Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain

NCT05053217 | Unknown

• 1 other identifier: 09.2021.685
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar radicular pain is defined as low back and leg pain caused by inflammation in the affected nerve root due to various etiological factors. In its treatment, there are various options such as anti-inflammatory drugs, physical therapy modalities, exercises, epidural steroid injections, and surgery. Epidural steroid injections have also become a frequently applied method in the treatment of lumbar radicular pain unresponsive to conservative treatments. The steroid applied here acts by suppressing the inflammation around the affected nerve root. Epidural steroid injections can be applied in lumbar radicular pain with 3 different approaches: caudal, interlaminar and transforaminal. In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term. As far as we know, there is no previous study investigating the effect of fibromyalgia on TFESE treatment outcomes. For this reason, the aim of our study is to examine the effect of fibromyalgia on treatment outcomes in patients who underwent TFESE for lumbar radicular pain.

Conditions

Herniated Disk Lumbar; Fibromyalgia

Keywords

fibromyalgia; lumbar disc herniation; tfese

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Response

  The primary outcome measure of our study is successful response (\>50% reduction in NRS)

  3 months

Secondary Outcomes (3)

• Numerical Rating Scale

  3 months

• Istanbul Low Back Pain Disability Index (ILBPDI)

  3 months

• Short Form 12 (SF-12)

  3 months

Study Arms (2)

Patients diagnosed with fibromyalgia

ACTIVE COMPARATOR

Procedure: transforaminal epidural steroid injection

Patients without a diagnosis of fibromyalgia

ACTIVE COMPARATOR

Procedure: transforaminal epidural steroid injection

Interventions

transforaminal epidural steroid injection PROCEDURE

In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.

Patients diagnosed with fibromyalgia; Patients without a diagnosis of fibromyalgia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Findings of root compression on MRI, lumbar radicular pain for at least 3 months, no previous history of lumbar spinal surgery, pain score of 4 and above according to the numerical rating scale (NRS), and ACR 2016 diagnostic criteria for the fibromyalgia group were met. patients

You may not qualify if:

• Patients who received lumbar epidural steroid injection in the last 3 months, who have pregnancy-breastfeeding, bleeding diathesis, contrast hypersensitivity, and patients who did not give consent for participation in the study

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Savaş Şencan

CONTACT

+905370665713; savasdr44@gmail.com

İmran Kalkan

CONTACT

+905303405594; imrankalkann55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 22, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)