NCT00257998已完成1 期
Comparison of the Effectiveness of Three Manual Physical Therapy Techniques in a Subgroup of Patients With Low Back Pain Who Satisfy a Clinical Prediction Rule: A Randomized Clinical Trial.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The Oswestry Disability Index, which will serve as the primary outcome measure.
研究概览
简要总结
Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain that are likely to benefit from a lumbo-pelvic manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result in the same outcome.Purpose: The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR.
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 (Outcomes Assessor)
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 numbness in the lumbar spine, buttock, and/or lower extremity
- •Oswestry disability score of at least 25%
- •Age greater than 18 years and less than 60 years
- •At least four out of five of the following criteria:
- •Duration of current episode < 16 days (judged from the patient's self-report)
- •No symptoms extending distal to the knee (judged from the pain diagram)
- •FABQ-W score <19
- •At least one hip with >350 internal rotation range of motion (measured in prone)
- •Stiffness in the lumbar spine (judged from segmental mobility testing)
排除标准
- •Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- •Signs consistent with nerve root compression, this includes any one of the following:
- •Reproduction of low back or leg pain with straight leg raise at less than 450
- •Muscle weakness involving a major muscle group of the lower extremity
- •Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
- •Diminished or absent sensation to pinprick in any lower extremity dermatome
- •Prior surgery to the lumbar spine or buttock
- •Current pregnancy
- •Past medical history of osteoporosis or spinal compression fracture
- •Inability to comply with treatment schedule (weekly sessions for four weeks)
结局指标
主要结局
The Oswestry Disability Index, which will serve as the primary outcome measure.
时间窗: 4 weeks, 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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