, Affymetrix).
To calculate the appropriate number of respondents, statistical methods will be applied as follows: - to observe a medium effect (f = 0.25) 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 = 0.5) in the difference of continuous variables between two groups of subjects, with a significance level of 0.05 and a power of 0.80, the minimum required sample size is 128 subjects. In conclusion, the minimum sample size in the research is 128 respondents (G*Power, 3.1.2).
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 Student's 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 10.0 program (StatSoft, Tulsa, OK, USA), with a selected significance level of α=0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy for disc herniation | Active comparator | Device: Physical therapy for disc herniationConservative 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 |
| Epidural steroid injection (ESI) | Active comparator | Drug: Transforaminal epidural steroid injectionMinimally 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforaminal epidural steroid injectionAlso: ESI TFTransforaminal epidural steroid injection (ESI TF) with corticosteroids like Methylprednisolone, Levobupivacaine and Lidocaine according to the protocol of the institution. They reduce inflammation by inhibiting pro-inflammatory mediators and causing a reversible local anesthetic effect. | Drug | Epidural steroid injection (ESI) |
| Physical therapy for disc herniationBTL Laser therapy, BTL ultrasound therapy and BTL Transcutaneous electrical nerve stimulation - TENS | Device | Physical therapy for disc herniation |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
Determine the degree of the patient's psychophysical condition and quality of life
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 36834367Budrovac D, Rados I, Hnatesen D, Harsanji-Drenjancevic I, Tot OK, Katic F, Lukic I, Skiljic S, Neskovic N, Dimitrijevic I. Effectiveness of Epidural Steroid Injection Depending on Discoradicular Contact: A Prospective Randomized Trial. Int J Environ Res Public Health. 2023 Feb 19;20(4):3672. doi: 10.3390/ijerph20043672.
- Results publication: PubMed 41303319Rozac K, Matic A, Budrovac D, Hnatesen D, Rados I, Kralik K, Smolic M, Kovac Lukic T. Biological Mechanisms of Pain Management in Lumbar Disk Herniation: Focus on Cytokine Correlations and Therapeutic Approaches. Int J Mol Sci. 2025 Nov 7;26(22):10830. doi: 10.3390/ijms262210830.
- Biological Mechanisms of Pain Management in Lumbar Disk Herniation: Focus on Cytokine Correlations and Therapeutic ApproachesLink provided by the sponsor.
- Individual participant dataSharing planned: No. I do not plan to make IPD available to other researchers. IPDs will be administrated and stored by one person.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Rožac, Master's principal investigator
Faculty of Dental Medicine and Health Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal epidural steroid injection and Physical therapy for disc herniation in people with Intervertebral Disc Herniation and Back Pain, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.