Benign Paroxysmal Positional VertigoNCT06001047
Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV
A study testing Group A and Group B in people with Benign Paroxysmal Positional Vertigo, run by Xi'an No.3 Hospital at 1 site in China.
Trial summary
Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and currently, manual repositioning techniques are often used for treatment. However, up to 30%-50% of patients may experience residual symptoms such as non-rotational dizziness, heaviness, instability, and emotional… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Group A and Group B
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an No3 Hospital
Xi'an
Mingze Chang, changmingze191@163.com, changmingze191@163.com
Yong Zhao, 13289867381@163.com, 13289867381@163.com
About this study
Official title: Effect of Head Acupuncture on Residual Symptoms After Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo: a Single-center Randomized Controlled Trial.
Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and currently, manual repositioning techniques are often used for treatment. However, up to 30%-50% of patients may experience residual symptoms such as non-rotational dizziness, heaviness, instability, and emotional disturbances even after successful repositioning, which significantly impacts their daily functioning and quality of life. Electroacupuncture therapy has been proven to be an effective treatment for dizziness and has been applied to various vestibular disorder patients. However, the efficacy of electroacupuncture on the residual effects of successfully repositioned BPPV patients remains unclear. This study aims to explore the effectiveness of three regimens: electroacupuncture, betahistine in patients with residual symptoms after successful manual repositioning.
Read the 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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Group A, Group B
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AProcedure or surgery
Also called Scalp acupuncture
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.
Group BDrug
Also called betahistine group
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (acupuncture group) | Experimental | Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture Receives: Procedure: Group A |
| Group B (betahistine group) | Active comparator | Treatment patients with residual symptoms after successful manual repositioning by oral betahistine Receives: Drug: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score
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.
Measured: 1weeks after treatment
Dizziness Handicap Inventory
Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
Measured: 1weeks after treatment
Secondary outcomes (1)
Foam posturography
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)
Measured: 1weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mingze Zhao, PhD, Study chair, Xi'an No.3 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001047
- Sponsor's protocol ID
- ACURS
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Acupuncture on Residual Symptoms After Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo: a Single-center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06001047
- Acronym / sponsor ID
- ACURS
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder, and currently, manual repositioning techniques are often used for treatment. However, up to 30%-50% of patients may experience residual symptoms such as non-rotational dizziness, heaviness, instability, and emotional disturbances even after successful repositioning, which significantly impacts their daily functioning and quality of life. Electroacupuncture therapy has been proven to be an effective treatment for dizziness and has been applied to various vestibular disorder patients. However, the efficacy of electroacupuncture on the residual effects of successfully repositioned BPPV patients remains unclear. This study aims to explore the effectiveness of three regimens: electroacupuncture, betahistine in patients with residual symptoms after successful manual repositioning.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (acupuncture group) | Experimental | Procedure: Group ATreatment patients with residual symptoms after successful manual repositioning by electroacupuncture |
| Group B (betahistine group) | Active comparator | Drug: Group BTreatment patients with residual symptoms after successful manual repositioning by oral betahistine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with other ear diseases, history of head trauma or surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: Scalp acupunctureAcupoint 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. | Procedure or surgery | Group A (acupuncture group) |
| Group BAlso: betahistine groupThe 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. | Drug | Group B (betahistine group) |
Primary outcome
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.
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
1 secondary outcome
Foam posturography
Time frame: 1weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingze Zhao, PhD study chair
Xi'an No.3 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Benign Paroxysmal Positional Vertigo, run by Xi'an No.3 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingze Chang, PhD (029+8661816100, changmingze191@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) score (time frame: 1weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.