Clinical trial

Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Name
Cukurova14980
Description
The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-10-12
Trial end
2023-10-26
Status
Completed
Phase
Early phase I
Treatment
Glucocorticoids
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
Arms:
Glucocorticoid injection
Other names:
Diprospan
Placebo
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
Arms:
Placebo injection
Size
60
Primary endpoint
Lumbar radicular pain
Week 1
Lumbar radicular pain
Month 1
Lumbar radicular pain
Month 3
Disability
Month 1
Disability
Month 3
Health related quality of Life
Month 1
Health related quality of Life
Month 3
Eligibility criteria
Inclusion Criteria: * Patients aged between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation. * Neurological findings such as sensory, motor and reflex abnormality matching the L4, L5 or S1 nerve distribution. * Patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations. Exclusion Criteria: * Contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids * Acute trauma * Inflammatory low back pain * Indications for neurosurgery (pronounced motor weakness or cauda equina syndrome) * Lumbar spinal stenosis * History of back surgery, history of steroid injection in the last 3 months * Pregnancy, lactation * Malignancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-11-01

1 organization

1 product

1 indication