Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
Primary Purpose
Degenerative Disc Disease, Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dexamethasone-Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring transforaminal epidural injection, degenerative disc disease, modic changes
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18-65
- Non-radicular, axial back pain
- Lack of response to conservative treatments
- Detection of Modic type 1 changes in contrast-enhanced Lumbar MRI or intervertebral disc findings that may be associated with discogenic pain (nuclear signal intensity change in the disc [black disc], height loss, or high-intensity zone)
Exclusion Criteria:
- Patients younger than 18 and older than 65
- Describing pain radiating to the lower extremity (those with radicular pain)
- Nerve root compression due to disc herniation or other reasons
- Modic changes in more than one level
- Positive facet loading test
- Spinal stenosis or spondylolisthesis
- Diagnosed with spondylodiscitis
- Pregnancy
- Patients with inflammatory rheumatic diseases
- Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
- Patients with exercise intolerance
Sites / Locations
- Marmara University, Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Modic Type-1 changes
Degenerative disc disease without Modic Type-1 changes
Arm Description
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Outcomes
Primary Outcome Measures
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most severe pain that could be. The patient scores between 0 and 10 for pain.
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Secondary Outcome Measures
Oswestry disability index
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Oswestry disability index
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Oswestry disability index
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Oswestry disability index
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930211
Brief Title
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
Official Title
The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
October 5, 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
Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. Modic type 1 change is considered an inflammatory process. The aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.
Detailed Description
Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. However, in degenerative disc disease, whether the pain could be attributed to Modic changes or not is still a matter of debate.
There are different options in the treatment of low back pain due to degenerative disc disease (DDD) and Modic changes. Conservative treatments and surgical approaches are some of them. Other interventional procedures include intradiscal and epidural steroid injections which have relatively less risk of complications than surgery.
The only study in the literature investigating the effectiveness of epidural steroid injections in patients with low back pain associated with modic changes belongs to Butterman et al. They reported that patients with Modic changes (type 1) responded better to epidural steroid injections than those without endplate irregularities. However, they did not report the details of the procedure, such as the steroid and local anesthetic they used, the amount of them and the level of the procedure. Moreover, they used different approaches including interlaminar and transforaminal, which may be misleading while interpreting the results.
Based on these results, the aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Low Back Pain
Keywords
transforaminal epidural injection, degenerative disc disease, modic changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modic Type-1 changes
Arm Type
Active Comparator
Arm Description
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Arm Title
Degenerative disc disease without Modic Type-1 changes
Arm Type
Active Comparator
Arm Description
Transforaminal Epidural Steroid Injection will be performed on patients at the pathology detected level bilaterally. The Kambin approach will be preferred in order to reach the intervertebral disc.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone-Lidocaine
Other Intervention Name(s)
Transforaminal epidural steroid injection
Intervention Description
Kambin's triangle approach in transforaminal epidural injection: Kambin's triangle is defined as a right triangle over the dorsolateral disc. The hypotenuse is the exiting nerve root, the base is the superior border of the caudal vertebra, and the height is the dura/traversing nerve root. it is possible to inject agents at the entrance and middle zone as the main areas of nerve entrapment by injecting at the retrodiscal area of the entrance zone, as proximal area of the targeted nerve root.
Primary Outcome Measure Information:
Title
numeric rating scale
Description
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most severe pain that could be. The patient scores between 0 and 10 for pain.
Time Frame
Baseline
Title
numeric rating scale
Description
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Time Frame
first month
Title
numeric rating scale
Description
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Time Frame
third month
Title
numeric rating scale
Description
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Time Frame
sixth month
Secondary Outcome Measure Information:
Title
Oswestry disability index
Description
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Time Frame
Baseline
Title
Oswestry disability index
Description
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Time Frame
first month
Title
Oswestry disability index
Description
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Time Frame
third month
Title
Oswestry disability index
Description
a functional disability index used in low back pain. The Oswestry Disability Index (ODI) consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. There are six statements under each item, marking what is appropriate for the patient's condition. The first statement is scored as "0" and the sixth statement as "5". The higher the total score, the higher the level of disability.
Time Frame
sixth month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 18-65
Non-radicular, axial back pain
Lack of response to conservative treatments
Detection of Modic type 1 changes in contrast-enhanced Lumbar MRI or intervertebral disc findings that may be associated with discogenic pain (nuclear signal intensity change in the disc [black disc], height loss, or high-intensity zone)
Exclusion Criteria:
Patients younger than 18 and older than 65
Describing pain radiating to the lower extremity (those with radicular pain)
Nerve root compression due to disc herniation or other reasons
Modic changes in more than one level
Positive facet loading test
Spinal stenosis or spondylolisthesis
Diagnosed with spondylodiscitis
Pregnancy
Patients with inflammatory rheumatic diseases
Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
Patients with exercise intolerance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar Kokar, M.D.
Phone
+905416415143
Email
srdrkkr@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rakib Sacaklidir
Phone
+905538044082
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar Kokar, M.D.
Organizational Affiliation
Saniurfa Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University, Faculty of Medicine
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savas Sencan
Phone
+905370665713
Email
savas-44@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16896838
Citation
Kjaer P, Korsholm L, Bendix T, Sorensen JS, Leboeuf-Yde C. Modic changes and their associations with clinical findings. Eur Spine J. 2006 Sep;15(9):1312-9. doi: 10.1007/s00586-006-0185-x. Epub 2006 Aug 9.
Results Reference
background
PubMed Identifier
22526703
Citation
Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Jensen TS, Manniche C. Is the development of Modic changes associated with clinical symptoms? A 14-month cohort study with MRI. Eur Spine J. 2012 Nov;21(11):2271-9. doi: 10.1007/s00586-012-2309-9. Epub 2012 Apr 24.
Results Reference
background
PubMed Identifier
20825564
Citation
Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6.
Results Reference
background
PubMed Identifier
15363419
Citation
Buttermann GR. The effect of spinal steroid injections for degenerative disc disease. Spine J. 2004 Sep-Oct;4(5):495-505. doi: 10.1016/j.spinee.2004.03.024.
Results Reference
background
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Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
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