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RECRUITING
NCT06545812
NA

Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation

Sponsor: Josip Juraj Strossmayer University of Osijek

View on ClinicalTrials.gov

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.

Official title: Serum Concentrations of Cytokines and Metallopeptidases During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2024-09-02

Completion Date

2026-03-02

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

Transforaminal epidural steroid injection

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.

DEVICE

Physical therapy for disc herniation

BTL Laser therapy, BTL ultrasound therapy and BTL Transcutaneous electrical nerve stimulation - TENS

Locations (1)

Faculty of Dental Medicine and Health Osijek

Osijek, Croatia