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临床试验/NCT02386085
NCT02386085已完成不适用

Patient-reported Adverse Events From Osteopathic Manipulative Treatment

A.T. Still University of Health Sciences0 个研究点目标入组 1,303 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,303
主要终点
Severity of adverse events related to osteopathic manipulative treatment (OMT)

研究概览

简要总结

Currently, there is a significant deficiency in evidence regarding the safety of osteopathic manipulative treatments (OMT). To address this deficit, this study is designed to systematically evaluate the incidence and severity of OMT adverse events and examine the relationship of these adverse events to the technique(s) used and the body region(s) treated. The study is being conducted at the clinics of participating members of DO-Touch.NET, the only known practice-based research network (PBRN) focused on osteopathic manual medicine research. Eligible patients who receive OMT at one of the participating clinics will be asked to complete either a paper or online survey regarding any adverse events they experience within 1, 3, and 7 days following their treatment. Information regarding their diagnoses, which osteopathic techniques were used in their OMT, and which body regions were treated will be obtained from participant medical records. This data will be used to answer the following research questions:

  1. What is the incidence of adverse events from osteopathic manipulative treatment?
  2. What types of adverse events occur following osteopathic manipulative treatment?
  3. Are there individual osteopathic techniques in particular body regions that have higher incidences of adverse events than other techniques or body regions?
  4. Is the incidence of adverse events higher for some patient conditions than others?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • received osteopathic manipulative treatment at one of participating clinics

排除标准

  • unable to communicate in English, Spanish, French, German, or Portuguese

结局指标

主要结局

Severity of adverse events related to osteopathic manipulative treatment (OMT)

时间窗: Within 1 week after receiving OMT

Data from surveys completed 24 hours, 72 hours, and 1 week after receiving OMT will be used to determine the severity, duration, and onset of symptoms/complaints experienced by participants. The 24- and 72-hour surveys assess the patient-reported severity, duration, and location of potential adverse events, as well as the existence and severity of these symptoms within the week prior to treatment and the participant's assessment of whether the symptom/complaint was related to the OMT they received. The 1-week survey will follow-up on symptoms/complaints reported on the 72-hour survey and whether participants have sought follow-up or urgent care, visited the emergency room, or been hospitalized during the week following OMT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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