Safety and Efficacy of Shi's Traumatology Osteopathic Manipulation for Cervicogenic Dizziness: A Randomized, Controlled, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- Change of vertigo within 2 weeks of treatment
研究概览
简要总结
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.
详细描述
Recruitment Participants will be recruited from outpatients of 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. Researcher will provide both oral and written information about the trial to patients, and explain detailed information about participating in the trail, including interventions, procedures and potential adverse reactions. Written informed consent will be obtained from all participants prior to their participation. Researcher will protect the confidentiality of the participants by keeping anonymous state. Documents that have the identity participants will be kept strictly confidential. The researchers in each clinical trail center should take responsibility for medical treatment of patients and make medical decisions related to clinical trail. Ensure patients can receive effective treatment for their diseases during the clinical period or when adverse events happen.
Data management The electronic case Report Form (eCRF) will be used to collect and manage data of this trial. The primary and secondary outcomes will be collected by the eCRF.
Electronic Data Capture Data collection and Management
- CRF: CRF will be designed by data manager according to the protocol, and set up data validation rules, according to Data Validation Plan. It will be used after passing the test and being approved by sponsor.
- Data Entry: CRF data are derived from original records. Data entry personnel enter visit data of patients into Electronic Data Capture (EDC) in time, according to instructions.
- Source Data Verification (SDV): The monitor performs source data verification (SDV) to check the consistency of CRF data and source data. Issue if there has questions.
- Data Questions and Answers: Questions come from EDC logical verification system questions, auditors, data managers and other manual questions. Researchers need to timely answer questions. The data manager and the monitor will reply to the question, and may issue the question again if necessary, until the data is "clean".
- Researcher Signature: After data entering and SDV, researchers use electronic signature to review and confirm data. If data should be modified after the signature, researchers need to sign the signature again.
- Database Locking: Database locking will be signed by the main researchers, sponsor, statistical analyst and data manager. The data manager locks the database.
- Database Submitting: Database will be submitted to statistical analyst by data manager.
- CRF Archiving: Each patient's CRF will generate as a PDF electronic document for preservation
- Data Management Report: Data manager write reports of data management.
- EDC Shutdown: Data manager will shut down the database after statistical analysis completed.
External data transmission Sign external data transmission protocol and manage external data according to DMP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Shi's traumatology osteopathic manipulation (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.
干预措施: Merislon (Drug)
结局指标
主要结局
Change of vertigo within 2 weeks of treatment
时间窗: At the end of baseline (0 week), treatment for 1 week, treatment for 2 weeks and follow-up for 4 weeks.
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.
次要结局
- 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)
研究者
Zhan Yunfan
Sponsor Investigator
ShuGuang Hospital