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

NCT06545812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Intervertebral Disc Herniation
  • Back Pain
  • Analgesic Nephropathy
  • Inflammatory Response

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

Sponsors & Collaborators

  • Josip Juraj Strossmayer University of Osijek

    lead OTHER

Principal Investigators

  • Karla Rožac, Master's · Faculty of Dental Medicine and Health Osijek

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2026-03-02
Completion
2026-03-02

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545812 on ClinicalTrials.gov