The Value of Traction in Treatment of Lumbar Radiculopathy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.
详细描述
Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.
The two primary aims of this study are:
- Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
- Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
- •Oswestry disability score of at least 20%
- •Age at least 18 years and less than 60 years
- •At least one of the following signs of nerve root compression:
- •Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees)
- •Sensory deficit to pinprick on the ipsilateral lower extremity
- •Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
- •Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity
排除标准
- •Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
- •Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
- •Patient reports the complete absence of low back and leg symptoms when seated
- •Recent surgery (< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
- •Recent (< 2 weeks) epidural steroid injection for low back and/or leg pain
- •Current pregnancy
- •Inability to comply with the treatment schedule
结局指标
主要结局
Oswestry Disability Index
时间窗: Baseline, 6 weeks, 6 months, 1year
次要结局
- Global Rating of Change(Baseline, 6 weeks, 6 months, 1 year)
研究者
Julie Fritz
Clinical Outcomes Research Scientist
Intermountain Health Care, Inc.