Lumbar Disc HerniationPhase 4NCT05626283
Impact of Transforaminal Epidural Steroid Injection in Lumbar Disc Prolpse on Micro RNA-155 Serum Level
A Phase 4 study testing transforaminal epidural injection. and micro RNA-155 serum level in people with Lumbar Disc Herniation, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Chronic pain could be considered a brain disease as it can affect multiple aspects of brain function, chemistry, neural networks and structure. Pain is associated with impaired cognitive function (1). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- transforaminal epidural injection. and micro RNA-155 serum level
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Sep 2023
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with clinical and radiological evidence of L4-L5 disc prolapse manifesting as radicular pain and/or low back pain unresponsive to medical treatment and physiotherapy over a period of at least three months.
Who cannot join
- Patients with severe lumbar disc prolapse affecting motor or sphincteric functions,
- History of spinal surgery, spinal trauma, spinal deformities, spinal neoplasm or any spinal inflammatory lesion, hip osteoarthritis or sacroiliitis.
- Patients with medical disorders known to cause cognitive impairment
- Pregnant women were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain and Cognition in Relation to Micro RNA-155 Serum Level
Chronic pain could be considered a brain disease as it can affect multiple aspects of brain function, chemistry, neural networks and structure. Pain is associated with impaired cognitive function (1). Around 45-50% of these patients report cognitive deficits such as forgetfulness (23.4%), minor accidents (23.1%), difficulty finishing tasks (20.5%), and difficulty maintaining attention (18.7%) (2,3). Many studies emphasised an impairment in the cognitive tests assessing executive functioning, attention abilities, processing speed, and memory in patients with chronic pain (4,5). Studies of community-dwelling older adults found that pain, particularly widespread or severe pain, was associated with mobility Limitations in physical performance (e.g., walking speed, stair climbing, and activities of daily living) (6-9) in individuals with chronic pain and correspond to the pain level (10,11). Finally, both pain and impaired cognition affect mobility status in older adults, and mobility is affected to a greater extent when both are present (12).
Recent data indicate that miR-155 has a typical multifunctional miRNA and plays a crucial role in various physiological and pathological processes such as immunity, inflammation, cognitive dysfunction and neuropathies (13). The available experimental evidence indicating that miR-155 is up-regulated in neuropathies allows us to include this miRNA in the list of genes of paramount importance in chronic low back pain diagnosis and prognosis. Exogenous molecular control in vivo of miR-155 expression could open up new ways to restore cognitive outcome or attenuate the pain intensity (14).
Read more
No study searched the role of intervention (epidural steroid injection) on cognitive function reserve, whether it is a better substitution or not for the conservative medical treatment. Since exogenous steroid is a part of epidural injection, the systemic effect of a single dose of steroids does not affect cognitive function, giving superiority to the intervention modality on the conservative medical therapy approach (15).
Aim ot the work This work aims to study the impact of transforaminal epidural steroid injection in lumbar disc prolapse on pain intensity and cognitive function in relation to Micro RNA-155 serum level.
Read the detailed description
Study design and Participants:
The study will be conducted in two stages:
Stage (1): It will be a case control study that will include 44 patients diagnosed as having symptomatic lumbar disc prolapse and 44 age and sex matched healthy controls. Both patients and control groups will be subjected to measurement of baseline miR-155 expression level.
Stage (2): It will be an interventional non-experimental study that will include only the 44 patients who had symptomatic lumbar disc prolapse. Those patients will be subjected to transforaminal epidural steroid injection. Assessment of pain intensity, functional disability, cognitive function, depression, and miR-155 expression level will be done for the included patients before and 1 month after transforaminal epidural steroid injection to clarify the effect steroid injection on these variables.
The included patients will be recruited from the neurology and pain clinics of Beni-Suef University Hospital, in the period from December 2022 to September 2023.
The study will include patients with clinical evidence of disc bulge in the form of disc related radicular pain of >3 months duration, not responding to conservative treatment and interfering with daily activities. The selected patients should have radiological evidence of posterolateral lumbar disc bulge by MRI lumbosacral.
Data collection History will be taken from the selected patients regarding the demographics and the duration of lumbar disc related radicular pain. The imaging findings regarding the number of prolapsed discs and the degree of the most prolapsed disc will be also obtained.
Assessment of pain intensity and functional disability Assessment of the pain intensity and functional disability will be done before and 1 month after the interventional pain management procedure. Assessment will be done using Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI).
Cognitive assessment Cognitive assessment will be done before and 1 month after the interventional pain management procedure. Assessment will be done using Paired Associate Learning test (PALT), Paced Auditory Serial Addition Test (PASAT), and Controlled Oral Word Association Test (COWAT).
Interventional pain Procedure:
The selected patients will be brought to the preparation room where reassurance will be done. Intravenous midazolam 0.2 mg/kg will be given to them, then they will be placed in the prone position on fluoroscopy table and draped in a sterile manner. They will be connected to a monitor (SPO2, NIBLP, and ECG) and given supplemental oxygen through a nasal cannula (3 L/min) to maintain the oxygen saturation. A 22-gauge, 3.5-inch spinal needle will be used in the injection procedure. With each insertion of the spinal needle, 1 ml with 20 mg of local anesthetic lidocaine 2% will be injected intradermally.
The patients will be given transforaminal epidural injection of steroids with local anesthetic (7 mg Betamethasone preceded by a test dose of 1 milliliter 2% lidocaine).
Laboratory assessment Estimation of miR-155 expression level: Blood samples (5 mL) will be collected from the patients (before and 1 month after the interventional procedure) and controls. The samples will be centrifuged at 3000 rpm for 10 min and plasma and/ or serum will be stored at -80 C till analysis. Total RNA will be extracted. Quantitative real-time polymerase chain reaction (PCR) will be performed. miR-155 expression level will be calculated by the difference in threshold cycle method.
- Conditions
- Lumbar Disc Herniation
- Being tested
- transforaminal epidural injection., micro RNA-155 serum level
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transforaminal epidural injection.Drug
transforaminal epidural steroid injection.
micro RNA-155 serum levelOther
Estimation of miR-155 expression level:
| Study group | Role | What they receive |
|---|---|---|
| lumbar disc prolapse group | Active comparator | 44 patients diagnosed as having symptomatic lumbar disc prolapse Receives: Drug: transforaminal epidural injection.; Other: micro RNA-155 serum level |
| Control | Placebo comparator | 44 age and sex matched healthy controls Receives: Other: micro RNA-155 serum level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
Change in Numeric Rating Scale following transforaminal epidural steroid injection: It is an 11-point numeric scale for pain intensity evaluation, ranging from 0 to 10, where higher scores denote more intense pain.
Measured: 1 month
Assessment of functional disability
Change in Oswestry Disability Index following transforaminal epidural steroid injection: It consists of ten questions, scored on a scale of 0-5 for each, where higher scores denote more limitations. After the summation of all these subscores, the result is multiplied by two to gain the index (ranging from 0 to 100).
Measured: 1 month
Assessment of functional disability
Change in Functional rating index following transforaminal epidural steroid injection: The scale consists of 10 items scored on a scale of 0-4 for each, where higher scores denote more disability.
Measured: 1 month
Memory assessment
Change in Paired Associate Learning test following transforaminal epidural steroid injection: The test was conducted on three trials. A score of 0.5 is given for each true well-matched pair, while a score of 1 is given for each true mismatched pair, with a total score ranging between 0 and 21.
Measured: 1 month
Attention assessment
Change in Paced Auditory Serial Addition Test following transforaminal epidural steroid injection: A set of single digits is audio recorded at a rate of one every 3 seconds and then introduced to the subject. The subject was requested to add each digit to the one just heard before. The number of correct answers was summed to gain the total score (0 to 60).
Measured: 1 month
Assessment of verbal fluency and executive function.
Change in Controlled Oral Word Association Test following transforaminal epidural steroid injection: The subject was inquired to generate words that begin with a specified letter in one minute, eliminating proper nouns.
Measured: 1 month
Assessment of miR-155 expression level
Change in miR-155 expression level following transforaminal epidural steroid injection.
Measured: 1 month
Secondary outcomes (1)
The relationship between pain intensity and functional disability, cognitive function, and miRNA-155 serum level in patients with lumbar disc prolapse.
The relationship between the scores of pain intensity and functional disability scales (Numeric Rating Scale, Oswestry Disability Index, and Functional Rating Index), scores of the psychometric tests (Paired Associate Learning test, Paced Auditory Serial Addition Test, Controlled Oral Word Association Test), and miRNA-155 serum level
Measured: At the same time point before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Hussein, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626283
- Sponsor's protocol ID
- FMBSUREC/050722022/Mohiee
- Status last verified
- May 2024
- First submitted
- 4 Nov 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fathy W, Hussein M, Magdy R, Nasser M, Mohamed J, Sayem DM, Elmoutaz H, Mounir N, Fakhry DM, Abdelbadie M. Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain Intensity and Cognitive Function in Relation to MicroRNA-155 Serum Level. Anesthesiol Res Pract. 2025 Apr 7;2025:2201031. doi: 10.1155/anrp/2201031. eCollection 2025.
PubMed 40230811
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain and Cognition in Relation to Micro RNA-155 Serum Level
- ClinicalTrials.gov ID
- NCT05626283
- Acronym / sponsor ID
- FMBSUREC/050722022/Mohiee
- Conditions
- Lumbar Disc Herniation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Nov 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.
Chronic pain could be considered a brain disease as it can affect multiple aspects of brain function, chemistry, neural networks and structure. Pain is associated with impaired cognitive function (1). Around 45-50% of these patients report cognitive deficits such as forgetfulness (23.4%), minor accidents (23.1%), difficulty finishing tasks (20.5%), and difficulty maintaining attention (18.7%) (2,3). Many studies emphasised an impairment in the cognitive tests assessing executive functioning, attention abilities, processing speed, and memory in patients with chronic pain (4,5). Studies of community-dwelling older adults found that pain, particularly widespread or severe pain, was associated with mobility Limitations in physical performance (e.g., walking speed, stair climbing, and activities of daily living) (6-9) in individuals with chronic pain and correspond to the pain level (10,11). Finally, both pain and impaired cognition affect mobility status in older adults, and mobility is affected to a greater extent when both are present (12).
Recent data indicate that miR-155 has a typical multifunctional miRNA and plays a crucial role in various physiological and pathological processes such as immunity, inflammation, cognitive dysfunction and neuropathies (13). The available experimental evidence indicating that miR-155 is up-regulated in neuropathies allows us to include this miRNA in the list of genes of paramount importance in chronic low back pain diagnosis and prognosis. Exogenous molecular control in vivo of miR-155 expression could open up new ways to restore cognitive outcome or attenuate the pain intensity (14).
No study searched the role of intervention (epidural steroid injection) on cognitive function reserve, whether it is a better substitution or not for the conservative medical treatment. Since exogenous steroid is a part of epidural injection, the systemic effect of a single dose of steroids does not affect cognitive function, giving superiority to the intervention modality on the conservative medical therapy approach (15).
Aim ot the work This work aims to study the impact of transforaminal epidural steroid injection in lumbar disc prolapse on pain intensity and cognitive function in relation to Micro RNA-155 serum level.
Detailed description
Study design and Participants:
The study will be conducted in two stages:
Stage (1): It will be a case control study that will include 44 patients diagnosed as having symptomatic lumbar disc prolapse and 44 age and sex matched healthy controls. Both patients and control groups will be subjected to measurement of baseline miR-155 expression level.
Stage (2): It will be an interventional non-experimental study that will include only the 44 patients who had symptomatic lumbar disc prolapse. Those patients will be subjected to transforaminal epidural steroid injection. Assessment of pain intensity, functional disability, cognitive function, depression, and miR-155 expression level will be done for the included patients before and 1 month after transforaminal epidural steroid injection to clarify the effect steroid injection on these variables.
The included patients will be recruited from the neurology and pain clinics of Beni-Suef University Hospital, in the period from December 2022 to September 2023.
The study will include patients with clinical evidence of disc bulge in the form of disc related radicular pain of >3 months duration, not responding to conservative treatment and interfering with daily activities. The selected patients should have radiological evidence of posterolateral lumbar disc bulge by MRI lumbosacral.
Data collection History will be taken from the selected patients regarding the demographics and the duration of lumbar disc related radicular pain. The imaging findings regarding the number of prolapsed discs and the degree of the most prolapsed disc will be also obtained.
Assessment of pain intensity and functional disability Assessment of the pain intensity and functional disability will be done before and 1 month after the interventional pain management procedure. Assessment will be done using Numeric Rating Scale (NRS) and Oswestry Disability Index (ODI).
Cognitive assessment Cognitive assessment will be done before and 1 month after the interventional pain management procedure. Assessment will be done using Paired Associate Learning test (PALT), Paced Auditory Serial Addition Test (PASAT), and Controlled Oral Word Association Test (COWAT).
Interventional pain Procedure:
The selected patients will be brought to the preparation room where reassurance will be done. Intravenous midazolam 0.2 mg/kg will be given to them, then they will be placed in the prone position on fluoroscopy table and draped in a sterile manner. They will be connected to a monitor (SPO2, NIBLP, and ECG) and given supplemental oxygen through a nasal cannula (3 L/min) to maintain the oxygen saturation. A 22-gauge, 3.5-inch spinal needle will be used in the injection procedure. With each insertion of the spinal needle, 1 ml with 20 mg of local anesthetic lidocaine 2% will be injected intradermally.
The patients will be given transforaminal epidural injection of steroids with local anesthetic (7 mg Betamethasone preceded by a test dose of 1 milliliter 2% lidocaine).
Laboratory assessment Estimation of miR-155 expression level: Blood samples (5 mL) will be collected from the patients (before and 1 month after the interventional procedure) and controls. The samples will be centrifuged at 3000 rpm for 10 min and plasma and/ or serum will be stored at -80 C till analysis. Total RNA will be extracted. Quantitative real-time polymerase chain reaction (PCR) will be performed. miR-155 expression level will be calculated by the difference in threshold cycle method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar disc prolapse group | Active comparator | Drug: transforaminal epidural injection., Other: micro RNA-155 serum level44 patients diagnosed as having symptomatic lumbar disc prolapse |
| Control | Placebo comparator | Other: micro RNA-155 serum level44 age and sex matched healthy controls |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical and radiological evidence of L4-L5 disc prolapse manifesting as radicular pain and/or low back pain unresponsive to medical treatment and physiotherapy over a period of at least three months.
Key exclusion criteria (4 listed)
- Patients with severe lumbar disc prolapse affecting motor or sphincteric functions,
- History of spinal surgery, spinal trauma, spinal deformities, spinal neoplasm or any spinal inflammatory lesion, hip osteoarthritis or sacroiliitis.
- Patients with medical disorders known to cause cognitive impairment
- Pregnant women were excluded
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 injection.transforaminal epidural steroid injection. | Drug | lumbar disc prolapse group |
| micro RNA-155 serum levelEstimation of miR-155 expression level: | Other | Control, lumbar disc prolapse group |
Primary outcome
Assessment of pain intensity
Time frame: 1 month
Change in Numeric Rating Scale following transforaminal epidural steroid injection: It is an 11-point numeric scale for pain intensity evaluation, ranging from 0 to 10, where higher scores denote more intense pain.
Assessment of functional disability
Time frame: 1 month
Change in Oswestry Disability Index following transforaminal epidural steroid injection: It consists of ten questions, scored on a scale of 0-5 for each, where higher scores denote more limitations. After the summation of all these subscores, the result is multiplied by two to gain the index (ranging from 0 to 100).
Assessment of functional disability
Time frame: 1 month
Change in Functional rating index following transforaminal epidural steroid injection: The scale consists of 10 items scored on a scale of 0-4 for each, where higher scores denote more disability.
Memory assessment
Time frame: 1 month
Change in Paired Associate Learning test following transforaminal epidural steroid injection: The test was conducted on three trials. A score of 0.5 is given for each true well-matched pair, while a score of 1 is given for each true mismatched pair, with a total score ranging between 0 and 21.
Attention assessment
Time frame: 1 month
Change in Paced Auditory Serial Addition Test following transforaminal epidural steroid injection: A set of single digits is audio recorded at a rate of one every 3 seconds and then introduced to the subject. The subject was requested to add each digit to the one just heard before. The number of correct answers was summed to gain the total score (0 to 60).
Assessment of verbal fluency and executive function.
Time frame: 1 month
Change in Controlled Oral Word Association Test following transforaminal epidural steroid injection: The subject was inquired to generate words that begin with a specified letter in one minute, eliminating proper nouns.
Assessment of miR-155 expression level
Time frame: 1 month
Change in miR-155 expression level following transforaminal epidural steroid injection.
1 secondary outcome
The relationship between pain intensity and functional disability, cognitive function, and miRNA-155 serum level in patients with lumbar disc prolapse.
Time frame: At the same time point before intervention
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 29 May 2024.
- Derived from this study: PubMed 40230811Fathy W, Hussein M, Magdy R, Nasser M, Mohamed J, Sayem DM, Elmoutaz H, Mounir N, Fakhry DM, Abdelbadie M. Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain Intensity and Cognitive Function in Relation to MicroRNA-155 Serum Level. Anesthesiol Res Pract. 2025 Apr 7;2025:2201031. doi: 10.1155/anrp/2201031. eCollection 2025.
- 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?
A Phase 4 study testing transforaminal epidural injection. and micro RNA-155 serum level in people with Lumbar Disc Herniation, run by Beni-Suef University at 1 site in Egypt.
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 1 inclusion and 4 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 29 May 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of pain intensity (time frame: 1 month). The study lists 7 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 NCT05626283, which also lists 1 linked publication.
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 29 May 2024.