Safety and Efficacy of Shi's Traumatology Osteopathic Manipulation for Cervicogenic Dizziness: A Randomized, Controlled, Multicenter Trial

Status: Completed
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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 4 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, and Shanghai General 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 Dizziness Handicap Inventory (DHI) from baseline in two groups after 2 weeks treatment, using Dizziness Handicap Inventory (DHI) 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, DHI, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 18\

⁃ 65 years old;

• Meet diagnostic criteria of cervicogenic dizziness;

• Had cervical odontoid process deviation showed ·on CT 3D reconstruction of cervical spine or CT plain scan of atlantoaxial joint cross-section at inclusion.

• Patients had dizziness symptom at inclusion

• 31 ≤ DHI ≤ 60;

• Course of disease ≥ 1 month;

• Patients were volunteer to joint this study, and signed written informed consent.

Locations
Other Locations
China
Baoshan traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Shanghai General Hospital
Shanghai
Yueyang traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Time Frame
Start Date: 2023-02-14
Completion Date: 2024-04-20
Participants
Target number of participants: 114
Treatments
Other: Manual therapy group
Patients receive Shi's traumatology osteopathic manipulative treatment twice a week and continues for 2 weeks. Receive a total of 4 manipulative treatments.
Other: Merislon group
Merislon (Betahistine Mesilate Tablets), specification 6mg, Sinopharm H20040130, Eisai (China) Pharmaceutical Co., LTD., is given to the control group, for 2 weeks, 6mg a day, three times a day.
Related Therapeutic Areas
Sponsors
Leads: Zhan Yunfan

This content was sourced from clinicaltrials.gov