- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001047
Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV
Effect of Head Acupuncture on Residual Symptoms After Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo: a Single-center Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research objectives:
- Explore the risk factors that influence residual effects after BPPV and develop a predictive score chart.
- Determine the gait characteristics of patients with residual effects after successful repositioning of BPPV.
- Compare the clinical efficacy of different intervention strategies for the treatment of residual symptoms after successful repositioning of BPPV.
Research subjects:
From June 2023 to June 2024, patients aged between 18-65 who are first diagnosed with BPPV will be recruited from the outpatient and inpatient departments of the Third Hospital of Xi'an City, affiliated to Northwest University. For posterior canal BPPV, Epley or Semont maneuver will be performed; for horizontal canal BPPV, Gufoni maneuver will be performed; for anterior canal BPPV, Yacovino maneuver will be performed. The patients will be observed for 30 minutes after the positioning maneuver to confirm the successful repositioning. On the second day after the maneuver, the follow-up personnel of the research team will contact the patient by phone or online to determine whether they have residual dizziness symptoms and whether they are willing to participate in the study. Those who agree can come to the hospital for reassessment to confirm the successful repositioning.
Residual symptom evaluation criteria:
On the 2nd day after successful repositioning, ask the patient if they have persistent nonspecific symptoms such as dizziness, feeling of heaviness in the head, unsteadiness, or floating sensation, without positional vertigo.
Sample size estimation:
According to the sample size design plan of randomized controlled studies, with a Type I error of α=0.05, a Type II error of 1-β=0.8, an incidence rate of P1=0.6 in the intervention group, an incidence rate of P2=0.45 in the control group, and a 1:1 ratio, 50 participants are allocated to each group with a total of 150 participants. Assuming a certain proportion of dropouts in each group, the sample size of each group required for enrollment is 60 participants.
Randomization and blinding:
The postoperative patients were randomly divided into two groups: Group A (acupuncture group) and Group B (betahistine group) using SPSS 20.0 software. This study did not apply blinding to the operators or patients, while the outcome assessors and data analysts were blinded.
Data collection: Baseline data including demographic information, medical history, physical examination, laboratory tests, and vestibular function tests were collected at enrollment. Dizziness Handicap Inventory (DHI) and Visual Analog Scale (VAS) scores were collected at baseline, 3 days after treatment, 1 week after treatment, 2 weeks after treatment, and 4 weeks after treatment. In addition, balance function and gait tests were performed at each time point.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mingze Chang, PhD
- Phone Number: 029+8661816100
- Email: changmingze191@163.com
Study Locations
-
-
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Xi'an, China
- Recruiting
- Xi'an No3 Hospital
-
Contact:
- Mingze Chang
- Phone Number: changmingze191@163.com
- Email: changmingze191@163.com
-
Contact:
- Yong Zhao
- Phone Number: 13289867381@163.com
- Email: 13289867381@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- According to the diagnostic criteria and therapeutic efficacy evaluation for benign paroxysmal positional vertigo (BPPV) formulated by the Otolaryngology-Head and Neck Surgery Branch of the Chinese Medical Association, the patient was confirmed as having BPPV and the repositioning maneuver was successful.
- After the maneuver, the patient's clinical symptoms were relieved, with no sense of rotation or dizziness, but residual symptoms such as discomfort and unsteady gait persisted.
- There were no obvious communication barriers or visual impairments.
- The patient and their family members agreed to the treatment plan.
Exclusion Criteria:
Patients with other ear diseases, history of head trauma or surgery;
Patients who are weak and unable to tolerate, pregnant women;
- Patients who have undergone vestibular rehabilitation training before this treatment; ④ Patients with joint diseases that affect balance and walking; ⑤ Patients with a history of brain organic diseases (such as tumors, stroke, cerebral hemorrhage) or severe neurological diseases; ⑥ Patients with incomplete data or who withdraw from treatment midway.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (acupuncture group)
Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture
|
Acupoint selection: The location of the vertigo-auditory area follows the positioning standard of Jiao Shunfa's Head Acupuncture.
Operation: Electroacupuncture stimulation in the vertigo-auditory area of affected side.
Pulse electrotherapy produced by Wujin Changcheng Medical Instrument.
Sparse-dense waveforms are selected, with a voltage of 2-4V, a frequency of 60-80 times/min, and the intensity is determined by the patient's tolerance.
The needle is in affected side for 30 minutes, and treatment is given once daily for a total of 5 days.
Other Names:
|
Active Comparator: Group B (betahistine group)
Treatment patients with residual symptoms after successful manual repositioning by oral betahistine
|
The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as "Minshilang" in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd.
The dosage is 12mg, three times a day (Tid) for four consecutive weeks.
Compliance monitoring is conducted by counting the remaining tablets in the medication packaging box brought by patients during the 4-week follow-up period.
Concurrent use of other medications that may affect the observation results, such as anti-anxiety drugs, vestibular suppressants, and anti-dizziness Chinese patent medicines, is considered a violation of the protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) score
Time Frame: 1weeks after treatment
|
A scale used to evaluate the degree of dizziness in patients, scores range from 0 to 10, with higher scores indicating more severe degree of dizziness they feel.
|
1weeks after treatment
|
Dizziness Handicap Inventory
Time Frame: 1weeks after treatment
|
Self-perceived handicapping effects imposed by dizziness.
Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
|
1weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foam posturography
Time Frame: 1weeks after treatment
|
The sponge-cushion posturing is a quantitative method for measuring postural stability.
The test-retest reliability of sponge-cushion posturing is good (ICC = 0.887-0.973)
|
1weeks after treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mingze Zhao, PhD, Xi'an No.3 Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Vertigo
- Benign Paroxysmal Positional Vertigo
- Dizziness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Histamine Agents
- Histamine Agonists
- Betahistine
Other Study ID Numbers
- ACURS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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