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-
71.
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.
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
ENT,
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:
1 Ear
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: -
i CVS
ii RS
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
To
June 2015
3.
June 2015
To
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