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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. Name of the candidate and address SUBODH KUMAR MAHATO Durgatol, Hariharpur-1, Dhanusha, Nepal 2. Name of the Institution and address K.T.G. COLLEGE OF PHYSIOTHERAPY 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 10/08/2013 5. Title of The Topic: “COMPARATIVE EFFECT BETWEEN HOLD RELAX VERSUS ISCHEMIC COMPRESSION TECHNIQUES ON UPPER TRAPEZIUS MYOFACIAL 1

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Page 1:  · Web viewDhanusha, Nepal 2. Name of the Institution and address K.T.G. COLLEGE OF PHYSIOTHERAPY Hegganahalli Cross, Vishwaneedam Post, Sunkadakatte Via Magadi Road, Bangalore –

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the candidate and

address

SUBODH KUMAR MAHATO

Durgatol, Hariharpur-1,

Dhanusha, Nepal

2. Name of the Institution and

address

K.T.G. COLLEGE OF PHYSIOTHERAPY

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 10/08/2013

5. Title of The Topic:

“COMPARATIVE EFFECT BETWEEN HOLD RELAX VERSUS

ISCHEMIC COMPRESSION TECHNIQUES ON UPPER TRAPEZIUS

MYOFACIAL TRIGGER POINT- A SINGLE BLIND STUDY”

1

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6. Brief resume of the intended work:

6.1 Need for the study:

Myofascial Trigger points (MTP) which comes under the non articular category of

musculoskeletal disorder are discrete, focal, hyperirritable spots in a taut band of

skeletal muscle causing pain on compression and also can produce referred pain,

tenderness, motor dysfunction and autonomic phenomena.1,2 The pain is usually a

deep and dull aching which can be both exquisite and continuous depending on the

circumstances and the anatomy.3 The mechanism of activation of the MTP is

hypothesized as the result from injured or overloaded muscle fibers, leading to

involuntary shortening of sarcomere and loss of oxygen and nutrient supply with

increased metabolic demand on local tissues.2

Clinically MTP are classified as active or latent where an active MTP is tender to

palpation with a referred pain pattern felt remote from the site causing pain at rest

and latent MTP restrict movement or cause muscle weakness causing pain when

pressure is applied directly over the point rather causing spontaneous pain.4 Pain

pressure threshold is the least stimulus intensity at which patient perceives pain and

measured by pressure algometer.5

It usually originates in skeletal muscles and/or their fascia2 and the most common

sites are the muscles involved in maintaining posture: upper trapezius, levator

scapulae, sternocleidomastoid, scalenes, and quadrates lumborum muscle. However,

it also can be located in fascia, ligaments and tendons.6 MTP mostly seen in upper

trapezius muscle as it works constantly to keep the head and neck vertical and normal

2

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antigravity function of upper trapezius getting overstressed by any position or activity

in which trapezius helps to carry the weight of arms for prolong period like

telephoning or sitting without armrest support. It is associated with the motor

endplate zone which is also known as the innervation zone where the α-motor neuron

divides into a number of branches and synapses onto trapezius muscle fibres. Hence,

it leads to shortening of sarcomere of trapezius muscle and affects the flexibility of

muscle decreasing the cervical range of motion followed with trapezius pain and

altering pain pressure threshold.7,1

MTP treatment methods can be divided into invasive and non-invasive methods.

Among the invasive methods, trigger point injections prove to be an effective

treatment for acute MTP. Non-invasive method includes electrical treatment and

exercise treatment. Electrical treatments include extracorporeal shockwave therapy,

transcutaneous electrical nerve stimulation, ultrasonic treatment, laser tic field

treatment and diathermy. Exercise treatments include hold relax (HR), ischemic

compression(IC), spray and stretching, massages, taping, stabilization exercises, post-

isometric relaxation, and positional release therapy.8-11

Hold Relax (HR) technique is the proprioceptive neuromuscular facilitation

stretching technique frequently used in clinics which works on four theoretical

physiological mechanisms: autogenic inhibition, reciprocal inhibition, stress

relaxation, and the gate control theory. These mechanisms are reflexes that occur

when the Golgi tendon organs (GTOs) detect harmful stimuli either in the tendons of

the target muscle or in the antagonist muscle to the target muscle.12 It uses the means

of facilitation to correct muscle imbalances and restore the patient’s ability to

3

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perform effective co-ordinated movement, increasing flexibility and improving

pain.13,14

Ischemic compression (IC) technique refers to trigger point pressure release which is

the application of slowly increasing, non-painful pressure over a MTP until a barrier

of tissue resistance is encountered. Contact is then maintained until the tissue barrier

releases, and pressure is increased to reach a new barrier to eliminate the trigger point

tension and tenderness.15 IC is firm sustained compression at a MTP. The hypothesis

suggests compression lengthens the shortened sarcomere, the subsequent release of

pressure corresponds to reactive hyperaemia which flushes away noxious substances

and by-products of cellular metabolism that enhance muscle contraction.16

Research examining the treatment methods independently is widely available, yet no

research has directly examined the effects between HR and IC for improving pain,

pressure pain threshold and flexibility of patients with MTP of the upper trapezius

muscle, thereby presenting precise and efficient treatment methods. There is a need

for further research to compare the effects between these two treatment methods so

clinicians have an objective basis for selecting a particular method in the treating

MTP. Hence the purpose of this study is to compare the effects of hold relax

technique versus ischemic compression technique on subjective pain, pressure pain

threshold and trapezius flexibility for subjects with upper trapezius muscle MTP.

4

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Research Question

Whether there is any differences in effect of hold relax technique versus ischemic

compression technique on pain, pressure pain threshold and flexibility of upper

trapezius myofascial trigger points?

Hypothesis:

Null hypothesis

There will be significant difference in effect of hold relax technique versus ischemic

compression technique on pain, pressure pain threshold and flexibility of upper

trapezius myofascial trigger points.

Research hypothesis

There will be significant differences in effect of hold relax technique versus ischemic

compression technique on pain, pressure pain threshold and flexibility of upper

trapezius myofascial trigger points.

6.2 Review of Literature:

Review on Myofascial Trigger Points :

Marco Barbero et al. (2013) carried out research on Myofascial trigger points and

innervations zone locations in upper trapezius muscles where they classified

myofascial trigger point under the non-articular category of musculoskeletal disorder.

They found that MTP in upper trapezius are proximally located to the IZ but not

5

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overlapped. 1

Cesar Fernandez de las Penas et al. (2005) reviewed on the manual therapies in

myofascial trigger point treatment where they defined myofascial trigger point as

discrete, focal, hyperirritable spots causing pain, tenderness, motor dysfunction and

autonomic phenomena.2

Review on Hold Relax :

Jung-Ho Lee et al. (2013) examined the effects of treatment using PNF extension

techniques on the pain, pressure pain, and neck and shoulder functions of the upper

trapezius muscles of myofascial pain syndrome (MPS) patients. In their study they

found exercise programs that apply hold relax techniques is said to be effective at

improving the pain and range of motion in MPS patients.10

Kayla B. Hindle et al. (2012) reviewed possible mechanisms, proposed theories and

physiological changes that occur due to proprioceptive neuromuscular facilitation

techniques. Four theoretical mechanisms that occur in hold relax were identified:

autogenic inhibition, reciprocal inhibition, stress relaxation, and the gate control

theory which are the reasoning behind the increase in range of motion and function.12

Review on Ischemic Compression:

Marie Alricsson(2012) published musculoskeletal disorder where it was concluded

that ischemic compression is effective technique as compression lengthens the

shortened sarcomere, the subsequent release of pressure corresponds to reactive

6

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hyperaemia which flushes away noxious substances and byproducts of cellular

metabolism that foster muscle contraction.16

William P Hanten, et al. (2000) conducted a study on effectiveness of a home

program of ischemic pressure followed by Sustained Stretch for treatment of

myofascial trigger points and the results suggested that clinicians can treat myofascial

trigger point through monitoring of home program.11

Review on Outcome measurement

Leighann Litcher-kelly, et al (2007) in their systemic review on measures used to

assess chronic musculoskeletal pain in clinical and randomized controlled clinical

trials by using many type of pain assessments available to researcher conducting

clinical trials ranging from simple, single item visual analogue scale (VAS) question

through extensive, multidimensional inventories. They stated that VAS were

responsive than the other complex measures as it is easy to assess pain.17

Ann L. Persson et al. (2004) conducted study on tender or not tender: test-retest

repeatability of pressure pain thresholds in the trapezius and deltoid muscles of

healthy women. They considered the device valid as the device itself was also highly

correlated with readings from a force plate.5

Polly E. Bijur, et al. (2001) measured the reliability of the visual analogue scale for

measurement of acute pain and found that reliability of the VAS for acute pain

7

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measurement as assessed by the ICC appears to be high.18

Richard L Gajdosik, et al. (1987) studied the emphasizing reliability and validity of

the goniometer for measuring range of motion. Study suggests that measurement of

range of motion by goniometer also represent flexibility. However they

recommended for future study on outcome measures.19

Review on inclusion and exclusion criteria:

Athanasios Trampas, et al. (2010) conducted study on clinical massage and

modified Proprioceptive Neuromuscular Facilitation stretching in males with latent

myofascial trigger points where they mentioned the following as exclusion criteria:

neck or shoulder surgery within the past year, neurological or rheumatic disorders,

whiplash in the previous 6 months, pregnancy, concomitant painful disorders, psycho

emotional distress, overweight,etc.20

Luke D. Rickards (2006) carried out study on the effectiveness of non-invasive

treatments for active myofascial trigger point pain where it has been mentioned that

myofascial trigger point includes the physical signs which are presence of a palpable

taut band in a skeletal muscle, the presence of a hypersensitive tender spot in the taut

band and palpable or visible local twitch response on snapping palpation. These

physical signs are used to categorise the patient for inclusion and exclusion.6

6.3 Objectives of the study:

8

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7.

Primary Objective

1. To determine the comparative effect between hold relax technique versus

ischemic compression technique by analyzing pain, pressure pain threshold

and flexibility in subjects with trapezius myofascial trigger point.

Secondary Objective

2. To evaluate the effect of hold relax technique by analyzing pain, pressure

pain threshold and flexibility before and after intervention in subjects with

trapezius myofascial trigger point.

3. To evaluate the effect of ischemic compression technique by analyzing pain,

pressure pain threshold and flexibility before and after intervention in

subjects with trapezius myofascial trigger point

Materials and Method

7.1 Study Design

Pre to post test comparative experimental study design with two groups-

Hold relax group (HR group)

Ischemic compression group (IC group)

7.2 Methodology

Study Population

9

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Subjects with unilateral upper trapezius myofascial trigger point.

Sample size

The study will be carried on total of 40(n=40) subjects.

20 subjects in HR group.

20 subjects in IC group.

Study Setting and Source of data

Study will be carried out at KTG Hospital, Bangalore.

Sampling Method

Simple Random Sampling.

Study Duration

Three sessions per week for two weeks.

Sample Selection

Inclusion Criteria

Age group between 18 and 50

Both male and female subjects

Pain of VAS scores more or equal to 3.

Pain on stretching of trapezius muscle.

Travell and Simon’s minimal criteria

10

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1. presence of a palpable taut band in the upper trapezius muscle,

2. presence of a tender spot in the taut band,

3. local twitch response elicited by the snapping palpation of the taut band,

4. reproduction of subject’s pain only upon palpation without patient

recognition of the symptom as familiar.6

Exclusion Criteria

Neck or shoulder surgery within the past year,

Neurological or rheumatic disorders,

Clinical evidence of radiculopathy, myelopathy or joint disorders,

Whiplash in the previous 6 months,

Concomitant painful disorders and psycho emotional distress to avoid adverse

effects and confounding factors during the MTP palpation procedure.

Overweight patients as excessive subcutaneous fat layer thickness can limit

the MTP palpation.20

Materials used:

Treatment couch

Visual Analogue Scale

Pressure algometer

11

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Universal Goniometer

Variables

Independent Variable

Hold Relax, Ischemic compression.

Dependent Variable

Pain, pressure pain threshold and flexibility.

7.3 Methods of data collection :

Ethical Clearance

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 will be taken.

Randomization into group

All the subjects who fulfill the inclusion criteria will be assigned to two groups based

on simple random sampling. The subjects were randomly allocated into two groups

of 20 each. Forty pieces of paper were used; in twenty papers written with the letter

“HR” to identify the subjects to take into hold relax group and the other twenty with

the letter “IC” to identify the subjects to take into ischemic compression group. All

the forty pieces of paper were tightly folded and placed in a box. 20 subjects with the

letter “HR” will be enlisted under hold relax group and the other 20 subjects twenty

12

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with the letter “IC” under Ischemic compression group. Complete explanations were

given to both the groups separately but the subjects were unaware to which group

they belonged. Once the subject agrees to participate in the study, an informed

written consent (Annexure-1) was taken from the subjects.

Subjects were blinded on either type of intervention and to which group they were

belonged. Throughout the treatment sessions, subjects from both the groups were not

allowed to have any interaction to each other and the subjects were not aware of what

kind of treatment they received and its effects.

No other conventional method of treating myofascial trigger point will be given as

the patients with the minimal pain intensity will be included in the both HR and IC

group.

Pre- Intervention Outcome measurement

All the patients will be assessed for the following:

1. Upper trapezius pain is measured by Visual Analogue Scale (Annexure-II) .

Pain intensity will be assessed using a visual analogue scale (VAS). Patients

placed a vertical mark on a continuous 10 cm line to indicate pain intensity,

ranging from no pain or discomfort to the worst pain they could possibly feel.

The VAS measurement will be used to assess local pain evoked by pressure

applied with the algometer on the MTP. The reliability and validity of this

instrument has been established previously.19

13

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2. Pressure pain threshold (PPT) is measured by pressure algometer .

The subject will be seated in a chair comfortably with a low support for the

back and with a pillow on their lap for arm support. The PPT will be measured

over the relaxed trapezius muscles. Three test trials, on a single point over

rhomboid muscle will be performed to familiarize the subject with the

procedure. Then pressure will be applied perpendicularly against the skin over

the marked points in a fixed order over the trapezius muscle. Thereafter, the

same sequence will be repeated on the affected trapezius muscle. The patient is

asked to say “yes” when they feel any discomfort or pain. Immediately the

pressure is stopped if the patient feels pain and the pain pressure threshold will

be noted. Time gap of 5 to 10 minutes will be given during the trails. The

average score of all three trails will used to determine the effect. To measure

PPT on the same after 2 weeks of intervention, the procedure is standardized by

marking a permanent marker (skin marker) and marking will be periodically

examined and marked to avoid erasing. Measuring PPT in this way has been

reported as a reliable method for assessing the severity of MTP.5

3. Flexibility is measured in degree by Goniometer

Universal goniometer will be used to measure cervical lateral flexion. Patient

will be asked to sit with thoracic and lumbar spine well supported by the back

of the chair. Cervical spine in 00 of flexion, extension, and rotation. Tongue

depressor can be held between teeth for reference. Shoulder girdle is stabilized

to prevent lateral flexion of thoracic and lumbar spine. The axis of goniometer

14

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placed over spinous process of C7. Stable arm placed over spinous processes of

thoracic vertebrae so that arm is perpendicular to ground and movable arm is

placed dorsal to midline of head where reference can be taken as occipital

protuberance. Patient will be asked to perform lateral flexion opposite to the

involved side and reading will be taken. This method of measuring range of

motion has previously been found to be reliable.19

Procedure of Intervention for HR Group

The patient in the sitting position and the therapist will be back of the patient.

Therapist stretch the upper trapezius until the stretching discomfort level reached the

“4 out of 10” intensity by pulling the head in direction opposite to the affected side

and rotating the patient’s face toward the affected side. Stretch perception is the

amount of force exerted in order to elicit the “4 out of 10” on the verbal NRS by the

patient. The patient will be asked to perform isometric contraction for 10 seconds

followed by relaxation of 10 seconds. Then new position is held for further 10

second. This procedure will be repeated for a total of five times for six sessions per

weeks for two weeks.

Procedure of Intervention for IC Group

Patients will be placed supine with head fully on the couch to reduce tension in the

upper trapezius muscle. Arm positioned in slight shoulder abduction with the elbow

bent and hands resting on stomach. Therapist stands at the head side of the couch. 15

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First, trigger point will be located by palpating the muscle to feel for a taut band or a

twitch response in the trapezius muscle. Then ischemic compression will be

performed till the pain tolerance by gradually applying pressure to the trigger point

with thumb. The patient may feel referred pain. Patient will be asked frequently to

ensure that he/she is staying within the limits of his/her pain tolerance. It will be held

till the patient tells that pain has diminished or until muscles fibers begins to relax

under pressure. Then pressure gradually released with few effleurage strokes to flush

out the area. This will be repeated for three to five times for six sessions per week for

two weeks.

Post intervention outcome measurement

All the patients will be assessed again after the treatment for the following outcome

measures:

1. Neck pain is measured by Visual Analogue Scale (Annexure-II).

2. Pressure pain threshold will be measured by Pressure algometer.

3. Flexibility of neck measured by Goniometer.

Statistical Tests

Statistical analysis will be performed by using SPSS software for window

(version16) and p value will be set as 0.05 (1-tailed hypothesis).

Descriptive statistics and Chi square test will be used to analyze baseline data for

16

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8.

demographic data.

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

of parameters pre to post test.

Independent t test and Mann Whitney U test will be used to find the significance of

parameters between the groups.

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.

List of References:

1) Marco Barbero, Corrado Cescon, Andrea Tettamanti, Vittorio Leggero, et al.

Myofascial trigger points and innervation zone locations in upper trapezius

muscles. Biomed central Musculoskeletal Disorders 2013; 14:179.

2) Cesar Fernandes de las, Monica Sohrbeck Campo, Josue Fernandez Carnero, et

al. Manual therapies in myofascial trigger point treatment: a systematic review.

Journal of Bodywork and Movement Therapies 2005; 9: 27–34.

3) Lucy Whyte Ferguson et al. Myofascial Pain: A Manual Medicine Approach to

17

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Diagnosis and Treatment. The Pain Practitioner 2012 summer; 22(2): 34-39.

4) David J Alvarez, Pamela G Rockwell. Trigger points: Diagnosis and

management. American Family Physician 15th February 2002; 65(4):653-660.

5) Ann L. Persson, Christina Brogardh and Bengt H. Sjolund. Tender or not tender:

test-retest repeatability of pressure pain thresholds in the trapezius and deltoid

muscles of healthy women. Journal of rehabilitation medicine 2004; 36: 17-27.

6) Luke D. Rickards. The effectiveness of non-invasive treatments for active

myofascial triggers point pain: A systematic review of the literature. International

Journal of Osteopathic Medicine 2006; 9:120-136.

7) Simons DG, Travell JG, Simons IS. Travell and Simon’s myofascial pain and

dysfunction: the trigger point manual: Vol 1, Upper half of body, 2nd ed.

Baltimore, Maryland: Williams and Wilkins; 1999.vol 2 p.287.

8) Kim GU, Choe SC, Song HJ, et al. Trigger point injection for the treatment of

cervical strain in the emergency department. Kor Soc Traumatol 2002; 15:33–38.

9) Edwards J, Knowles N. Superficial dry needling and active stretching in the

treatment of myofascial pain. Acupuncture Medicine 2003; 21: 80–86.

10) Jung-Ho Lee, Soo-Jin Park, Sang-Su Na. The Effect of Proprioceptive

Neuromuscular Facilitation Therapy on Pain and Function. Journal of Physical

Therapy Science 2013; 25:713–716.

11) William P Hanten, Sharon L Olson, Nicole L Butts, Aimee L Nowicki.

18

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Effectiveness of a Home Program of Ischemic Pressure Followed by Sustained

Stretch for Treatment of Myofascial Trigger Points. Physical therapy 2000;

80:997-1003.

12) Kayla B. Hindle, Tyler J. Whitcomb, Wyatt O. Briggs, Junggi Hong.

Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on

Range of Motion and Muscular Function. Journal of Human Kinetics March

2012; 31:105–113.

13) Chow TP, Ng GY. Active, passive and proprioceptive neuromuscular facilitation

stretching are comparable in improving the knee flexion range in people with

total knee replacement: a randomized controlled trial. Clinical Rehabilitation

2010; 24: 911–918.

14) Lim CH. Effects of static, dynamic, PNF stretching on the isokinetic peak torque.

Journal of Korean Society Physical Therapy 2011; 23: 37–42.

15) Simons DG, Travell JG. Chronic myofascial pain syndromes. Mysteries of the

history, chapter 6. In: friction JR, Awad EA, editors. Myofascial Pain and

Fibromyalgia, Advances in Pain Research and Therapy. Vol. 17 New York:

Raven press; 1990.p. 129-37.

16) Bang Nguyen. Myofascial Trigger Point: Symptoms, Diagnosis, Intervention. In:

Marie Alricsson,editor. Musculoskeletal Disorder. Croatia: Janeza Trdine 9;

2012.

17) Leighann Litcher Kelly, et al. A systemic review of measures used to assess

19

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chronic musculoskeletal pain in clinical trials. Pub Med Central 2007.

18) Polly E. Bijur, Wendy Silver, E. John Gallagher. Reliability of the Visual

Analogue Scale for Measurement of Acute Pain. Academic Emergency Medicine

December 2001; 8(12):1153-1157.

19) Richard l. Gajdosik and Richard w. Bohannon. Clinical Measurement of Range of

Motion- Review of Goniometry Emphasizing Reliability and Validity. Physical

Therapy 1987; 67:1867-1872.

20) Athanasios Trampas, Athanasios Kitsios, Evagelos Sykaras, Stamatios

Symeonidis, Lazaros Lazarou. Clinical massage and modified Proprioceptive

Neuromuscular Facilitation stretching in males with latent myofascial trigger

points. Physical Therapy in Sport 2010; 11:91-98.

9. Signature of Candidate

10. Remarks of the Guide

11. Name and Designation of

11.1 Guide :

20

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11.2 Signature

11.3 Co-Guide :

11.4 Signature

11.5Head of Department :

11.6 Signature

12. 12.1Remarks of the Chairman and Principal

12.2Signature

ANNEXURE –I

CONSENT FORM

I Subodh Kumar Mahato 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:21

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Place:

CONSENT TO PARTICIPATE IN THE STUDY

Purpose of Research

I .........................have been informed that this study is for neck pain like mine. All

test measures are acceptable Physiotherapy interventions for this problem. This

study will help physiotherapy better understand the comparative effect between

hold relax technique and ischemic compression technique on upper trapezius

myofascial trigger points

Procedure

I understand that I will be performing both hold relax technique and ischemic

compression. I will be expected to perform treatment in the Physiotherapy

department or an outside setting in 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

measuring pain, pressure pain threshold and flexibility. I have been informed that

these treatments 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.

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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 technique 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 investigator’s 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

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 Subodh Kumar Mahato may terminate my participation in this study at any

time after he explains the reasons for doing so.

I confirm that Subodh Kumar Mahato 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

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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

Visual Analogue Scale(VAS)

VAS is presented as 10cm line.

No pain at one end and worst imaginable pain at other end.

Patient is asked to mark a 100mm line to indicate pain intensity.

I----------------------------------------------------------------------------------------I

No pain Worst Pain

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If used as a graphic rating scale, 10 cm baseline is recommended for VAS scale.

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