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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05053217
Enrollment
70
Registered
2021-09-22
Start date
2021-09-01
Completion date
2022-09-30
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herniated Disk Lumbar, Fibromyalgia

Keywords

fibromyalgia, lumbar disc herniation, tfese

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.

Interventions

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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Successful Response3 monthsThe primary outcome measure of our study is successful response (\>50% reduction in NRS)

Secondary

MeasureTime frameDescription
Numerical Rating Scale3 monthsNumerical rating scale (NRS) is used to convert some values into numeric values that cannot be evaluated numerically
Istanbul Low Back Pain Disability Index (ILBPDI)3 monthsIstanbul Low Back Pain Disability Index (ILBPDI) is a scale developed to evaluate functional disability in patients with chronic low back pain, scoring 18 subjects
Short Form 12 (SF-12)3 monthsShort Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items

Countries

Turkey (Türkiye)

Contacts

Primary ContactSavaş Şencan
savasdr44@gmail.com+905370665713
Backup Contactİmran Kalkan
imrankalkann55@gmail.com+905303405594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026