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
NCT Number: NCT06545812
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intervertebral Disc Herniation|Back Pain|Analgesic Nephropathy|Inflammatory Response
Interventions: DRUG: Epidural steroid injection (ESI)|DEVICE: Physical therapy for disc herniation
Sponsor: Josip Juraj Strossmayer University of Osijek
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 128
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2026-03-02
Locations: Faculty of Dental Medicine and Health Osijek, Osijek, 31000, Croatia

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, 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.

Primary Outcome Measures: 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., Up to 3 months
Secondary Outcome Measures: 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., Up to 3 months