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
Launched by JOSIP JURAJ STROSSMAYER UNIVERSITY OF OSIJEK · Aug 5, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how certain substances in the blood, called cytokines and metallopeptidases, change during treatment for pain caused by a bulging disc in the lower back. Many older adults experience this kind of pain, known as radicular pain, which can happen when a disc presses on nearby nerves. The trial will look at how effective treatments like epidural steroid injections are in reducing pain and improving movement over time, while also measuring the levels of these substances in the blood before the treatment and at two weeks and three months after.
To be eligible to participate, you must be between 18 and 70 years old and have pain on one side of your lower back that has lasted for up to six months due to a diagnosed herniated disc. You should also have a pain level of at least 5 on a scale of 0 to 10. If you join the study, you will receive treatment and then have follow-up appointments to assess your pain and overall quality of life. It’s important to note that there are certain conditions that would prevent you from participating, such as having infections, being pregnant, or having had previous spine surgery. Your involvement will help researchers understand how these treatments work and potentially improve care for others with similar conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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.
About Josip Juraj Strossmayer University Of Osijek
Josip Juraj Strossmayer University of Osijek is a distinguished academic institution located in Croatia, dedicated to advancing research and education across various disciplines, including health sciences. With a commitment to fostering innovative clinical research, the university collaborates with healthcare professionals and institutions to enhance medical knowledge and improve patient outcomes. Through its rigorous clinical trials, the university aims to contribute valuable insights into the efficacy and safety of new therapies, demonstrating its role as a key player in the global research community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Osijek, , Croatia
Patients applied
Trial Officials
Karla Rožac, Master's
Principal Investigator
Faculty of Dental Medicine and Health Osijek
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported