Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV

NCT06001047 | Recruiting DMC

• 1 other identifier: ACURS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1weeks after treatment

Secondary Outcomes (1)

• Foam posturography

  1weeks after treatment

Study Arms (2)

Group A (acupuncture group)

EXPERIMENTAL

Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture

Procedure: Group A

Group B (betahistine group)

ACTIVE COMPARATOR

Treatment patients with residual symptoms after successful manual repositioning by oral betahistine

Drug: Group B

Interventions

Group A PROCEDURE

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.

Also known as: Scalp acupuncture

Group A (acupuncture group)

Group B DRUG

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.

Also known as: betahistine group

Group B (betahistine 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an No.3 Hospital: lead

Study Sites (1)

Xi'an No3 Hospital

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

• Mingze Zhao, PhD

  Xi'an No.3 Hospital

  STUDY CHAIR

Central Study Contacts

Mingze Chang, PhD

CONTACT

029+8661816100; changmingze191@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: August 21, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)