Clinical trial NCT03230513: Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: vertigo
benign paroxysmal positional vertigo
particle repositioning manoeuvre
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to either the SEM group (written as "Group A") or the BDE group (written as "Group B") throughout the duration of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vertigo resolution
timeFrame: Assessed at 1 month and 6 months following initiation of home-based exercise.
Secondary outcomes:
measure: Conversion of a positive to negative Dix-Hallpike test
timeFrame: Assessed at 1 month following initiation of home-based exercise.
measure: Vertigo intensity
timeFrame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
measure: Dizziness Handicap Inventory
timeFrame: Assessed on first assessment during recruitment, at 1 month and 6 months following initiation of home-based exercise.
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: Mazlina Mazlan, MBBS, MRM
role: STUDY_CHAIR
affiliation: University of Malaya
name: Nor Hanim Mohamad Hanapi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: