Rajiv Gandhi University of Health Sciences s28

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE- II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE AND COLACO LOVELINA WALTER

ADDRESS PANGAR BHAT, GIRIZ, VASAI ( WEST), DIST- THANE, MAHARASHTRA, INDIA 401201

2. NAME OF THE INSTITUTION THE OXFORD COLLEGE OF PHYSIOTHERAPY, No.6/9, 1st CROSS

BEGUR ROAD, HONGASANDRA,

BANGALORE- 560068

3. COURSE OF THE STUDY AND MASTERS OF PHYSIOTHERAPY SUBJECT (PHYSOTHERAPY IN MUSCULOSKELETAL DISORDERS AND SPORTS)

4. DATE OF THE ADMISSION TO 20-10-2011 THE COURSE

5. TITLE OF THE STUDY : “A COMPARATIVE STUDY ON CORE STABILISATION EXERCISES WITH SWISS BALL VERSUS CORE STABILISTION EXERCISES WITH PRESSURE BIOFEEDBACK IN REDUCING PAIN AND DISABILITY IN MECHANICAL LOW BACK PAIN SUBJECTS.” BRIEF RESUME OF THE INTENDED WORK : 6.

6.1. NEED OF THE STUDY :

Back pain is one of the most common patient complaint brought forth to the physicians.1

The lifetime prevalence of mechanical low back pain (LBP) in the United States is 60-80%. The prevalence of serious mechanical LBP (persisting >2 wk) is 14%. The prevalence of true sciatica (pain radiating down one or both legs) is approximately 2%.2

Of all cases of mechanical LBP, 70% are due to lumbar strain or sprain , 10% are due to age- related degenerative changes in disks and facets, 4% are due to herniated disks, 4% are due to osteoporotic compression fractures, and 3% are due to spinal stenosis. All other causes account for less than 1% of cases.3

Mechanical LBP is the most common cause of work-related disability in persons younger than 45 years in the United States.2

Mechanical low back pain (LBP) exists in every culture and country. Estimates by numerous investigators indicate that at some point in their lives, 80% of all human beings experience LBP.2

While mechanical low back pain is not associated with mortality, morbidity in terms of lost productivity, use of medical services, and cost to society is staggering. Total workers' compensation costs for cases occurring in 1989 in the United States amounted to $11.4 billion, making it the most costly ailment for working-age adults. No evidence has been found to indicate that these costs are declining.2

In Durham, N. C. , a research team of Duke University Medical Center has found that patients suffering from back pain in consume more than $ 90 billion annually in health-care expenses , with $ 26 billion of that amount directly attributable to treating the back pain.3

Worldwide 37 % of low back pain was attributed to occupation. The attributable was higher for men than women because of higher participation in labour force and in occupation with heavy lifting or whole body vibration.4

In India, back pain is the second most common reason for visits to office based physicians. Conventionally, treatment of this problem has revolved around NSAIDS, physical therapy and spine exercises.5. Specific causes for most LBP are not known. Although negative social interaction (for example, dissatisfaction at work) has been found to relate to chronic LBP, a significant portion of the problem is of mechanical origin. It is often referred to as clinical spinal instability.6

The stabilizing system of spine may be divided into 3 subsystems7:

• The spinal column ,

• The spinal muscles &

• The neural control unit

the spinal column carries the loads and provides information about the position, motion, and loads of the spinal column. The spinal muscles provide significant stability to the spine. When neuromuscular control system is affected there is increased body sway which has been found in patients with low back pain indicating a less efficient muscle control system with decreased ability to provide the needed spinal stability.7

Mechanical low back pain is described as a musculoskeletal pain which varies with physical activities and not involving root compression or serious spinal diseases.

Potential signs and symptoms of ILBP or MLBP.8

1) Morning pain on waking

2) Intermittent pain during day

3) Pain later in the day

4) Palpatory pain of muscles

5) Palpatory pain of spinous process

6) Pain wakes the person up

7) Stiffness after resting(includes sitting)

8) Morning and afternoon pain

9) Pain is either burning/ aching/stabbing/constant

10) Pain on activities like i. trunk extension

ii. lateral bending

iii. straight leg raising

iv. sitting for a while

v. when standing for a while

vi. walking more than 50 m

vii. doing a sit up is painful viii. when lifting

ix. driving long distances

x. bending forward a little

xi. running

xii. repetitive bending xiii. getting out of a chair

xiv. cough or sneeze

xv. trunk flexion

The stability of the spine is provided by :9

1) Passive system ( bone and joint structures & ligaments )

2) Active system ( spinal muscles )

3) Neural control unit

Under normal conditions these systems work together in harmony , providing the spine with the necesssary mechanical stability and maintains the intervertebral ROM within a safe limit to enable activities to be carried out during daily living .9 CORE has been described as a box10

1) Abdominals –front

2) Paraspinals & gluteals –back

3) Diaphragm –roof

4) Pelvic floor & hip girdle musculature –bottom.

Within this box are 29 pairs of muscles that help to stabilise the spine , pelvis and kinetic chain during functional movements.10

The role of the active neuromuscular system in spinal stability should not be underestimated since the passive system is unstable when exposed to forces far less than that of body weight. For example, human osteoligamentous lumbar spine becomes mechanically unstable (in vitro) under a compressive load of approximately 90N , a load much less than the weight of the upper body.11 However the muscles modulate spinal stiffness to match the demands of stability & movement.

In rehabilitation sector , improvements in lower back injuries have been reported by improving core stability.12 Particular attention has been paid to the core because it serves as the muscular corset that works as a unit to stabilise the body & spine, with & without limb movement . In short , the core serves as the center of the functional kinetic chain12.

In Alternative Medicine world, the core has been referred to as the “POWERHOUSE”, the foundation or engine of all limb movement12 .

Local muscles such as transverse abdominis and multifidus are attached to lumbar vertebrae and responsible for segmental stability as well as controlling the position of lumbar segments. Studies have shown that there is dysfunction of transverse abdominis and multifidus in low back pain subjects13

Research has developed specific exercise for transverse abdominis with the help of pressure biofeedback unit and concluded that this specific type of therapeutic exercise with pressure biofeedback provides effective pain relief for chronic and recurrent back pain sufferers through enhanced segmental stability.13

For a person with low back pain swiss ball can be used for a variety of purposes including 14 a) Find neutral spine position

b) Learn proper posture

c) Increase lumbar mobility

d) Increase abdominal and back muscle strength

e) Increase balance and stability

f) Develop overall control and strength of the core muscles

g) Learn to lift properly

Hence, need of my study is to compare the effect of core stabilization exercises for global muscles responsible for lumbar spinal stability with use of swiss ball and isometric contraction of local muscles responsible for lumbar spine stability with the use of pressure biofeedback in reducing pain and disability in subjects with mechanical low back pain.

6.2. REVIEW OF LITERATURE :

 INCIDENCE AND PREVALENCE

1) Xuemei Luo, Ricardo Pietrobon, Lloyd Hey, Shawn Sun, and Gordon Liu3: this team from the Duke University collected data from the Medical Expenditure Panel Survey (MEPS) in 1998. They highlighted the prevalence of back pain in the U.S. and its impact on the health- care system. They found that out of 198.6 million adults, 25.9 million adults reported back pain. They spend more than $ 90 billion annually in health-care expenses , with $ 26 billion of that amount directly attributable to treating the back pain.

2) Punnett L et al (2005)4 : Estimated the global burden of low back pain attributable to combined occupational exposures. They catagorized the world according to WHO sub- region. Population was catagorised based on age and gender specific distribution of work force aged 15 or older in each occupational group as given by International Labour Organization. They found that low back pain was estimated to cause 818,000 disability adjusted life years lost annually (DALY).

3) S C Sharma, R Singh, A K Sharma (2002)5 : did a study on Incidence of low back pain in workage adults in rural North India. Out of 11,234 patients reported to their institution, there were 2,594 (23.09%) patients of low back pain. In 1,738 patients (67%) nonorganic or psychosocial issues were present. 1,457 patients (57%) were heavy manual workers. These patients were interviewed and their psychosocial and demographic details were compared with 1000 controls who did not have back pain but attended outdoor for other reasons. In the low back pain group, 67% had psychosocial issues, 57% were in blue-collar jobs, 26% had to change/leave their profession, and 38% did not enjoy their present job. All patients had used NSAIDS at some stage of illness and 64% were advised exercises for the back.

SPINAL INSTABILITY AND LOW BACK PAIN

4) Manohar M. Panjabi (2003)7 : explains that

The stabilizing system of spine may be divided into 3 subsystems:

. the spinal column ,

. the spinal muscles &

. the neural control unit

the spinal column carries the loads and provides information about the position, motion, and

loads of the spinal column. The spinal muscles provide significant stability to the spine. When

neuromuscular control system is affected there is increased body sway which has been found in

patients with low back pain indicating a less efficient muscle control system with decreased

ability to provide the needed spinal stability.

5) Bruce F. Walker, Owen D. Williamson(2009)8 said that non- specific low back pain is commonly labeled, conceptualised and managed as being inflammatory and / or mechanical in nature.

CORE STRENGTHENING 6) Venu Akuthota , Scott F. Nadler (2004)10 conducted study on core strengthening, they concluded that core strengthening has been promoted as preventive regimen, as a form of rehabilitation and as a performance enhancing program for various lumber spine and musculoskeletal injuries.

SWISS BALL

7) Jerrold S. Petrofsky et al(2007)13 analyzed to determine muscle use that occurred during core body exercise using a 7-inch diameter mini stability ball compared with abdominal crunches on the floor and on a swiss ball. Muscle use was evaluated through the surface electromyogram recorded above the abdominal and lower back muscles. Three levels of core exercise were tested with the mini stability ball and concluded that rectus abdominis muscle activity increased dramatically, there was almost no back extensor activity seen therefore allowing the isolation of the abdominal muscles while not increasing stress on back muscles.

8) Stephenson J, Swank A M (2004)16 believed that a core strength development programme should include : flexibility of the abdominal and lower back , hip extensor and flexor muscles ; exercises in an unstable environment ; as well as isometric and dynamic exercises.

9) Thomas E . Hyde (2010)14. In his article says that physioball exercises is a treatment option for backpain sufferers and is designed to help prevent or minimize further episodes of low back pain.

10) Carolyn Richardson, Gwendolen Jull, Paul Hodges, Julie Hides(1999)17 : states that a principle of unstable surfaces such as physio ball can be used in general stabilization programme for low back pain .

Pressure biofeedback

11) C. A. Richardson and G. A. Jull (1995) 13: They developed specific exercise for transverse abdominis with the help of pressure biofeedback unit and concluded that this specific type of therapeutic exercise with pressure biofeedback provides effective pain relief for chronic and recurrent back pain sufferers through enhanced segmental stability.

12) Gwendolen A.Jull, Shaun P.OLeary, and Deborah L.Falla(2008)18: Air filled pressure sensor used to measure the endurance determined the intraclass correlation coefficient (ICC=.81 and .93 for the activation score and performance index respectively). 13) Pedro Olava de Paula et. al (2011)19 : Systematically reviewed studies on the measurement properties of pressure biofeedback unit for the assessment of transverse abdominis activity and found that there is moderate to good reproducibility (intra-class correlation coefficients from 0.47-0.82) and acceptable construct validity (intra-class correlation coefficients from 0.48-0.90)13

14) Storheim K, BO K, Pederstad O, Jahnsen R.(2002)20 used pressure biofeedback unit in measurement of transverse abdominals function.

OUTCOME MEASUREMENT

15) Polly E.Bijur et al(2002)21.Reliality of Visual Analog Scale for measurement of acute pain (2001) ; states that VAS is sufficient reliable to use to asses acute pain measurement as assessed by the ICC to be high. The summary ICC for all paired VAS scores was 0.97(95%

CI=0.96 to 0.98).

16) Megan Davidson and Jennifer L Keating(2002)22 in a study “A Comparison of Five Low Back Disability Questionnaires: Reliability and Responsiveness” concluded that measurements obtained with the modified Oswestry Disability Questionnaire, the SF-36 Physical Functioning scale, and the Quebec Back Pain Disability Scale were the most reliable and had sufficient width scale to reliably detect improvement or worsening in most

subjects.23

6.3. OBJECTIVES OF THE STUDY:

 To find the effectiveness of core stabilization exercises with swiss ball in reducing pain and disability in mechanical low back pain .

 To find the effectiveness of core stabilization exercises with pressure biofeedback in reducing pain and disability in mechanical low back pain.

 To compare the effectiveness of core stabilization exercises with swiss ball and core stabilization with pressure biofeedback in reducing pain and disability in mechanical low back pain.

6.4. HYPOTHESES : a). Research hypothesis : There will be a significant difference between core stabilization exercise training with swiss ball & core stabilization exercise training with pressure biofeedback unit in reducing pain & disability in mechanical low back pain subjects.

b). Null hypothesis : There will be no significant difference between core stabilization exercise training with swiss ball & core stabilization exercise training with pressure biofeedback unit in reducing pain & disability in mechanical low back pain.

MATERIALS AND METHODS : 7. 7.1. STUDY DESIGN AND SETTING:

7.1.1. STUDY DESIGN : Experimental study

7.1.2. SOURCE OF DATA :

1) The Oxford college of Physiotherapy & Rehabilitation Center

2) Hospitals in and around Bangalore.

7.2. METHODOLOGY :

7.2.1. POPULATION : Mechanical low back pain

Both males and females who satisfy the selection criteria from the population of the study.

7.2.2. SELECTION CRITERIA :

1. INCLUSION CRITERIA :

 Age: 30 to 35

 Gender : both

 Subjects diagnosed with mechanical low back pain .

 Mechanical low back pain since 3 months.

 Subjects willing to participate

2. EXCLUSION CRITERIA : 1. All the patients with chronic low back pain, truly constant severe sciatica with Neurological deficit.

2. During the acute (beginning) phase of a low back pain episode.

3. Cauda equina syndrome, cord compression.

4. Severe trauma, fracture, inflammatory disease.

5. History of medical conditions ( respiratory like asthma/COPD , cardiac like hypertension , dermatological like psoriasis/allergic to material used , renal like renal calculi.)

6. Pregnancy.

7. Menstruation.

8. Any previous history of abdominal ,spine or hip surgery .

9. Patients with specific unstable spine injuries or spinal disease that can be exacerbated by the movements.

10. Cases where the patient's pain increases when using the ball.

11. For people who have fear of falling or who do not feel comfortable on the ball.

7.2.3. SAMPLING METHOD AND SAMPLE SIZE :

▸ Sampling method : Convenient sampling

▸ Sample size: 30

7.2.4. PROCEDURE :

All 30 subjects will be selected and divided into two groups : Group A and Group B according to the inclusion criteria and with informed consent. Patients in both the groups will be assessed for pain on VAS scale and disability on ODI questionnaire on first day and last day. Subjects will be instructed to do warm up exercises for 5 minutes, which consists of static jogging, followed by some free exercises and light stretches held for 15 seconds. Cool down period is for 5 minutes.

Both groups have to perform 4 types of core stability exercises for 10 days . Progression of each exercise will be increase in hold time , increase in repetitions and loading of the limbs. Treatment session will be given 30 minutes for 5 days in a week .

Group A – subjects performing core stabilisation exercises with swiss ball

On the first day, orientation to the swiss ball and its exercises is done.

1) Bridging-lie flat on the ground with legs straight. Place both legs together on exercise ball at the calf area with arms at sides and hands flat on the floor; tighten and lift the buttocks up off the floor to straighten the back, keeping abdominal muscles tight and hold for 5 secs. Return to start position.

2) Pelvic lifts- sit on the floor with your hands behind your shoulder and your heels on top of the swiss ball . Lift your pelvis up and hold for 5 seconds.

3) Roll out- starting position for the roll out involves kneeling with knees flexed at 900 trunk erect ,elbows fully extended , shoulder flexed approximately to 300 , both the hands positioned approximately in the center of swiss ball. From this position subject rolled out on the swiss ball maintaining a neutral spine and pelvis onto the forearm until the proximal forearms were approximately centered on the swiss ball with shoulders flexed approximately 900 to 1000 and return to starting position.

4) Lumbar extension - place lower chest/ abdomen area over the exercise ball with legs straight, spread apart for stability and feet flexed up on toes( or with legs together and feet against a wall); rest hands on the ball, but do not use arms to push up; slowly lift head and chest off the ball as far as comfortable, squeezing shoulder blades while lifting; return to start position.

Group B –subjects performing core stabilisation exercises with pressure biofeedback unit. On the first day orientation of pressure biofeedback unit is done and activation of transverse abdominis and multifidus is taught.

1) Exercise in prone position

• Place the three-chamber pressure cell under the abdomen and inflate to baseline of 70 mmHg. (brown band)

• Draw abdominal wall up and in without moving the spine or pelvis.

• Pressure should decrease 6-10 mmHg.

• Hold 10-15 seconds, breathe normally.

• Perform 10 repetitions.

2) Training the Corset Action in Crook Lying

• Place the three-chamber pressure cell under the lumbar spine and inflate to a baseline of 40 mmHg (orange band).

• Draw in the abdominal wall without moving the spine or pelvis.

• Pressure should remain at 40 mmHg (i.e. no movement of the spine).

• Hold for 10-15 seconds; breathe normally.

• Perform 10 repetitions.

3) Training the Corset Action with Leg Loading in Sitting (hip and knee flexed to 900)

• Place the three-chamber pressure cell behind the lumbar spine and inflate to baseline of 40 mmHg (orange band).

• Draw in the abdominal wall without moving the spine or pelvis.

• Pressure should remain at 40 mmHg (i.e. no movement of the spine) while leg lifts.

• Hold for 10-15 seconds; breathe normally

4) Training the Corset Action with Leg Loading in Standing (against the wall )

• Place the three-chamber pressure cell behind the lumbar spine and inflate to baseline of 40 mm Hg (orange band).

• Draw in the abdominal wall without moving the spine or pelvis.

• Pressure should remain at 40 mmHg (i.e. no movement of the spine) while leg lifts. • Hold for 10-15 seconds; breathe normally

7.2.5. MATERIALS REQUIRED :

 Swiss ball and its mat

 Pen and Paper

 Pressure biofeedback unit

7.3. STATISTICAL ANALYSIS :

1) Wilcoxon’s test.

7.4 a) Does the study require any investigation to be conducted on patients or other humans or

Animals?

No.

b) Has the ethical consent for the study has been obtained from the institution is case?

Yes.

REFERENCES :

8 1) James J. Chien and Zahid H. Bajwa. What is mechanical back pain and how best to treat it?: Current Pain And Headache Reports 2008; (12), 406-411.

2) Everett C Hills, Rene Cailliet et al. Mechanical Low Back Pain . updated Jan 12, 2012. http://emedicine.medscape.com/article/310353-overview#a0199.

3) Xuemei Luo, Ricardo Pietrobon, and Lloyd Hey, Shawn Sun and Gordon Liu, Economic Impact Of Back Pain Substantial. ScienceDaily 2004: Jan 1. www.sciencedaily.com/releases/2004/01/040101090402.htm

4) Laura Punnett, Annette Pruss-Ustun, Deborah Imel Nelson, Marilyn A. Fingerhut, James Leigh, SangWoo Tak, Sharonne Phillips. Estimating the global burden of low back pain attributable to combined occupational exposures: The American Journal of Industrial Medicine2005.

5) Sharma SC, Singh R, Sharma AK, Mittal R. Incidence of low back pain in workage adults in rural North India. Indian J Med Sci 2003;(57):145-7.

6) A.L. Nachemson, Advances in low-back pain, Clin Orthop 200 1985 ;266–278.

7) Manohar M. Panjabi. Clinical spinal instability and low back pain: Journal of Electromyography and Kinesiology 13 (2003) ;371-379.

8) Bruce F. Walker , Owen D. Williamson. Mechanical or inflammatory low back pain. What are the potential signs and symptoms?: Manual Therapy 14(2009); 314-320.

9) Manohar M. Panjabi. The Stabilizing System of the Spine. Part I. Function, Dysfunction, Adaptation, and Enhancement. Journal Of Spinal Disorders & Techniques 1992 ; 5. No.4

10) Akuthota V, Nadler SF. Core strengthening: Arch Phys Med Rehabil 2004; 85(3):S86-96.

11) Crisco JJ, Panjabi MM, Yamamoto I, Oxland TR. Euler stability of the human ligamentous lumbar spine. Part II: Experiment: Clin Biomech 1992;7:27-32.

12) Angela E. Hibbs , Kevin G. Thompson, Duncan French, Allan Wrigley and Iain Spears. Optimizing Performance by Improving Core Stability and Core Strength: Sports Med2008; 38 (12): 995-1008.

13) C A Richardson and G. A. Jull. Muscle control – pain control. What exercises would you prescribe?: Manual therapy 1995 ;1: 2-10.

14) Thomas E . Hyde. Exercise Ball Uses. updated at 18 /11/2010. www.spine- health.com/treatment/physical-therapy/exercise-ball-uses.

15) Jerrold S. Petrofsky, Jennifer Batt, Nicceta Davis, Everett Lohman, Michael Laymon, Gerson E. De Leon, et al. Core Muscle Activity During Exercise on a Mini Stability Ball Compared With Abdominal Crunches on the Floor and on a Swiss Ball :The Journal of Applied Research 2007;7,255- 272.

16)Stephenson, J. and Swank, A. M. Core- training: Designing a program for anyone. Strength and Conditioning Journal 2004, 26(6): 2-5.

17) Carolyn Richardson, Gwendolen Jull, Paul Hodges, Julie Hides. Textbook of therapeutic exercise for spinal segmental stabilization in low back pain :152-153.

18) Gwendolen A. Jull, Shaun P. O'Leary and Deborah L. Falla. CLINICAL ASSESSMENT OF THE DEEP CERVICAL FLEXOR MUSCLES: THE CRANIOCERVICAL FLEXION TEST: Journal of Manipulative and Physiological Therapeutics September 2008; 525-533.

19) Pedro Olavo de Paula Lima, Rodrigo Riberio de Oliveira, Leonardo Oliveira Pena Costa, Gloria Elizabeth Carneiro Laurentino. Measurement properties of pressure biofeedback unit in the evaluation of transversus abdominis muscle activity: a systematic review. Physiotherapy 97 ;100- 106.

20) Storheim K, BO K, Pederstad O, Jahnsen R. Intra-tester reproducibility of pressure biofeedback in measurement of transverse abdominis function. 2002; 7(4): 239-249.

21) E John Gallagher, Polly E Bijur, Clarke Latimer, Wendy Silver. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. The American journal of emergency medicine2002 ;20(4): 287-290

22) Megan Davidson, Jennifer L Keating. A comparison of five low back disability questionnaires: reliability and responsiveness. Physical therapy 2002;82(1):8-24. 9. Signature of the Candidate

10. Remarks of the guide

11. NAME AND DESIGNATION OF THE DR.T. SATHIYA SELVAM, MPT GUIDE ASSISTANT PROFESSOR

11.1 Guide

11.2 Signature

11.3 Co- Guide

11.4 Signature

11.3 Head of the Department

11.4 Signature

12 12.1 Remarks of chairman & Principal

12.2 Signature

APPENDIX- I

THE OXFORD COLLEGE OF PHYSIOTHERAPY,

NO 6/9, 1ST CROSS, BEGUR ROAD, HONGASANDRA, BANGALORE:560068

Review Board on Ethics for Research

Review Category: Exemption from Review Expedited Review Full Review

We hereby declare that the project titled,“ A COMPARATIVE STUDY ON CORE STABILISATION EXERCISES WITH SWISS BALL VERSUS CORE STABILISTION EXERCISES WITH PRESSURE BIOFEEDBACK IN REDUCING PAIN AND DISABILITY IN MECHANICAL LOW BACK PAIN” carried out by MISS. COLACO LOVELINA WALTER, of 1st Year M.P.T. has been brought forward for scrutiny to the board members.

Involvement of Special groups: Yes No

If Yes Pregnant/ Nursing women; Children; Economically Disadvantaged;

Socially Disadvantaged; Mentally Challenged

Type of Study: Cross sectional survey Case Control Cohor

RCT AV Needs: Yes No

After analyzing the objectives, subjects involved and the methodology of the study, the following conclusions were drawn. The study does not cause any mental or physical harm to the subjects involved and there are no risks involved in the study. The board has evaluated and confirmed that the experimenter is trained and qualified in measuring outcome. The informed consent form ensures that the experimenter explains the procedure of the study to the subjects, their voluntary participations is confirmed and the identification of subjects is maintained confidential.

More over the finding of the study will benefit the profession and the society. Hence the review board has no objections on the conduct of the study.

Chairman Vice Chairman

Date:

APPENDIX-II

ETHICAL CONSENT FORM

I, the undersigned, have fully understood that

Mrs./Miss……………………………………………………………………………………………… ………………… is being used as a subject for undertaking the scientific study titled

“ A COMPARATIVE STUDY ON CORE STABILISATION EXERCISES WITH SWISS BALL VERSUS CORE STABILISTION EXERCISES WITH PRESSURE BIOFEEDBACK IN REDUCING PAIN AND DISABILITY IN MECHANICAL LOW BACK PAIN SUBJECTS”

I have been made aware of the purpose for this study. I understand that I have to cooperate with the researcher for this study and a copy of the consent form has been given to me for my reference.

Date:

Permission of the subject

Place:

APPENDIX-III

CONSENT FORM

TITLE:

INVESTIGATOR: Miss. COLACO LOVELINA WALTER (post graduate student)

Contact Detail of Principal Investigator:

Chairman IEC No. 6/9, 1st cross, Hongasandra, Begur main road,

Bangalore – 68.

Phone: 080-30219842.

SUBJECT’S CONSENT:

I Miss/ Mrs. ……………………. agree to participate in the study. I have understood the procedure of the study as explained to me by the investigator of the study.

This study will help the health care professionals to know about the public awareness of physiotherapy and helped them to know about physiotherapy.

PURPOSE OF THE RESEARCH:

I have been informed by Miss. Colaco Lovelina Walter , is going to do an Experimental study will help physiotherapy to understand the effects of core stabilization exercises with swiss ball and pressure biofeedback for faster recovery and prevent reoccurance of mechanical low back pain.

PROCEDURE: I have been explained that this study is an Experimental study in which core stabilization exercises are conducted by the use of swiss ball and pressure biofeedback and the results will be obtained through Visual Analogue Scale and Modified Oswestry Disability Index. 30 subjects will be taken for this study purpose.

RISK AND DISCOMFORT:

I know there are no risks involved in participating in the study as this a questionnaire & during filling the questionnaire if I feel any discomfort Miss. Colaco Lovelina Walter will take appropriate care to safeguard the welfare and best interests of the subjects.

BENEFITS:

This study will give the knowledge about effects of core stabilization exercises with swiss ball and pressure biofeedback in subjects with mechanical low back pain by decreasing pain and disability. This technique can be used in physiotherapy for faster recovery and prevention of reoccurance of mechanical low back pain. In society, it will reduce work absenteism , morbidity and economic impact.

CONFIDENTIALITY:

I understand that the medical information produced by this study will be confidential. Apart from the investigator no one will ever access to the data without my consent. If the data are used for the publication in the medical literature or for teaching purpose no name will be used.

PHOTOGRAPHY CONSENT DOCUMENT:

I………….. Have been explained by Miss. COLACO LOVELINA WALTER that photograph are required in order to illustrate various aspect of the study for the thesis and other article, and at presentation and conference. These images may also be converted to electronic format for use in multimedia presentation and document accessible to other by computer for the purpose of sharing the result of the study and for promoting this research. By giving my consent I authorize her to use any of the photographs taken in printed format, in slides for presentation, and in electronic format. If the photograph is use the face will be taped to prevent identification.

REQUEST FOR MORE INFORMATION: I understand that I am encouraged to discuss any concerns regarding this study at any time. Miss. COLACO LOVELINA WALTER is available to answer my question to the best of his knowledge. A copy of this consent form will be given to me for my careful reading.

REFUSAL OR WITHDRAWAL OF PARTICIPATION:

I understand that my participation is voluntary and I may withdraw consent and discontinue participation any time without fear of prejudice. My decision whether or not to participate will not affect relationship with any agency, heath care provider, etc. I also understand that she may terminate my participation in the study after she has explained the reason for doing so.

NON COMMERCIALIZATION:

The data collected will not be distributed for monetary benefit.

INJURY STATEMENT:

I understand that in the unlikely event of injury resulting directly from the participation in the study, medical treatment would be available, but no further compensation will be provided. I understand my agreement to participate in the study and I am not waiving any of the legal rights for the same. Injury is least possible because of the study as it a survey study.

I have explained to Mr./ Ms.…………………..the purpose of the research, the procedures required and possible risks and benefits associated, to the best of my ability.

INVESTIGATOR: DATE:

I confirm that Miss. Colaco Lovelina Walter has explained me the purpose of this research, the study procedure and the possible risks and benefits associated that I may experience. I have read and understood this consent form to let myself participate as a subject in this research project and I am giving the consent willfully.

SUBJECT: DATE:

SIGNATURE OF WITNESS: