Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

Comparison of Home-Based Modified Self-Epley Manoeuvre and Brandt-Daroff Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms: A Randomized Single-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230513
• Other study ID #: MREC ID NO: 20155-1337
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: July 30, 2017
• Start date: October 1, 2015
• Est. completion date: May 1, 2017

Study information

• Verified date: July 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Benign paroxysmal positional vertigo (BPPV) is the most common vestibular disorder in adults and the treatment of choice is by particle repositioning manoeuvres (PRM). This study aims to compare the treatment efficacy of two home-based exercises, self-Epley manoeuvre (SEM) and Brandt-Daroff exercise (BDE) in patients with posterior canal BPPV based on vertigo resolution, reduction of vertigo intensity, the Dizziness Handicap Inventory scores and the conversion of a positive to negative Dix-Hallpike test.

Description:

Study Objective:

To compare the efficacy of the self-Epley manoeuvre to the Brandt-Daroff exercise in resolving vertigo symptoms in patients with unilateral posterior canal BPPV.

Study Design:

Single-blind randomized controlled study

Sample Size:

Fifty patients were recruited in the study and were divided with 25 patients in each treatment arm.

Study Method:

Patients who satisfy the inclusion criteria and have given informed consent were randomized into the 2 treatment groups. A dedicated physiotherapist will demonstrate the selected exercise (either SEM or BDE) and observed the patient performing the exercise twice to ensure the ability of the patient to perform it correctly at home. A diary was provided for the patients to chart the therapy sessions performed at home as well as a pamphlet with simple illustrated instructions of the chosen exercise. The patients were asked to perform the home-based exercise for 2 weeks.

Primary Outcome Measure

• Resolution of vertigo symptoms in patients with unilateral posterior canal BPPV.

Secondary Outcome Measures

• Vertigo resolution at 1 and 6 months;

• The conversion of positive to negative Dix-Hallpike test between both groups after 1 month;

• Vertigo intensity in unresolved vertigo patients at 1 & 6 months;

• The Dizziness Handicap Inventory between both groups at 1 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2017
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who have had symptoms of vertigo for at least 1 week duration,

• patients with a documented positive Dix-Hallpike test on referral,

• patients with intact cognitive function and had the ability to communicate and understand instructions to perform a home-based exercise.

Exclusion Criteria:

• patients with history of prior ear surgery,

• patients with orthopaedic or connective tissue disorder that impairs functional neck or trunk range of motion,

• patients with a significant neurological disorder or spinal cord damage, and

• patients who have been prescribed with home-based exercises for BPPV.

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

Other:
• Self Epley Manoeuvre
The patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks.
• Brandt-Daroff Exercise
The patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertigo resolution	Present or absent	Assessed at 1 month and 6 months following initiation of home-based exercise.
Secondary	Conversion of a positive to negative Dix-Hallpike test	Positive or negative	Assessed at 1 month following initiation of home-based exercise.
Secondary	Vertigo intensity	Patients were asked to rate the average severity or intensity of the vertigo episode in the previous one week based on a 1-to-5 Likert scale, with a scale of 5 implying the most intense or severe.	Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Secondary	Dizziness Handicap Inventory	A 25 item questionnaire that encompasses 3 domains which are functional, physical and emotional. The scores are summed with maximum score of 100 and the higher the score, the greater the perceived handicap.	Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.