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.
Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution. The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections. In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
Cukurova University
Adana, Turkey (Türkiye)
Lumbar radicular pain
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Week 1
Lumbar radicular pain
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 1
Lumbar radicular pain
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 3
Disability
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 1
Disability
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 3
Health related quality of Life
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 1
Health related quality of Life
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Time frame: Month 3
Electrophysiological evaluation (Sensory NCS)
Sensory nerve conduction study (m/s)
Time frame: Month 1
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Electrophysiological evaluation (Motor NCS)
Motor nerve conduction study (m/s)
Time frame: Month 1
Electrophysiological evaluation (F wave)
F wave (m/s)
Time frame: Month 1
Electrophysiological evaluation (H reflex)
H reflex (m/s)
Time frame: Month 1