Measuring inflammation and pain relief in patients with lumbar disc herniation

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

This study is testing whether epidural steroid injections or physical therapy works better to relieve pain and reduce inflammation in patients with lumbar disc herniation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Josip Juraj Strossmayer University of Osijek (other)
• Locations: 1 site (Osijek)
• Trial ID: NCT06545812 on ClinicalTrials.gov

What this trial studies

This research focuses on patients suffering from radicular pain due to bulging intervertebral discs in the lumbar spine. It aims to compare the effects of epidural steroid injections and conservative pain management methods on pain relief and inflammation markers. Patients will be divided into two groups, with one receiving steroid injections and the other undergoing physical therapy. The study will track changes in pro-inflammatory and anti-inflammatory cytokines in the serum over an 18-month period. The research is conducted at the Institute for Pain Management at the Clinical Hospital Center Osijek.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with unilateral radicular pain due to confirmed intervertebral disc herniation.

Not a fit: Patients with bilateral radicular pain or those whose pain is caused by factors other than a herniated disc may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective pain management strategies for patients with lumbar disc herniation.

How similar studies have performed: Previous studies have shown promising results with epidural steroid injections for similar conditions, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Osijek

• Faculty of Dental Medicine and Health Osijek — Osijek, Croatia (RECRUITING)

Study contacts

• Principal investigator: Karla Rožac, Master's — Faculty of Dental Medicine and Health Osijek
• Study coordinator: Karla Rožac, Master's

Conditions: Intervertebral Disc Herniation, Back Pain, Analgesic Nephropathy, Inflammatory Response, Bulging of intervertebral disc, Physical therapy, Epidural steroid injection, Pro-inflammatory cytokines