Clinical trial

Transforaminal Epidural Steroid Injection in Lumbar Disc Prolapse: Impact on Pain and Cognition in Relation to Micro RNA-155 Serum Level

Name
FMBSUREC/050722022/Mohiee
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.
Trial arms
Trial start
2022-12-01
Estimated PCD
2023-09-01
Trial end
2023-09-01
Status
Completed
Phase
Early phase I
Treatment
transforaminal epidural injection.
transforaminal epidural steroid injection.
Arms:
lumbar disc prolapse group
micro RNA-155 serum level
Estimation of miR-155 expression level:
Arms:
Control, lumbar disc prolapse group
Size
88
Primary endpoint
Assessment of pain intensity
1 month
Assessment of functional disability
1 month
Assessment of functional disability
1 month
Memory assessment
1 month
Attention assessment
1 month
Assessment of verbal fluency and executive function.
1 month
Assessment of miR-155 expression level
1 month
Eligibility criteria
Inclusion criteria • 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. Exclusion criteria * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 88, 'type': 'ACTUAL'}}
Updated at
2024-05-29

1 organization

1 product

1 indication

Indication
Herniated Disc