The Effect of Adding Oral Resolvins to Patients Undergoing Transforaminal Epidural Steroid Injection for Low Back Pain Treatment"

In the general population, about 70% to 80% of adults experience low back pain at some point in their lives. In primary care, the point prevalence ranges from 16% to 55%, making low back pain the most common neuropathic pain.5 In this context, radiculopathy is a common type of neuropathic pain. Pain can arise not only from direct mechanical pressure, such as from a herniated disc or degenerated bone, but also from inflammation and its associated proinflammatory cytokines. Inflammatory mediators contributing to neuropathic pain include nucleus pulpous cells and sequestered macrophages.6,7 Cytokines, as regulatory proteins acting as pro-inflammatory biomarkers, modulate the inflammatory response of all immune system cells during instances of inflammation.8 Despite its high prevalence, the response to medical treatment, physical therapy, and epidural steroid injections varies widely. For years, the widely accepted explanation for this variability has been the complex mechanisms involved in pain transmission. However, in recent years, it has been increasingly recognized that the lack of resolution of neuroinflammatory cells and mediators may be the most significant factor contributing to the varying treatment responses observed in individuals.9 Resolvins are specialized compounds derived from DHA (docosahexaenoic acid) and omega-3 fatty acids. Prior research indicates that certain resolvin subtypes, particularly D and E, aid in pain reduction by facilitating inflammation resolution. These specialized compounds, known as SPMs (Specialized pro-resolving mediators), regulate immune cell functions, modulate cytokine levels, and promote tissue repair mechanisms. 9,10 The aim of this study is to evaluate the impact of orally administered resolvins, in conjunction with epidural steroid injection, over a period of 6 months, on pain intensity and cytokine release during the remission phase. These effects will be assessed using magnetic resonance imaging.

Materials and Methods This clinical trial will be a randomized, controlled trial conducted at Bezmialem Vakıf University Hospital. A total of 30 patients will be enrolled in the study at this hospital. The study has received approval from the Ethics Boards of Bezmialem Vakif University Hospital. Prior to participation, all study participants will provide written informed consent.

Inclusion criteria: Patients must be classified as ASA I-II-III, aged between 18-75, presenting to the Algology department with low back pain due to lumbar disc herniation, have a pain intensity of ≥4 on the 0-10 scale pain NRS for low back pain, and/or experience radiating pain from the lower extremities caused by LDH (MRI scan confirmed lumbar disc herniation in our hospital).

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/m²), female patients during pregnancy and breastfeeding, not approving the informed consent form.

30 patients scheduled for caudal epidural injection, transforaminal epidural steroid injection will be included. Patients will be randomly assigned to two groups (Group K: control group, Group R: patients treated with resolvin) using opaque sealed envelopes. The physician performing the procedure (AT) and collecting data (AB) will be blinded to the groups. In Group R, treatment with 700 mg resolvin (omega DHA) will commence on the day the procedural decision is made.