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临床试验/NCT01900925
NCT01900925已完成2 期

Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial

Regis University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Change in Modified Oswestry Disability Index

研究概览

简要总结

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

详细描述

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). For inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of >2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. This finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. Exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators will track the outcomes of disability (Oswestry), Pain (Numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. Our aims are to determine if differences in groups exist, with our primary outcome measure of ODI. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Mechanically producible LBP.
  • Minimum Modified Oswestry Disability Index score of 20%
  • Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain

排除标准

  • Presence of any red flags
  • Signs consistent with nerve root compression
  • Prior surgery to the lumbar spine
  • Current pregnancy

结局指标

主要结局

Change in Modified Oswestry Disability Index

时间窗: Baseline, 2 weeks, End of Intervention (Discharge)

The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome.

次要结局

  • Change in Numeric Pain Rating Scale(Baseline, 2 weeks, End of Intervention (Discharge))
  • Change in Patient Satisfaction(2 weeks and End of Intervention (Discharge))
  • Change in Global Rating of Change Score(2 weeks and End of Intervention (Discharge))
  • Recovery(End of Intervention (Discharge))

研究者

发起方
Regis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Bade

Professor

Regis University

研究点 (2)

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