Download rajiv gandhi university of health sciences, karnataka, bangalore

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
Name of the candidate and
address
2.
Name of the institution
3.
4.
5.
Course of study and subject
Dr. JAPNEET KAUR
POST GRADUATE STUDENT
DEPT OF OTORHINOLARYNGOLOGY
BANGALORE MEDICAL COLLEGE
RESEARCH INSTITUTION
BANGALORE-02
BANGALORE MEDICAL COLLEGE
AND RESEARCH INSTITUTE,
BANGALORE
MS OTORHINOLARYNGOLOGY
Date of admission of the course
31/05/2013
Title of the topic
“MANAGEMENT OF BENIGN PAROXYSMAL POSITIONAL VERTIGO: EPLEY’S MANOEUVRE WITH CONVENTIONAL DRUG THERAPY VS
CONVENTIONAL DRUG THERAPY ALONE.”
6. Brief resume of the intended work
6.1 Need for the study:
Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular
disorder, accounting for 20% of all vertigo cases1, 2. Idiopathic BPPV is most common
between the ages of 50 and 70, although the condition is found in all age groups. The
incidence of idiopathic BPPV ranges from 11 to 64 per 100,000 per year1, 3.Sex distribution is
about equal for post-traumatic and post-vestibular neuritis BPPV2, although in its idiopathic
form appears to be approximately twice as common in females.4
It was first described by Barany in 1921, and later described in more detail by Dix and Hall
pike in 19525. Benign Paroxysmal Positional Vertigo (BPPV) is a common complaint of
emergency department patients. The importance of early diagnosis and treatment can lead to
a much improved quality of life for patients afflicted by this ailment. Common practice by
physicians is to rule out serious medical causes for their symptoms. It is presently common
for physicians to treat these patients mainly with benzodiazepines, antihistamines, and
anticholinergic medications, especially if the history and physical is consistent with BPPV.
This method of treatment has had questionable success. Several reviews of the management
of vertigo have shown that no medication in current use has well established curative or
prophylactic value or is suitable for long-term treatment.
Epleys manoeuvre is also used in the treatment of BPPV. This manoeuvre relocates free
floating particles from the affected semicircular canals back into utricle, thus relieving the
symptoms of vertigo
The purpose of this study is to compare the efficacy of Epleys manoeuvre with conventional
drug therapy vs. conventional therapy alone in patients who present with vertigo. It is the
purpose of this study to evaluate and examine two methods of treatment.
6.2 Review of literature:
1. Study conducted by Sridhar et al found only a 15% spontaneous resolution rate in the
control group which formed patients treated with Epleys Manoeuvre as compared to placebo
group after 12 months.6
2. Study by Itaya et al compared PRMs to a medication-alone treatment group PRMs had
substantially higher treatment responses (78.6%-93.3% improvement) compared with
medication alone (30.8% improvement) at 2 weeks follow-up.7
3. Study done by Steenerson and Cronin in which they randomly allocated 20 patients into
either a PRM or vestibular habituation group and 20 patients into a no-treatment group. At 3
months, all patients in the treatment group had resolution of their symptoms, whereas only
25% of the no-treatment group were symptom free.8
4. A Study by Lynn and colleagues 46 randomly allocated 36 patients to either a PRM group
or placebo treatment group with assessment at 1 month by an audiologist who was unaware
of the patients’ treatment allocation. Resolution of vertigo was significantly higher in the
PRM group (89%) compared with the placebo group (27%) 9, 10
6.3 Aims and Objectives of the study
1. To compare the effectiveness of Epley’s manoeuvre along with drug therapy vs drug
therapy alone in the management of BPPV.
2. To compare Long term improvement of symptomatology between the two methods of
treatment.
7.1 Materials and methods:
Study design:
Prospective Study
Study area:
Outpatient Department of Sri Venkateshwara ENT Institute and Department of ENT
Bowring and Lady Curzon Hospital, Bangalore Medical College and Research Institute
Study population:
Patients presenting with symptoms of positional vertigo to the outpatient department ,Sri
Venkateshwara ENT Institute and Department of ENT Bowring and Lady Curzon Hospital,
Bangalore Medical College and Research Institute.
Inclusion criteria:
1. Subject is a male or female above 18 years of age and below 60yrs
2. Patients with strong history suggestive of BPPV and positive Dix-Hall pike manoeuvre. A
Dix-Hall pike manoeuvre will be considered positive when the patient experiences nystagmus
but resolves or fatigues in less than 60 seconds.
3. Informed consent can be obtained for participation in this study.
Exclusion criteria:
1. Subjects who are unable to ambulate.
2. Subjects with severe cervical spine disease
3. Subjects with known cerebral vascular disease like carotid stenosis
4. Subjects with a known history of Meniere's disease.
5. Subjects with h/o cardiac complaints
6. Vertigo due to other CNS causes
Study period:
October 2013 to May 2015.
Study sample size:
60 patients diagnosed with BPPV via positive Dix hallpike will be included in the study and
it will be carried out for the above mentioned time period.
Methodology for data collection:
Data collection will be started after obtaining clearance from the Ethics Committee.
Informed consent for the study will be obtained from all the patients presenting with
symptoms of vertigo.
In this study 60 Patients presenting to OPD who have been diagnosed with BPPV via a
Positive Dix Hall pike will be randomized into two age and sex matched groups of 30 each
one group will receive the more common conventional medication therapy and second group
will receive the canalith repositioning technique (Epleys manoeuvre) along with drug therapy
for 2 weeks.
The patients will be followed up weekly for 6 weeks to assess the efficacy of the treatment .
The efficacy of the treatment will be assessed using
1. Subjective resolution of symptomatic vertigo on change in posture
2. Conversion of positive to negative Dix Hall pike
3. Frequency and severity of attacks of vertigo
4. Visual Analogue Scale for vertigo
Methodology for data analysis:
Data will be analyzed using descriptive statistics and chi-square test. Suitable statistical
software will be utilized for analysis and will be presented in the form of tables, figures,
graphs, diagrams wherever necessary.
7.8 Does the study require any investigation or intervention to be conducted on patients
or other humans or animals? If so please describe briefly.
Yes. After informing the patient and obtaining prior written consent, the patients will be
subjected to investigations as indicated. No animal study is required.
Investigations:-Complete Haemogram, Urine examination, ECG, Colour Doppler, X-ray
cervical spine where ever necessary
Intervention: - Epleys manoeuvre
7.9 Has ethical clearance has been obtained from your institution in case of 7.8?
Dissertation will be submitted for Ethics Committee clearance
8. List of references
1.Froehling DA, Bowen JM, Mohr DN, Brey RH, Beatty CW, Wollan PC, et al. The canalith
repositioning procedure for the treatment of benign paroxysmal positional vertigo: a
randomized controlled trial. Mayo Clinic Proceedings. 2000;75(7): 695–700.
2. Parnes LS, Agrawal SK, Atlas J. Diagnosis and management of benign paroxysmal
positional vertigo (BPPV). Canadian Medical Association Journal [serial online] 2003 Sep
[cited 2013 Sep 18]; 169(7): 10-12. Available from:
URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC202288.
3.Hilton MP, Pinder DK. The Epleys (canalith repositioning) manoeuvre for benign
paroxysmal positional vertigo. Cochrane Database of Systematic Reviews 2004, Issue 2. Art.
No.: CD003162. DOI:10.1002/14651858
4
4...Baloh RW, Honrubia V, Jacobson K. Benign positional vertigo: clinical and oculographic
features in 240 cases. Neurology 1987;37(3): 371–8.
5.Scott- Brown’s Textbook of Otorhinolaryngology, Head and Neck Surgery, 7th Edition vol3. Great Britain: Hodder Arnold; 2008: p. 3678.
6.Sridhar S, Panda N, Raghunathan M. Efficacy of particle repositioning manoeuvre in
BPPV:a prospective study. American Journal of Otolaryngology 2003;24(6): 355–60.
7.Itaya T, Yamamoto E, Kitano H, et al. Comparison of effectiveness of manoeuvres and
medication in the treatment of benign paroxysmal positional vertigo. ORL J
Otorhinolaryngology Relat Spec 1997;59:155–8.
8.Steenerson RL, Cronin GW. Comparison of the canalith repositioning procedure and
vestibular habituation training in forty patients with benign paroxysmal positional vertigo.
Otolaryngology - Head and Neck Surgery 1996;114(1): 61–4.
9.Bhattacharyya N, Baugh RF, Orvidas L, Barrs, D, Bronston, L, Cass, S, Chalian, A,
Desmond, A, Earll J. “Clinical practice guideline:benign paroxysmal positional vertigo”.
Otolaryngology Head Neck Surg[serial online] 2008 Aug [cited 2013 Sep 15]; 139(5): 47-81.
Available from: URL:doi:10.1016/j.otohns.2008.08.022. PMID 18973840. Lay summary
10.Lynn S, Pool A, Rose D, Brey R, Suman V. Randomized trial of the canalith repositioning
procedure. Otolaryngology - Head and Neck Surgery 1995;113(6):712–20. 1048–53.
9.
Signature of the
candidate
10.
Remarks of the Guide
BPPV presents as an alarming condition affecting the
patient’s daily activities. Epley’s manoeuvre appears to
be very effective in its management. In this study we
would to like compare the efficacy of Epley’s
manoeuvre with that of conventional drug therapy.
11
11.1
Name and designation of
Guide
11.2
Dr. Karthik Shamanna
MBBS,MS(Otorhinolaryngology)
Assistant Professor
Department of Otorhinolaryngology
Bangalore Medical College and Research
Institute, Bangalore.
Signature
11.3
Head of the Department
11.4
Signature
12.1
Remarks of the,
Director cum Dean
12.2
Signature
Dr.H.S Satish
MBBS,DLO,MS(Otorhinolaryngology)
Professor and H.O.D
Dept of Otorhinolaryngology
Bangalore Medical College and
Research Institute, Bangalore.