跳至主要内容
临床试验/NCT03225599
NCT03225599已完成不适用

Cranial Osteopathic Manipulative Medicine as an Adjunct Treatment for Concussion

Northwell Health0 个研究点目标入组 9 人开始时间: 2010年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
主要终点
Change in Concussive Symptoms on the Post Concussion Symptom Scale

研究概览

简要总结

Patients who have concussions exhibit an array of symptoms, also known as post-concussive symptoms, including headaches, feeling slowed down or foggy and difficulty with concentration. This study aims to determine if cranial osteopathy can provide additional or expedited symptom relief when accompanying current conventional treatments. The patients will be identified through routine clinical contact. If patients are found to be eligible and agree to participate, they receive a single session of cranial osteopathy in addition to their usual care through the concussion program.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Concussion occurred within 8 weeks
  • Age greater or equal to 14 years
  • Complains of post-concussive symptoms with a symptom score of >10 on PCSS

排除标准

  • Concussion occurred > 8 weeks
  • Age less than 14 years
  • Surgery of the cervical and/or thoracic spine within the last 3 months
  • Currently receiving or has received workers compensation within the last 3 months
  • Currently or potentially become involved in litigation related to the injury
  • Received osteopathic craniosacral treatments within the last 3 months
  • History of hydrocephalus, current infection or active tumor
  • Active or marked depression, anxiety or psychosis

研究组 & 干预措施

Procedure

Experimental

干预措施: Cranial Osteopathic Manipulative Medicine (Other)

结局指标

主要结局

Change in Concussive Symptoms on the Post Concussion Symptom Scale

时间窗: 2 months

The Post Concussion Symptom Scale (PCSS) is a scale used to subjectively measure concussion symptoms. The minimum score is 0 and the maximum score is 132 (a maximum score of 6 for 22 items). The higher the value the worse the symptom. Twenty-two possible symptoms are graded and are the following:Headache, Nausea, Vomiting, Balance Problems, Dizziness, Lightheadedness, Fatigue, Trouble falling asleep, Sleeping more than usual, Sleeping less than usual, Drowsiness, Sensitivity to light, Sensitivity to noise, Irritability, Sadness, Nervous/Anxious, Feeling more emotional, Numbness or tingling, Feeling slowed down, Feeling like "in a fog," Difficulty concentrating, Difficulty remembering, and/or Visual problems. Total score can range from 0 to 132. Units of a scale is used.

次要结局

未报告次要终点

研究者

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

Rosanna C. Sabini, DO

Assistant Professor

Northwell Health

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