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

NCT05604937 | Completed

• 1 other identifier: ZYunfan
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cervicogenic dizziness; Vertigo; Manipulation; Osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (1)

• Change of vertigo within 2 weeks of treatment

  Change of vertigo within 2 weeks of treatment will be the primary outcome of this study. Dizziness Handicap Inventory (DHI) will be used to evaluate. The DHI consists of 25 questions, evaluated the influencing factors of vertigo or dizziness of patients from three dimensions: functional (F), emotional (E) and physical (P). Patients give scores according to their subjective conditions. Total score is DHIT (100 points), functional score is DHIF (36 points), emotional score is DHIE (36 points), and physical score is DHIP (28 points). Each question gives 4 points for answering Yes, 2 points for answering sometimes, and 0 points for answering No. The lower score means less disability. 0-30: mild vertigo; 31-60: moderate vertigo; 61-100: severe vertigo.

  At the end of baseline (0 week), treatment for 1 week, treatment for 2 weeks and follow-up for 4 weeks.

Secondary Outcomes (2)

• disappearing and happening time of vertigo symptom

  up to 6 weeks

• recurrence rate of vertigo symptom within 4 weeks of follow-up after treatment

  from 3rd week to 6th week

Study Arms (2)

Manual therapy group

OTHER

Patients receive Shi's traumatology osteopathic manipulative treatment twice a week and continues for 2 weeks. Receive a total of 4 manipulative treatments.

Other: Shi's traumatology osteopathic manipulation

Merislon group

OTHER

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.

Drug: Merislon

Interventions

Shi's traumatology osteopathic manipulation OTHER

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.

Manual therapy group

Merislon DRUG

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.

Merislon group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~65 years old；
• Meet diagnostic criteria of cervicogenic dizziness；
• ≤ DHI ≤ 60；
• Course of disease ≥ 1 month；
• Patients were volunteer to joint this study, and signed written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhan Yunfan: lead

Study Sites (3)

Yueyang traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200083, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200940, China

Location

Baoshan traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201999, China

Location

Related Publications (1)

• Zhan Y, Zhang Y, Liu K, Zhao Y, Ning J, Chai Y, Kong L, Yuan W. Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial. Contemp Clin Trials Commun. 2024 Aug 18;41:101349. doi: 10.1016/j.conctc.2024.101349. eCollection 2024 Oct.

  PMID: 39262903 DERIVED

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei'an Yuan, Chief

  Shuguang Hospital Affiliated with Shanghai University of TCM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 3, 2022
• Study Start: February 14, 2023
• Primary Completion: June 7, 2023
• Study Completion: April 20, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (3)