Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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