RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.

Name of the candidate and GAZAL KANTI NIROULA

address

House No. 19/169, Ratna Marga,

Dharan 19, Sunsari,

2.

Nepal
Name of the Institution and K.T.G COLLEGE OF PHYSIOTHERAPY
address

Hegganahalli Cross,Vishwaneedam Post,

Sunkadakatte Via Magadi Road,
Bangalore 560091

3.

Course of study and subject

MASTER OF PHYSIOTHERAPY
(Musculoskeletal

Disorders

and

Sports

Physiotherapy )
4.

Date Of Admission To Course

5.

Title of The Topic:

RELATIONSHIP
BALANCE

BETWEEN

ASSESSMENT

05/08/2013

TWO
TESTS

OSTEOARTHRITIS OF KNEE

DIFFERENT
FOR

STRENGTH

SUBJECTS

AND
WITH

6.

Brief resume of the intended work:

6.1 Need for the study:
Knee osteoarthritis (OA) is one of the most prevalent musculoskeletal complaints
worldwide, affecting 3040% of the population by the age of 65 year. 1 In India, it is
the second most common rheumatological problem and is the most frequent joint
disease with prevalence of 22% to 39%.2 Individuals with knee OA suffers
progressive loss of function, displaying increasing dependency in walking, stair
climbing and other lower extremity tasks involving balance. Understanding the
impact of knee OA on balance may allow possible mechanisms of disability in this
patient population to be elucidated, and may permit more effective management of
patients with the disease.1
Postural control impairment (balance), defined as the capacity to maintain the centre
of mass within the base of support in the upright position in diverse situations, is
associated with activity limitations in OA.3 Adequate postural control allows not only
the maintenance of posture when carrying out activities, but it is also essential for the
prevention of serious injuries due to falls.1 Neuromuscular disorders, such as muscle
weakness and proprioceptive inaccuracy, as well as knee instability, are present in
patients with OA and might contribute to decreased postural control. Some studies
have documented the existence of decreased postural control in patients with OA 3,
and its association with muscle strength and proprioception. 4-6

Postural sway is often used as an indicator of static standing balance measured using
force platforms. These expensive apparatus are not readily available to the majority
of clinicians. Furthermore, falls and loss of balance most commonly occur during
movement-related tasks therefore it is important that the evaluation of balance
incorporates testing procedures that reect the dynamic nature of such locomotor
tasks, as static tests of balance are less able to identify individuals at risk of falls.
Simple, inexpensive and easy-to- administer clinical tests are required to allow the
clinician to assess balance readily and quickly in patients with knee OA.1 A set of user
friendly physical performance measures for assessing lower limb strength and
balance for patients with established knee OA has been recommended by the
Osteoarthritis Research Society International (OARSI). Two of the minimal core set
of the tests include the 30 second Chair Stand Test (CST) and stair negotiation or
Stair Climb Test (SCT).7

During chair standing, there is a powerful concentric contraction of knee extensors

along with hip extensors to lift the trunk from the chair. During standing to sitting,
the hip and knee extensors act eccentrically to slow the descent of the trunk. 8 CST
measures of the ability to rise from a chair, which is an activity that is commonly
limited in people with lower extremity OA. The test is quick and easy to perform and
has minimal administrative or respondent burden. Kim Bennell and colleagues used
the CST where more repetition within 30 second represented better balance and lower
limb strength.9
During stair climbing, knee flexors concentric contraction starts at the end of swing
3

phase and continues during mid-stance. During descending there is active contraction
of knee extensors and knee flexors acts as well at the end of swing phase. 10 SCT
measures the ability to negotiate stairs, which is a common activity limitation and
rehabilitation goal in people with lower extremity. It appears to be responsive to
detect change (expected improvement and expected deterioration) following
interventions such as physiotherapy and joint replacement surgery. Kim Bennell and
colleagues in their study used SCT to assess balance in a number of subjects with
OA. They recorded the time (seconds) taken to complete the task, where smaller
values represent better performance. The SCT correlates well with other physical
performance measures.9
These two measures were chosen because each represents an important function for
older adults that can be affected by impairments such as knee pain, muscle force
deficits, decreased range of motion, decreased endurance, poor balance and postural
control all of which are associated with OA of the knee.11
Research examining both the measures independently is widely available, yet no
research has directly examined the relationship between these two tests for assessing
balance and lower limb strength in patients with knee OA. Thus there is a need for
further research for examining relationship between these two tests so clinicians have
an objective basis for selecting a particular test in the evaluative and rehabilitation
stages of knee OA. Establishing whether relationship exists is the first step in
providing evidence regarding whether the different tests may be assessing unique
aspects of the construct of postural control. Hence the purpose of this study is to
determine the relationship between the chair stand test and stair climb test that assess
4

lower limb strength and balance for subjects with OA of knee.

Research Question
Whether there is any significant relationship between the chair stand test and the stair
climb test for assessment of balance and lower limb strength in subjects with OA
knee?

Hypothesis:
Null hypothesis
There is no significant relationship between the chair stand test and the stair climb
test for assessing balance and lower limb strength in subjects with osteoarthritis of
knee.

Research hypothesis
There is a significant relationship between the chair stand test and the stair climb test
for assessing balance and lower limb strength in subjects with osteoarthritis of knee.

6.2 Review of Literature:

Review on Osteoarthritis of Knee Joint :
Marc C. Hochberg et al. (2012) studied the recommendations for the use of
nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and
5

knee. These recommendations were based on the consensus judgment of clinical

experts from a wide range of disciplines informed by available evidence, balancing
the benefits and harms of both nonpharmacologic and pharmacologic modalities. In
their study they found the most strongly recommended non pharmacological and
pharmacological modalities for knee osteoarthritis.12

Joern W. et al. (2010) carried out analysis to find out epidemiology, etiology,
diagnosis and treatment of osteoarthritis of the knee and database were selectively
searched for current studies. In their study they stated that about one third of the adult
population have radiological signs of osteoarthritis of the knee and that the likelihood
of developing osteoarthritis increases with age.13

Milisa Blagojevic et al. (2010) carried out an analysis to determine the current
evidence on risk factors for knee osteoarthritis. They found out that obesity and
previous knee trauma were the main factors associated with it along with other
secondary factors.14

G Peat et al. (2006) studied clinical classification criteria for knee osteoarthritis and
performance in the general population and primary care. In their study they have
summarized the relationship between fulfilling the American College of
Rheumatology clinical classification criteria for knee osteoarthritis and the presence
of symptomatic radiographic knee osteoarthritis.15

Review on Balance and Strength tests :

Kim Bennett et al. (2011) evaluated the physical performance measures that relate
directly with lower extremity OA. They concluded that Stair Climbing Test has more
responsiveness hence is used to assess balance and lower limb strength.9
Harrison (2004) studied the effects of balance on function using 3 physical
functions: walking 20m, climbing up and down stairs and going from sitting to
standing. Timed sit to stand was associated with independence in instrumental
activities of daily living. Timed stair climbing had a correlation with balance.11

Y-C. Lin et al. (2001) assessed balance and physical function of older patients with
clinical knee and/or hip osteoarthritis using a battery of physical function tests like
walking, stair climbing, chair rising and range of motion of affected OA joints and
found that the performance scores were correlated with each other.16

Review on Outcome measurement

Review on Chair Stand Test:
F Dobson et al. (2012) in their systematic review for the measurement properties of
21 performance based measures to assess physical function in hip, knee OA patients
reported that on balance, 30 second Chair Stand Test and timed up and go test were
the best rated sit to stand tests on evaluation of its internal consistency, reliability,
measurement error, validity, responsiveness and interpretability.17

Stephen Gill et al. (2008) studied the reliability of 30 second Chair Stand Test in
subjects with knee, hip OA and found that it is a reliable measure of physical
performance.18

Ostchega Yechiam et al. (2000) studied the reliability of timed chair stand, full
tandem stand, and timed 8-foot walk and concluded that lower extremity functions
measured by timed chair stand and walk are reliable.19

Review on Stair Climb Test:

Gustavo J. Almeida et al. (2010) studied interrater reliability and measurement error
of an stair ascend/descend test and concluded that it has good interrater reliability and
minimum detectable changes adequate for clinical use. The pattern of associations
supports the validity of the stair test.20

Deborah M Kennedy et al. (2005) examined the reliability and sensitivity to change
of stair measure in patients with hip or knee OA. Test- retest reliability using Shrout
and Fleiss Type 2, 1 intra-class correlation was assessed. In their study, they found
out that it met the required standards for making decisions at individual patient level.
All measures were responsive to detecting deterioration in physical function and
improvement.21

C. J. McCarthy et al. (2003) evaluated the intra-tester reliability, criterion-related

validity and responsiveness of timed walking, stair climbing in a sample of patients
8

with knee osteoarthritis. The study showed that the tests demonstrated excellent intratester reliability, with excellent intra-class correlation coefficient (ICC) statistics
(ICC2,k 0.99; 95% CI 0.980.99), and low standard error of measurement (0.86 s).22

6.3 Objectives of the study:

1. To assess balance and lower limb strength in knee OA patients using Chair
Stand Test and Stair Climb Test.
2. To determine relationship between Chair Stand Test and Stair Climb Test for
subjects with OA knee.

Materials and Method

7.1 Study Design
7.

Correlational study design with cross over trail for two different tests, Chair Stand
Test and Stair Climb Test.

7.2 Methodology
Study Subjects
Subjects with bilateral knee osteoarthritis.

Sample size
9

The study will be carried on total of 80 subjects.

Study Setting and Source of data

Subjects will be recruited from KTG Hospital, K.C General Hospital and Ravi
Kirloskar Memorial Hospital, Bangalore. Study will be carried out at KTG Hospital,
Bangalore.

Sampling Method
Convenience Sampling.

Study Duration
Three days

Sample Selection
Inclusion Criteria

merican college of rheumatology criteria for classification and reporting of

osteoarthritis of knee joint (age > 50 years, stiffness < 30 min., crepitus, bony
tenderness, bony enlargement, no palpable warmth). For clinical finding study
suggested that knee pain plus three of the above criteria should be fulfilled for
osteoarthritis of knee.15

Both male and female subjects.

Mild to moderate severity of pain measured by Numeric Pain Rating Scale

10

between 5 and 7.

Age group between 60 and 79 years.23

WOMAC physical function score of either mild difficulty in 4 items or

moderate difficulty in 2 items.24

Kellgren-Lawrence Scale grade 2 (grade 2-definite osteophytes and possible

narrowing of the joint space)25, grade 3 (grade 3-moderate multiple
osteophytes, definite narrowing of joint space, some sclerosis and possible
deformity of bone contour.26

History of knee OA since last two years.13

CST Score <11 repetition for both male and female subjects.27

SCT Score >12(s) for male subjects and >20(s) for female subjects.27

Exclusion Criteria

a medical history of stroke or other disorder that substantially affected lowerextremity function11

total knee replacement

Plasma rich growth factors or Hyaluronic injections during last 6 months.28

rheumatoid arthritis

any other form of inflammatory arthritis (i.e. crystal arthropathy, septic

arthritis, spondylarthropathy) 3

Patients with maximum score in WOMAC.11

11

Materials used:

Chair without arm rests

Stop Watch

Stairs with suitable step heights between 16-20cm

Numeric Pain Rating Scale

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Outcome Measurements
1.Chair Stand Test(CST)No. of times the patient can stand up and down from a chair in 30 seconds is
measured by the CST.
A previous study found that the intra-tester reliability has been reported to be
between 0.97 and 0.98 (95% CI: 0.94, 0.99) (within session) and the inter-tester
reliability was reported to range between 0.93 and 0.98 (95% CI: 0.87, 0.99).29
2.Stair Climb Test(SCT)Time required by the patient to ascend and descend 12 steps is measured by the

12

SCT.
Step test interrater reliability was reported to be 0.90 (95% condence interval
[95% CI].30

Variables
Independent Variable
Chair Stand Test and Stair Climb Test.
Dependent Variable
Number of repetitions and Time required to climb stairs in seconds.

7.3 Methods of data collection :

As the study includes human subjects ethical clearance is obtained from ethical
committee of K.T.G. college of physiotherapy. All subjects fulfilling the inclusion
criteria will be informed about the study and a written consent (Annexure-I) will be
taken. First the subject performs CST then the next day subject will be asked to rest
and the day after that the SCT will be performed.

Procedure of Chair Stand Test

A chair will be placed against a wall. Comfortable walking footwear (e.g. tennis
shoes/cross trainers) will be worn. The participant sits in the chair in a position that
allows them to place their feet flat on the floor, shoulder width apart, with knees
flexed slightly more than 90 degrees so that their heels are somewhat closer to the
13

chair than the back of their knees. The arms are crossed at the wrists and held close to
the chest (across chest).
The tester stands close to the side of the chair for safety and so as to observe the
technique, ensuring that the participant comes to a full stand and full sit position
during the test. A practice trial of one or two slow paced repetitions is done before
testing to check technique and understanding.
From the sitting position, the participant stands completely up so hips and knees are
fully extended, then completely back down, so that the bottom fully touches the seat.
This is repeated for 30 seconds. Same chair should be used for re-testing within site.

If the person cannot stand even once then the hands are allowed to be placed on their
legs or use their regular mobility aid. This is then scored as an adapted test score.
On the signal to begin, the stop watch is started. The total number of chair stands (up
and down equals one stand) completed in 30 seconds is counted. If a full stand has
been completed at 30 seconds (i.e. standing fully erect or on the way down to the
sitting position), then this final stand is counted in the total. The participant can stop
and rest if they become tired. The time keeps going. If a person cannot stand even
once then the score for the test is zero. Next, the hands are allowed to be placed on
their legs or use their regular mobility aid. If the person can stand with adaptions,
then the number of stands is recorded as an adapted test score. The adaptations made
to the test are indicated.

14

Procedure of Stair Climb Test

Comfortable walking footwear (e.g. tennis shoes/cross trainers) will be worn by the
subjects.
If safety is of concern, the tester guards behind/below the participant going up the
stairs and ahead/to the side coming down the stairs. A practice trial with tester
guarding is done before testing to assess for safety.
Ascending and descending flight of stairs is performed by the subjects as quickly as
possible but in a safe manner. Use of a handrail and walking aid is permitted if
needed. Use is recorded. Same stairs should be used for re-testing within site.
Timing begins on the signal to start and is terminated when the participant returns
with both feet to the ground level. Total time to ascend and descend steps for 1 test
trial is recorded to nearest 100th of a second. The participant can stop and rest if
needed but the time keeps going.
Statistical Tests
Statistical analysis will be performed by using SPSS software for window (version
16) and p-value will be set as 0.05 (1 tailed Hypothesis).
Descriptive statistics and Chi-square (x2) will be used to analyze the base line
demographic data.
Pearson coefficient of correlation as a parametric test and Spearmans rho rank test as
a non-parametric test will be used to correlate between the assessment tests.

15

7.4 Ethical Clearance

As this study involve human subjects, the ethical clearance has been obtained from
research and ethical committee of K.T.G college of physiotherapy, Bangalore as per
the ethical guidelines for Bio-Medical research on human subjects, 2000 ICMR, New
Delhi.

A pilot study was done prior to this study on 10 subjects and the study methodology
was found feasible.

8.
List of References:
1. R S Hinman, K L Bennell, B R Metcalf, K M Crossley. Balance impairments
in individuals with symptomatic knee osteoarthritis: a comparison with
matched controls using clinical tests. Rheumatology 2002;41:138894.
2. A Mahajan, S Verma, V Tandon. Osteoarthritis. Journal of the Association of
Physicians of India 2005 July;53:634-41.
3. Diana C. Sanchez-Ramirez, Marike van der Leeden. Association of postural
control with muscle strength, proprioception, self-reported knee instability
and activity limitations in patient with knee osteoarthritis. Journal of
Rehabilitation Medicine 2013 February;45(2):192-97.

4. Hassan BS, Mockett S, Doherty M. Static postural sway, proprioception, and

16

maximal voluntary quadriceps contraction in patients with knee osteoarthritis

and

normal

control

subjects. Annals

of

the

Rheumatic

Diseases

2001;60(6):612618.
5. Duman I, Taskaynatan MA, Mohur H, Tan Ak. Assessment of the impact of
proprioceptive exercises on balance and proprioception in patients with
advanced knee osteoarthritis. Rheumatology International 2012;32:379398.
6. Hunt MA, McManus FJ, Hinman RS, Bennell KL. Predictors of single-leg
standing balance in individuals with medial knee osteoarthritis. Arthritis care
and Research (Hoboken) 2010;62:496500.
7. Patrice Wendling. OARSI recommends physical function tests for knee, hip
OA [Online].
Available

from:

URL:

http://www.rheumatologynews.com/single-

view/oarsi-recommends-physical-function-tests-for-knee-hipoa/fc8c4513dd031b28bf79f69a994dfff6.html

8. Sit to Stand: Discussion [Online]. Available from: URL: sit to standhttp://www.clinicalgaitanalysis.com/teach-in/answer.html

9. Kim Bennell, Fiona Dobson, Rana Hinman. Measures of Physical

Performance

Assessments.

Arthritis

care

and

research

2011

November;63;s350-70.
10. Maria Grazia Benedetti, Valentina Agostini, Mareo Knaflitz, Paolo Bonato.
Muscle activation patterns during level walking and stair ambulation.[Online].
2012

January

11.

Available

http://cdn.intechopen.com/pdfs/25822/InTech17

from:

URL:

Muscle_activation_patterns_during_level_walking_and_stair_ambula
tion.pdf

11. Anne L Harrison. The influence of pathology, pain, balance and self-efficacy
on function in women with osteoarthritis of the knee. Physical Therapy 2004
September;84(9):822-31.
12. Marc C. Hochberg1, Roy D. Altman, Karine Toupin April, Maria Benkhalti,
Gordon Guyatt. American College of Rheumatology 2012 recommendations
for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis
of the hand, hip, and knee. Arthritis Care Research 2012 March;64(4):46574.
13. Joern W.-P. Michael, Klaus U Schlter-Brust, Peer Eysel. The Epidemiology,
Etiology, Diagnosis, and Treatment of Osteoarthritis of the Knee. Deutsches
Arzteblatt International Journal 2010 March;107(9):152-62.
14. M. Blagojevic C. Jinks, A. Jeffery, K.P. Jordan. Risk factors for onset of
osteoarthritis of the knee in older adults: a systematic review and metaanalysis. Osteoarthritis and Cartilage 2010 January;18(1):24-33.
15. G Peat, E Thomas, R Duncan, L Wood, E Hay, P Croft. Clinical classification
criteria for knee osteoarthritis: performance in the general population and
primary care. Annals of Rheumatic Diseases 2006 April;65(10):1363-67.
16. Y-C. Lin, R. C. Davey, T. Cochrane. Tests for physical function of the elderly
with knee and hip osteoarthritis. Scandinavian Journal of Medicine & Science
in Sports 2001 October;11(5):28086.
18

17. F Dobson, R S Hinman, M Hall et al. Measurement properties of

performance based measures to assess physical function in hip and knee OA:
a

systematic

review.

Osteoarthritis

and

Cartilage

2012

December;20(12):1548-62.
18. Stephen Gill, Helen McBurney. Reliability of performance-based measures in
people awaiting joint replacement surgery of the hip or knee. Physiotherapy
Research International 2008 September;13(3):141-52.
19. Ostchega Yechiam, Harris Hamara, Hirsch Rosemarie, Parsons Van, Kington
Raynard, Katzoff Myron. Reliability and prevalence of physical performance
examination assessing mobility and balance in older persons in the US : Data
from the Third National Health and Nutrition examination Survey. Journal of
the American Geriatrics Society 2000;48(9):1136-41.
20. Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater
reliability and validity of the stair ascend/descend test in subjects with total
knee arthroplasty. Archives of Physical Medicine and Rehabilitation 2010
June;91(6):932-38.
21. Deborah M Kennedy, Paul W Stratford, Jean Wessel, Jeffrey D Gollish,
Dianne Penney. Assessing stability and change of four performance measures:
a longitudinal study evaluating outcome following total hip and knee
arthroplasty. BMC Musculoskeletal Disorders 2005 January;6(3).
22. C. J. McCarthy and J. A. Oldham. The reliability, validity and responsiveness
of an aggregated locomotor function (ALF) score in patients with
19

osteoarthritis of the knee. Rheumatology 2003 October;43(4):514-17.

23. Teresa M Steffen, Timothy A Hacker and Louise Mollinger. Age- and
Gender-Related Test Performance in Community-Dwelling Elderly People:
Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and Gait
Speeds. Physical Therapy February 2002;82(2):128-37.
24. Goggins J, Baker K, Felson D. What WOMAC pain score should make a
patient eligible for a trial in knee osteoarthritis? J Rheumatol 2005;32:540-42.
25. Adriano P. Simao, Nubia C Avelar, Rosalina Tossige-Gomes, Camila D.
Neves, Vanessa A. Mendonca et al. Functional performance and Inflammatory
Cytokines after squat exercises whole-body vibration in elderly individuals
with knee osteoarthritis. Arch Phys Med Rehabil 2012;93:1692-1700.
26. Pradeep Shankar,

Renukadevi M., Adithi Bhandiwad, Harish Pai.

Effectiveness of retrowalking in chronic osteoarthritis of knee joint.

Innovative journal of medical and health science 2013;3(1):19-22.
27. Fiona Dobson, Kim L. Bennell, Rana S. Hinman, J Haxby Abbott, Ewa M.
Roos. Recommended performance- based tests to assess physical function in
people diagnosed with hip or knee osteoarthritis. [Online]. 2013 January.
Available

from:

URL:

http://www.oarsi.org/pdfs/OARSI_Recommended_Performance_Measures_M
anual.pdf.
28. Mikel Snchez, Nicols Fiz, Juan Azofra, Jaime Usabiaga, Enmanuel Aduriz
20

Recalde. A Randomized Clinical Trial Evaluating Plasma Rich in Growth

Factors (PRGF-Endoret) Versus Hyaluronic Acid in the Short-Term Treatment
of Symptomatic Knee Osteoarthritis. Arthroscopy: The Journal of
Arthroscopic and Related Surgery 2012 August;28(8):1070-78.
29. Gill S, McBurney H. Reliability of performance-based measures in people
awaiting joint replacement surgery of the hip or knee. Physiother Res Int.
2008;13(3):141-52.
30. Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing
stability and change of four performance measures: a longitudinal study
evaluating outcome following total hip and knee arthroplasty. BMC
Musculoskelet Disord 2005;6:3

21

9. Signature of Candidate

10. Remarks of the Guide

11.

Name and Designation of

11.1 Guide

AYYAPPAN V. R.
Associate Professor

11.2 Signature
11.3 Co-Guide

VINOD BABU. K
Assistant Professor

11.4 Signature
11.5 Head of Department

SAI KUMAR. N

11.6 Signature
1
2.

12.1 Remarks of the Chairman & Principal

12.2 Signature

ANNEXURE I
22

CONSENT FORM
I Gazal Kanti Niroula have explained to................................the purpose of the
research, the procedures required, and the possible risks and benefits to the best of
my ability.
.........................................

....................................

...........
Investigator Signature

Date

College:
Place:
CONSENT TO PARTICIPATE IN THE STUDY
Purpose of Research
I .........................have been informed that this study is for knee pain like mine. All
test measures are acceptable Physiotherapy interventions for this problem. This
study will help physiotherapy better understand the relationship between Chair
Stand Test and Stair Climb Test in assessing balance and lower limb strength in
subjects with knee OA.
Procedure
I understand that I will be performing both Chair Stand test and Stair Climb test. I
will be expected to perform tests in the Physiotherapy department or an outside
setting for a day.
I am aware that in addition to ordinary care received, I will be examined by a
research Physiotherapist. The Physiotherapist examination will consist of
23

measuring pain and functional disability. I have been informed that these tests will
be conducted at the beginning of the study, and after the study.
Risk and Discomforts
I understand that I may experience some pain or discomfort during the
examination or during my treatment. This is mainly the result of my condition, as
the procedure of this study is not expected to exaggerate these feelings which are
associated with the usual course of assessment.
Benefits
I understand that my participation in the study will have no direct benefit to me
other than the major potential benefit that is to find out which assessment test is
more effective.
Confidentiality
I understand that the information produced by this study will became part of my
research record and will be subject to the confidentiality and privacy regulation,
but will be stored in the investigators research file.
If the data is used for publication in the literature or for the teaching purpose, no
names will be used, and other identifiers, such as photographs and audio or
videotapes, will be used without my special written permission.

Refusal or Withdrawal of Participation

24

I understand that my participation is voluntary and that I may refuse to participate

or may withdraw consent and discontinue participation in the study at any time
without prejudice to my present or future care at the Hospital. I also understand
that Ms Gazal Kanti Niroula may terminate my participation in this study at any
time after she explains the reasons for doing so.
I confirm that Ms Gazal Kanti Niroula has explained to me the purpose of this
research, the study procedures that I will undergo, and the possible risks and
discomforts as well as benefits that I may experience. Alternatives to my
participation in the study have also been discussed. I have read and I understand
this consent form. Therefore, I agree to give my consent to participate as a subject
in this research project.
...............................................

........................

..................
Participant Signature

Date

..............................................

........................

..................
Witness to Signature

Date

ANNEXURE II
25

Numerical Pain Rating Scale (NPRS)

Indications: Adults and children (> 9 years old) in all patient care settings who are able
to use numbers to rate the intensity of their pain.
Instructions:
The patient is asked any one of the following questions:
What number would you give your pain right now?
What number on a 0 to 10 scale would you give your pain when it is the worst that it gets
and when it is the best that it gets?
At what number is the pain at an acceptable level for you?
2. When the explanation suggested in #1 above is not sufficient for the patient, it is
sometimes helpful to further explain or conceptualize the Numeric Rating Scale in the
following manner:
0 = No Pain
5 = Moderate Pain (interferes significantly with ADLs)
10 = Severe Pain (disabling; unable to perform ADLs)

26