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

NCT06356844 | Recruiting

• 1 other identifier: 27.02.2023-E.142568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Low Back Pain; Inflammatory Response; Lumbar Disc Herniation

Keywords

Transforaminal Steroid İnjection; Resolvin Therapy; Magnetic resonance imaging; Lumbar disc herniation; Cytokines level

Outcome Measures

Primary Outcomes (1)

• changes in protruded/extruded disc size

  measure will be changes in protruded/extruded disc size assessed via MRI

  Preoperatif, postoperative 6th month

Secondary Outcomes (2)

• Pain intensity score

  Preoperative, postoperative 1st week, postoperative 1th month, postoperative 6th month

• Cytokine markers

  Preoperative, postoperative 1st week, postoperative 6th month

Study Arms (2)

Treated with resolvin

ACTIVE COMPARATOR

Transforaminal steroid injection with ultrasound and resolvin therapy

Dietary Supplement: Resolvin supplement

No resolvin treatment

NO INTERVENTION

Transforaminal steroid injection with ultrasound and no resolvin treatment

Interventions

Resolvin supplement DIETARY_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.

Treated with resolvin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Aylin Ceren Şanlı

Istanbul, Turkey (Türkiye)

RECRUITING

Aylin Ceren

Istanbul, Turkey (Türkiye)

COMPLETED

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• zübeyde özdemir

  ethics committee chairman

  STUDY CHAIR

Central Study Contacts

zübeyde özdemir

CONTACT

+90 2125232288; etikkurul@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Dr

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 10, 2024
• Study Start: February 27, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

TU (2)