The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain
Launched by BEZMIALEM VAKIF UNIVERSITY · Apr 4, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a treatment called resolvins, which come from omega-3 fatty acids, on patients with inflammatory low back pain caused by issues like lumbar disc herniation. The main goal is to see if taking oral resolvins alongside epidural steroid injections can help reduce pain and improve the size of the affected disc. Participants will be divided into two groups: one will receive only the epidural steroids, while the other will receive both the steroids and resolvins. The trial will monitor changes in disc size using MRI scans and pain levels through a simple rating scale, along with some blood tests to check inflammation markers.
To be eligible for the trial, participants should be between the ages of 18 and 75 and have previously had certain types of injections for their back pain. However, people with specific health issues, like allergies to the medications used, infections near the treatment site, or certain serious medical conditions, will not be able to participate. If you join the study, you can expect to take oral resolvins for six months while receiving regular check-ups to assess your progress. This trial aims to find out if this combination treatment can lead to better outcomes for those suffering from low back pain.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • ASA I-II-III
- • Patients who underwent caudal epidural injection, facet joint injection and transforaminal injection due to lumbar disc herniation
- Exclusion Criteria:
- • Patients with known allergies to the drugs to be used in treatment
- • Infection near the puncture site
- • Known clotting disorders
- • Alcohol and drug use
- • Those who have used fish oil before
- • Disorder of consciousness
- • Liver failure, renal failure, advanced cardiac failure
- • Uncontrolled diabetes mellitus
- • Morbid obesity (body mass index (BMI) \> 35 kg m-2)
- • Female patients during pregnancy and breastfeeding
- • Not approving the informed consent form
About Bezmialem Vakif University
Bezmialem Vakif University is a prominent academic institution based in Istanbul, Turkey, dedicated to advancing medical research and education. As a clinical trial sponsor, the university leverages its state-of-the-art facilities and a multidisciplinary team of experts to conduct innovative research that aims to improve patient outcomes and enhance therapeutic strategies. Bezmialem Vakif University is committed to adhering to rigorous ethical standards and regulatory guidelines, ensuring the integrity and reliability of its clinical trials while fostering collaboration with global research communities. Through its initiatives, the university seeks to contribute significantly to the field of medicine and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Istanbul, , Turkey
Istanbul, , Turkey
Patients applied
Trial Officials
zübeyde özdemir
Study Chair
ethics committee chairman
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported