Oral Steroids in the Treatment of Acute Sciatica A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Physical examination findings:
研究概览
简要总结
Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in approximately one percent of all patients with acute low back pain. (1, 2) Traditional treatment generally involves pain control (acetominophen, NSAID's, or narcotics), activity as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually receive epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2, 8, 9)
Low back pain and sciatica result in tremendous losses to our society in terms of decreased productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe medications that, if effective in reducing the pain and disability associated with sciatica, could improve the quality of patients' lives, and result in significant cost savings to society at large. We hypothesize that the use of oral steroids to treat acute sciatica will speed patients' recovery as measured by: changes in physical findings, rates of return to work and activities of daily living, pain and disability assessment scores, and decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID's), and in the need for epidural injection or surgical intervention.
详细描述
Inclusion Criteria
To be included in this study patients had to have a diagnosis of acute sciatica as determined by the principle investigator based on the following criteria: unilateral leg pain extending below the knee (with or without strength, sensory, or reflex changes), and a positive straight leg raising sign (defined as as pain radiating from the buttock to below the knee with elevation of the leg between zero and sixty degrees). Patients had to be between twenty and sixty years of age, and had to be entered in [recruited into] the study within one week of the onset of their symptoms.
Exclusion Criteria
Patients were excluded from the study if they were pregnant or had a history of diabetes, renal failure, upper gastro-intestinal bleed, or major psychiatric disease. Patients also had to be free of symptoms suggesting more serious underlying disease as defined by the United States Agency for Healthcare Policy Research document: "Acute Low Back Problems In Adults". (11) "Red Flag" symptoms" included: a history of cancer, unexplained weight loss, fever or chills, night sweats, a history of intravenous drug use, saddle anesthesia, bowel or bladder incontinence, bone pathology, or a Neurologic emergency. Additionally, patients could be excluded for any condition that the principle investigator thought might jeopardize their safety.
Randomization and Blinding
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
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of acute sciatica as determined by the principle investigator based on the following criteria:
- •unilateral leg pain extending below the knee (with or without strength, sensory, or reflex changes); and
- •a positive straight leg raising sign (defined as as pain radiating from the buttock to below the knee with elevation of the leg between zero and sixty degrees)
- •recruited into the study within one week of the onset of symptoms
排除标准
- •Current pregnancy
- •A history of:
- •diabetes renal failure upper gastro-intestinal bleed major psychiatric disease
- •Presence of any 'red flag' symptoms suggestive of more serious underlying disease as defined by the United States Agency for Healthcare Policy Research document: "Acute Low Back Problems In Adults" (11) including:
- •a history of cancer
- •unexplained weight loss
- •fever or chills
- •night sweats
- •a history of intravenous drug use, saddle anesthesia, bowel or bladder incontinence, bone pathology, or a Neurologic emergency.
- •Any condition that the principle investigator thought might jeopardize the patient's safety
结局指标
主要结局
Physical examination findings:
straight leg raising test (positive or negative)
contralateral straight leg raising (positive or negative)
knee and ankle stretch reflexes (0-3+)
foot sensation (normal or decreased)
strength (0-5) of quadriceps
foot dorsiflexors
foot plantar flexors
ability to perform five heel lifts (0-5)
Written instruments:
HSQ 12 (Health Status Questionaire)(13)
Roland-Morris Disability Questionaire (14)
Roland-Morris Pain Rating Scale (14)
次要结局
- Number of hours/week of work
- Estimated percent of daily living activities subjects were able to accomplish
- Epidural steroid injection
- Surgical intervention