Effect of Head Acupuncture on Residual Symptoms After Canalith Repositioning Procedure for Benign Paroxysmal Positional Vertigo: a Single-center Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) score
研究概览
简要总结
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.
详细描述
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:
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
- Double (Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A (acupuncture group)
Treatment patients with residual symptoms after successful manual repositioning by electroacupuncture
干预措施: Group A (Procedure)
Group B (betahistine group)
Treatment patients with residual symptoms after successful manual repositioning by oral betahistine
干预措施: Group B (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) score
时间窗: 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
时间窗: 1weeks after treatment
Self-perceived handicapping effects imposed by dizziness. Internal consistency (Cronbach's alpha: 0.92), Test-retest reliability r = 0.95
次要结局
- Foam posturography(1weeks after treatment)