Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06356844

The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain

Led by Bezmialem Vakif University · Updated on 2024-05-17

30

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Brief Summary: Inflammatory back pain is a chronic condition localized in the axial spine and sacroiliac joints.1 It often accompanies mechanical issues like lumbar disc herniation. While non-surgical interventions such as medication, physiotherapy, and epidural steroid injections are typically the initial approach, surgical options may be considered if these prove ineffective.2 Resolvins, derived from omega-3 fatty acids, have shown promise in reducing inflammation and pain. They help to resolve inflammatory responses, promote tissue repair, and decrease disc size, potentially reducing the need for surgery.3,4 This clinical trial aims to evaluate the efficacy of adding oral resolvins to transforaminal epidural steroid injections for treating lumbar disc herniation (LDH) The control group (Group C: n=25) will receive epidural steroids, while the study group (Group R: n=25) will receive both oral omega-3 supplementation and epidural steroids on the same day. Additionally, the study group will continue taking oral omega-3 supplements for six months. The primary outcome measure will be changes in protruded/extruded disc size assessed via MRI, with secondary outcomes including pain levels measured by the Numeric Rating Scale (NRS) and serum cytokine levels (IL-6, IL-17, IL-1 beta, TNF-alpha) over the study period. Discussion: This trial anticipates that combining the anti-inflammatory properties of resolvins with epidural steroid injection will provide a beneficial treatment for patients suffering from inflammatory low back pain.

CONDITIONS

Official Title

The Effect of Resolvins on the Resolve of Inflammatory Low Back Pain

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status classification I-II-III
  • Patients who underwent caudal epidural injection, facet joint injection, and transforaminal injection due to lumbar disc herniation
  • Age between 18 and 75 years
  • Low back pain confirmed by MRI with pain intensity of 4 or higher on a 0-10 scale
Not Eligible

You will not qualify if you...

  • Known allergies to medications used in treatment
  • Infection near the puncture site
  • Known clotting disorders
  • Alcohol and drug use
  • Prior use of fish oil supplements
  • Disorder of consciousness
  • Liver failure, renal failure, or advanced cardiac failure
  • Uncontrolled diabetes mellitus
  • Morbid obesity (BMI greater than 35 kg/m2)
  • Female patients who are pregnant or breastfeeding
  • Not providing informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Aylin Ceren Şanlı

Istanbul, Turkey (Türkiye)

Actively Recruiting

2

Aylin Ceren

Istanbul, Turkey (Türkiye)

Completed

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Research Team

Z

zübeyde özdemir

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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