Safety and Efficacy of Shi's Traumatology Osteopathic Manipulative Treatment for Cervicogenic Dizziness

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.

Conditions

• Cervicogenic Dizziness

Interventions

OTHER

Shi's traumatology osteopathic manipulation

Patients receive treatment twice a week and continues for 2 weeks. Receive a total of 4 manipulative treatments. The manipulation intervention has mainly two steps: First, doctors perform soft-tissue manipulation on neck and shoulders to relax for 10 min; Second, doctors perform manipulation to reconstruct atlantoaxial joint. The strength of manipulation is based on the patient's tolerance. Do not use too much force.

DRUG

Merislon

Merislon (Betahistine Mesilate Tablets), specification 6mg, Sinopharm H20040130, Eisai (China) Pharmaceutical Co., LTD., is given to patients of the control group, for 2 weeks, 6mg a day, three times a day.

Sponsors & Collaborators

• Zhan Yunfan

  lead OTHER

Principal Investigators

• Wei'an Yuan, Chief · Shuguang Hospital Affiliated with Shanghai University of TCM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-14

Primary Completion

2023-06-07

Completion

2024-04-20

Countries

• China

Study Locations