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临床试验/NCT01969513
NCT01969513已完成不适用

Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
2
主要终点
PERSISTENCE OF VERTIGO

研究概览

简要总结

Vertigo is a common medical issue with a broad expectrum of diagnoses that requires a global approach to patients through structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV) that is confirmed by a positive Dix-Hallpike positional test and treated with repositioning manoeuvres. Objective: To evaluate the effectiveness of Epley's manoeuvre performed by general practitioners (GPs) in the treatment of BPPV. Design: randomized clinical trial conducted in primary care. Scope: Two urban centres serving about 50,000 patients. Patients: All patients with newly diagnosed BPPV will be offered to participate in the study and will be randomly assigned to the treatment group (Epley manoeuvre) or control group (sham manoeuvre) and both groups will receive betahistine. Outcome variables will be: response to the Dix Hallpike test, patients will inform if vertigo was present during the last week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert scale in the past week, score of Vertigo Handicap Inventory and quantity of betahistine taken. Statistical analysis: Descriptive statistics of all variables collected. Groups will be compared using the intent-to-treat approach and either parametric or nonparametric tests depending on the nature and distribution of the variables. Chi-square test or exact Fisher test will be used to compare qualitative measures and Student's t test o Mann Whitney U test will be used for between-group comparison of variables.

Positive results from our study will highlight that treatment of BPPV can be performed by trained GPs and its widespread practice can greatly improve the quality of life of these patients.

详细描述

DESIGN:

Randomized clinical trial conducted by general practitioners (GP) who received a two hour training to perform the manoeuvres under the supervision of an otorhinolaryngologist. Patients will be reevaluated 1 week, 1 month and 1 year after the first visit by a different GP from the first visit to accomplish blinding of study participants and personnel.

MAIN OBJECTIVE:

The aim of this study is to determine whether the improvement is greater in intervention group than in control group in terms of Dix-Hallpike manoeuvre turning negative, subjective perception of vertigo and quality of life, and less amount of betahistine taken.

The main objective is the response of treatment in the second visit (1 week after the first visit), although new assessments will be carried out at day 30 and one year after the first visit.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and older who attend our primary care centre, with suspected diagnosis of BPPV, and present vertigo or nystagmus with DH manoeuvre. All other causes of vertigo will be ruled out.
  • Written informed consent will be obtained from all subjects of both intervention group and control group prior to its inclusion in the study.

排除标准

  • Previous or current diagnoses of labyrinth's diseases such as Meniere's disease, labyrinthitis or vestibular neuronitis.
  • Contraindications to canalith repositioning procedures: cervical spinal stenosis, severe kyphoscoliosis, limited cervical mobility, Down syndrome, advanced rheumatoid arthritis, cervical radiculopathies, Paget's disease, morbid obesity, ankylosing spondylitis, severe lumbar dysfunction and spinal cord injuries.
  • Pregnancy or breastfeeding.
  • Contraindications of betahistine.
  • Refusal of patients to participate in the study.

结局指标

主要结局

PERSISTENCE OF VERTIGO

时间窗: One week after recruitment

Evaluate if the Dix Hallpike manoeuvre produces dizziness or nystagmus to the right or left or both sides. If they are present at both sides the manoeuvre will be considered positive for the side where the symptoms are intense.

次要结局

  • SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE(One week after recruitment)
  • DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)(One year after recruitment)
  • BETAHISTINE TABLET COUNT(One month after recruitment)
  • NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT(One year after recruitment)
  • PATIENTS REPORTING PERSISTENCE OF VERTIGO(One year after recruitment)

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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