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

Not Applicable

• Conditions: Fibromyalgia; Herniated Disk Lumbar
• Interventions: Procedure: transforaminal epidural steroid injection

• Registration Number: NCT05053217
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-22
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without a diagnosis of fibromyalgia	transforaminal epidural steroid injection	-
Patients diagnosed with fibromyalgia	transforaminal epidural steroid injection	-

Primary Outcome Measures

Name	Time	Method
Rate of Successful Response	3 months	The primary outcome measure of our study is successful response (\>50% reduction in NRS)

Secondary Outcome Measures

Name	Time	Method
Short Form 12 (SF-12)	3 months	Short Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items
Istanbul Low Back Pain Disability Index (ILBPDI)	3 months	Istanbul Low Back Pain Disability Index (ILBPDI) is a scale developed to evaluate functional disability in patients with chronic low back pain, scoring 18 subjects
Numerical Rating Scale	3 months	Numerical rating scale (NRS) is used to convert some values into numeric values that cannot be evaluated numerically

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey