NCT05626283

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

Completed Phase 4 Last updated 29 May 2024

What this trial tests

Phase 4 trial testing transforaminal epidural injection. in Lumbar Disc Herniation in 88 participants. Completed in 1 September 2023.

Timeline

1 December 2022

Primary endpoint
1 September 2023

1 September 2023

Quick facts

Lead sponsor	Beni-Suef University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	88
Start date	1 December 2022
Primary completion	1 September 2023
Estimated completion	1 September 2023
Sites	1 location across Egypt

Drugs / interventions tested

• transforaminal epidural injection. — full drug profile →
• micro RNA-155 serum level

Conditions studied

• Lumbar Disc Herniation — all drugs for Lumbar Disc Herniation →

Sponsor

Beni-Suef University

Who can join

Adults 20 to 80, any sex, with Lumbar Disc Herniation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain Intensity and Cognitive Function in Relation to MicroRNA-155 Serum Level.
   Fathy W, Hussein M, Magdy R, Nasser M, et al · · 2025 · cited 1× · PMID 40230811 · DOI 10.1155/anrp/2201031