Rajiv Gandhi University of Health Sciences, Karnataka,



Rajiv Gandhi University of Health Science

Bangalore, Karnataka.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1. |Name of the Candidate |SWEETY CHARLES CARVALHO |

| | |Devdar Bhat, Near Diwan wadi Society, Papdy, Dist- Thane, Tal- Vasai (W)-401207,|

| |and Address |State-Maharashtra. |

|2. |Name of the Institution | |

| |and Address |K.T.G. COLLEGE OF PHYSIOTHERAPY |

| | |Vishwaneedam Post, Hegganahalli cross, 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 |18/06/2012 |

|5. |TITLE OF THE TOPIC: |

| | |

| |“EFFECT OF POSITIONAL RELEASE TECHNIQUE IN SUBJECTS WITH TRAPEZITIS”. |

| | |

|6. |Brief resume of the intended work: |

| |Need for the study : |

| |Trapezitis is inflammation of trapezius muscle. The pain is present even during rest and is aggravated by activity; it may be referred to other |

| |area from the site of primary inflammation. Skin and the tissue temperature raised at the site of the lesion. This occurs due to increased blood |

| |flow due to dilatation of capillaries. Passive range of motion may be painful and restricted due to pain and protective spasm in antagonist groups |

| |of muscles. In order to relieve the spasm of these muscles varieties of conservative treatment methods are available in general practice including |

| |analgesics, rest or referred to a physical therapist or manual therapist.1 |

| |Working postures with the neck in extreme flexion increase the load moment three to four times on the neck causing spasm of the neck muscles. Also |

| |working tasks that involve continuous arm movements always generate a static load component on these muscles, the principal muscle to carry this |

| |load is the trapezius.1 |

| |Neck pain is the common problem in general population with prevalence between 10% to 15%. Population based surveys has shown lifetime prevalence of|

| |neck pain between 67% to 87%. On the other hand between 13% to 22% of the population in the industrialized society experience neck pain at any |

| |point of time 2. |

| |Any position which places trapezius in a shortened state for a period of time without rest may shorten the fibers and lead to dysfunction and |

| |restricted movements of neck. Long telephone conversations particularly those which elevate the shoulder to hold the phone, working from a chair |

| |set too low for the desk or computer, watching television or working on a computer with an awkward posture, terminal and elevation of the arm for |

| |painting, playing musical instruments particularly for extended period of time can all shorten trapezius fibers creating muscle spasm.2 |

| |Recent studies have hypothesized that the pathogenesis results from the overloading and injury of muscle tissue, leading to involuntary shortening |

| |of localized fibers. The areas of stressed soft tissue receive less oxygen, glucose, and nutrient delivery, and subsequently accumulate high levels|

| |of metabolic waste products. The end result of this cascade of events is the creation of altered tissue status, pain, and the development of Tender|

| |Points. TPs have been associated with hyperalgesia and limited range of motion (ROM) and are therefore clinically important to identify as these |

| |possess the potential to restrict functional activies. Identification is accomplished through the recognition of a pattern of clinical signs on |

| |physical examination. Signs that may include the presence of a taut band in a skeletal muscle, the presence of a tender spot within the taut band, |

| |a palpable or visible local twitch response upon palpation, and/or needle inspection of the TP (called a jump sign), the presence of a typical |

| |referred pain pattern, and restricted ROM of the affected tissues.3 |

| |Strain Counterstrain (SCS) is the fourth most commonly used osteopathic manipulative technique following soft tissue techniques, high velocity low |

| |amplitude thrust, and muscle energy technique (Johnson and Kurtz). Also known as Positional Release technique (PRT). Positional release therapy is |

| |a gentle manual treatment for muscle pain and spasm which involve resetting muscle tone and enhancing circulation.4 |

| |According to Chaitow, mechanism of PRT intervention include aberrant neuromuscular activity mediated by muscle spindles known as Proprieceptive |

| |theory which is based on neurophysiologic regulation of muscle spindle activity and local circulation or in inflammatory reaction influenced by |

| |sympathetic nervous system.4 |

| |PRT is typically used to treat orthopedic disorders involving pain, fascial tension, local edema, joint hypomobility, muscle spasm, muscle |

| |dysfunction or weakness (d’Ambrogio and Roth). This approach involves identification of the active TPs, followed by the application of pressure |

| |until a nociceptive response is produced. The area is then positioned in such a manner as to reduce the tension in the affected muscle and |

| |subsequently the pain in the TP. When the position of ease/pain reduction is attained, the stressed tissues are felt to be at their most relaxed |

| |and a local reduction of tone is produced.5 |

| |Studies have been found on effectiveness of positional release technique used as an adjunct along with conventional treatment such as ultrasound |

| |therapy and isometrics found useful in alleviating the neck pain and improving the functional ability as shown in terms of visual analog scale and |

| |Neck disability index.2 |

| |Stretching and Transcutaneous Electrical Stimulation (TENS) are also found to be effective as conventional treatment in the management of |

| |trapezitis.9,12,13 There is a need to know the effect of positional release technique alone in the treatment of trapezitis.2 |

| |There are no studies found on the effect of positional release technique alone in the treatment of unilateral upper trapezitis.2 |

| |Hence, the purpose of the study is to determine the effect of positional release therapy alone in the treatment of trapezitis. |

| | |

| |Research Question: Whether positional release technique does have an effect in reducing pain and improving range of motion and function in subjects|

| |with trapezitis ? |

| |Hypothesis : |

| |Null hypothesis: There will no significant effect of positional release technique in subjects with trapezitis. |

| |Alternate hypothesis: There will be significant effect of positional release technique in subjects with trapezitis. |

| |6.2 Review of Literature: |

| |Review on Trapezitis: |

| |A.kumaresan et al (2011) studied effectiveness of positional release therapy in treatment of trapezitis and concluded that interventions in the |

| |form of conventional physiotherapy and positional release therapy showed that, positional release therapy can be useful in alleviating the neck |

| |pain and improve the functional ability as shown in terms of visual analog scale and Neck disability index. 2 |

| |Carlos Alberto Kelencz et al (2011) studied about trapezius upper portion trigger points treatment purpose in positional release therapy with |

| |electromyographic analysis and showed results that all patients had a gradual decrease in pain after each session proved effective because it |

| |reduced the muscle tension in the upper trapezius and decreased the musculoskeletal pain, with consequent improvement of posture and daily life |

| |activities. 6 |

| |Jagatheesan Alagesan et al in the International Journal of Health and Pharmaceutical Science in research paper studied conventional treatment with|

| |PRT or conventional treatment with taping is equally effective and produced significant pain relief in tender point of unilateral upper trapezius |

| |muscle as like the conventional treatment by moist heat and shoulder girdle exercises. 1 |

| |Review on Positional release technique: |

| |Christopher Kevin Wong (2011) studied the current concepts and clinical evidence of strain counter-strain presented that highlight how the |

| |positioning guidelines are applied and provide the clinician tools to use at important transitional zones. While evidence to support SCS has only |

| |begun to emerge, clinical applications may stimulate further controlled research into the physiologic mechanisms and clinical outcomes of SCS. 4 |

| |Christopher K. Wong et al (2011) determined the effects of strain counterstrain (SCS) techniques on forearm pronation and supination muscle |

| |strength comparing to passive sham positioning and concluded that forearm strength increased after SCS in a healthy population with muscle |

| |tenderness, with greater strength increase apparent than after passive sham positioning. 7 |

| |Roderic MacDonald et al (2011) studied positional release technique in the treatment of restless leg syndrome and results showed that demonstration|

| |of benefit from a course of manipulation that lessened or removed the need for drug treatment would change the management of Restless Leg Syndrome |

| |and stimulate reconsideration of present ideas about the mechanisms involved in RLS and the action of manipulation. 8 |

| |Sirikarn Somprasong et al (2011) studied effects of strain counter-strain and stretching technique in active myofascial pain syndrome and they |

| |found to have of benefit in pain reduction more than stretching technique and suggested strain counter strain as a treatment of choice. 9 |

| |Harmon L. Myers et al (2007) studied the strain and counterstrain manipulation techniques and found that it provides immediate relief of |

| |discomfort, helps the body regain normal function and range of motion that may have been limited by chronic myofascial dysfunction.10 |

| |Review on Stretching exercise: |

| |Che-Hsiang Wang et al (2009) Stretching and strengthening exercises: Their effect on three-dimensional scapular kinematics, the exercise program |

| |improved muscle strength, produced a more erect upper trunk posture, increased scapular stability, and altered scapulohumeral rhythm.11 |

| | |

| |Cunha ACV et al (2008) studied Effect of global posture re education and of static stretching on pain, range of motion, and quality of life in |

| |women with chronic neck pain: a randomized clinical trial concluded Conventional stretching and muscle chain stretching in association with manual|

| |therapy were equally effective in reducing pain and improving the range of motion and quality of life of female patients with chronic neck pain, |

| |both immediately after treatment and at a six-week follow-up, suggesting that stretching exercises should be prescribed to chronic neck pain |

| |patients. 13 |

| | |

| |Dimitrios Kostopoulos et al (2008) studied Reduction of Spontaneous Electrical Activity and Pain Perception of Trigger Points in the Upper |

| |Trapezius Muscle through Trigger Point Compression and Passive Stretching and concluded that each technique significantly reduced pain perception |

| |and Spontaneous Electrical Activity, and the combination of Ishaemic Compression and Passive Stretching was superior, apparently because of the |

| |complementary nature of the therapeutic interventions.18 |

| |Hakkinen et al (2007) studied Effect of manual therapy and stretching on neck muscle strength and mobility in chronic neck pain and concluded both |

| |manual therapy and stretching were effective short-term treatments for reducing both spontaneous and strain-evoked pain in patients with chronic |

| |neck pain. It is possible that the decrease in pain reduced inhibition of the motor system and in part improved neck function.14 |

| | |

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| | |

| | |

| |Review on Transcutaneous electrical stimulation: |

| |Rodriguez-Fernandez AL et al (2011) studied Effects of burst-type transcutaneous electrical nerve stimulation on cervical range of motion and |

| |latent myofascial trigger point pain sensitivity and concluded a 10-minute application of burst-type TENS increases in a small but statistically |

| |significant manner the Referred Pressure Pain Threshold over upper trapezius latent MTrPs and the ipsilateral cervical range of motion.12 |

| |Rogger Scudds et al (1983) studied Pain Control With Transcutaneous Electrical Nerve Stimulation and has been shown to be effective in the control |

| |of acute and chronic pain. 20 |

| | |

| |Review on Outcome measurements used in the study: |

| |Williams MA  et al (2010) in systematic review of reliability and validity studies of methods for measuring active and passive cervical range of |

| |motion. |

| |Concluded considerable number of reliability and concurrent validity studies for CROM. The CROM device has undergone most evaluation and has been |

| |shown to be clinimetrically sound.16 |

| | |

| |Joy C. Mac dermid et al (2009) studied in a systematic Review Measurement Properties of the Neck Disability Index and concluded the NDI has |

| |sufficient support and usefulness to retain its current status as the most commonly used self-report measure for neck pain. 15 |

| |Boonstra et al (2008) studied to determine the reliability and concurrent validity of a visual analogue scale (VAS) as a single-item instrument |

| |measuring disability in chronic pain patients and conclusion of the study was that the reliability of the VAS for disability is moderate to good.19|

| |M. Tousignant et al (2000) studied criterion validity of the cervical range of motion (CROM) goniometer for cervical flexion and extension found to|

| |be valid for measurements of cervical flexion and extension. 17 |

| | |

| | |

| |6.3 Objectives of the study: |

| |To measure pain and range of motion and function before and after intervention in study and control group in subjects with trapezitis. |

| |To compare the pain, range of motion and neck function between study group and control group in subjects with trapezitis. |

| |Material and Methods |

| |Study design: |

| |Experimental Study design with two groups- Study and Control group. |

| |Methodology |

| |Study subject /population: |

| |Subjects with trapezitis. |

| |Sample size: |

| |Study will be done on 40 subjects (20 in study group and 20 in control group) |

| |Study setting and source of data: |

| |Study will be conducted in K.T.G. Hospital, Bangalore and other Rehabilitation Centre. |

| |Sampling method: |

| |Simple random sampling method. |

| |Study duration: |

| |2 weeks study: 8 sessions. |

| |Sample selection: |

| |Inclusion Criteria: |

| |Both male and female2 |

| |Subjects with age 20-40 years.3 |

| |Subject with trapezius muscle spasm- Tenderness grading is as follows:21 |

| |0- No tenderness |

| |1- Tenderness to palpation without grimace or flinch |

| |2- Tenderness with grimace & or flinch to palpation |

| |3- Tenderness with withdrawal (+ “ Jump sign”) |

| |4- Withdrawal (+ “Jump sign”) to non-noxious stimuli (i.e. superficial palpation, pin prick, gentle percussion) (Annexure-1) |

| | |

| |Subjects who are willing to participate.3 |

| |Subjects with  neck pain of less than 3 months duration.3 |

| |Exclusion Criteria: |

| |History of recent surgery to neck or upper back , cervical spine or shoulder or open wounds in the neck region.3 |

| |History of a whiplash injury.3 |

| |History of trauma or fractures in the neck or upper back or shoulder.3 |

| |Skin diseases and lesions in the area of trapezius.3 |

| |Any sensory disturbances in the trapezius region.3 |

| |Any Vascular syndromes such as basilar insufficiency.3 |

| |Neck and back deformities like Torticollis, scoliosis etc.3 |

| |Diagnosis of cervical radiculopathy or myelopathy determined by their primary care physician.3 |

| |Diagnosis of fibromyalgia syndrome.3 |

| |Subjects who are not willing to participate.3 |

| |Malignancy in neck region.3 |

| |Material used: |

| |Couch with pillow. |

| |Assessment Performa. |

| |Pen and paper. |

| |Methods of data collection: |

| | |

| |Ethical clearance- will be obtained from the ethical committee of KTG College of Physiotherapy. |

| | |

| |All the subjects fulfilling the inclusion and exclusion criteria will be informed about the study and a written consent will be taken. (Annexure |

| |-2) |

| |Subjects who meet the inclusion criteria will be assigned to two groups based on simple random sampling. |

| |Study group – In this group, the subjects will receive positional release technique and trapezius stretching and Transcutaneous Electrical |

| |Stimulation (TENS).2,12 |

| |Control group – In this group, the subject will only receive stretching of trapezius and TENS.2,12 |

| |Pre intervention evaluation: for Intensity of Pain using Visual Analog Scale (VAS), Cervical Range of the Motion (Active Range Of Cervical |

| |Rotation) and (Active Range Of Lateral Flexion using Goniometer and Neck Disability Index scoring for all the 10 items to ask the subject to mark |

| |their ability to perform each of the 10 activities will be measured for each patient before starting the treatment (For Study group and Control |

| |Group).2 |

| |Initially, the subject will be supine and relaxed completely. The therapist will sit at the head of the table and scapula of the subject elevated |

| |by taking the shoulder or scapular superior and medial to the ear, neck will be rotated to the opposite side, extended and side bend to the same |

| |side to be treated. Then tunning of the release will be done through either the neck or shoulder. This position is to be held for 90 seconds. After|

| |the release, subject will be put back to normal position.2 |

| | |

| | |

| |Trapezius stretch: the treatment position for passive stretching in supine lying while neck is set in three different positions depending on the |

| |location of pain: |

| |(1) Flexion and lateral flexion to the opposite side; (2) Flexion with rotation to the same side of the treatment; (3) Flexion, lateral flexion to |

| |the opposite side and rotation to the same side. Subject must feel mild to moderate pain during the treatment and should not have too much |

| |overpressure on the upper cervical spine. The stretching session was 30 seconds with 10 seconds resting between treatment sessions.The treatment |

| |was conducted within 15 minutes. 9 |

| |TENS: Burst TENS with pulse width of 200 µseconds, pulse frequency of 100Hz and a burst frequency if 2Hz will be applied for 10 minutes at |

| |comfortable intensity able to induce contraction of the trapezius muscle.12 The active electrode size (3.2 cm2) and ground electrode size (24 cm2) |

| |placed over the tender spot in the trapezius muscle belly.21 |

| |Interventions will be given for 2 week (8 sessions). |

| |At the completion of eight treatment sessions, outcome measures will be re-evaluated and pre and post scores will be compared. |

| |Post intervention measurements for Intensity of Pain using Visual Analog Scale (VAS), Cervical Range of the Motion using Goniometer and Neck |

| |Disability Index will be measured for each patient after the treatment (For both Study and Control group) and the data will be used for statistical|

| |analysis. |

| |Outcome measures: |

| |Visual Analogue Scale (VAS) to measure intensity of pain. (Annexure-3) |

| |Neck Disability Index (NDI) to measure functional disability. (Annexure-4) |

| |Cervical Range of Motion (ROM) measured using goniometer in degrees. |

| |To measure cervical lateral flexion the examiner centers the body of the goniometry over the subjects 7th cervical vertebra. The freely movable |

| |proximal goniometry arm hangs so that it is perpendicular to the floor. At the end of the lateral flexion ROM, the examiner maintains alignment of |

| |the proximal Goniometry arm and measurement is taken. |

| |To measure cervical rotation, the examiner stands at the back of the patient, who is seated in a low chair. The examiner Centers the Goniometry |

| |fulcrum on the top of the subjects’ head and aligns the proximal Goniometry arm parallel to an imaginary line between the subjects’ Acromion |

| |process. The examiner uses left hand to align the distal Goniometry arm with either the tip of the subject’s nose or the tip of the tongue |

| |depressor. At the end of the right cervical rotation the examiners left hand maintains alignment of the distal Goniometry arm with the tip of the |

| |subject’s nose or with the tip of the tongue depressor. The examiners right hand keeps the proximal arm aligned parallel to the imaginary line |

| |between the Acromion process. 2 |

| |Variables: |

| |Independent variables: - Positional Relesese Technique (PRT), Trapezius stretch and Transcutaneous Electrical Stimulation (TENS). |

| |Dependent variables:- Pain, Range of Motion and Neck Functional disability. |

| |Statistical test: |

| |Statistical analysis will be performed by using SPSS software for window (version 16) and p-value will be set as 0.05. |

| |Descriptive statistics and Chi Square test will be used to analyze the baseline data for demographic data. |

| |Unpaired t test and Wilcoxon signed rank test will be used to analyse the variables within the group. |

| |Independent ‘t’ test and Mann-Whitney test will be used to analyse the variables between the groups. |

| |Ethical Clearance:- |

| |As this study involves human subjects, the ethical clearance will be obtained from the ethical Committee of KTG College of Physiotherapy, |

| |Bangalore as per the ethical guidelines for Biomedical research on human subjects, 2000 ICMR, New Delhi. Also a written consent will be taken from |

| |each subjects who participates in the study. |

| |List of References: |

| |Jagatheesan Alagesan, Unnati S. Shah. Effect of positional release therapy and taping on unilateral upper trapezius tender points. International |

| |Journal of Health and Pharmaceutical Sciences. |

| |Jagatheesan Alagesan, Unnati S. Shah. Effect of positional release therapy and taping on unilateral upper trapezius tender points. International |

| |Journal of Health and Pharmaceutical Sciences. |

| |A.kumaresan1 G.Deepthi, Vaiyapuri Anandh, S.Prathap. Effectiveness of Positional Release Therapy in treatment of Trapezitis. International Journal |

| |of Pharmaceutical Science and Health Care. 2012, Feb; 1(2). |

| |Amit V Nagrale, Paul Glynn, Aakanksha Joshi, and Gopichand Ramteke. The efficacy of an Integrated Neuromuscular Inhibition Technique on upper |

| |trapezius trigger points in subjects with non-specific neck pain: a randomized controlled trial. Journal of Manual & Manipulative Therapy. 2010; 18|

| |(1):37-43. |

| |Christopher Kevin Wong. Strain Counterstrain: Current concepts and clinical evidence Manual Therapy 17, 2012;2-8. |

| |D’Ambrogio KJ, Roth GB, Positional release therapy: assessment and treatment of musculoskeletal dysfunction. St. Louis: Mosby; 1997. |

| |Carlos Alberto Kelencz, Victor Alexandre F. Tarini, and Cesar Ferreira Amorim. Trapezius upper portion trigger points treatment purpose in |

| |Positional Release Therapy with electromyographic analysis. North American Journal of Medical Sciences.2011, October; 3(10): 451–455. |

| |Christopher K. Wong, Neil Moskovitz, Rico Fabillar. Effect of Strain Counterstrain (SCS) on forearm strength compared to sham positioning. |

| |International Journal of Osteopathic Medicine 2011international journal of osteopathic medicine, September ;14(3):86-95. |

| |Roderic MacDonald, Theo Peters, Janine Leach: A randomized controlled pilot trial of Positional Release Manipulation (Counterstrain) in the |

| |treatment of Restless Legs Syndrome. International Musculoskeletal Medicine. 2011;331. |

| |Sirikarn Somprasong, Keerin Mekhora, Roongtiwa Vachalathiti, Sopa Pichaiyongwonglee. Effects of Strain Counter-strain and Stretching technique in |

| |active Myofascial Pain Syndrome. Journal of Physical Therapy Science. 2011; 23: 889-893 |

| |Harmon L. Myers, David Rakel. Strain and Counterstrain Manipulation Technique. 2nd edition. Rakel: Integrative Medicine 2007; chp 109. |

| |Che-Hsiang Wang, Philip McClure, Neal E. Pratt, Robert Nobilini. Stretching and Strengthening exercises: Their effect on three-dimensional scapular|

| |kinematics. Archives of Physical Medicine Rehabilitation. 1999; 80: 923-9 |

| |Rodriguez-Fernandez AL, Garrido-Santofimia V, Gueita-Rodriguez J, Fernandez-de-las-Penas C. Effects of burst-type transcutaneous electrical nerve |

| |stimulation on cervical range of motion and latent myofascial trigger point pain sensitivity. Archives of Physical Medicine Rehabilitation |

| |2011;92:1353-8. |

| |Cunha ACV, Burke TN, França FJR, Marques AP. Effect of global posture reeducation and of static stretching onto pain, range of motion, and quality |

| |of life in women with chronic neck pain: a random clinical trial. Clinics 2008;63:763-70. |

| |Hakkinen, Arja; Salo, Petri; Tarvainen, Ulla; Wiren, Kaija; Ylinen, Jari. Effect of manual therapy and stretching on neck muscle strength and |

| |mobility in chronic neck pain. Rehabilitation Medicine 2007; 39: 575–579. |

| |Joy C. Mac dermid, David M. Walton, Sarah Avery, Alanna Blanchard, Evelyn Etruw, Cheryl Mcalpine, Charlie H. Goldsmith Measurement Properties of |

| |the Neck Disability Index: a systemic review. Journal of Orthopaedic & Sports Physical Therapy, 2009 May;39:5. |

| | |

| | |

| |Williams MA, McCarthy CJ, Chorti A, Cooke MW, Gates S. Reliability and validity studies of methods for measuring active and passive cervical range |

| |of motion: a systematic review. Journal Manipulative and physiological Therapeutics 2010;3(2):138-55. |

| |M. Tousignant, L. de Bellefeuille, S. O'Donoughue, S. Grahovac. Criterion validity of the cervical range of motion (CROM) goniometer for cervical |

| |flexion and extension. Spine. 2000, Feb 1;25(3):324-30. |

| |Dimitrios Kostopoulos, Arthur J. Nelson, Reuben S. Ingber, Ralph W. Larkin. Reduction of Spontaneous Electrical Activity and Pain Perception of |

| |Trigger Points in the Upper Trapezius Muscle through Trigger Point Compression and Passive Stretching. Journal of Musculoskeletal Pain. 2008;16:4. |

| |Boonstra, Anne M; Schiphorst Preuper, Henrica R; Reneman, Michiel F; Posthumus, Jitze B; Stewart, Roy E. Reliability and validity of the Visual |

| |Analogue Scale for disability in patients with chronic musculoskeletal pain. International Journal of Rehabilitation Research. 2008 June; |

| |31(2)165-169. |

| |Rogger Scudds, Bruce Lai. Pain Control With Transcutaneous Electrical Nerve Stimulation. The Journal of The Hong Kong Physiotherapy |

| |Association.1983;5. |

| |Priya Kannan. Management of Myofascial Pain of Upper Trapezius: A Three Group Comparison Study. Global Journal of Health Science. 2012;4:5. |

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|9. |Signature of Candidate: |

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|10. |Remarks of the Guide: |

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|11. |Name and Designation of |

| |11.1 Guide : |

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| |11.2 Signature |

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| |11.3 Co-Guide : |

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| |11.4 Signature |

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| |Head of Department : |

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| |11.6 Signature |

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|12. |Remarks of the Chairman & Principal: |

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| |Signature |

ANNEXURE -1

TENDERNESS GRADING SCALE

The “Tenderness grading scale” (Hubbard, 1993) is a proposed grading system for the soft tissue tenderness. It is also a method for documenting patient responses to “provocative” tests, such as orthopedic tests or the

McKenzie analysis. Tenderness grading is as follows:

• Tenderness grading is as follows:

0- No tenderness

1- Tenderness to palpation without grimace or flinch

2- Tenderness with grimace & or flinch to palpation

3- Tenderness with withdrawal (+ “ Jump sign”)

4- Withdrawal (+ “Jump sign”) to non-noxious stimuli (i.e. superficial palpation, pin prick, gentle percussion)

ANNEXURE -2

CONSENT FORM

I Sweety Charles Carvalho have explained to........... (Subject name)........... 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 trapezitis like mine. Both approaches/ techniques are acceptable Physiotherapy intervention for this problem. This study will help physiotherapy better understand the use of Physiotherapy services in management of trapezitis with study of effect of positional release technique in subjects with trapezitis.

Procedure

I understand that I will be examined and asked a series of questions by the research Physiotherapist.

I am aware that in addition to ordinary care received. The Physiotherapy examination consists of measuring Visual Analog Scale, Neck Disability Index and cervical range of motion. I have been asked to undergo these tests only once during this study.

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 increase neck function. 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, but will be stored in the investigator’s research file.

If the data are 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 with 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 Miss Sweety Charles Carvalho may terminate my participation in this study at any time after she explained the reasons for doing so.

I confirmed that Miss Sweety Charles Carvalho 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

ANNEXURE-3

VISUAL ANALOG SCALE (VAS)

VAS is measured as 10 cm line.

NO PAIN WORST POSSIBLE PAIN

[pic]

0 1 2 3 4 5 6 7 8 10

Directions: Ask the patient to indicate on the line where the pain is in relation to the two

Extremes “no pain” and “worst possible pain”. Measure from the left hand side to the mark.

Total scores range from 0 to 10 with a higher score indicating more severe pain.

ANNEXURE-4

NECK DISABILITY INDEX (NDI)

[pic]

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