Clinical trial NCT01969513: Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Benign Paroxysmal Positional Vertigo
Official title: Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Positional Paroxysmal Vertigo
Keywords: Vestibular Diseases
Vertigo
Primary care
Epley maneuver
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Red Española de Atención Primaria (REAP)
name: Instituto de Salud Carlos III
First posted: 2013-10-25
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: INCLUSION CRITERIA

* 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.

EXCLUSION CRITERIA

* 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.

Primary outcomes:
measure: PERSISTENCE OF VERTIGO
timeFrame: One week after recruitment
Secondary outcomes:
measure: BETAHISTINE TABLET COUNT
timeFrame: One week after recruitment
measure: NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT
timeFrame: One year after recruitment
measure: SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
timeFrame: One year after recruitment
measure: DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
timeFrame: One week after recruitment
measure: PATIENTS REPORTING PERSISTENCE OF VERTIGO
timeFrame: One week after recruitment
measure: PATIENTS REPORTING PERSISTENCE OF VERTIGO
timeFrame: One month after recruitment
measure: PATIENTS REPORTING PERSISTENCE OF VERTIGO
timeFrame: One year after recruitment
measure: DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
timeFrame: One month after recruitment
measure: DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
timeFrame: One year after recruitment
measure: SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
timeFrame: One month after recruitment
measure: SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
timeFrame: One week after recruitment
measure: BETAHISTINE TABLET COUNT
timeFrame: One month after recruitment
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: CAP Florida
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: José Luis Ballvé
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrillo Munoz R, Ballve Moreno JL, Villar Balboa I, Rando Matos Y, Cunillera Puertolas O, Almeda Ortega J, Rodero Perez E, Monteverde Curto X, Rubio Ripolles C, Moreno Farres N, Matos Mendez A, Gomez Nova JC, Bardina Santos M, Villarreal Minano JJ, Pacheco Erazo DL, Hernandez Sanchez AM; Grupo de estudio del vertigo en atencion primaria Florida. Disability perceived by primary care patients with posterior canal benign paroxysmal positional vertigo. BMC Fam Pract. 2019 Nov 13;20(1):156. doi: 10.1186/s12875-019-1035-3.
citation: Ballve Moreno JL, Carrillo Munoz R, Villar Balboa I, Rando Matos Y, Arias Agudelo OL, Vasudeva A, Bigas Aguilera O, Almeda Ortega J, Capella Guillen A, Buitrago Olaya CJ, Monteverde Curto X, Rodero Perez E, Rubio Ripolles C, Sepulveda Palacios PC, Moreno Farres N, Hernandez Sanchez AM, Martin Cantera C, Azagra Ledesma R. Effectiveness of the Epley's maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial. Trials. 2014 May 21;15:179. doi: 10.1186/1745-6215-15-179.