Safety and Efficacy of Shi's Traumatology Osteopathic Manipulative Treatment for Cervicogenic Dizziness
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled, multi-center clinical trail to objectively evaluate safety
and efficacy of shi's traumatology Osteopathic manipulative treatment for cervicogenic
dizziness. Multi-center study is planned to be carried out in 5 medical institutions in
Shanghai, including Shuguang Hospital Affiliated to Shanghai University of Traditional
Chinese Medicine, Yueyang traditional chinese and western medicine Hospital Affiliated to
Shanghai University of Traditional Chinese Medicine, Baoshan traditional chinese and western
medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Traditional Chinese Medicine Hospital Affiliated to Shanghai University of Traditional
Chinese Medicine and Shanghai Jing'an Zhabei Central Hospital. Randomly Assigned 106 patients
(18 < ages <65 ) who meet the diagnostic criteria of cervicogenic dizziness to the treatment
group and the control group by a ratio of 1:1, using betahistine mesylate tablets as positive
control. Observe and compare the variations of Vertigo Syndrome Scale, Chinese Version
(VSS-C) from baseline in two groups after 2 weeks treatment, using Vertigo Syndrome Scale
(VSS-C) as the main efficacy index. After the end of treatment, performing 4weeks follow-up,
focus to compare the recurrence rate of vertigo symptoms in the period of 4weeks follow-up
after 2 weeks treatment. The safety indexes will be observed and compared, including vital
sign, physical examination and adverse event, in the trail.
The electronic case Report Form (eCRF) will be used to collect and manage the study data.
The data of the primary efficacy index, VSS-C, patient's vertigo condition report, both use
electronic patient-reported outcome (e-PRO) to collect. To ensure quality of study, this
trail intends to set safeguard measures for clinical trail including setting Clinical
Research Associate (CRA) to monitor study quality, evaluating efficacy by the third person,
training manual therapy physicians, make access and regular and irregular assessment
consistent.