Radiculopathy Lumbar
Conditions
Keywords
glucocorticoid, radicular pain, lumbar radiculopathy
Brief summary
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.
Detailed description
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.
Interventions
DRUGGlucocorticoids
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
OTHERPlacebo
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar radicular pain | Week 1 | Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome) |
| Disability | Month 1 | Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome) |
| Health related quality of Life | Month 1 | Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrophysiological evaluation (Sensory NCS) | Month 1 | Sensory nerve conduction study (m/s) |
| Electrophysiological evaluation (H reflex) | Month 1 | H reflex (m/s) |
| Electrophysiological evaluation (Motor NCS) | Month 1 | Motor nerve conduction study (m/s) |
| Electrophysiological evaluation (F wave) | Month 1 | F wave (m/s) |
Countries
Turkey (Türkiye)
Outcome results
None listed