Status:
RECRUITING
Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation
Lead Sponsor:
Josip Juraj Strossmayer University of Osijek
Conditions:
Intervertebral Disc Herniation
Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 radicula...
Detailed Description
The location of the research is the Institute for Pain Management at the Clinic for Anesthesiology, Reanimatology and Intensive Care, Clinical Hospital Center Osijek, then the Translational Medicine L...
Eligibility Criteria
Inclusion
- 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
Exclusion
- patients younger than 18 or older than 70 years;
- refusal of patients to participate in research;
- patients with systemic, local infections in the area of the lumbar spine;
- dermatological diseases in the area of the lumbar spine;
- pregnancy;
- central stenosis of the lumbar canal;
- patients with bilateral radicular pain;
- lumbar radicular pain caused by causes other than a herniated disc;
- allergy to steroids, local anesthetics, fentanyl, midazolam and contrast media;
- positive history of prolonged bleeding;
- local or systemic infection; previous lumbar spine surgery;
- abuse of opioids;
- proven inflammatory rheumatic disease;
- proven inflammatory bowel disease;
- other infections.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06545812
Start Date
September 2 2024
End Date
March 2 2026
Last Update
September 4 2025
Active Locations (1)
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1
Faculty of Dental Medicine and Health Osijek
Osijek, Croatia, 31000