Lumbar Disc HerniationNCT05556538
The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
An observational study of Lumbar Disc Herniation and Radiculopathy Lumbar, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Nerve compression due to lumbar disc herniation and related radicular pain is a very common condition when the lifetime prevalence is considered. Lumbosacral radicular pain can be defined as pain originating from the lumbar level and spreading to the lower extremities along the distribution area of one or more spinal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Radiculopathy Lumbar, Obesity
- What is being tested?
- Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 11 Aug 2023
- Phase
- Observational
- 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
Study population: The study group will consist of patients who are planned to receive transforaminal epidural steroid injection treatment by the clinician, and who want to participate in the study.
Who may be able to join
- Being between the ages of 18-65
- Patients with a diagnosis of lumbosacral radiculopathy with low back and leg pain for at least 3 months that did not respond to other treatment methods
- Çalışmaya katılma için gönüllü olmak ve onam formu imzalamış olmak
- Presence of single root nerve compression due to MR imaging-proven single-level lumbar disc herniation
- Completeness of 3-month clinical evaluation data after the procedure
Who cannot join
- Having had lumbosacral surgery
- Multilevel disc herniation
- Presence of foraminal disc herniation
- Presence of local and/or systemic infection
- History of malignancy
- Presence of spinal stenosis
Show all 11Show fewer
- Pregnancy
- Presence of known coagulopathy
- Having a known psychiatric illness diagnosis
- History of allergy to any of the injection substances
- Epidural steroid injection in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Nerve compression due to lumbar disc herniation and related radicular pain is a very common condition when the lifetime prevalence is considered. Lumbosacral radicular pain can be defined as pain originating from the lumbar level and spreading to the lower extremities along the distribution area of one or more spinal nerves. It is thought that the mechanical pressure of the disc material herniated to the dorsal nerve root or ganglion or the inflammation created by the chemokines and enzymes in the disc are involved in the pain formation mechanism.
Various methods such as medical agents, physical therapy modalities, epidural steroid injections and surgical methods can be used in the treatment of the related condition. Epidural injections have been used for the treatment of lower back and lower extremity pain since about 1900. Epidural injections exert their effects through the anti-inflammatory and neural membrane stabilizing effects of steroids, as well as by local anesthetics increasing blood flow to the ischemic spinal root and by the removal of cytokines from the area by the injection material. Epidural injections can be performed with various different approaches, including caudal, interlaminar and transforaminal. Among these approaches, the transforaminal approach is the most recently developed approach in the late 1990s, which allows drugs to be administered directly to the pathology area.
Read more
The effect of obesity, which is one of the factors thought to predispose to low back pain and lumbosacral radicular pain, has been evaluated in various studies and it has been found that it is positively correlated with low back pain and is an independent risk factor for lumbar herniation. So, does obesity have an effect on the success of transforaminal epidural steroid injection treatment? According to the literature, no significant effect on treatment success has been demonstrated.
Although the body mass index, which is used in the evaluation of obesity, has provided us important information about the health of the person in general for a long time, it is now thought to lead to an incomplete assessment. Because it does not provide information about body composition ratios (fat amount / lean body mass). Studies have shown that there is a high correlation between the percentage of body fat and the thickness of the subcutaneous fat tissue in the lumbar region, and there is a significant relationship between the lumbar region subcutaneous fat tissue thickness (especially L1-L2 level) and the degree of intervertebral disc degeneration and vertebral surface change. From this point of view, in another study, the L1-L2 disc level subcutaneous fat tissue thickness, was called the subcutaneous fat index, and the cut-off values that showed a significant relationship with spinal degeneration were determined.
In the study we planned, in cases of spinal radicular pain (etiologically caused by intervertebral disc herniation), body mass index, lumbar level subcutaneous fat tissue thickness and subcutaneous fat index data whether be or be not correlated with treatment effectiveness/success in patients who received transforaminal epidural steroid injection, and if so, the level of significance intended to work. Before applying for surgery, we aim to develop a practical approach that can be used by relevant clinicians and contribute to the literature, which can predict 'what level of treatment success can we achieve in which patient?' with this injection method.
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar, Obesity
- Being tested
- Transforaminal Epidural Steroid Injection
- Keywords
- Transforaminal Epidural Injection, Subcutaneous Fat Tissue Thickness, Subcutaneous Fat Index, Lumbar Disc Hernia, Radicular Pain, Obesity
- Medical subject headings
- Intervertebral Disc Displacement, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural Steroid InjectionProcedure or surgery
Patients are placed in the prone position, with a pillow under their abdomen (to reduce lumbar lordosis) and taken to the operating table. The procedure area is cleaned 3 times with povidone-iodine antiseptic and covered with a sterile cover. In order to view the foramen to be processed, the fluoroscopy arm is evaluated at AP-oblique / cranial or caudal angles to obtain an optimal image. Local anesthetic (3 cc 2% prilocaine) is injected into the skin and subcutaneous tissue. The spinal Quincke 21-gauge 90 mm needle is advanced by targeting the relevant foramen under the guidance of fluoroscopy image. Needle position is confirmed by taking a lateral view. Needle aspiration is checked for blood. 1-2 ml of contrast material is injected to confirm that there is no vascular distribution and that it is in the epidural space. When distribution without vascular invasion is observed, an injection of a mixture of 10 mg dexamethasone, 1 cc saline and 1 cc (0.5%) bupivacaine is performed.
| Study group | Role | What they receive |
|---|---|---|
| Those who had TFESI and whose subcutaneous fat index was above the cut-off value | Those who are above the subcutaneous fat index cut-off values (9.4 mm in men, 8.45 mm in women) will be included in this group. Receives: Procedure: Transforaminal Epidural Steroid Injection | |
| Those who had TFESI and whose subcutaneous fat index was below the cut-off value | Those who are below the subcutaneous fat index cut-off values (9.4 mm in men, 8.45 mm in women) will be included in this group. Receives: Procedure: Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
More than 50% reduction in NRS (Numeric Rating Scale) and more than 40% reduction in ODI (Oswestry Disability Index) will be taken as criteria.
(NRS is a scale that is defined as '0' = no pain, '10' = the most severe, unbearable pain, in which the patient gives points between '0' and '10' for the low back and leg pain felt by the patient.)
(ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
Measured: 3 weeks after TFESI
Treatment Success
More than 50% reduction in NRS (Numeric Rating Scale) and more than 40% reduction in ODI (Oswestry Disability Index) will be taken as criteria.
(NRS is a scale that is defined as '0' = no pain, '10' = the most severe, unbearable pain, in which the patient gives points between '0' and '10' for the low back and leg pain felt by the patient.)
(ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
Measured: 3 months after TFESI
Secondary outcomes (3)
NRS (Numeric Rating Scale)
NRS is a scale that is defined as '0' = no pain, '10' = the most severe, unbearable pain, in which the patient gives points between '0' and '10' for the low back and leg pain felt by the patient.
Measured: Before TFESI / 1 Hour After TFESI / 3 weeks after TFESI / 3 months after TFESI
ODI (Oswestry Disability Index)
ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.
Measured: Before TFESI / 3 weeks after TFESI / 3 months after TFESI
SF-12 (12-item Short Form Survey)
SF-12 is a scale that evaluates the patient's quality of life.
Measured: Before TFESI / 3 weeks after TFESI / 3 months after TFESI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start10 Oct 2022
- Primary completion11 May 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556538
- Sponsor's protocol ID
- MU-AS-SŞ-22.09.22
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success
- ClinicalTrials.gov ID
- NCT05556538
- Acronym / sponsor ID
- MU-AS-SŞ-22.09.22
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar, Obesity
- Keywords
- Transforaminal Epidural Injection, Subcutaneous Fat Tissue Thickness, Subcutaneous Fat Index, Lumbar Disc Hernia, Radicular Pain, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 27 Sep 2022 (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.
Nerve compression due to lumbar disc herniation and related radicular pain is a very common condition when the lifetime prevalence is considered. Lumbosacral radicular pain can be defined as pain originating from the lumbar level and spreading to the lower extremities along the distribution area of one or more spinal nerves. It is thought that the mechanical pressure of the disc material herniated to the dorsal nerve root or ganglion or the inflammation created by the chemokines and enzymes in the disc are involved in the pain formation mechanism.
Various methods such as medical agents, physical therapy modalities, epidural steroid injections and surgical methods can be used in the treatment of the related condition. Epidural injections have been used for the treatment of lower back and lower extremity pain since about 1900. Epidural injections exert their effects through the anti-inflammatory and neural membrane stabilizing effects of steroids, as well as by local anesthetics increasing blood flow to the ischemic spinal root and by the removal of cytokines from the area by the injection material. Epidural injections can be performed with various different approaches, including caudal, interlaminar and transforaminal. Among these approaches, the transforaminal approach is the most recently developed approach in the late 1990s, which allows drugs to be administered directly to the pathology area.
The effect of obesity, which is one of the factors thought to predispose to low back pain and lumbosacral radicular pain, has been evaluated in various studies and it has been found that it is positively correlated with low back pain and is an independent risk factor for lumbar herniation. So, does obesity have an effect on the success of transforaminal epidural steroid injection treatment? According to the literature, no significant effect on treatment success has been demonstrated.
Although the body mass index, which is used in the evaluation of obesity, has provided us important information about the health of the person in general for a long time, it is now thought to lead to an incomplete assessment. Because it does not provide information about body composition ratios (fat amount / lean body mass). Studies have shown that there is a high correlation between the percentage of body fat and the thickness of the subcutaneous fat tissue in the lumbar region, and there is a significant relationship between the lumbar region subcutaneous fat tissue thickness (especially L1-L2 level) and the degree of intervertebral disc degeneration and vertebral surface change. From this point of view, in another study, the L1-L2 disc level subcutaneous fat tissue thickness, was called the subcutaneous fat index, and the cut-off values that showed a significant relationship with spinal degeneration were determined.
In the study we planned, in cases of spinal radicular pain (etiologically caused by intervertebral disc herniation), body mass index, lumbar level subcutaneous fat tissue thickness and subcutaneous fat index data whether be or be not correlated with treatment effectiveness/success in patients who received transforaminal epidural steroid injection, and if so, the level of significance intended to work. Before applying for surgery, we aim to develop a practical approach that can be used by relevant clinicians and contribute to the literature, which can predict 'what level of treatment success can we achieve in which patient?' with this injection method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Those who had TFESI and whose subcutaneous fat index was above the cut-off value | – | Procedure: Transforaminal Epidural Steroid InjectionThose who are above the subcutaneous fat index cut-off values (9.4 mm in men, 8.45 mm in women) will be included in this group. |
| Those who had TFESI and whose subcutaneous fat index was below the cut-off value | – | Procedure: Transforaminal Epidural Steroid InjectionThose who are below the subcutaneous fat index cut-off values (9.4 mm in men, 8.45 mm in women) will be included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will consist of patients who are planned to receive transforaminal epidural steroid injection treatment by the clinician, and who want to participate in the study.
Key inclusion criteria (5 listed)
- Being between the ages of 18-65
- Patients with a diagnosis of lumbosacral radiculopathy with low back and leg pain for at least 3 months that did not respond to other treatment methods
- Çalışmaya katılma için gönüllü olmak ve onam formu imzalamış olmak
- Presence of single root nerve compression due to MR imaging-proven single-level lumbar disc herniation
- Completeness of 3-month clinical evaluation data after the procedure
Key exclusion criteria (11 listed)
- Having had lumbosacral surgery
- Multilevel disc herniation
- Presence of foraminal disc herniation
- Presence of local and/or systemic infection
- History of malignancy
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 |
|---|---|---|
| Transforaminal Epidural Steroid InjectionPatients are placed in the prone position, with a pillow under their abdomen (to reduce lumbar lordosis) and taken to the operating table. The procedure area is cleaned 3 times with povidone-iodine antiseptic and covered with a sterile cover. In order to view the foramen to be processed, the fluoroscopy arm is evaluated at AP-oblique / cranial or caudal angles to obtain an optimal image. Local anesthetic (3 cc 2% prilocaine) is injected into the skin and subcutaneous tissue. The spinal Quincke 21-gauge 90 mm needle is advanced by targeting the relevant foramen under the guidance of fluoroscopy image. Needle position is confirmed by taking a lateral view. Needle aspiration is checked for blood. 1-2 ml of contrast material is injected to confirm that there is no vascular distribution and that it is in the epidural space. When distribution without vascular invasion is observed, an injection of a mixture of 10 mg dexamethasone, 1 cc saline and 1 cc (0.5%) bupivacaine is performed. | Procedure or surgery | Those who had TFESI and whose subcutaneous fat index was above the cut-off value, Those who had TFESI and whose subcutaneous fat index was below the cut-off value |
Primary outcome
Treatment Success
Time frame: 3 weeks after TFESI
More than 50% reduction in NRS (Numeric Rating Scale) and more than 40% reduction in ODI (Oswestry Disability Index) will be taken as criteria. (NRS is a scale that is defined as '0' = no pain, '10' = the most severe, unbearable pain, in which the patient gives points between '0' and '10' for the low back and leg pain felt by the patient.) (ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
Treatment Success
Time frame: 3 months after TFESI
More than 50% reduction in NRS (Numeric Rating Scale) and more than 40% reduction in ODI (Oswestry Disability Index) will be taken as criteria. (NRS is a scale that is defined as '0' = no pain, '10' = the most severe, unbearable pain, in which the patient gives points between '0' and '10' for the low back and leg pain felt by the patient.) (ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
3 secondary outcomes
NRS (Numeric Rating Scale)
Time frame: Before TFESI / 1 Hour After TFESI / 3 weeks after TFESI / 3 months after TFESI
ODI (Oswestry Disability Index)
Time frame: Before TFESI / 3 weeks after TFESI / 3 months after TFESI
SF-12 (12-item Short Form Survey)
Time frame: Before TFESI / 3 weeks after TFESI / 3 months after TFESI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Radiculopathy Lumbar, 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 5 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: finished, as of the sponsor's last update on 12 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: 3 weeks after TFESI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.