Back to resultsEffect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
Primary Purpose
Herniated Disk Lumbar, Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transforaminal epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Herniated Disk Lumbar focused on measuring fibromyalgia, lumbar disc herniation, tfese
Eligibility Criteria
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
Sites / Locations
- Marmara UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients diagnosed with fibromyalgia
Patients without a diagnosis of fibromyalgia
Arm Description
Outcomes
Primary Outcome Measures
Rate of Successful Response
The primary outcome measure of our study is successful response (>50% reduction in NRS)
Secondary Outcome Measures
Numerical Rating Scale
Numerical rating scale (NRS) is used to convert some values into numeric values that cannot be evaluated numerically
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05053217
Brief Title
Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
Official Title
Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disk Lumbar, Fibromyalgia
Keywords
fibromyalgia, lumbar disc herniation, tfese
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with fibromyalgia
Arm Type
Active Comparator
Arm Title
Patients without a diagnosis of fibromyalgia
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
transforaminal epidural steroid injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Successful Response
Description
The primary outcome measure of our study is successful response (>50% reduction in NRS)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
Numerical rating scale (NRS) is used to convert some values into numeric values that cannot be evaluated numerically
Time Frame
3 months
Title
Istanbul Low Back Pain Disability Index (ILBPDI)
Description
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
Time Frame
3 months
Title
Short Form 12 (SF-12)
Description
Short Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Savaş Şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
İmran Kalkan
Phone
+905303405594
Email
imrankalkann55@gmail.com
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savaş Şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name & Degree
İmran Kalkan
Phone
+905303405594
Email
imrankalkann55@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain
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