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: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhan Yunfan

Criteria

Inclusion Criteria:

• 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

• 33 ≤ VSS-C score ≤ 67；

• Course of disease ≥ 1 month；

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

Exclusion Criteria:

• Dizziness caused by other diseases (like otogenic, cerebral, traumatic, ophthalmogenic, neurofunctional, intracranial tumor, subclavian steal syndrome etc.)

• Cervical vertebra has fracture, dislocation, tuberculosis, acute cervical spine disc protrusion, infection, cancer;

• Patients has severe heart, liver, brain, kidney complications or other serious diseases;

• Uncontrolled hypertension grade Ⅱ or higher, or blood pressure≥160/100mmHg after antihypertensive treatment;

• Patients has a history of carotid plaque;

• Pregnancy, lactation, family planning, or patients judged not to use effective contraception.

• Patients has mental diseases;

• Has Suspected or confirmed history of alcohol or drug abuse

• Patients are afraid of Manual therapy

• Patients are allergic to betahistine mesylate tablets

• Had participated in other clinical trials within 3 months before screening

• Researchers considered Other conditions that were not appropriate to participate in the trial