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临床试验/NCT06016543
NCT06016543已完成不适用

Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study

A.T. Still University of Health Sciences1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Patient recruitment rate (feasibility)

研究概览

简要总结

The goal of this observational study is to determine the feasibility of conducting a large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat patients with post-COVID-19 symptoms. The main questions it aims to answer are:

  1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with post-COVID-19 symptoms (based on how many patients agree to participate and how many complete the study)?
  2. How much change in patients' post-COVID-19 symptom severity, quality of life, and ability to return to work can we expect to see following OMT?

Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session.

  1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of life, ability to return to work, and adverse events they experienced 3 days after every other OMT session.
  2. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.
  3. Additionally, participants will complete a follow-up questionnaire 2 months after they stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the study, whichever comes first.

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

  • at least one symptom of post-COVID-19 (eg, fatigue, dyspnea, anosmia, arthralgia, headache, sleep disturbances, anxiety/depression, or other problems related to mental health) which was new after diagnosis with COVID-19 and has persisted for at least 4 weeks after diagnosis

排除标准

  • unable to speak, read, and write in English
  • not mentally competent to give informed consent
  • inability to complete surveys/questionnaires online

结局指标

主要结局

Patient recruitment rate (feasibility)

时间窗: Through study completion, an average of 1 year

Proportion of patients who enroll in the study out of the number of patients who were eligible for and invited to enroll in the study.

Data completion rate (feasibility)

时间窗: Through study completion, an average of 1 year

Proportions of participants and physicians who complete all their questionnaires.

次要结局

  • Physical symptoms(3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session)
  • Global health(3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session)
  • Return to work(3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session)
  • Neurocognitive and psychological symptoms(3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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