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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053217
• Other study ID #: 09.2021.685
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Marmara University
• Contact: Savas Sencan
• Phone: +905370665713
• Email: savasdr44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Herniated Disk Lumbar
• Intervertebral Disc Displacement
• Myofascial Pain Syndromes

Intervention

Procedure:
• transforaminal epidural steroid injection
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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Successful Response	The primary outcome measure of our study is successful response (>50% reduction in NRS)	3 months
Secondary	Numerical Rating Scale	Numerical rating scale (NRS) is used to convert some values into numeric values that cannot be evaluated numerically	3 months
Secondary	Istanbul Low Back Pain Disability Index (ILBPDI)	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	3 months
Secondary	Short Form 12 (SF-12)	Short Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items	3 months