Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1. |Name of the candidate & address |SUMANA SHARMA |

| | |K.T.G. Girls Hostel, |

| | |Hegganahalli Cross, Vishwaneedam Post, |

| | |Sunkadakatte Via Magadi Road, |

| | |Bangalore- 560091 |

|2. |Name of the Institution |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 |

| | |(Physiotherapy in Musculoskeletal Disorders and Sports Physiotherapy) |

|4. |Date Of Admission To Course | 13-07-2013 |

|5. |Title of The Topic: |

| |“EFFECT OF MCGILL EXERCISES COMBINED WITH CORE STABILITY EXERCISES ON PAIN AND FUNCTIONAL DISABILITY FOR SUBJECTS WITH CHRONIC |

| |NON-SPECIFIC LOW BACK PAIN” |

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

| |6.1 Need for the study: |

| |Low back pain is usually described as discomfort in the lumbosacral region of the back that may or may not radiate to the legs, hips,|

| |and buttocks.1 It is one of the most common musculoskeletal ailments in the general population, affecting approximately 60–80% of the|

| |general population at one point or another in their lives.3,4 |

| |Conventionally low back pain is categorized according to its duration as acute (12 weeks).2 The majority of lower back pain is due to the musculoskeletal problems are referred to as non specific low back pain; |

| |this type may be due to muscle or soft tissues sprain or strain particularly in instances where pain arose suddenly during physical |

| |loading of the back, with the pain lateral to the spine. Over 99% of back pain instances fall within this category.4 |

| |Non specific low back pain is defined as pain between the costal margins and the inferior gluteal folds, usually accompanied by |

| |painful limitation of movement, often influenced by physical activities and posture, which may be with or without associated with |

| |referred pain in leg.5 It indicates that no precise structure has been identified causing the pain which includes common diagnosis, |

| |such as myofascial syndrome, muscle spasm, mechanical low back pain.6 Mechanical low back pain is due to the stresses of the tissues |

| |in the low back so is usually worse with movement.7 |

| |Nonspecific Low Back Pain has become a major worldwide public health problem.2 For individuals younger than 45 years mechanical Low |

| |Back Pain represents the most common cause of disability and for individuals older than 45 years.6 |

| |One possible factor for non-specific chronic low back pain is the trunk musculature, which, during functional activities, ensures |

| |the mobility and stability of the lumbopelvic region.8,9,10 Individuals with acute and Chronic low back pain (CLBP) show changes in |

| |trunk muscle activity, particularly in the transversus abdominis and multifidi.11 |

| |Various programs of stabilizing exercises have been used in treatment of patients with LBP.12,13,14 McGill proposed safe stabilizing |

| |exercises to enhance spinal stability without imposing high loads on the spine in patients with LBP.15 These exercises would achieve |

| |appropriate levels of activation of all back and abdominal muscles (rectus abdominis, quadrates lumborum, obliques, transversus |

| |abdominis, multifidus, and erector spinae), with minimal spinal loading to ensure spinal stability in patients with LBP.15 |

| |Tarek A. Ammar compared the effects of McGill exercises and conventional exercises on physical function in patients with nonspecific |

| |chronic low back pain (LBP). However that study has been limited to find these effect on pain and functional disability in chronic |

| |non-specific lowback pain.16 |

| |“CORE” is described as a box with the abdominals in the front, paraspinals and gluteus in the back, the diaphragm as the roof, and |

| |the pelvic floor and hip girdle musculature as the bottom. |

| |Particular attention has been paid to the core because it serves as a muscular corset that works as a unit to stabilize the body and |

| |spine, with or without limb movement.8 |

| |The term core stability is a generic description for the training of the abdominal and lumbopelvic region. Bergmark et al divided the|

| |active muscle subsystem (core) into "global" and "local" groups, based on their primary roles in stabilizing the core. The global |

| |muscles (dynamic, phasic, torque producing) which includes Rectus abdominis, External oblique, Internal oblique, Iliocostalis |

| |(thoracic portion) which are superficial muscles that they are the prime movers for the trunk, of hip flexion, extension, and |

| |rotation and the local muscles (postural, tonic, segmental stabilizers) which are deep intrinsic ones include Multifidus, Psoas |

| |major, Transversus abdominis, Quadratus lumborum, Diaphragm, Internal oblique (posterior fibers), Iliocostalis and longissimus |

| |(lumbar portions) are associated with the segmental stability of the lumbar spine during gross whole body movements and where |

| |postural adjustments are required. 9,16,17 |

| |Therefore, there is a need to know the effect of McGill exercises combined with core stability exercises for Chronic nonspecific low |

| |back pain. |

| |As there are no studies found on effectiveness of McGill exercises o combined with core stability exercises on pain and functional |

| |disability for chronic non-specfic low back pain. Hence, the purpose of present study is to find the effect of McGill exercises |

| |combined with core stability exercises on pain and functional disability for chronic non-specfic low back pain |

| |Research Question |

| |Whether McGill exercises combined with core stability exercises does have greater effect on improving Pain, Functional disability for|

| |subjects with chronic non-specific low back pain? |

| | |

| |Hypothesis: |

| |Null hypothesis |

| |“There will be no significant effect of McGill exercises combined with core stability exercises on improving pain and functional |

| |disability for chronic non-specfic low back pain” |

| | |

| |Experimental hypothesis |

| |“There will be a significant effect of McGill exercises combined with core stability exercises on improving pain and functional |

| |disability for chronic non-specfic low back pain” |

| | |

| |6.2 Review of Literatures: |

| |Tarek A. Ammar et.,al, (2012) studied to compare between the effects of McGill exercises and conventional exercises on physical |

| |function in patients with nonspecific chronic low back pain (LBP). They found that McGill exercises increased physical function of |

| |patients with nonspecific chronic LBP. In this study, McGill exercises were of value for patients with nonspecific chronic LBP. |

| |However that study has been limited to find these effect on pain and functional disability in chronic non-specific lowback pain.16 |

| |Fabio Renovato Franca et.,al, (2012) studied the effects of 2 exercise programs, segmental stabilization exercises (SSEs) and |

| |stretching of trunk and hamstrings muscles, on functional disability, pain, and activation of the transversus abdominis muscle (TrA),|

| |in individuals with chronic low back pain. They found that both techniques improved pain and reduced disability. However the study |

| |was limited to find the effect on particular type of lower back pain, and measuring Quality of life.17 |

| | |

| |Keisuke Ohtsuki, et al (2012) studied to compare the immediate changes in subject with Chronic Lower Back Pain exercises and direct |

| |stretching of the Tensor Fasciae Latae, Hamstring and Adductor Magnus. There are nine subjects with Chronic Lower Back Pain, they |

| |gave immediate direct stretching intervention to Hamstring, Tensor Fasciae latae, Lower Back. In their study they found that the |

| |recovery in muscle tissue flexibility, decrease in pain and improvement in circulation were cause by the back exercises and |

| |stretching of Lower Back, Tensor fasciae Latae and Hamstring muscle in Chronic Lower Back Pain.18 |

| |Fabio Renovato Franca, Thomaz Nogueira Burke et. al. (2010): performed a study wherein he took two groups into consideration where |

| |one group was trained with segmental stabilization exercises and the other with only superficial strengthening regime and in which he|

| |proved that both do reduce the pain but segmental stabilization of the core muscles was superior to superficial strengthening regime|

| |in reducing the pain and disability in patients with chronic back pain, and the superficial strengthening does not improve |

| |transverses abdominis activation capacity. 19 |

| |Steven P. Cohen, et al (2009) studied on Management of Low Back Pain and found that Mechanical Back Pain often radiates into the |

| |upper thigh and buttocks. In Mechanical Low Back Pain the pain is typically worsened with movement and improved by rest. In their |

| |study they stated that the diagnostic criteria of Mechanical Low Back Pain is done on the basis of clinical symptom and can be |

| |differentiated from radicular pain.20 |

| | |

| |Saeid Alemo, et al (2008) studied to determine the significance of facet joint arthropathy in Chronic Mechanical Lower Back Pain and |

| |the role of discopathy in Chronic Mechanical Lower back Pain. In their study, they stated that the diagnosis of Chronic Mechanical |

| |Low Back Pain is solely based on clinical Symptoms. In Chronic Mechanical Low Back Pain the pain is worsened by activity and improved|

| |partially by rest. Physical activity like bending, extending, twisting and lifting aggravates the pain in Chronic Mechanical Low Back|

| |Pain.21 |

| |Eyal Lederman et. al. (2008): studied the myth of core stability, followed the principles of core strengthening program and proved |

| |that it is essential in prevention as well as rehabilitation in case of lower back pain.22 |

| |Christopher Norrisa, Martyn Matthewsb et. al. (2008): studied the role of an integrated back stability program in patients with |

| |chronic low back pain and proved that the integrated back stability program including core strengthening along with the other trunk |

| |stabilising exercises improved the patients with chronic low back pain by reducing their pain and disability.23 |

| |Garry T. Allison, BApp Sci et. al. (2008): in his research reports to find whether the feed forward response in transverses abdominis|

| |are directionally specific and act symetrical studied, the feed forward transverse abdominalis activity is specific to the direction |

| |of the arm movement and not bilaterally symmetrical which is to stabilize the spine and not contribute to the control of the centre |

| |of mass or the individual task.24 |

| |Felipe Pivetta Carpes, Fernanda Beatriz Reinehr et. al. (2008): studied to find that ffects of a program for trunk strength and |

| |stability on pain, low back and pelvis kinematics, and body balance: A pilot study, wherein the results suggested that the |

| |recruitmentment of trunk strength and stability has positive effect on low back and pelvis pain and kinematics as well as on body |

| |balance.25 |

| |Barr KP, Griggs M, Cadby T et. al. (2005): in their study to assess the benefits of lumbar stabilisation program to treat low back |

| |pain proved their point that the core muscles strengthening does play a major role in the lumbar stabilization and hence reduces low |

| |back pain.26 |

| | |

| |Jill A. Hayden DC, et al (2005) studied to identify particular exercise intervention characteristics that decrease pain and improve |

| |function in adults with nonspecific chronic low back pain. Forty three trials of Seventy two exercise treatment and thirty one |

| |comparison groups were included in the study. They concluded in their study that Exercise therapy including stretching and |

| |strengthening with supervision was found most effective for improving functional outcomes in Chronic Low Back Pain.27 |

| |Julie M Fritz, Julie M Whitman et. al. (2004): in their study about the factors related to the inability of individuals with low back|

| |pain to improve with a spinal manipulation established their idea about inability of the manipulative therapy only, to reduce the low|

| |back pain.28 |

| | |

| |Martin Descarreaux, et al (2002) studied to compare the effectiveness of two home exercises programs in decreasing disability and |

| |pain related to subacute and chronic nonspecific low back pain. Twenty subjects were taken for the study and the study was done for |

| |six weeks. The exercise programs like stretching, flexion and extension exercises are given. In their study, they concluded that the |

| |extensibility and muscular force of low back muscle are increased in Chronic Nonspecific Low Back Pain.29 |

| |J Brent Feland, et al (2001) studied to determine the effectiveness of three duration of stretches to produce and maintain the |

| |greatest gains in knee extension range of motion with the femur held at 90˚ of hip flexion in a group of elderly individuals. Age |

| |ranging from 70-97 subjects was taken for the study, stretching was given five times per week for six weeks for 15, 30 and 60 |

| |seconds. In their study, they concluded that longer hold times during stretching of the hamstring muscle resulted in a more sustained|

| |increase in range of motion in elderly.30 |

| |Amy Brown, et al (1999) studied to demonstrate the usefulness of a classification system for determining appropriate treatment in |

| |patients to describe how the diagnostic process influenced treatment choices in Mechanical Low Back Pain. In their study, they stated|

| |that diagnosis is based on their clinical symptoms. In Mechanical Chronic Low Back Pain there is limited forward flexion in standing |

| |by 30%. During movement the mechanical stress causes pain.31 |

| |William D Brandy, et al (1997) studied the effect of time and frequency of static stretching on flexibility of the hamstring muscle |

| |to ninety three subjects, age ranging from 21 to 39 years who had limited hamstring muscle flexibility. Stretching was given for five|

| |days per week for six weeks. In their study, they found that thirty second duration is an effective amount of time to sustain a |

| |hamstring muscle stretch in order to increase range of motion.32 |

| |Review on outcome Measurement in chronic low back pain |

| |Deyo, Richard A et al (1998) studied that Outcome measures should be routinely assessed in CLBP patients, and should be chosen based |

| |on the patient’s most important domains, such as pain, function, and quality of life. Based on the ease of administration and the |

| |patient’s responsiveness, the Visual Analog Scale or the Numeric Rating Pain Scale is recommended for measuring pain, the Oswestry |

| |Disability Index or the Roland Morris Disability Questionnaire for measuring function, and the SF-36 or SF-12 for measuring quality |

| |of life.33 |

| |Boonstra AM et al (2008) studied the reliability and validity of Visual analogous scale (VAS) for disability in patient with chronic |

| |musculoskeletal pain and conclude that the reliability of VAS for disability is moderate to good because of weak correlation with |

| |other disability instrument.34 |

| |Fritz JM, Irrgang JJ (2001) examined the validity of a global rating of change as a reflection of meaningful change in patient |

| |status and to compare the measurement properties of a modified Oswestry Low Back Pain Disability Questionnaire (OSW) and the Quebec |

| |Back Pain Disability Scale (QUE). They found that the modified OSW demonstrated superior measurement properties compared with the |

| |QUE.35 |

| | |

| |6.3 Objectives of the study: |

| |To determine the effect of McGill exercises combined with core stability exercises on improving pain and functional disability for |

| |subjects with non-specific mechanical low back pain. |

| |Materials and Method |

| |7.1 Study Design |

| | |

| |Pre and post test Experimental study design with two groups –Control group and study group. |

| | |

| |7.2 Methodology |

| |Sample size: |

| |The study will be carried on 40 subjects. 20 subjects in Study group and 20 subjects in control group |

| |Source of data: |

| |Study will be carried at K.T.G. Hospital |

| |Sampling Method: |

| |Random sampling Method. |

| |Study Duration |

| |Total duration of intervention will be for 6 week. 2 sessions per week, each lasting 30 minutes for a total of 12 treatments |

| |sessions. |

| |Sample Selection |

| |Inclusion Criteria |

| |Both male and female subjects. |

| |Age group between 20 to 50 years. 16 |

| |Patients with LBP for more than 3 months (pain felt between T12 and the gluteal fold) 16 |

| |Subjects who referred to physiotherapy after diagnosed with chronic non-specific Mechanical low back pain conformed by Orthpedician |

| |for no specific pathology in Spine. |

| |Who agreed to participate in the study |

| |Exclusion Criteria |

| |Subjects with inflammatory arthritis. |

| |Known osteoporosis. |

| |Subjects for whom exercise is contraindicated. |

| |Subjects whose presented with neurological disease. |

| |Non-stabilised cardio-vascular disorder, acute injury or inflammation affecting the musculoskeletal system, motor disorder, state |

| |post surgery. |

| |History of previous lumbar surgery, spinal stenosis, spondylolisthesis, neurological dysfunction, systemic disease, injection |

| |therapy, carcinoma, or pregnancy. |

| |Materials used: |

| |Couch |

| |Exercise mat |

| |Treatment table |

| |Outcome measures |

| |Intensity of pain was measured using visual analogue scale in millimeter.34 |

| |Functional disability will be measured using Modified Oswestry Disability Index in percentage.35 |

| |Intensity of pain |

| |Intensity of pain estimated using a visual analog scale (VAS), with 10cm scale scores ranging from no pain to very severe pain, |

| |representation 0 as an absence or no pain of pain and 10 very severe pain. |

| |Functional disability |

| |Functional disability will be measured using Modified Oswestry Disability Index in percentage. |

| |Variables |

| |Independent Variable |

| |conventional exercises, McGill exercises, core stability exercises |

|7 |Dependent Variable |

| |Pain, Functional disability. |

| | |

| |7.3. Method 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. |

| |Pre-test evaluation |

| |Individually informed consent will be taken from all the 40 subjects selected for the study on the basis of inclusion criteria. The |

| |subjects were randomly divided into two groups, 20 subjects in study group and 20 subjects in control group. Forty pieces of paper |

| |used, with twenty pieces having the word “stuyd” written on them, and twenty having the words “control” written on them. All the |

| |pieces of paper will be tightly folded and placed in a box. After shaking the box each piece of paper will be withdrawn individually |

| |and the group name will be written on a list that corresponds with the patient numbers from 1 to 40. |

| |Pre test Outcome measurement: |

| |Pre treatment measurements on pain will be measured using VAS score, Disability will be measured using Modified Oswestry Disability |

| |Index (Annexure–2, 3) |

| |Procedure: |

| |Procedure of Intervention for control – controlled conventional exercises group |

| |The conventional exercises included stretching and strengthening exercises for the trunk and the lower limbs. Participants will |

| |receive a series of progressive exercises building up to a maximum of 10-12 exercises by the final visit based on their individual |

| |needs. Participants will ask to carry out one set of 10 repetitions for each exercise, with a 30-second to one-minute rest between |

| |each set during each exercise session. For a home exercises, participants will adviced to perform four to six exercises of the |

| |conventional exercises on the basis of individual needs. Participants performed two sets of 10 repetitions for each exercise, with a |

| |30-second to one-minute rest between each set, twice per day. |

| |Exercises will be focused on the Transverse abdominus and LM muscles stretching of Erector spinae (ES), Hamstring (HS), and triceps|

| |surae (TS) muscles and connective tissues posterior to column will be performed |

| |2 sessions per week, each lasting 30 minutes, for a total of 12 treatments over 6 consecutive weeks. |

| | |

| |Procedure of Intervention for study group – |

| |Subject in study group will receive McGill exercises combined with core stability exercises along with conventional exercises |

| |Core stability Exercises:17 |

| |3 series of 15 repetitions were done for each subjects, each exercise will be performed with set of 30 times each. And then the |

| |exercises are performed in the next progressions once the present exercise is performed successfully. |

| |Base position Cue: Supine with knees bent and feet on floor; spine stabilized in neutral position with instructing the subject to get|

| |his “navel to spine”, also termed the Abdomen Hollowing exercise, the tummy tuck or Bracing the abdomen. |

| |Once the subject is through with this level of exercise the further progression are: |

| |Base position with 1 foot lifted |

| |Base position with 1 knee held to chest and other foot lifted |

| |Base position with 1 knee held lightly to chest and other foot lifted |

| |Base position with Knee to chest (at 90° of hip flexion) held actively and other foot lifted |

| |Base position with Knee to chest (at 90° of hip flexion) held actively and other foot lifted and slide on ground. |

| |Base position with Knee to chest (at 90° of hip flexion) held actively and other foot lifted and slide not on ground |

| |Base position with Bilateral heel slides |

| |Base position with Bilateral leg lifts to 90° |

| |Bracing in standing |

| |Bracing with standing row |

| |Bracing with walking |

| | |

| |Further the progression in Quadriped position wherein the subjects are made to go on both his knees and his hands like the all four |

| |position. |

| |Quadruped arm lifts with bracing |

| |Quadruped leg lifts with bracing |

| |Quadruped alternate arm and legs lifts with bracing. |

| |Controlled lowering and raising of legs together: here the patient lie’s supine and has to raise both legs up to maximum and then |

| |gradually put it down. |

| |Stretching of the ES, HS, and TS will be performed, 2 series of 4 minutes were performed, with 1 minute of resting interval. |

| |Stretching of the ES in dorsal decubitus, with flexed hips and knees |

| |Stretching of the HS and TS in dorsal decubitus, with forced flexion of 1 limb at |

| |a time with assistance of the therapist. |

| |Stretching of the ES with the patient sitting on heels, flexed trunk with the abdomen resting on the front of the thighs Global |

| |stretching of the posterior muscular chain (TS, HS, ES) |

| |McGill exercises:16 |

| | |

| |Each patient will be trained to find his/her neutral spinal posture prior to initiating the stabilizing exercises. The McGill program|

| |will be begning with a motion exercise (cat-camel motion exercise). It consists of six-to-eight cycles of spinal flexion and |

| |extension in a quadruped position. This is followed by the curl-up exercises, in which the patient flexes one knee while keeping the |

| |other straight to minimize loss of the neutral posture. Then, the patient wil gently raises just the head and shoulders a short |

| |distance off the floor. This exercise will be followed by the side-support exercise. The patient is will be positioned as follows: |

| |lying on the side supported on his/her elbow and hip, knees |

| |bent to 90º, free hand placed on the opposite shoulder. The patient then raises his/her trunk until the body is supported on the |

| |elbow and the knee. If the patient is not able to perform the side support exercise, the patient would assume the side lying position|

| |and initiate an isometric contraction of the quadrates lumborum by trying to lift both lower |

| |limbs up toward the ceiling. Upon successful performance of the side support exercise, the birddog exercise (opposite arm and leg |

| |extension in the quadruped position) will be carried out. In the quadruped position, the patient can also perform single leg lifting|

| |and/or single arm lifting. However, they will be advised to perform one set of 10 repetitions for each McGill exercise, with a |

| |30-second to one-minute rest between each set during each exercise session. |

| |For a home program, participants will be advised to perform four to six McGill exercises with two sets of 10 repetitions for each |

| |exercise, with a 30-second to one-minute rest between each set, twice per day. |

| |In both groups, the therapist will; be asked the participants to use weekly self-report exercise logs to monitor the home program. |

| |Post test Outcome measurement: |

| |Post treatment measurements on pain will be measured after 6 weeks using VAS score, Functional Disability will be measured using |

| |Modified Oswestry Disability Index. (Annexure–2, 3) |

| | |

| |Statistical Tests: |

| |Statistical analysis will be performed by using SPSS software for window ( version16) and p value will be set as 0.005. |

| |Descriptive statistics and Chi sq. Test will be used to analyze baseline data for demographic data. |

| |Chi-square (x2) test has been used to analyze the significant of basic characteristic of gender, age and side distribution of the |

| |subjects studied. |

| |Independent ‘t’ test as a parametric and Mann Whitney U test as a non-parametric test have been used to compare the means of VAS and|

| |Modified Oswestry Disability Index scores between the groups with calculation of percentage of difference between the means. |

| |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. |

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| |J Brent Feland, J Williams Myrer, Shane S Schulthies, Gill W Fellingham, Gary W Measom. The effect of Duration of stretching of the |

| |hamstring Muscle. Group for increasing Range of Motion in people Aged 65 years or older. APTA 2001 May 5; 81: 1110-1117. |

| |Amy Brown, Lynn Snyder Mackler. Diagnosis of Mechanical Low Back Pain in a Labourer. Jour of Ortho & Sport Phy Therapy 1999; 29(9): |

| |534-539. |

| |Ghj |

| |Deyo, Richard A . Outcome Measures for Low Back Pain Research: A Proposal |

| |for Standardized Use. Spine 15 September 1998;23(18): 2003-2013. |

| |Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB. Reliability and validity of the visual analogue scale for disability in|

| |patients with chronic musculoskeletal pain. International Journal of Rehabilitation Research.2008; 31(2): 165-169. |

| |Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability |

| |Scale. Phys Ther. 2001;81:776-788. |

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|9 |Signature of the Candidate | |

|10 |Remarks of the Guide |Recommended for approval |

|11 |Name & Designation of: | |

| |11.1 Guide | |

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| |11.2 Signature | |

| |11.3 Co-Guide (If Any) | |

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| |11.4 Signature | |

| |11.5 Head of the Department | |

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| |11.6 Signature | |

|12 |12.1 Remarks of Chairman and Principal |Recommended for approval |

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| |12.2 Signature | |

APPENDIX I

CONSENT FORM

I SUMANA SHARMA 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 chronic non-specific low back pain Both treatments are acceptable Physiotherapy intervention for this problem. This study will help physiotherapy better understand the use of Physiotherapy services in management of patients with chronic non-specific low back pain.

Procedure

I understand that I will be assigned by lot to receive exercise therapy. I will be expected to attend Physiotherapy treatment session with followup. I am aware that in addition to ordinary care received, I will be examined and asked a series of questions by a research Physiotherapist. The Physiotherapist examination consists of measuring pain by visual analogue scale, functional disability. I have been asked to undergo these tests 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 and treatment. 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 improve my functional 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, 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 SUMANA SHARMA may terminate my participation in this study at any time after he explained the reasons for doing so.

I confirmed that SUMANA SHARMA 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-2

A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. From the patient's perspective this spectrum appears continuous ± their pain does not take discrete jumps, as a categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised. Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, as illustrated in Fig. 1. 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.

0 100

0-Absence of pain 100- Severe pain

ANNEXURE-3

MODIFIED OSWESTRY SCALE

To be completed by patient

This questionnaire has been designed to give your therapist information as to how your back pain has affected your ability to manage in everyday life. Please answer every question by placing a mark on the line that best describes your condition today. We realize you may feel that two of the statements may describe your condition, but please mark only the line which most closely describes your current condition.

Pain Intensity

_____The pain is mild and comes and goes.

_____The pain is mild and does not vary much.

_____The pain is moderate and comes and goes.

_____The pain is moderate and does not vary much.

_____The pain is severe and comes and goes.

_____The pain is severe and does not vary much.

Personal Care (Washing, Dressing, etc.)

_____I do not have to change the way I wash and dress myself to avoid pain.

_____I do not normally change the way I wash or dress myself even though it causes some pain.

_____Washing and dressing increases my pain, but I can do it without changing my way of doing it.

_____Washing and dressing increases my pain, and I find it necessary to change the way I do it.

_____Because of my pain I am partially unable to wash and dress without help.

_____Because of my pain I am completely unable to wash or dress without help.

Lifting

_____I can lift heavy weights without increased pain.

_____I can lift heavy weights but it causes increased pain

_____Pain prevents me from lifting heavy weights off of the floor, but I can manage if theyare conveniently positioned (ex. on a table, etc.).

_____Pain prevents me from lifting heavy weights off of the floor, but I can manage light to medium weights if they are conveniently positioned.

_____I can lift only very light weights.

_____I can not lift or carry anything at all.

Walking

_____I have no pain when walking.

_____I have pain when walking, but I can still walk my required normal distances.

_____Pain prevents me from walking long distances.

_____Pain prevents me from walking intermediate distances.

_____Pain prevents me from walking even short distances.

_____Pain prevents me from walking at all.

Sitting

_____Sitting does not cause me any pain.

_____I can only sit as long as I like providing that I have my choice of seating surfaces.

_____Pain prevents me from sitting for more than 1 hour.

_____Pain prevents me from sitting for more than 1/2 hour.

_____Pain prevents me from sitting for more than 10 minutes.

_____Pain prevents me from sitting at all.

To be completed by patient

Standing

_____I can stand as long as I want without increased pain.

_____I can stand as long as I want but my pain increases with time.

_____Pain prevents me from standing more than 1 hour.

_____Pain prevents me from standing more than 1/2 hour.

_____Pain prevents me from standing more than 10 minutes.

_____I avoid standing because it increases my pain right away.

Sleeping

_____I get no pain when I am in bed.

_____I get pain in bed, but it does not prevent me from sleeping well.

_____Because of my pain, my sleep is only 3/4 of my normal amount.

_____Because of my pain, my sleep is only 1/2 of my normal amount.

_____Because of my pain, my sleep is only 1/4 of my normal amount.

_____Pain prevents me from sleeping at all.

Social Life

_____My social life is normal and does not increase my pain.

_____My social life is normal, but it increases my level of pain.

_____Pain prevents me from participating in more energetic activities (ex. sports, dancing, etc.)

_____Pain prevents me from going out very often.

_____Pain has restricted my social life to my home.

_____I have hardly any social life because of my pain.

Traveling

_____I get no increased pain when traveling.

_____I get some pain while traveling, but none of my usual forms of travel make it any worse.

_____I get increased pain while traveling, but it does not cause me to seek alternative forms of travel.

_____I get increased pain while traveling which causes me to seek alternative forms of travel.

_____My pain restricts all forms of travel except that which is done while I am lying down.

_____My pain restricts all forms of travel.

Employment/Homemaking

_____My normal job/homemaking activities do not cause pain.

_____My normal job/homemaking activities increase my pain, but I can still perform all that is required of me.

_____I can perform most of my job/homemaking duties, but pain prevents me from performing more physically stressful activities (ex. lifting, vacuuming)

_____Pain prevents me from doing anything but light duties.

_____Pain prevents me from doing even light duties.

_____Pain prevents me from performing any job or homemaking chores.

Section 3: To be completed by physical therapist/provider

SCORE: Initial_____% Subsequent_____% Subsequent_____% Discharge_____%

Number of treatment sessions:________________

Diagnosis/ICD-9 Code:_______________________

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