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

NCT05626283 | Completed Phase 4 DMC

• 1 other identifier: FMBSUREC/050722022/Mohiee
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (7)

• 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.

  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).

  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.

  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.

  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).

  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.

  1 month

• Assessment of miR-155 expression level

  Change in miR-155 expression level following transforaminal epidural steroid injection.

  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.

  At the same time point before intervention

Study Arms (2)

lumbar disc prolapse group

ACTIVE COMPARATOR

44 patients diagnosed as having symptomatic lumbar disc prolapse

Drug: transforaminal epidural injection.; Other: micro RNA-155 serum level

Control

PLACEBO COMPARATOR

44 age and sex matched healthy controls

Other: micro RNA-155 serum level

Interventions

transforaminal epidural injection. DRUG

transforaminal epidural steroid injection.

lumbar disc prolapse group

micro RNA-155 serum level OTHER

Estimation of miR-155 expression level:

Control; lumbar disc prolapse group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Mona Hussein

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40230811 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Neurology

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 23, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)