Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Lumbar radicular pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Glucocorticoid injection
Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)
干预措施: Glucocorticoids (Drug)
Placebo injection
Intramuscular saline (%0.9 isotonic sodium chloride)
干预措施: Placebo (Other)
结局指标
主要结局
Lumbar radicular pain
时间窗: Month 3
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Disability
时间窗: Month 3
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life
时间窗: Month 3
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
次要结局
- Electrophysiological evaluation (Sensory NCS)(Month 1)
- Electrophysiological evaluation (F wave)(Month 1)
- Electrophysiological evaluation (H reflex)(Month 1)
- Electrophysiological evaluation (Motor NCS)(Month 1)
研究者
Sibel Basaran
Head of Physical Medicine and Rehabilitation
Cukurova University