Developing a Core Outcome Set for Assessing Efficacy and Safety Outcomes in Cervical Vertigo Trials of Traditional Chinese Medicine

Cervical vertigo (CV), or cervicogenic dizziness, is that dizziness from the cervical spine, where reasonable alternatives have been ruled out. CV is characterized by the presence of imbalance, unsteadiness, disorientation, neck pain, limited cervical range of motion, and may be accompanied by a headache. It is a common symptom in patients with cervical spondylosis. However, there is no definitive test or resource for the condition and that diagnosing the condition is difficult. More objective measurements remain warranted for CV.
In recent years, more and more people are suffering from CV and neck pain in China. There is a growing number of randomised controlled trials (RCTs) on the treatment of CV with traditional Chinese Medicine (TCM). However, the diagnosis standard is not explicit and outcome reports are inconsistency. Therefore, our aim is to develop a core outcome set (COS) for TCM clinical trials of CV to help establishing a set of standardized diagnosis criteria and dialectical standard, as well as improve the consistency and significance of outcomes in future trials.

Contributors

Jinyu Li and Hongcai Shang are the principal investigators.

Contributors: Ruijin Qiu, Wei Wang, Guiyu Feng,Jian Huang

Dongzhimen Hospital, Beijing University of Chinese Medicine

Further Study Information

Current Stage: Ongoing
Date: July 2020 - June 2022
Funding source(s): the Young Talents Training Program of Dongzhimen Hospital of the Beijing University of Chinese Medicine (DZMYS-201802), the Basic Scientific Research Service Fee project of the Beijing University of Chinese Medicine (2020-JYB-ZDGG-111),Young Talent Lifting Project of China Association of Traditional Chinese Medicine(NQRC2-C08)


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Cervical vertigo

Target Population

Age Range: 18 - 65

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

We will conduct systematic review, drug instructions review, and semi-structured interviews to develop a long list of outcomes, including benefits and harms. Then we will carry out two rounds of Delphi survey and a consensus meeting to develop the final core outcome set.

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