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 During the Application of Physical Therapy and Epidural Steroid Injection

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Both sexes; age 18-70 years;

• unilateral radicular pain of the lumbar segment;

• diagnosis: intervertebral disc herniation;

• confirmed diagnosis by clinical picture;

• consent to participate in the study, which is confirmed by signing the informed consent;

• unilateral lumbar radicular pain;

• duration of pain up to six months;

• symptomatic disc herniation at one level;

• pain intensity measured by the VAS scale from 0 to 10, which is equal to or greater than 5;

• pain intensity along the leg

Locations
Other Locations
Croatia
Faculty of Dental Medicine and Health Osijek
RECRUITING
Osijek
Contact Information
Primary
Karla Rožac, Master's
krozac@fdmz.hr
+385989850120
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-03-02
Participants
Target number of participants: 128
Treatments
Active_comparator: Physical therapy for disc herniation
Conservative treatment in the form of physical therapy consists of several physical factors, namely laser therapy, ultrasound and transcutaneous electroneurostimulation (TENS). Blood samples for analysis for multicomplex quantitative analysis of anti-inflammatory cytokines (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
Active_comparator: Epidural steroid injection (ESI)
Minimally invasive methods such as epidural steroid injection (ESI). Blood samples for analysis for multicomplex quantitative analysis of anti-inflammatory cytokines (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
Related Therapeutic Areas
Sponsors
Leads: Josip Juraj Strossmayer University of Osijek

This content was sourced from clinicaltrials.gov

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