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Recruiting NCT05626283

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

Conditions: Lumbar Disc Herniation

Sex: All
Ages: 20 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 92
Sponsor: Beni-Suef University

Location: Egypt

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.

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.

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Source: ClinicalTrials.gov (NCT05626283). StuddyBuddy aggregates publicly available trial information.