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Impact of Transforaminal Epidural Steroid Injection in Lumbar Disc Prolpse on Micro RNA-155 Serum Level

Primary Purpose

Lumbar Disc Herniation

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
transforaminal epidural injection.
micro RNA-155 serum level
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: Patients with a history of spinal trauma, spinal surgery or spinal deformities. Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the vertebral column or spinal cord. Patients with facet or hip osteoarthritis or sacroiliitis. Patients with severe lumbar disc prolapse causing lower limb weakness or sphincteric troubles. Patients with contraindications to interventions (sepsis, coagulopathy, or allergy from the used drugs). Patients with central or metabolic disorder known to cause cognitive dysfunction. Pregnant patients will be also excluded from our study.

Sites / Locations

  • Mona HusseinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

lumbar disc prolapse group

Control

Arm Description

46 patients diagnosed as having symptomatic lumbar disc prolapse

46 age and sex matched healthy controls

Outcomes

Primary Outcome Measures

Assessment of pain intensity
Change in Numeric Rating Scale (NRS)
Assessment of functional disability
Change in Oswestry Disability Index (ODI)
Assessment of miR-155 expression level
Change in miR-155 expression level

Secondary Outcome Measures

Memory assessment
Change in Paired Associate Learning test (PALT)
Attention assessment
Change in Paced Auditory Serial Addition Test (PASAT)
Assessment of depression
Change in Beck depression inventory (BDI).

Full Information

First Posted
November 4, 2022
Last Updated
November 19, 2022
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT05626283
Brief Title
Impact of Transforaminal Epidural Steroid Injection in Lumbar Disc Prolpse on Micro RNA-155 Serum Level
Official Title
Transforaminal Epidural Steroid Injection in Lumbar Disc Prolpse: Impact on Pain Intensity and Cognitive Function in Relation to Micro RNA-155 Serum Level
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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 emphasized 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 of 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 46 patients diagnosed as having symptomatic lumbar disc prolapse and 46 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 46 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 August 2022 to August 2023. Eligibility criteria: 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. The following patients will be excluded from our study: patients with a history of spinal trauma, spinal surgery or spinal deformities, patients with radiological evidence of any inflammatory or neoplastic lesion affecting the vertebral column or spinal cord, patients with facet or hip osteoarthritis or sacroiliitis, patients with severe lumbar disc prolapse causing lower limb weakness or sphincteric troubles, patients with contraindications to interventions (sepsis, coagulopathy, or allergy from the used drugs), and patients with central or metabolic disorder known to cause cognitive dysfunction. Pregnant patients will be also excluded from our study. 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). Numeric Rating Scale (NRS) is a single 11-point numeric scale for assessment of intensity of pain. It ranged from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. [16] Oswestry Disability Index (ODI) is a questionnaire used to quantify the disability from low back pain. It includes the following items: pain intensity, the level of disability of personal care, lifting, walking, sitting, standing, sleeping, traveling, sexual and social life. Each question is scored on a scale of 0-5 with 0 representing no limitation, and 5 representing maximal limitation. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). [17] 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). Paired Associate Learning test (PALT) will be used to assess auditory verbal memory. In this test, the examiner says 6 semantically related pairs of words and 4 semantically unrelated pairs. After few minutes, the examiner says the first word of each of these pairs to the patient, and the patient was asked to recall the other word. The test must be performed three times. Each correct compatible pair takes a score 0.5, while each correct incompatible pair takes a score 1. The range of the total score was between 0 to 21. [18] Paced Auditory Serial Addition Test (PASAT) will be used for assessment of attention and auditory working memory. In this test, a series of 61 single digit numbers are spoken on an audiotape (or CD) at a rate of one every 3 seconds. The subject is asked to add each number to the one immediately preceding it and not to give a running total. The subject has to report the sum orally. Total score is the sum of correct responses and it ranges from 0 to 60. [19] Controlled Oral Word Association Test (COWAT) is a verbal fluency test that assess attention and executive function. The participant is usually asked to name words beginning with a letter, excluding proper nouns, for one minute. [20] Assessment of depression Assessment of depression will be done before and 1 month after the interventional pain management procedure using Beck depression inventory (BDI). It is a self-rated questionnaire consisting of 21 items, in which four response options are presented on a scale of 0 to 3. [21] 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lumbar disc prolapse group
Arm Type
Active Comparator
Arm Description
46 patients diagnosed as having symptomatic lumbar disc prolapse
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
46 age and sex matched healthy controls
Intervention Type
Drug
Intervention Name(s)
transforaminal epidural injection.
Intervention Description
transforaminal epidural steroid injection.
Intervention Type
Other
Intervention Name(s)
micro RNA-155 serum level
Intervention Description
Estimation of miR-155 expression level:
Primary Outcome Measure Information:
Title
Assessment of pain intensity
Description
Change in Numeric Rating Scale (NRS)
Time Frame
1 month
Title
Assessment of functional disability
Description
Change in Oswestry Disability Index (ODI)
Time Frame
1 month
Title
Assessment of miR-155 expression level
Description
Change in miR-155 expression level
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Memory assessment
Description
Change in Paired Associate Learning test (PALT)
Time Frame
1 month
Title
Attention assessment
Description
Change in Paced Auditory Serial Addition Test (PASAT)
Time Frame
1 month
Title
Assessment of depression
Description
Change in Beck depression inventory (BDI).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients with a history of spinal trauma, spinal surgery or spinal deformities. Patients with radiological evidence of any inflammatory or neoplastic lesion affecting the vertebral column or spinal cord. Patients with facet or hip osteoarthritis or sacroiliitis. Patients with severe lumbar disc prolapse causing lower limb weakness or sphincteric troubles. Patients with contraindications to interventions (sepsis, coagulopathy, or allergy from the used drugs). Patients with central or metabolic disorder known to cause cognitive dysfunction. Pregnant patients will be also excluded from our study.
Facility Information:
Facility Name
Mona Hussein
City
Banī Suwayf
State/Province
Beni-Suef
ZIP/Postal Code
62511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Hussein
Phone
01005131318
Email
mona.neuro@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Transforaminal Epidural Steroid Injection in Lumbar Disc Prolpse on Micro RNA-155 Serum Level

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