Degenerative Disc DiseaseNCT04930211
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain
A study testing Dexamethasone-Lidocaine in people with Degenerative Disc Disease and Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Degenerative Disc Disease, Low Back Pain
- What is being tested?
- Dexamethasone-Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Rakib Sacaklidir contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University, Faculty of Medicine
Istanbul
Savas Sencan, +905370665713, savas-44@hotmail.com
About this study
Official title: The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change
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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Low Back Pain
- Being tested
- Dexamethasone-Lidocaine
- Keywords
- transforaminal epidural injection, degenerative disc disease, modic changes
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone-LidocaineDrug
Also called Transforaminal epidural steroid injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Modic Type-1 changes | Active comparator | 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. Receives: Drug: Dexamethasone-Lidocaine |
| Degenerative disc disease without Modic Type-1 changes | Active comparator | 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. Receives: Drug: Dexamethasone-Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Measured: first month
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Measured: third month
numeric rating scale
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
Measured: sixth month
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: first month
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.
Measured: third month
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.
Measured: sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start5 Oct 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion5 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serdar Kokar, M.D., Principal investigator, Saniurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930211
- Sponsor's protocol ID
- 09.2020.961
- Status last verified
- Aug 2021
- First submitted
- 1 May 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16896838Jensen 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.
PubMed 22526703Kallewaard 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.
PubMed 20825564Buttermann 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.
PubMed 15363419
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain Associated With Modic Type-1 Change
- ClinicalTrials.gov ID
- NCT04930211
- Acronym / sponsor ID
- 09.2020.961
- Conditions
- Degenerative Disc Disease, Low Back Pain
- Keywords
- transforaminal epidural injection, degenerative disc disease, modic changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 5 Oct 2022 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modic Type-1 changes | Active comparator | Drug: Dexamethasone-LidocaineTransforaminal 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. |
| Degenerative disc disease without Modic Type-1 changes | Active comparator | Drug: Dexamethasone-LidocaineTransforaminal 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone-LidocaineAlso: Transforaminal epidural steroid injectionKambin'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. | Drug | Degenerative disc disease without Modic Type-1 changes, Modic Type-1 changes |
Primary outcome
numeric rating scale
Time frame: Baseline
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
Time frame: first month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
numeric rating scale
Time frame: third month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
numeric rating scale
Time frame: sixth month
a scale used to measure the severity of pain. "0" is scored as no pain, "10" as the most
4 secondary outcomes
Oswestry disability index
Time frame: Baseline
Oswestry disability index
Time frame: first month
Oswestry disability index
Time frame: third month
Oswestry disability index
Time frame: sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 16896838Kjaer 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.
- Background: PubMed 22526703Jensen 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.
- Background: PubMed 20825564Kallewaard 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.
- Background: PubMed 15363419Buttermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakib Sacaklidir contact
Serdar Kokar, M.D. principal investigator
Saniurfa Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone-Lidocaine in people with Degenerative Disc Disease and Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Kokar, M.D. (+905416415143, srdrkkr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930211, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.