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临床试验/NCT01704625
NCT01704625Unknown不适用

Will the Use of Osteopathic Manipulative Treatments on Patients With Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale?

Good Samaritan Hospital Medical Center, New York2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Headache Pain as Measured by a VAS

研究概览

简要总结

PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy (OMT) is a useful adjunct in evaluation and treatment of headaches.

PROCEDURES If a practitioner determines that a patient has a significant headache he/she may order tests. He/ She may give the patient medications to treat the headache.

The investigators will also ask permission to evaluate and treat the headache using osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and OMT is not standard of care for this condition. The investigators also may call the patient in 7 days to see how they are doing.

The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests. The investigators wish to see whether in the future they can use OMT in certain cases instead of or in conjunction with medications. The investigators plan on asking 50 patients to participate.

详细描述

Will the Use of Osteopathic Manipulative Treatments on Patients with Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale? PROTOCOL

Patients will be triaged to the appropriate part of the Emergency Department in the usual fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint is headache the provider will determine if they are a candidate for the study utilizing exclusion criteria for the study TABLE 1.

___ Table 1. Exclusion Criteria for the Study

  • Temperature 100.4 or greater
  • Healthcare provider suspects meningitis, brain abscess, encephalitis
  • Altered mental status
  • History of trauma
  • Cyclic vomiting
  • Abdominal migraines
  • Analgesic medication taken prior to treatment within an hour
  • Providing physician suspects intracranial hemorrhage
  • Focal deficits or other neurological abnormalities that lead providing physician to suspect a pathologic process in which osteopathic treatment would not be safe for the patient
  • Providing physician feels osteopathic treatment would not be safe for the patient

If patients have none of the above criteria, they may be selected for the study by the Providing Physician.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Patients will be triaged to the appropriate part of the Emergency Department in the usual fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint is headache the provider will determine if they are a candidate for the study utilizing

排除标准

  • for the study -
  • Exclusion Criteria:
  • Exclusion Criteria for the Study
  • Temperature 100.4 or greater
  • Healthcare provider suspects meningitis, brain abscess, encephalitis
  • Altered mental status
  • History of trauma
  • Cyclic vomiting
  • Abdominal migraines
  • Analgesic medication taken prior to treatment within an hour
  • Providing physician suspects intracranial hemorrhage
  • Focal deficits or other neurological abnormalities that lead providing physician to suspect a pathologic process in which osteopathic treatment would not be safe for the patient
  • Providing physician feels osteopathic treatment would not be safe for the patient

结局指标

主要结局

Headache Pain as Measured by a VAS

时间窗: Immediately before and after intervention (less than 30 minutes)

The primary outcome will be the change in pain before and immediately after intervention as measured by a 100 mm visual analog scale (VAS) for pain in patients with headaches that meet the inclusion criteria.

次要结局

未报告次要终点

研究者

发起方
Good Samaritan Hospital Medical Center, New York
申办方类型
Other
责任方
Sponsor

研究点 (2)

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