Rajiv Gandhi University of Health Sciences,

Karnataka, Bangalore

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the Candidate &

Address

STUTI RAGESH SHAH

6-TEJDHARA 2, B/H MADHUR HALL, 100 FT

ROAD, SATELLITE, AHMEDABAD-15,

GUJARAT.

2. Name of the Institution K.T.G. COLLEGE OF PHYSIOTHERAPY

Hegganahalli cross, Vishwaneedam Post,

Sunkadakatte via Magadi Road, Bangalore- 560 091

3. Course of Study & Subject MASTERS OF PHYSIOTHERAPY

(Musculoskeletal Disorders and Sports

Physiotherapy)

4. Date of Admission to the

Course

18/03/2013

5 Title of the Topic:

“IMMEDIATE EFFECTS OF KINESIO VERSUS MCCONNELL TAPING

ON PATELLOFEMORAL PAIN SYNDROME DURING FUNCTIONAL

ACTIVITIES- A COMPARATIVE STUDY”.

1

6 Brief Resume of the Intended Work:

6.1 Need of the Study:

Patellofemoral pain syndrome (PFPS) is a condition presenting with anterior

knee pain or pain behind the patella (retro-patellar pain).1 The incidence in the general

population is 25% in adolescents and adults.4 Incidence rates vary from 22 new cases per

1000 persons/year in highly active populations to 5 to 6 new cases per 1000 in general

practice.2

It is commonly experienced during running, squatting, stair climbing,

prolonged sitting, and kneeling. In the patellofemoral joint, the patella serves as a link to

converge the fibers of the quadriceps femoris muscle group to increase its lever arm and

maximize its mechanical advantage. To ensure this functional efficacy, maintaining the

patellar alignment in the trochlear groove of the femur is necessary. Malalignment of the

patella, or altered patellar tracking, may be a predisposing factor for patellofemoral pain,

chondromalacia, and articular cartilage degeneration.1

Patients often complain of medial knee pain, with pain occurring with activities

such as prolonged sitting with a flexed knee, walking up stairs, or running. Often pain

will occur along the medial patella facet or patellar tendon. Most often there is more

tightness of the lateral retinaculum.3

Clinically, rehabilitation regimes for patients with PFPS often include VMO

strengthening to promote active medial stabilization of the patella within the femoral

trochlea and patellar realignment procedures, such as stretching, taping, and bracing. The

patella is taped specifically to address the individual’s abnormal glide, rotation and tilt,

and to maintain the patella correctly within the femoral trochlea during the full knee

range of motion.4

Taping is frequently used in the field of rehabilitation as a means of treatment for

knee injuries. Two taping techniques commonly used for anterior knee pain in the clinical

2

setting include McConnell Taping (MT) and Kinesio Taping (KT). 5

The MT is structurally supportive and uses a tape that is rigid, highly adhesive,

and can be worn for up to 18 hours. MT has been reported to reduce anterior knee pain,

regulate the mediolateral pulling force of the patella, improve joint alignment and

facilitate the vastus medialis obliqus (VMO). Although MT has been reported to reduce

pain and improve function in people with patellofemoral pain syndrome during activities

of daily living, strong evidence to identify the underlying mechanisms is still not

available.5

Kinesiotape (KT), created by KenzoKase in 1996, is thin, cotton, porous fabric

with acrylic adhesive that is nonmediated and latex-free.3 The method incorporates a

special tape product plus different techniques for various conditions. The elastic tape is

unique in that it can stretch to 130-140% of its static length; theoretically allowing full

range of motion while the muscle is placed on gentle functional stretch during the

application. The tape can be worn for 3-5 days.5

It was hypothesized that KT has multiple functions: improvement of muscle

function, gathering fascia to align tissue in the desired position, activation of the

circulation (blood and lymph) by lifting the skin over areas of inflammation, pain and

edema, deactivation of the pain system by stimulating cutaneous mechanoreceptors,

supporting the function of the joints by stimulating proprioceptors, correcting the

direction of movement and increasing stability and segmental influences.6

Marc Campolo and Jenie Babu compared the effectiveness of Kinesio taping and

McConnell taping versus no tape in subjects with anterior knee pain during functional

activity and found that both KT and MT were effective in reducing pain during functional

activities like stair climbing and squat lift. There is a need to know the effect of these

tapes in other functional activities like squatting, stair ascending and stair descending.

Although taping techniques are used in clinical practice, there is limited scientific

evidence evaluating the effectiveness of the KT and MT in patellofemoral pain syndrome

3

subjects.

Therefore, the purpose of this study is to compare the immediate effect of KT

versus MT on pain levels during stair ascent, stair descent and squat lift functional

activity in subjects with patellofemoral pain syndrome.

Research Question: Whether there is any difference in immediate effect between

Kinesio tapping versus McConnell taping on pain level during stair ascent, stair descent

and squat lift functional activity for subjects with Patellofemoral pain syndrome (PFPS)?

HYPOTHESIS

Null Hypothesis:

There will be no significant difference between Kinesio taping versus McConnell

taping on immediate effect on pain level during stair ascending and descending and squat

lift functional activities for subjects with patellofemoral pain syndrome.

Alternate Hypothesis:

There will be statistically significant difference between Kinesio taping versus

McConnell taping on immediate effect on pain level during stair ascending and

descending and squat lift functional activities for subjects with patellofemoral pain

syndrome.

4

6.2 Review of Literature:

Reviews on patellofemoral pain syndrome:

Michael J Callaghan, et al (2012) assessed the effects of patellar taping on pain and

function for treating patellofemoral pain syndrome in adults for one week to three months

trial and concluded that more research should be done to draw conclusions on effects of

taping, whether used on its own or as a part of treatment programme.13

Sallie M Cowan, KIM L. Bennell (2002) investigated the effect of physical therapy

treatment specifically vastus medialis obliqus retraining in the timing of EMG activity of

the vasti in individuals with patellofemoral pain syndrome and they found that

McConnell based physical therapy treatment for PFPS improved the motor control of

VMO relative to vastus lateralis in a functional task and this is associated with a positive

clinical outcome.7

AdityaDerasari, et al (2010) studied the changes in the 6 degrees-of-freedom

patellofemoral kinematics due to McConnell taping in patients with PFPS with dynamic

magnetic resonance imaging and they found that there was inferior shift in patellar

displacement with taping decreases pain that caused due to increases in contact area. 12

Reviews on kinesiotaping and McConnell taping:

Marc Campolo, et al (2013) Compared the effectiveness of Kinesiotaping (KT) and the

McConnell taping (MT) versus no tape before and after the treatment in subjects with

anterior knee pain during a squat lift and stair climbing and they found that both KT and

the MT may be effective in reducing pain during stair climbing activities whereas there

wasn’t any change seen during squatting.5

Chen, W.C Hong, et al (2008) examined the effects of kinesio taping on biomechanics

and ratio of VMO and vastus lateralis (VL) for people with patellofemoral pain syndrome

5

and proved kinesio tape would result in change in timing of VMO and improve ratio of

VMO/VL for mechanism of efficacy.9

Naoko Aminaka, et al (2008) evaluated the effects of patellar taping on sagittal-plane

hip and knee kinematics, reach distance and perceived pain level during the star

excursion balance test (SEBT) in individuals with and without PFPS and proved patellar

taping seemed to reduce pain and improved SEBT performance of participants with

PFPS.1

EdaAkbas, et al (2011) studied the effect of kinesiotaping in treatment of patients with

patellofemoral pain syndrome in females using VAS scale and proved faster

improvement in hamstring muscle flexibility.4

Kelly Bockrath, et al (1993) determined the effects of patellar taping on patella position

and perceived pain in 12 subjects with anterior knee pain syndrome using VAS scale to

measure pain. The results demonstrated that patella taping significantly reduced

perceived pain levels during a 0.2-meter step down; however this reduction in pain was

not associated with patella position changes.20

Chen PL, et al (2008) examined the biochemical effects of kinesiotaping for participants

with patellofemoral pain syndrome during stair climbing and proved that there was

significant difference between no tape and kinesio tape condition in patellofemoral pain

group during descending stairs.9

Jolanta Zajt-Kwiatkowska, et al (2007) presented the kinesiotapingmethod enhancing

the therapy applied in sports medicine and then proved that it reduces the levels of pain,

increases the functional capabilities of the patient, constitutes a good method

supplementing a regular physiotherapeutic treatment.15

Overington M, et al (2006) did a study on-A critical appraisal and literature critique on

the effect of patellar taping-is patellar taping effective in treatment of patellofemoral pain

6

syndrome. They found that patellar taping appears to reduce pain in short term, may be

beneficial in conjunction with physiotherapy in long term, and can alter VMO activity.19

Review on Outcome Measurement:

Review on 100mm Visual Analogue Scale:

Crossley KM, et al (2004) examined the test-retest reliability, validity and

responsiveness of several outcome measures in the treatment of patellofemoral pain. The

outcome measures they used were Visual Analogue Scale (VAS), functional index

questionnaire (FIQ), kujala anterior knee pain scale and global rating of change. They

found that kujala anterior knee pain scale and visual analogue scale for usual or worst

pain are reliable, valid and responsive and are therefore recommended for future clinical

trials or clinical practice in assessing treatment outcome in persons with patellofemoral

pain.16

Natalie J. Collins, et al (2010) identified prognostic factors that may have clinical utility

in predicting poor outcome on measures of pain and function in individuals with

Patellofemoral pain and found strategies aimed at preventing chronicity of more severe

patella femoral pain may optimize prognosis.17

From review of literature, there are no studies found on comparing Kinesio taping versus

McConnell taping effect on pain during specific functional activity in subjects with

patellofemoral pain syndrome. Therefore this study is aimed to find the immediate effects

of both the taping.

6.3 Objectives of the Study:

7

Primary Objective:

1. To compare the immediate effects of Kinesio taping versus McConnell taping on

pain level during functional activities for subjects with patellofemoral pain

syndrome.

Secondary Objectives:

2. To measure the immediate effect of kinesio taping, McConnell taping and sham

taping on pain level during stair ascending, stair descending and squat lift

functional activities for subjects with patellofemoral pain syndrome.

3. To compare the immediate effects of Kinesio taping, McConnell taping and Sham

taping on pain levels during stair ascending, stair descending and squat lift

functional activities for subjects with patellofemoral pain syndrome.

7 Material and Methods:

7.1 Study Design:

An experimental study design with three groups: Kinesiotaping group (KT

group), McConnell taping (MT group) and Sham group.

7.2 Methodology:

Study Subject:

Subjects with patellofemoral pain syndrome.

Sample Size:

Study will be done on total of 60 subjects. 20 in each KT group, MT group and

Sham respectively.

8

Study setting and source of data:

Study will be carried at KTG Hospital, Bangalore.

Sampling Method:

Simple Random Sampling.

Study Duration:

Single time study.

Sample Selection:

Inclusion Criteria:

1. Both male and female.

2. BMI<30.

3. Age group- 13 to 30 years of age.5

4. Subjects diagnosed with patellofemoral joint, anterior- or retro-patellar knee pain

aggravated by at least two activities that load the PFJ (e.g. stair ascends and

descends, squatting and/or rising from sitting).6

5. Pain on patellar palpation.6

6. Symptoms for atleast 3 months.6

7. VAS scale during stair ascends and descends and squat lift greater than 6 .6

8. Subjects who have never received patellar taping (McConnell, Kinesio and Sham)

before this study.

9. Subjects not undergone any other form of physical therapy or are on pain killer

drugs in past 2 weeks.4

10. Subjects who are willing to participate and give consent.

9

Exclusion Criteria:

1. Any recent injury (<1 year) around the knee joint.4

2. Chronic knee pain greater than 4 years.4

3. Corticosteroid injections of knee joints within the past 3 months.4

4. Presence of severe graded knee osteoarthritis based on radiographic evidence.4

5. Presence of any other non-orthopedic diseases that may affect the knees.4

6. Pregnancy or possibility of pregnancy.6

7. Referred pain from spine.6

8. Allergic reactions to taping (Kinesio and McConnell).6

Material Used:

1. Plinth.

2. Pillow.

3. McConnell tape.

4. Kinesiotape.

5. Adhesive tape.

6. Leukotape.

7. Weighted box.

8. Scissors.

9. Sterilizer & cotton.

7.3 Methods of Data Collection:

Ethical Clearance:

As the study includes human subjects, ethical clearance is obtained from human ethical

committee of K.T.G. College of Physiotherapy, Bangalore.

Selection of subjects into groups:

Subjects who will meet the inclusion criteria will be assigned into randomization.

Subjects will be informed about the study and a written consent (ANNEXURE I) will be

10

taken. Subjects will be randomly allocated to KT Group, MT Group or Sham Group, with

20 subjects in each group respectively. Sixty small chits will be used, with 20 chits

having KT Group, 20 chits having MT Group and 20 chits having Sham Group written

on them. All pieces of paper will be tightly folded & placed in a box. After shaking the

box thoroughly, each subject will be called forward to pick up a chit & go to the allotted

group.

KT Group: In this group, subjects will be given kinesiotaping.

MT Group: In this group, subjects will be given McConnell taping.

Sham Group: In this group, subjects will be given non-elastic taping (placebo effect).

Pre taping Outcome Measurement:

Pain status using VAS score will be checked in subjects prior to application of

taping. Each participant’s pain level will be tested during two functional activities stair

ascending, stair descending and squat lift.

Stair ascending and descending: three flights of stairs (16 steps per flight, 9 inches high).

Squat lift: squatting while lifting a weighted box (10 % of his/her body weight, plus the

weight [8.5 pounds] of the box).

Procedure of intervention for Kinesiotaping Group:

Before applying kinesiotaping, a sensitivity test will be done one day priorly. A

small portion of tape will be applied on inner part of calf and kept for a day. Next day the

tape will be removed and if the subject does not have any reaction, we will proceed with

the method.

Instruct the participant to shave the area to be exposed for the taping technique.

11

The K-tape will be applied from origin to insertion of quadriceps muscle. Superior ‘Y’

technique will be applied. Beige colored kinesio tape would be applied and colour of the

tape would be same for all the subjects in the study.

The subject will be sitting at the edge of the plinth with the thigh little flexed (small

roll of towel under the knees) position and the part taped will be exposed. The application

of tape will begin with the kinesio “Y” strip approximately from the insertion of

quadriceps. It will be applied light (25% of available stretch) or paper off tension until

“Y” in kinesio strip reaches the superior pole of patella. Tape activation will be done

prior to any further patient movement.

Then the subject will flex the knees to maximum flexion. The tails of kinesio strip

will be then applied around the medial and lateral border of patella. The tails will be

applied with light (25 % of available stretch) or paper off tension. The tip of the tail will

end with no tension on tibial tuberosity. Tape activation will be done prior to any further

movement.

Subjects will also be instructed to remove tape if they feel itching, heat, redness or

discomfort and would be instructed how to remove it in such conditions.

Procedure of intervention for McConnell Taping Group:

Participants will be informed priorly to remove the hair from the area to be taped.

Initially, the part to be taped will be exposed and cleaned with water. Two pieces

of rigid tape (Leukom Sportstape Premium Plus, Beiersdorf Australia Ltd) applied a

medial patellar glide and corrected lateral and AP tilt. Two further pieces of tape applied

distal to the patella unloaded the infrapatellar fat pad. Hypoallergenic undertape was

applied beneath the rigid tape to prevent skin irritation. Next, a medial glide of patella

was obtained by manually pushing the patella medially to its end range of motion. Rigid

strapping tape then was used to maintain glide of patella by pulling the skin and patella

12

medially.

Subjects will also be instructed to remove tape if they feel itching, heat, redness or

discomfort and would be instructed how to remove it in such conditions.

Procedure of intervention for Sham Group:

The participants will be informed to shave the part to be exposed for taping one day

prior to the treatment.

Here the part to be taped will be exposed and cleaned with water. Nonrigid

hypoallergenic tape was placed on the skin in a vertical direction from the center of the

patella to 5 cm proximal to the patella while the participant was sitting (with the knee

flexed). The alignment of the patella was not visibly altered, nor was knee motion

restricted.

Subjects will also be instructed to remove tape if they feel itching, heat, redness or

discomfort and would be instructed how to remove it in such conditions.

Post taping Evaluation:

Pain status using VAS score will be checked in subjects immediately after application of

taping. Each participant’s pain level will be tested during two functional activities stair

ascending, stair descending and squat lift. After each activity, subjects need to rest so that

pain reduces to pre level and then the next activity should be performed. Post taping pain

level values should be compared with pre taping pain level values.

Stair ascending and descending: three flights of stairs (16 steps per flight, 9 inches high).

Squat lift: squatting while lifting a weighted box (10 % of his/her body weight, plus the

weight [8.5 pounds] of the box).

13

Outcome Measures:

100 mm Visual Analogue Scale:

It’s basically used to describe pain level.

Crossley KM found that kujala anterior knee scale and visual analogue scale for usual or

worst pain are reliable, valid and responsive and are therefore recommended for future

clinical trials or clinical practice in assessing treatment outcome in persons with

patellofemoral pain.16

Variables in study:

Independent: Kinesiotaping, McConnell taping and Sham taping.

Dependent: Pain during activity.

7.4 Statistical Test:

Statistical analysis will be performed by using SPSS software for window (version 16)

and p-value will be set as 0.10 (2 tailed Hypothesis) 95% Confidence interval of the

difference was set during analysis.

Unpaired t-test and Wilcoxon signed ranked test will be used to find the

significance of parameters within the group.

Independent t-test and Mann-whitney U test will be used to analysis the variables

between the two groups.

Kruskal-Wallis H test and ANNOVA for multiple comparisons will be used to

compare the independent variables between the three groups.

7.5 Ethical clearance:

The study includes human subjects ethical clearance has been obtained from the

ethical committee of KTG college of Physiotherapy, Bangalore as per the ethical

guidelines for Bio-medical research on human subjects. Also a written consent will be

taken from each subject who participates in the study.

14

8 List of References:

1. Naoko Aminaka; Phillip A. Gribble. A systematic Review of the effects of

therapeutic taping on patellofemoral pain syndrome. Journal of athletic training

2005; 40 (4): 341-351.

2. Robbart Van Linschoten, Marienke Van Middlekoop, Edith M. Heintjes. Exercise

therapy for patellofemoral pain syndrome. Br J Sports Med 2011; 9.

3. Warren Hammer. Treatment for patellofemoral pain syndrome. Dynamic

Chiropractic 2001; 19(4).

4. Eda AKBAS, AhmetOzgur. The effects of additional kinesiotaping over exercise in

treatment of patellofemoral pain syndrome. ActaOrthopTraumatolTurc 2011;

45(5): 335-341.

5. Marc Campolo, Jenie Babu. A comparison of two taping techniques Kinesio and

McConnell and their effect on anterior knee pain during functional activities. The

international journal of sports physical therapy 2013; 8(2); 105.

6. FahadAlbahel, Ashraf Ramadan Hafez. Kinesio Taping for the Treatment of

Mechanical Low Back pain. World Applied Sciences Journal 2013;22 (1): 78-84.

7. Cowan SM, Bennell KL, Crossley KM, Hodges PW; McConnell J. Physical

therapy alters recruitment ofthe vasti in patellofemoral pain syndrome. Medicine

and Science in Sports and Exercise. 2002; 34: 1879-1885.

8. Kay M. Crossley, Kim L Bennell, Sallie M Cowan. Analysis of outcome measures

for persons with patellofemoral pain: which are reliable and valid? Archives of

physical Medicine and rehabilitation. 2004;85(5);815-822.

9. Chen PL, Hong WH, Lin CH, Chen WC. Biomechanics Effects of Kinesio Taping

15

for Persons with Patellofemoral Pain Syndrome During Stair Climbing. IFMBE

Proceedings.2008; 21:395-397.

10. Lan TY, Lin WP, Jiang CC, Chiang H. Immediate Effect and Predictors of

Effectiveness of taping for Patellofemoral Pain Syndrome: A Prospective Cohort

Study. American Journal of Sports Medicine. 2010; 38 (8): 1626-1630.

11. Slupik A, Dwornik M, Bialoszewski D, Zych E. Effect of Kinesio Taping on

bioelectrical activity of vastus medialis muscle. Preliminary Report.

OrtopediaTraumatologiaRehabilitacja. 2007; 6(6); 644-651.

12. Derasari A, Brindle TJ, Alter KE, Sheehan FT. McConnell Taping Shifts the

Patella Inferiorly in Patients With Patellofemoral Pain: A Dynamic Magnetic

Resonance Imaging Study. Journal ofPhysical Therapy. 2010; 90 (3): 411-419.

13. Callaghan MJ, Selfe J, Bagley PJ, Oldham JA. The effects of patellar taping on

knee joint proprioception. Journal of Athletic Training. 2002; 37: 19-24.

14. Callaghan MJ, Selfe, J, McHenry A, Oldham JA. Effects of Patellar taping on knee

joint proprioception in patients with patellofemoral pain syndrome. Manual

Therapy. 2008; 13: 192-199.

15. JolantaZajt-Kwiatkowska, ElzbietaRajkowskalabon. Application of kinesio taping

for treatment of sports injuries (2007); Research yearbook; MEDSPORTPRESS:

Volume 13: 130-134.

16. Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical

intervention for patellofemoral pain syndrome. Clinical Journal of Sports Med

2001; 11:103-110.

17. Natalie J Collins, Kay M Crossley, Ross Darnell. Predictors of short and long term

outcome in patellofemoral pain syndrome: a prospective longitudinal study. BMC

Musculoskeletal Disorders 2010.

18. Sara R Piva, Kelley Fitzgerald, James J Irrgang. Reliability of measures of

16

associated with patellofemoral pain syndrome. BMC Musculoskeletal Disorders

2006.

19. Mark Overington, Damian Goddard. A critical appraisal and literature critique on

the effect of patellar taping – is patellar taping effective in the treatment of

patellofemoral pain syndrome?NZ Journal of Physiotherapy 2006, Vol. 34 (2).

20. Kelly Bockrath, Cindi Wooden, Teddy Worrell. Effects of patellar taping on patella

position and perceived pain. Med. Sci. Sports Exerc. 1993; 25(9); 989-992.

21. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically

important changes in chronic musculoskeletal pain intensity measured on a

numerical rating scale. European Journal of Pain. 2004; 8: 283-291.

22. Kase K, Wallis J, Kase T. Clinical Therapeutic Applications of the Kinesio Taping

Method:.Tokyo, Japan: Ken Ikai Co.; 2003; 2nd edition.

23. Osterhues DJ. The use of Kinesio Taping in the management of traumatic patella

dislocation. A case study. Physiotherapy Theory and Practice. 2004; 20: 267-270.

24. Thelen MD, Dauber JA, StonemanPD. The clinical efficacy of kinesio tape for

shoulder pain: a randomized, double-blinded, clinical trial. J Orthop Sports

PhysTher. 2008; 38:389-395.

25. Chang HY, Chou KY, Lin JJ, Lin CF, Wang CH. Immediate effect of forearm

Kinesio taping on maximal grip strength and force sense in healthy collegiate

athletes. Physical Therapy in Sport. 2010; 11: 122-127.

26. Thelen MD, Dauber JA, StonemanPD. The clinical efficacy of kinesio tape for

shoulder pain: a randomized, double-blinded, clinical trial. J Orthop Sports

PhysTher. 2008; 38:389-395.

17

9. Signature of Candidate

10. Remarks of the Guide:

11. Name and Designation of

11.1 Guide :

11.2 Signature

11.3 Co-Guide :

11.4 Signature

11.5Head of Department :

11.6 Signature

1

2. 12.1 Remarks of the Chairman & Principal

12.2Signature

18

ANNEXURE - 1

CONSENT FORM

I Stuti Shah 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 .......(Subject name)........ have been informed that this study is for patellofemoral pain

syndrome subjects like mine. All techniques are acceptable Physiotherapy intervention for

this problem. This study will help physiotherapy better understand the use of Physiotherapy

services in management of patellofemoral pain syndrome patients using Kinesiotaping,

McConnell taping and Sham taping.

Procedure

I understand that I will be given taping procedure (Kinesio/ McConnell/Sham tape)I am

aware that in addition to ordinary care received. The Physiotherapy examination consists of

taping procedures. I have been asked to undergo this therapy for total 6 sessions in a period

of 2 weeks.

19

Risk and Discomforts

I understand that I may experience some pain or discomfort during the examination. This is

mainly the result of my condition, and the procedures of this study are not expected to

exaggerate these feelings, which are associated with the usual course of treatment.

Benefits

I understand that my participation in the study will have no direct benefit to me other than

potential benefit of the treatment, which is planned to reduce my pain and function and to

improve the functional ability to carry out my daily activities. The major potential benefit is

to find out which treatment program 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.

Refusal or Withdrawal of Participation

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. Stuti Shah may terminate

my participation in this study at any time after she explained the reasons for doing so.

I confirmed that Stuti Shah has explained to me the purpose of the 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

20

ANNEXURE 2

100 mm Visual Analogue Scale

No Pain Very severe pain

A VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each

end. The patient marks on the line the point that they feel represents their perception of their

current state. The VAS score is determined by measuring in millimetres from the left hand

end of the line to the point that the patient marks.

Scoring: Using a ruler, the score is determined by measuring the distance (mm) on the 10-

cm line between the “no pain” anchor and the patient’s mark, providing a range of scores

from 0–100.

Score interpretation. A higher score indicates greater pain intensity.

21

22