RecruitingNot ApplicableNCT06356844

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

The Effect of Adding Oral Resolvins to Patients Undergoing Transforaminal Epidural Steroid Injection for Low Back Pain Treatment"


Sponsor

Bezmialem Vakif University

Enrollment

30 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • ASA I-II-III
  • Patients who underwent caudal epidural injection, facet joint injection and transforaminal injection due to lumbar disc herniation

Exclusion Criteria11

  • Patients with known allergies to the drugs to be used in treatment
  • Infection near the puncture site
  • Known clotting disorders
  • Alcohol and drug use
  • Those who have used fish oil before
  • Disorder of consciousness
  • Liver failure, renal failure, advanced cardiac failure
  • Uncontrolled diabetes mellitus
  • Morbid obesity (body mass index (BMI) > 35 kg m-2)
  • Female patients during pregnancy and breastfeeding
  • Not approving the informed consent form

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Interventions

DIETARY_SUPPLEMENTResolvin supplement

Transforaminal steroid injection will be administered to patients who are being followed up due to inflammatory low back pain. Patients will receive resolvin supplements for 6 months postoperatively.


Locations(2)

Aylin Ceren Şanlı

Istanbul, Turkey (Türkiye)

Aylin Ceren

Istanbul, Turkey (Türkiye)

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NCT06356844


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