Post Graduate in Department ENT

From, Dr Reena Valsamma George, Post Graduate in Department ENT, A.J. Institute of Medical Sciences, Mangalore- 575004 To, The Registrar, Rajiv Gandhi University of Health Sciences, Bangalore

(Through proper channel)

Sub: Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am submitting synopsis of my dissertation work: “COMPARISON OF SEMONT’S MANOEUVRE AND EPLEY’S MANOEUVRE WITH AND WITHOUT BETAHISTINE THERAPY IN RELIEVING VERTIGO IN POSTERIOR SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO(p-BPPV)” for the registration in Rajiv Gandhi University of Health Sciences, Bangalore.

Thanking you,

Yours faithfully,

Dr. Reena Valsamma George

Place: Mangalore

Date: 18/11/2013 CURRICULUM VITAE Name : Dr.Reena Valsamma George

Date of Birth : 1st February, 1985-28 Years

Present Designation : Junior Resident

Department : ENT

College : A.J.Institute of Medical Science

City : Mangalore

Residential Address : Door No: 3-32/10, Sonal House, Down Town, Kadri-B, Bejai post, Mangalore-575004.

Ph & Fax No with code : Office : 0824– 2225533

Mob No : 8197855204

Email Address : [email protected]

Date of joining present Institution : June 05th, 2013 as Junior Resident

Qualification:

Qualification College University Year Registration No Name of the of UG & PG with State Medical date Council MBBS WUHAN WUHAN 2010 11-38976 MEDICAL UNIVERSITY UNIVERSITY,CHINA Dt:30th COUNCIL OF SCHOOL OF MARCH,2011 INDIA MEDICINE

Details of the previous appointments / teaching experience

Designation Department Name of Institution From DD/MM/YY To DD/MM/YY PG/Jr Resident ENT A.J.Institute of Medical 05th June, 2013 Till date Sciences, Mangalore

CURRICULUM VITAE Name : Dr.Sheetal D

Date of Birth : July 22, 1977 – 36Years

Present Designation : Associate Professsor

Department : ENT

College : A.J.Institute of Medical Science

City : Mangalore

Residential Address : Flat No.202, Inland Salute, 4th mile, Konchadi, Kavoor P.O, Mangalore-15

Ph & Fax No with code : Office : 0824– 2225533

Residence : 0824 – 2241487

Mob No : 9342856795

Email Address : [email protected]

Date of joining present Institution : March 04, 2008 as Assistant Professor

Qualifications:

Qualification College University Year Registration No Name of the of UG & PG with State Medical date Council MBBS B.M Patil Medical Karnataka Dec 1999 58553 Karnataka Medical College, Bijapur University Dt: Mar 13, 2001 Council

MS (ENT) J.J.M Medical RGUHS April 2006 58553 Karnataka Medical College, Bangalore Dt: April 2006 Council Davangere DM/M.Ch NA NA NA NA NA Details of the previous appointments / teaching experience

Designation Department Name of From To Total Insttution DD/MM/YY DD/MM/YY Experience in years & months PG/Resident ENT J.J.M Medical Jan 1, 2003 April 30, 2006 3 Years and 4 College, Months Davangere

Registrar ENT A.J.B ENT Aug 1, 2006 Jan 30, 2007 6 Months Muncipal Hospital, Mumbai

Senior Registrar ENT L.T Muncipal Feb 16, 2007 Jul 31, 2007 6 Months Medical College, Mumbai Assistant ENT A.J Institute of Mar 04, 2008 Aug 08, 2012 4 Years and 5 Professor Medical Months Sciences, Mangalore

Associate ENT A.J Institute of Aug 09, 2012 Till Date 1 Year and 1 Professor Medical Month Sciences, Mangalore

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

ANNEXURE II SYNOPSIS FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE CANDIDATE DR.REENA VALSAMMA GEORGE POSTGRADUATE STUDENT AND ADDRESS DEPT OF ENT A.J.INSTITUTE OF MEDICAL SCIENCES MANGALORE- 575004

A.J.INSTITUTE OF MEDICAL SCIENCES 2 NAME OF THE MANGALORE- 575004 INSTITUTION

3 COURSE OF STUDY AND MS COURSE IN ENT

SUBJECT

4 DATE OF ADMISSION TO 5th JUNE 2013

COURSE “COMPARISON OF SEMONT’S

5 TITLE OF THE TOPIC MANOEUVRE AND EPLEY’S MANOEUVRE WITH AND WITHOUT BETAHISTINE THERAPY IN RELIEVING VERTIGO IN POSTERIOR SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO(p- BPPV)” 6 BRIEF RESUME OF INTENDED WORK:

6.1. NEED FOR THE STUDY:

Benign paroxysmal positioning vertigo(BPPV) is a disorder characterized by brief

attacks of vertigo, with associated nystagmus, precipitated by certain changes in head

position with respect to gravity.1 It is the most common cause of the syndrome of

provoked vertigo.

BPPV occurs due to the inappropriate stimulation of

SemiCircularCanal( SCC) hair cells, in response to changes in head position with

respect to gravity, by sequestered otoconia.2 Otoconia are crystals of calcium

carbonate that are normally found embedded in the gelatinous otolithic membranes of

the utricle and saccule.3 If free floating otoconia find their way into the duct of an

SCC (canalolithiasis ) or attach themselves to the cupula of an SCC( cupulolithiasis),

changes in head position in the plane of that SCC will result in displacement of the

cupula, either directly in the case of cupulolithiasis or indirectly by altering

endolymphatic fluid pressure in the case of canalolithiasis.4 The cupular

displacement results in vertigo and nystagmus in the plane of stimulated SCC.5 In

cases where the otoconia are in the posterior or anterior SCC, the nystagmus will be

vertical –torsional.The characterstic clinical sign of BPPV is nystagmus following a

Dix-Hallpike manoeuvre. To perform a provocative Dix- Hallpike manoeuvre, the patient’s head is turned to left and the patient is quickly pitched backwards until the head is hanging over the end of the bed.6 In this position, the midpoint of the posterior SCC duct is lowermost and any otoconia in the duct will therefore move away from the ampulla and come to at the midpoint of the duct. As the otoconia move away from the ampulla, they create a negative fluid pressure and thereby produce an excitatory ampullofugal deflection of the cupula.7 The clinician will observe, after a latent period of several seconds,vertical- torsional nystagmus, with the quick phases directed upwards and towards the lowermost(affected) ear.8 With gaze

towards the lowermost ear, the nystagmus will appear to be predominantly torsional,

whereas with gaze towards the uppermost ear, it will appear to be predominantly

vertical. 9The nystagmus typically lasts for less than 30 seconds and is associated

with such intense vertigo that patients are often inclined to shut their eyes.10 The characteristic nystagmus is observed to confirm the diagnosis.

BPPV can be treated effectively by relocating otoconia from the SCC duct into the vestibule by using different repositioning manoeuvres. However they are different manoeuvres in use for repositioning and only few studies have been done so far to compare the efficacy of each.

6.2. REVIEW OF LITERATURE:

1. In a study done by Dispenza F, Kulamarva G and De Stefano A in Italy did a randomized comparison study of repositioning manoeuvres for benign paroxysmal positional vertigo of posterior semicircular canal in 2 tertiary referral centers. All consecutive patients with diagnosis of BPPV of posterior canal matching the inclusion criteria were enrolled. Patients underwent treatment soon after the initial diagnosis in all cases with a repositioning manoeuvre. The manoeuvre was casually selected among Semont, Epley, and hybrid. Patients were divided into 3 groups according to the manoeuvre adopted. Eighty-eight patients with posterior canal BPPV

were enrolled for treatment. Fisher exact test showed that no statistical differences exist between hybrid manoeuvre and other manoeuvres in terms of efficacy. All manoeuvres evaluated demonstrated similar efficacy The hybrid manoeuvre showed a

good percentage of success similar to most manoeuvres used. It is also more comfortable for the patients with hip or neck functional limitation allowing an effective treatment of the posterior canal BPPV. . 2. In another study done by Babac S and Arsović N for studying the efficacy of Epley manoeuvre in treatment of benign paroxysmal positional vertigo of the

posterior semicircular canal. This prospective study included 75 patients. In all the cases medical history showed and the positioning Dix- Hallpike test confirmed the diagnosis of p-BPPV. They performed clinical ENT examination, searching for spontaneous nystagmus, vestibulospinal tests, caloric test, and audiometry. All the patients were treated by the modified Epley canalith repositioning manoeuvre. The patients were followed up at the intervals of seven and, fourteen days, and one, tree, and six months and one year. The manoeuvre was repeated if vertigo and nystagmus on control positioning test persisted. The transition from positive into negative Dix Hallpike test after one or two Epley manoeuvre was considered as success in treatment. After the initial Epley manoeuvre the recovery rate was 90.7%, and after the second 96%. In three (4%) patients with secondary p- BPPV, symptoms did not cease even after the second repositioning manoeuvre. The etiology of p-BPPV had a significant effect on the manoeuvre's success rate (p < 0.01), whereas duration of symptoms, age and gender had no effect (p > 0.05). The Epley manoeuvre is very successful repositioning procedure in treating p-BPPV. The patients with idiopathic form p-BPPV showed higher success rate with Epley manoeuvre than those with secondary p-BPPV.

3. Study by Soto-Varela A, Rossi-Izquierdo M, Martínez-Capoccioni G, Labella-Caballero T and Santos-Pérez S,Santiago to evaluate the efficacy of the Santiago treatment protocol for benign paroxysmal positional vertigo of the posterior semicircular canal, to analyse recurrence and to establish prognostic factors.Four hundred and twelve patients with unilateral benign paroxysmal positional vertigo of the posterior semicircular canal were treated with the Semont manoeuvre and, if symptoms did not resolve, successive application of three Epley manoeuvres plus

Brandt-Daroff exercises.Symptoms resolved in 404 patients (98.1 per cent); a single Semont manoeuvre was sufficient in 334 (81.2 per cent). Aetiology had no impact on resolution of symptoms or number of maneuvers required. The estimated likelihood of recurrence was 14 per cent in the first year and 27 per cent after 10 years.In unilateral benign paroxysmal positional vertigo of the posterior semicircular canal, the above treatment protocol cured 98 per cent of patients. More than half of recurrences occurred in the first year. None of the analyzed factors increased the likelihood of recurrence.

4. In a study done by M. Cavalier, G. Mottola and M. Iemma in Moscati Hospital, Avellino, Italy conducted a study of two manoeuvres with and without betahistine in BPPV. Efficacy of the liberatory manoeuvre and of gradual otolitis dispersion technique, with or without associated drug therapy, have been compared. Included in this prospective study were 103 patients with benign paroxysmal positional vertigo seen in the Outpatient Department. Patients were classified into 4 groups according to treatment: Liberatory Maneuver according to methods described by Semont et al., with and without betahistine, Gradual Otolitis Dispersion Technique according to Brandt and Daroff, with and without betahistine. Evaluation was performed at baseline and at 3, 7, 14, 30, 60 and 90 days after start of treatment. Response to treatment was evaluated using criteria of Epley. Both liberatory manoeuvre and Brandt and Daroff, when associated with betahistine, were significantly more effective than manoeuvres alone. Improvement in liberatory manoeuvre-betahistine group, in the initial phase, was greater that in Brandt and Daroff-betahistine group. 5. Study by Califano L, Capparuccia PG, Di Maria D, Melillo MG and

Villari D in a treatment of Benign Paroxysmal Positional Vertigo based on Semont's

Liberatory manoeuvres and on so-called "Canalith Repositioning manoeuvres",

derived from the original Epley technique. In the present randomised trial, 300

patients with posterior canalo/cupulolithias were divided into 3 treatment groups:100

treated by Semont Technique; 100 by a Repositioning procedure (Parnes technique);

100 by a new manoeuvre called "Quick Liberatory Rotation". Results of treatment are

also compared with the natural evolution of Benign Paroxysmal Positional Vertigo observed in 18 untreated patients. Quick Liberatory Rotation is similar in the

sequence of the positions of the head in the horizontal plane, to repositioning procedures, but is more like the Semont manoeuvres in the speed of the movement

(about 180 degrees in less than one second). Quick Liberatory Rotation is easy to perform, well tolerated and very effective (success rate: 98% in one-three cycles). In

the present investigation, a secondary liberatory nystagmus was observed in 76.1%, with a sensitivity of 81.9% in detecting patients who had completely recovered and a specificity of 43.8% in detecting failures. Effectiveness, in short and medium period

(1-15 months), is similar to Semont and Parnes techniques. Authors consider Quick

Liberatory Rotation, at present, a possible first choice technique in the treatment of posterior canalolithiasis.

6. A retrospective study by Wolf JS, Boyev KP, Manokey BJ and Mattox DE Division of Otolaryngology-Head and Neck Surgery, University of Maryland Medical System, Baltimore, USA. They conducted a chart review of 107 patients diagnosed with BPPV at their institution between March of 1993 and June of 1995. Each patient was diagnosed with isolated BPPV by history and Hallpike-Dix manoeuvres. There were no other vestibular symptoms or electronystagmogram abnormalities. Patients diagnosed with BPPV received modified Epley manoeuvres, were instructed to remain upright for 48 hours, and wore a soft collar for a week.

Patients were followed up with repeat Hallpike-Dix manoeuvres at 1 to 2 weeks. If symptoms persisted, the manoeuvre was repeated for up to a maximum of three times, at which point patients were considered to have failed treatment. The average age of patients was 57.8 years old. Thirty percent were male and the right ear was affected in 54%. The posterior semicircular canal was affected in 105 ears. The average patient received 1.23 Epley manoeuvres, with a success rate of 93.4%. No successfully treated patients received mastoid vibration. Seven out of 107 patients failed after three Epley manoeuvres. Two failure patients had a history of temporal bone fracture. Two failure patients were treated with posterior semicircular canal block surgery.

6.3. AIMS & OBJECTIVES OF STUDY

1. To determine the role of the manoeuvres in BPPV.

2. To study the efficacy of the manoeuvres in BPPV.

7 MATERIALS AND METHODS:

7.1. SOURCE OF DATA:

Patients presenting to ENT department of A J Institute of

Medical Sciences Mangalore. Study group consists of 4 groups

of adults (age group 30-70years) with 20 individuals in each

study group.

SAMPLING TECHNIQUE- Random sampling technique will

be adopted.

STUDY DESIGN-Interventional Study.

Inclusion criteria: Adults between age groups of 30-70 years

presenting to ENT outpatient department with history of brief

recurrent history of vertigo that occur following certain

changes in head position with respect to gravity. The vertigo

worsens while getting in or out of bed, pitching the head

forwards while bending over or pitching head backwards while

looking up. Each episode of vertigo lasting 10-20seconds. The

vertigo is so intense and accompanied by nausea and

occasional vomiting. Patients who are constantly dizzy.

Patients with p-BPPV, who are positive Dix–Hallpike

manoeuvre and normal study in Pure Tone Audiometry(PTA)

will be recruited into 4 study groups with each group having at

least 20 patients. Positive Dix-Hallpike maneuvre for posterior canal disease is defined by the presence of upbeating and torsional nystagmus with the top pole of rotation beating toward the affected (downside) ear.

Exclusion criteria: Adults suffering from cervical spondylosis, multiple canal disease, inner ear disease and vertigo caused by

CNS lesions.

7.2. METHOD OF COLLECTION OF DATA:

80 patients with posterior canal BPPV will be recruited after obtaining the informed consent into 4 study group(each study group containing 20 number each)who are fulfilling the inclusion criteria. After explaining the procedure and obtaining informed consent from each participant, all the patients will be divided into 4 study group by random selection. First study group will be treated with Semont’s manoeuvre. Second study group with Semont’s manoeuvre with beta histine therapy. Third study group with Epley’s manoeuvre. Fourth study group with Epley’s manoeuvre with beta histine therapy. Patients diagnosed with BPPV and who received manoeuvres, were instructed to remain upright position at 45degree for 48 hours, and wore a soft collar for a week. Evaluation of outcome will be done for each study group at the end of 4th week and after 3 months of the initial therapy with Dix- Hallpike maneuver and an arbitrary patient-rated vertigo intensity and frequency scale of 1 to 10 (10 being the most severe or frequent). Each will be considered recovered if they have complete symptom resolution with a negative Dix-Hallpike manoeuvre. If thesymptoms persist the treatment protocol will be repeated until they are free of symptoms with negative Dix-Hallpike manoeuvre. STATISTICAL ANALYSIS-Analysis of Variance will be used to test the significance of the difference between the groups.Various forms of presentations such as tables and diagrams will be used to represent the data.

7.3 Does the study require any investigation or interventions to be conducted on patients or other human or animals? If so, please describe briefly.

Yes, mentioned in 7.2

7.4 Has the ethical clearance obtained from your

institution?

YES LIST OF REFERENCES:

8 1. Dispenza F, De Stefano A, Kulamarva G. Comparison of

repositioning manoeuvres for Benign Paroxysmal Positional

Vertigo of posterior semicircular canal: advantages of hybrid

manoeuvre. Am J Otolaryngol. 2012 Sep-Oct;33(5):528-32.

2. Babac S, Arsović N. Efficacy of Epley maneuver in treatment of benign

paroxysmal positional vertigo of the posterior semicircular canal. Vojnosanit

Pregl(Serbian). 2012 Aug;69(8):669-74.

3.Soto-Varela A, Rossi-Izquierdo M, Martinez-Capoccioni G,

Labella-Caballero T, Santos-Perez S. Benign Paroxysmal

Positional Vertigo of the posterior semicircular canal: efficacy

of Santiago treatment protocol, long –term follow up and

analysis of recurrence. J Laryngol Otol. 2012 Apr; 126(4): 363-

4. Fife TD, Iverson DJ, Lempert T, Furman JM, Baloh RW,

Tusa RJ, Hain TC, Herdman S, Morrow MJ, Gronseth GS.

Practice parameter: therapies for Benign Paroxysmal

Positional Vertigo (an evidence –based review): report of the

Quality Standards Subcommittee of the American Academy of

Neurology. Neurology. 2008 May 27; 70(22): 2067-74.

5. Cavaliere M, Lemma M, Mottola G.Benign Paroxysmal

Positional Vertigo: a study of two manoeuvres with and

without betahistine. Acta Otorhimolaryngol Ital. 2005 April; 25(2): 107-112.

6.Califano L, Capparuccia PG, Di Maria D, Melillo MG,

Villari D. Treatment of Benign Paroxysmal Positional Vertigo of posterior semicircular canal by “Quick Liberatory Rotation

Manoeuvre”. Acta Otorhinolaryngol Ital. 2003 Jun; 23(3): 161-

7. Wolf JS, Boyev KP, Manokey BJ, Mattox DE. Success of the modified Epley manoeuvre in treating Benign Paroxysmal

Positional Vertigo. Laryngoscope. 1999 Jun; 109(6): 900-3.

8.1-10G Michael Halmagyi, Mathew J Thurtell and Ian S

Curthoys. Vertigo: Clinical Syndromes. Scott-Brown’s

Otorhinolaryngolgy, Head and Neck Surgery.7th Edition 2008.

Volume 3:3760-3.

9. Hilton M, Pinder D. The Epley manoeuvre for benign paroxysmal positional vertigo--a systematic review. Clinical Otolaryngology and allied Sciences 2002

Dec;27(6):440-5.

10. López-Escámez J, González-Sánchez M, Salinero J. Meta- analysis of the treatment of benign paroxysmal positional vertigo by Epley and Semont maneuvers.

Acta Otorrinolaringol Esp. 1999 Jun-Jul;50(5):366-70.

9 SIGNATURE OF

CANDIDATE: 10 REMARKS OF THE GUIDE:

11 NAME AND DESIGNATION OF:

11.1. GUIDE DR. SHEETAL D

ASSOCIATE PROFESSOR DEPARTMENT OF ENT A.J.INSTITUTE OF MEDICAL SCIENCES KUNTIKANA, MANGALORE - 575004

11.2. SIGNATURE

11.3. HEAD OF THE OF DR.DEVAN P.P,

THE DEPARTMENT: PROFESSOR AND HOD

A.J.INSTITUTE OF

MEDICAL

SCIENCES,KUNTIKANA,M

ANGALORE-575004 11.4. SIGNATURE:

12 12.1.REMARKS OF THE

CHAIRMAN AND

PRINCIPAL: 12.2.SIGNATURE OF THE

PRINCIPAL:

A. J. INSTITUTE OF MEDICAL SCIENCES, MANGALORE

TITLE: “COMPARISON OF SEMONT’S MANOEUVRE AND EPLEY’S MANOEUVRE WITH

AND WITHOUT BETAHISTINE THERAPY IN RELIEVING VERTIGO IN POSTERIOR

SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO (p-BPPV)”

PROFORMA FOR DATA COLLECTION

A. PERSONAL DETAILS

1. Name :

2. Age :

3. Sex :

4. Occupation :

5. Father’s/Mother’s name :

6. I.P. No. /O.P. No :

7. Date :

8. Address :

B. QUESTIONNAIRE FOR HISTORY TAKING

1. Vertigo: Character of Vertigo: (i) Duration and periodicity:

(ii) Visual Analog Scale

No Dizziness Worst dizziness

Severity scale 0 to 10 (0=no Vertigo, 10= maximum severity)

Relation to head position:

Interval of attacks:

2. Dizziness Handicap Inventor 16-34 Points (mild handicap) Score: ______36-52 Points (moderate handicap)

54+ Points (severe handicap)

Dizziness Handicap Inventory Survey. The patient is asked to answer each question as it pertains to dizziness or unsteadiness problems, specifically considering their condition during the last month. Questions are designed to incorporate functional (F), physical (P), and emotional (E) impacts on disability.

Question Yes Sometimes No 1.Does looking up increase your problem? 2.Because of your problem, do you feel frustrated? 3.Because of your problem, do you restrict your travel for business or recreation? 4. Does walking down the aisle of a supermarket increase your problem? 5. Because of your problem, do you have difficulty getting into or out of bed? 6. Does your problem significantly restrict your participation in social activities, such as going out to dinner, going to the movies, dancing or going to parties? 7. Because of your problem, do you have difficulty reading? 8. Does performing more ambitious activities like sports, dancing, household chores such as sweeping or putting dishes away increase your problem? 9. Because of your problem, are you afraid to leave your home without having someone accompany you? 10. Because of your problem, have you been embarrassed in front of others? 11. Do quick movements of your head increase your problem? 12. Because of your problem, do you avoid heights? 13. Does turning your head in bed increase your problem? 14. Because of your problem, is it difficult for you to do strenuous housework or yard work? 15. Because of your problem, are you afraid people may think you are intoxicated? 16. Because of your problem, is it difficult for you to walk by yourself? 17. Does walking down a sidewalk increase your problem? 18. Because of your problem, is it difficult for you to concentrate? 19. Because of your problem, is it difficult for you to walk around your home in the dark? 20. Because of your problem, are you afraid to stay home alone? 21. Because of your problem, do you feel handicapped? 22. Has your problem placed stress on your relationships with members of your family or friends? 23. Because of your problem, are you depressed? 24. Does your problem interfere with your job or household responsibilities? 25. Does bending over increase your problem? Total=(#”yes”×4)+(#”sometimes”×2)+(#”no”×0) #*4 #*2 #*0

3.Associated Nausea or Vomiting:

4. Hearing Loss:

5. Fullness of Ear: 6. Tinnitus:

7. Diplopia:

8. Speech disorders:

9. Any neurological symptoms- tremor, weakness:

10. History of drug intake and head injury:

C. EXAMINATION OF EAR, NOSE AND THROAT:

Preauricular region:

Pinna:

Post auricular region:

External Auditary Canal:

Tuning fork test: ( i ) Rinne

(ii ) Weber

(iii) Absolute bone conduction

Otoscopy:

Dix-Hall pike manoeuvre:

2 Nose

External nose

Vestibule Anterior rhinoscopy

Nasal cavity

Posterior rhinoscopy

3 Throat

Anterior pillar

Posterior pillar

Tonsils:

Posterior pharyngeal wall

4 PNS tenderness:

5 Neck:

6 Lymph node examination:

D. SYSTEMIC EXAMINATIONS: -

iii PA

iv CNS

v Simple vestibular test (i) Romberg test

(ii) Positional nystagmus

(iii) Unterberger test

vi Ophthalmological examination

vii Cerebellar test

viii Presence of nystagmus and type and character of nystagmus.

E. INVESTIGATIONS:

1. Pure tone audiometry

2. Blood investigations

a. Hemoglobin (g%):

b. Total count:

c.Differential count ;

d.ESR:

e. Serum electrolytes: Na+ - K+- Cl- -

f. B.Urea:

g. S.Creatinine :

h. RBS:

F. DIAGNOSIS:

H. TREATMENT:

SEMONT’S MANOEUVRE/SEMONT’S MANOEUVRE WITH BETAHISTINE/

EPLEY’S MANOEUVRE/EPLEY’S MANOEUVRE WITH BETAHISTINE THERAPY

TIMELINE

TITLE : “COMPARISON OF SEMONT’S MANOEUVRE AND EPLEY’S MANOEUVRE WITH AND WITHOUT BETAHISTINE THERAPY IN RELIEVING VERTIGO IN POSTERIOR SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO(p-BPPV)”

Phase Time Period

1. August - 2013 to

December – 2013

2. January 2014

June 2015

November 2015 Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE.

Informed consent form for the volunteers at “A J Institute of Medical Sciences, Kuntikana, Mangalore”, who will be participating in the research project (MS dissertation) entitled : “COMPARISON OF SEMONT’S MANOEUVRE AND EPLEY’S MANOEUVRE WITH AND WITHOUT BETA HISTINE THERAPY IN RELIEVING VERTIGO IN CASE OF POSTERIOR SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO(p-BPPV)”

Name of Principal Investigator Dr. Reena Valsamma George, Postgraduate student Name of Organization Department of ENT,

A J Institute of Medical Sciences, Kuntikana, Mangalore

This Informed Consent Form has two parts:

• Information Sheet (to share information about the research with you) • Certificate of Consent (for signatures if you agree to take part) You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction

I, Dr. Reena Valsamma George, postgraduate student in the Department of ENT, A J Institute of Medical Sciences, Kuntikana, Mangalore, am working on my MS dissertation titled “COMPARISON OF SEMONT’S MANOEUVRE AND EPLEY’S MANOEUVRE WITH AND WITHOUT BETAHISTINE THERAPY IN RELIEVING VERTIGO IN POSTERIOR SEMICIRCULAR CANAL BENIGN PAROXYSMAL POSITIONAL VERTIGO (p-BPPV)”.

I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified. Purpose of the research

Vertigo is defined by Cawthorne (1957) as a “Hallucination of movement and can be applied to any movement provided that it does not exist outside the sense sufferer ”True vertigo is a sense rotation of once body or head, or of the environment, or sense of falling.

Type of Research Intervention

In this study if you are selected, detailed history taking, clinical examination and routine investigations will be done.

Participant selection

Study group: Adult between age groups of 30-70 years presenting to ENT outpatient department of A.J Institute of medical science with history of brief recurrent history of vertigo that occur following certain changes in head position with respect to gravity. The vertigo worsens while getting in or out of bed, pitching the head forwards while bending over or pitching head backwards while looking up. Each episode of vertigo lasting 10-20seconds.

The vertigo is so intense and accompanied by nausea and occasional vomiting. Patients who are constantly dizzy.

Procedures and Protocol

Eighty patients who are between 30-70 years with Vertigo will be recruited in study group

after obtaining the informed consent. Detailed history, clinical examination and routine blood investigation will be done. After explaining the procedure all the patients will be

divided into 4 study group each study group consisting of atleast 20 patients. First study group will be treated with Semont’s manoeuvre. Second study group with Semont’s manoeuvre with beta histine therapy. Third study group with Epley’s manoeuvre. Fourth study group will be treated with Epley’s manoeuvre with beta histine therapy. Evaluation of

outcome will be done for each study group at the end of 4th week and after 3 months.The data will be analysed statistically. Duration: 3 months

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not affect your patient’s treatment process.

Benefits

Personally you might be or may not be benefited in any way directly from the research. But by taking part in this research, you will be helping the scientific community.

Possible risks

There are no major physical risks for the person associated with these methods. Complications include exacerbation of symptoms after manoeuvre which is rare possibility.

Reimbursements

You won’t be given any monetary incentives or gifts for being a part of this research.

Confidentiality

The information that we collect from this research project will be kept confidential. Information about the patient that will be collected during the research will be put away and no-one but the researchers will be able to see it.

Sharing the Results

The knowledge that we get from doing this research will be shared with you. Confidential information will not be shared. We will publish the results in order that other interested people may learn from our research. Right to Refuse or Withdraw

You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.

Who to Contact

This proposal has been reviewed and approved by the Research and Ethical committee of A J institute of Medical Science, Kuntikana Mangalore, which is a committee whose task it is to make sure that research participants are protected from harm.

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have been explained the procedure and complications. I am willing to participate in the study. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.

Name of Participant______

Signature of Participant ______

Date ______

Day/month/year If illiterate a literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Name of witness______Thumb print of participant

Signature of witness ______Date ______

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1. Blood investigations:

• Hb, TC, DC, ESR, RBS, Serum electrolytes, Blood Urea and Serum Creatinine.

2.Pure tone audiometry. 3. Semont’s manoeuvre, Semont’s manoeuvre with beta histine therapy, Epley’s manoeuvre and Epley’s manoeuvre with beta histine therapy.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

A copy of this informed consent from has been provided to the participant.

Name of Researcher/person taking the consent______Signature of Researcher /person taking the consent______

Date ______

Day/month/year