跳至主要内容
临床试验/NCT01744015
NCT01744015撤回不适用

Influence of Patient-Informed Choice in a Novel Treatment Model for LBP: A Randomized Controlled Trial

Walsh University2 个研究点 分布在 1 个国家开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Care Seeking Behavior (recurrence of back pain) at 1 year

研究概览

简要总结

  1. (Primary) To compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain.

(We hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach) 2. (Secondary) To qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (We hypothesize that dialogue method of patient guided choice will be identified as most useful)

详细描述

The purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. Evidence exists that patients are eager to play an active role in decisions concerning their health. Recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. In our proposed randomized controlled trial (RCT), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. Patients will receive decision making information to assist in making an informed choice. The structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. The control group of patients will receive the Physical therapist-directed care model that is presently used and has shown success. Patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Care Provider)

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 with mechanically producible LBP

排除标准

  • the presence of any red flags (i.e., tumor, metabolic diseases, RA, 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.

结局指标

主要结局

Care Seeking Behavior (recurrence of back pain) at 1 year

时间窗: 1 year status post discharge from formal physical therapy care

Care seeking behavior is defined as a recurrence of symptoms, no resolution of symptoms at 1 year

次要结局

  • Oswestry Disability Index(participants will be followed for the duration of the treatment which is on average 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chad Cook

Professor

Walsh University

研究点 (2)

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