跳至主要内容
临床试验/NCT04063618
NCT04063618终止不适用

Reduction of Concussion Symptoms Through the Use of Osteopathic Manipulative Therapy: A Prospective Study

Matthew T. Mcelroy, DO2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
2
主要终点
Duration of concussion symptoms

研究概览

简要总结

Concussion incidence in high school and collegiate sports is high, especially in football. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT may be used to decrease the severity and the duration of this symptom.

详细描述

Concussion incidence in high school and collegiate sports is high, especially in football. These injuries have become the focus of the sports world, as coaches, trainers, and medical personnel are more vigilant than ever in screening for concussions. Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. Osteopathic Manipulative Therapy (OMT) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. With the main subjective symptom tracked for concussion being headache, OMT can be used to decrease the severity and the duration of this symptom. In a prospective superiority comparison between standard of care for concussion (rest and return to play protocol) and a single OMT treatment in combination with standard therapy, we hypothesize that OMT decreases symptom duration and severity of headache in concussion management.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to the Geisinger sports medicine clinic or athletic training room for concussion evaluation and management
  • Age less than 25 years old
  • Enrolled in high school or college
  • Participating in a sport at either collegiate or high school level

排除标准

  • Diagnosis does not meet criteria for concussion
  • Symptoms of concussion not present on initial visit
  • Patient unable to tolerate the OMT treatment
  • Patient needs intervention beyond standard concussion management
  • Patients not able to provide consent to be a part of the study

结局指标

主要结局

Duration of concussion symptoms

时间窗: 7 days

Measured in days; how does Concussion Severity Score change over time

Concussion Severity Score

时间窗: 7 days

Patient will score him or herself on a scale from 0-6 for each of 22 concussion related symptoms. A score of "0" is equal to no symptoms, a score of 1-2 is mild, a score of 3-4 is moderate, a score of 5-6 is severe. Total score is calculated by adding each individual item score. Higher scores are worse than lower scores.

Time to start of the return to play protocol

时间窗: 7 days

Measured in days; Once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated.

次要结局

未报告次要终点

研究者

发起方
Matthew T. Mcelroy, DO
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthew T. Mcelroy, DO

Staff Physician

Geisinger Clinic

研究点 (2)

Loading locations...

相似试验

Reduction of Concussion Symptoms Through the Use of... | 临床试验