Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Conditions
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Radiculopathy Lumbar

Intervention / Treatment
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* Drug: Glucocorticoids
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucocorticoid injection<br>Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate) | Drug: Glucocorticoids<br>* Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)<br>* Other names: Diprospan;|
| Placebo Comparator: Placebo injection<br>Intramuscular saline (%0.9 isotonic sodium chloride) | Other: Placebo<br>* Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar radicular pain | Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Week 1 | 
| Lumbar radicular pain | Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Month 1 | 
| Lumbar radicular pain | Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome) | Month 3 | 
| Disability | Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome) | Month 1 | 
| Disability | Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome) | 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) | 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) | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological evaluation (Sensory NCS) | Sensory nerve conduction study (m/s) | Month 1 | 
| Electrophysiological evaluation (Motor NCS) | Motor nerve conduction study (m/s) | Month 1 | 
| Electrophysiological evaluation (F wave) | F wave (m/s) | Month 1 | 
| Electrophysiological evaluation (H reflex) | H reflex (m/s) | Month 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucocorticoid, radicular pain, lumbar radiculopathy