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

NCT01969513 | Completed DMC

• 2 other identifiers: 4R13/029-1ID: 4R13/017
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Positional Paroxysmal Vertigo

Keywords

Vestibular Diseases; Vertigo; Primary care; Epley maneuver

Outcome Measures

Primary Outcomes (1)

• PERSISTENCE OF VERTIGO

  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.

  One week after recruitment

Secondary Outcomes (12)

• BETAHISTINE TABLET COUNT

  One week after recruitment

• NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT

  One year after recruitment

• SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE

  One year after recruitment

• DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)

  One week after recruitment

• PATIENTS REPORTING PERSISTENCE OF VERTIGO

  One week after recruitment

Study Arms (2)

INTERVENTION ARM

EXPERIMENTAL

Patients meeting the inclusion criteria will be randomly assigned to the experimental group. They will receive Epley's manoeuvre plus betahistine 8mg three times a day until they no longer have symptoms. The Epley's manoeuvre will be performed only on the first visit.

Procedure: PROCEDURE: EPLEY MANOEUVRE

CONTROL GROUP

SHAM COMPARATOR

Patients meeting the inclusion criteria will be randomly assigned to the control group. These patients will receive sham manoeuvre (simulated Epley manoeuvre) plus betahistine 8mg three times a day until they no longer have symptoms. Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.

Procedure: PROCEDURE: SHAM MANOEUVRE

Interventions

PROCEDURE: EPLEY MANOEUVRE PROCEDURE

The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.

Also known as: Canalith repositioning manoeuvre

INTERVENTION ARM

PROCEDURE: SHAM MANOEUVRE PROCEDURE

Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.

Also known as: Simulated Epley manoeuvre

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Red Española de Atención Primaria (REAP): collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

CAP Florida

L'Hospitalet de Llobregat, Barcelona, 08905, Spain

Location

Related Publications (2)

• 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.

  PMID: 31722671 DERIVED

• 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.

  PMID: 24886338 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vestibular Diseases; Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

• José Luis Ballvé

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: October 25, 2013
• Study Start: November 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

ES (1)