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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION 1. KAVAN TK, 26, KSRP OFFICERS NAME OF THE CANDIDATE AND ADDRESS QUARTERS, GODAVARI SANKIRNA, KORAMANGALA, BANGALORE [KARNATAKA] 2. NAME OF THE INSTITUTION KRUPANIDHI COLLEGE OF PHYSIOTHERAPY, BANGALORE COURSE OF THE STUDY AND SUBJECT MASTER OF PHYSIOTHERAPY IN MUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY DATE OF ADMISSION TO THE COURSE TITLE OF THE TOPIC: 19th MAY 2011 3. 4. 5. MULTI -MODAL TREATMENT APPROACH FOR CHRONIC SHOULDER IMPINGEMENT SYNDROME - A RANDOMIZED CONTROL TRIAL 6 BRIEF RESUME OF THE INTENDED WORK INTRODUCTION Chronic shoulder pain is a term that refers to pain that occurs for duration longer than four to six months1. An estimated 20 percent of the population in the world suffers from shoulder pain during their lifetime2. Shoulder pain is second only to low back pain in patients seeking care for musculoskeletal ailments3. Shoulder pain is responsible for approximately 16% of all musculoskeletal complaints4, with a yearly incidence of 15 new episodes per 1,000 patients seen in the primary care setting5. The prevalence of shoulder pain in the general population ranges from 6.9% to 34%. For people greater than 70 years of age, the prevalence of shoulder pain was reported to be 21% in one study. Forty percent of the population probably will suffer from shoulder pain at some point of their life time6. The four most common conditions that lead to chronic shoulder pain are1: Rotator cuff tears, Shoulder impingement syndrome (SIS) Frozen shoulder and Shoulder arthritis. Shoulder impingement is among the most common function-limiting disorders of the musculoskeletal system7-8. The point prevalence of shoulder symptoms has been reported to range from 20 to 33%9, and the incidence of shoulder complaints in the general population is increasing10. Furthermore, several authors have reported low rates of perceived recovery (patient reports of ‘being cured’) for patients with a new episode of shoulder pain10 -13. Less than 25% of patients with a first episode of shoulder pain may recover and be symptom free after 3 months5. Recovery rates at 18 months have been reported only between 49% and 59%11, 12, 14, and 25% of patients with shoulder or neck pain experience at least one episode of recurrence within 12 months15. These findings suggest that shoulder pain can be recurrent and frequently progresses to the chronic stage. The rotator cuff muscles of the shoulder are sandwiched between the arm bone and the top of the shoulder (acromion). This unique arrangement of muscle between bone leads to the condition of impingement syndrome (shoulder bursitis, rotator cuff tendinitis) 16. Neer first introduced the concept of rotator cuff impingement in 1972. He described the syndrome as a mechanical impingement of the rotator cuff tendons beneath the anteriorinferior portion of the acromion occurring when the shoulder is placed in the forwardly flexed and internally rotated position17. It is important to remember that the function of the rotator cuff, in addition to generating torque, is to stabilize the glenohumeral joint; thus, stronger rotator cuff muscles result in better glenohumeral joint stabilization and less impingement18. Conservative management for chronic shoulder pain involves specific strengthening program for the rotator cuff for the prevention of future injuries. The motions of the rotator cuff that are emphasized for strengthening the internal rotation, external rotation and abduction. Patients may require a formal physical therapy program18. Thus, the shoulder exercises should be done with a fixed weight rather than a variable weight such as a thera band. Repetitions are emphasized, and a relatively light weight is used. Sometimes, sports-specific techniques are useful, particularly when strengthening the throwing motion, the serving motion or swimming motions. In addition, physical therapy modalities such as electro galvanic stimulation, ultrasound treatment and transverse friction massages can also be helpful. Some authors routinely advocate the usage of ultrasound in conjunction with other modalities and report positive outcomes19, 20, 21. The physiologic benefits of ultrasound have been attributed to its thermal actions; these involve an increase in peripheral blood flow, increased tissue metabolism and greater tissue extensibility22. In addition to this transverse friction massage has been advocated by a number of authors in the management of shoulder disorders. Hammer describes friction massage as a technique where an involved muscle, tendon or ligament is massaged by applying pressure with a reinforced finger. The transverse motion across the involved tissue and the resultant hyperaemia are said to be the chief healing factors of friction massage. The transverse action is said to prevent the formation of scar tissue while longitudinal friction effects the transportation of blood and lymph23, 24. The goals of manual therapy of subacromial impingement are to decrease subacromial inflammation, to allow healing and strengthening of a dysfunctional rotator cuff and to restore pain-free shoulder function18. Studies have also shown that incorporation of joint mobilizations to treat shoulder impingement results in superior outcomes compared with therapeutic exercise alone25, 26, 27. Some researchers propose that a mobilization force can be selectively directed to a specific area of the capsule to restore capsular extensibility26, 28. Studies have found that individuals with shoulder impingement often have a tight posterior capsule resulting in altered glenohumeral arthrokinematics29, 30 and a decrease in glenohumeral internal rotation range of motion (ROM) 31, 32, 30. Many studies have reported the effectiveness of exercise therapy programs in treatment of chronic shoulder impingement syndrome as a non surgical intervention, research on the combination of multimodality treatment in treating a shoulder impingement syndrome is insufficient. Mario Pribicevic and Henry Pollard reported that there is a significant improvement in pain, range of motion and in functions of those individuals who were been diagnosed with shoulder impingement syndrome using a multi- modal treatment approach like therapeutic ultrasound, soft tissue release, joint mobilization and exercise therapy33. It seems reasonable to suggest that multimodality treatment in treating a shoulder impingement syndrome may be helpful in the management of shoulder impingement that do not respond to conservative management. Unfortunately, there is little evidence on the efficacy of these types of interventions for patients with chronic subacromial impingement syndromes not responding to conservative management. Thus, the aims of this study were to investigate the effectiveness of a combination of multimodal therapy which includes therapeutic ultrasound, soft tissue release, spinal and peripheral mobilization and exercise therapy on pain, function and Range of motion of chronic shoulder impingement syndrome patients and if beneficial, to develop a more effective intervention protocol. 6.1 NEED FOR THE STUDY Various studies in the past showed that conventional therapy approaches in treating impingement syndrome was more effective than patient opting for surgery. Studies have also suggested that multiple modality treatment approach is helpful in reducing pain, improving ROM and restoring functional activities. Limited randomized control studies have been conducted on chronic shoulder impingement syndrome and also on limited number of patient samples. Thus, the proposed study intends to find the efficacy of a multi-modal treatment approach for chronic shoulder impingement on a larger group of randomized targeted population. 6.2 OBJECTIVES OF THE STUDY (A) OBJECTIVES: To investigate the effectiveness of multi-modal treatment approach to reduce pain in chronic shoulder impingement syndrome. To investigate the effectiveness of multi-modal treatment approach to restore the lost range of motion in chronic shoulder impingement syndrome. To investigate the effectiveness of multi-modal treatment approach to restore lost functional activities in chronic shoulder impingement syndrome. (B) HYPOTHESIS NULL HYPOTHESIS: There is no significant effect of multimodal treatment approach in treating chronic shoulder impingement syndrome. EXPERIMENTAL HYPOTHESIS: I. There is a significant effect of multimodal treatment approach in reducing pain in chronic shoulder impingement syndrome. II. There is a significant effect of multimodal treatment approach in restoring the lost range of motion in chronic shoulder impingement syndrome. III. There is a significant effect of multimodal treatment approach in restoring lost functional activities in chronic shoulder impingement syndrome. 6.3 REVIEW OF LITERATURE 1. Phil Page (2011) suggested that Subacromial impingement is a frequent and painful condition among athletes, particularly those involved in overhead sports such as baseball and swimming. There are generally two types of subacromial impingement: structural and functional. While structural impingement is caused by a physical loss of area in the subacromial space due to bony growth or inflammation, functional impingement is a relative loss of subacromial space secondary to altered scapulohumeral mechanics resulting from glenohumeral instability and muscle imbalance. 2. Carel Bron, et al (2011) suggested that patients who received 12-week comprehensive treatment of myofacial trigger point release technique in shoulder muscles reduces the number of muscles with active myofacial trigger points and is effective in reducing symptoms and improving shoulder function in patients with chronic shoulder pain. 3. Hidalgo-Lozano A, Fernández-de-las-Peñas C, (2011) suggested that twelve patients diagnosed with unilateral shoulder impingement attended four sessions for 2 weeks received trigger point pressure release and neuromuscular interventions showed that manual treatment of active muscle trigger points can help to reduce shoulder pain and pressure sensitivity in shoulder impingement syndrome. 4. Jeffrey A. Fleming (2010) suggested that exercise is beneficial for reducing pain and improving function in individuals with rotator cuff impingement syndrome. The effects of exercise might be augmented with implementation of manual therapy. In addition, supervised exercise might not be more effective than a home exercise program. 5. F. Angst, J. Goldhahn (2009) suggested that the German Shoulder Pain and Disability Index (SPADI) is a practicable, reliable and valid instrument, and can be recommended for the self assessment of shoulder pain of shoulder pain and function. 6. Aimie F. Kachingwe (2008)39 suggested that patients diagnosed with shoulder impingement syndrome received physical therapy interventions of glenohumeral mobilizations and MWM in combination with a supervised exercise program showed significant decrease in pain and improved function compared to the patients who were only managed by supervised exercise and control groups. Hence suggesting that manual therapy techniques can be an important adjunct to supervised exercise in the treatment of individuals with shoulder impingement syndrome. 7. Gamze Senbursa, Gul Baltac, Ahmet Atay (2007) suggested that patients diagnosed with impingement syndrome treated with manual physical therapy applied by experienced physical therapists combined with supervised exercise in a brief clinical trial showed improvement of symptoms including increasing strength, decreasing pain and improving function earlier than with exercise program. 8. Joy C MacDermid (2006) suggested that Shoulder Pain and Disability Index (SPADI) is a valid measure to assess pain and disability in community-based patients reporting shoulder pain due to musculoskeletal pathology. 9. Kenneth Hing-Sum Tsui (2005) suggested that impingement syndrome is common in clinical practice. Knowledge of basic anatomy of the shoulder and mechanism of the disease process is essential for management. Non-steroidal anti-inflammatory drug has only very limited evidence of effectiveness. Subacromial steroid injection has some evidence of effectiveness but the optimal type of steroid, dosage, frequency and timing of injection is still unclear. Structured and supervised exercise programs have been shown to offer long-term benefit. Weight pendulum exercise and other simple exercises could be recommended to patients in the clinic setting. Orthopedic surgery is indicated for refractory cases of shoulder impingement syndrome. 10. Karen A. Ginn and Milton L. Cohen (2005) suggested that patients who underwent individually-tailored exercise therapy which was aimed at restoring dynamic joint stabilizing mechanisms and muscle coordination or a combination of various physical modalities and ROM exercises is equally effective in the short term improvement in chronic shoulder pain. 11. Per Jonsson et. al (2004) suggested a specially designed painful eccentric training model for the supraspinatus and deltoideus muscles showed promising short-term clinical results on a small group of patients with severe pain from impingement of the shoulder. 12. Wing K. Chang (2004) suggested that Shoulder impingement syndrome and rotator cuff disease are increasingly more common in athletes whose sports involve repetitive overhead motions. The increased forces and repetitive overhead motions can cause attritional changes in the distal part of the supraspinatus tendon, which is most at risk due to its poor blood supply. No commercial party having a direct financial interest in the results of the research. 13.Markus Walther,Andreas Werner,Theresa Stahlschmidt,Rainer Woelfel, Frank Gohlke,(2004) suggested that patients with subacromial impingement syndrome of the shoulder treated with guided self-training program and by conventional physiotherapy or a functional brace, showed a significant improvement in shoulder function as well as a significant reduction in pain. 14. E.John Gallagher, Polly E. Bijur, Clarke Latimer, Wendy Silver,(2001) suggested that VAS is a methodologically sound instrument for quantitative assessment of acute abdominal pain and for detecting clinically important changes in such pain. 15. Review of goniometry emphasizing reliability and validity by richard l. gajdosik and richard w. bohannon (1987): Clinical measurement of range of motion is fundamental evaluation procedure with ubiquitous application in physical therapy. The purpose of this article is to review the related literature on the reliability and validity of goniometric measurements of the extremities. They conclude that clinicians should adopt standardized methods of testing and should interpret and report goniometric results as ROM measurements only, not as measurements of factors that may affect ROM. 16. Griffin et al [41] (1967) showed in his comparative study the effectiveness between phonophoresis and ultrasound in patients suffering from shoulder impingement syndrome that patients receiving phonophoresis showed significant improvement in range of motion and pain as compared to the patients receiving ultrasound group. 7.MATERIALS AND METHOD 7.1 SOURCE OF DATA (A) POPULATION: Patients diagnosed with shoulder impingement syndrome. (B) SAMPLE SIZE: 30 subjects who fulfill inclusion criteria will be recruited from the population given above and divided into two groups- 15 subjects in each group. GROUP 1: Experimental group; Multimodality treatment approach. GROUP 2: Control group; Conventional physiotherapeutic approach. MATERIALS USED FOR THE STUDY: 1. Universal goniometry 2. Assessment chart 3. Therapeutic Ultrasound 4. Couch 5. Mobilization belt 6. Cold packs 7.2 METHOD OF COLLECTION OF DATA: (A) SAMPLING TECHNIQUES: Simple random sampling. (B) TOOLS: Standard universal goniometry for range of motion (ROM). Subjective/objective visual analog scale (VAS) for pain assessment. Shoulder pain and disability index scale (SPADI) for function. (C) METHODOLOGY: (I) STUDY DESIGN: Randomized control trial. (II) INCLUSION CRITERIA: In order to participate in this study, subjects will have to fulfill following criteria’33 A positive clinical Neer’s test Shoulder pain resistant to rest Shoulder pain resistant to anti-inflammatory drugs Shoulder pain resistant to subacromial steroid injections Shoulder pain resistant to conventional physiotherapy with a minimum history of three months (III) EXCLUSION CRITERIA: Glenohumeral or acromioclavicular arthritis’33 Glenohumeral instability Total rupture of the rotator cuff Cervical syndrome Adhesive capsulitis Neuropathy of the shoulder region (IV) PROCEDURE and INTERVENTION: Subjects who fulfill the selection criteria will be included in the study. They will be taken in to the research once they sign the informed consent. A total of 30 subjects will be selected and divided into 2 groups of 15 subjects each by simple randomization. The study will be carried out in three stages- a) Pre- intervention measurement b) Intervention c) Post-intervention measurement. a) Pre- intervention measurement Here the subjects are measured for pain, range of motion and function. Pain measurement using subjective/objective visual analog scale The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge. The VAS score correlates well with acute pain levels34. Hawkins test involves positioning the arm at 90 degrees of flexion with subsequent internal rotation. Neer's impingement test is performed with the patient sitting as the practitioner stands behind the patient with one hand supporting the scapula to prevent scapula rotation and the other hand holding the forearm. The shoulder is brought into maximum flexion with a small degree of internal rotation. The test is considered positive if there is pain in the last 10–15 degrees of flexion. Pain is produced because the greater tuberosity is compressed against the anterior acromion or coracoacromial ligament, hence this test may aggravate an inflamed bursa (subacromial), the supraspinatus tendon or the anterior structures of the coracoacromial arch33. Pain will also be measured at rest, motion and at night pre and post intervention18. Joint range of motion using universal goniometer Universal goniometer measurements A 12-inch, 3601 goniometer, marked in 11 increments, with two adjustable overlapping arms was used. Shoulder flexion ROM was taken by asking the patient to raise their arm straight over-head as far as possible. Standard measurement positioning was used by placing the stationary arm parallel to the midline of the thorax, and the moving arm aligned with the shaft of the humerus and lateral epicondyle. Shoulder ER was taken by passively placing the patient’s arm in 90degree abduction with the elbow flexed 90degree and asking the patient to rotate their arm backward as far as possible so that their palm was facing the ceiling. Standard goniometric positioning was used by placing the stationary arm perpendicular to the floor, and the moving arm was aligned with shaft of the ulna and styloid process. Shoulder IR was taken by passively placing the patients arm in 90degree abduction with the elbow flexed 90degree and asking the patient to rotate their arm forward as far as possible so that their palm was facing the floor. Positioning of the goniometer for measurement was also used in a standardized fashion (Norkin and White, 1988)35. Functional assessment using Shoulder pain and disability index (SPADI) The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. Scoring instructions To answer the questions, patients place a mark on a 10cm visual analogue scale for each question. Verbal anchors for the pain dimension are ‘no pain at all’ and ‘worst pain imaginable’, and those for the functional activities are ‘no difficulty’ and ‘so difficult it required help’. The scores from both dimensions are averaged to derive a total score36. b) Intervention GROUP 1: Experimental group; Multimodality treatment approach. The subject will be given multi modal treatment which includes soft tissue release technique, ultrasound therapy, peripheral joint mobilization and therapeutic exercises. The treatment would be given for a week period, with each subject in groups 1 and 2 receiving respective interventions one time a day. The subjects would be tested at approximately same time each day. During this period, the subjects will be asked to refrain from any kind of sports activity or exercise. Pre- test measurement will be taken on 1st day and intervention will be carried out for 5 days in the week with post-test measurement taken on 5th day. 6th day will be a resting day and on the 7th day measurement will be taken to check maintenance of gained ROM. All of the patients receive soft tissue therapy that involves the application of ischaemic pressure to the supraspinatus and infraspinatus muscles, as well as the rhomboids, upper trapezius and levator scapulae. The application involves palpating the muscle bellies and applying a sustained pressure into areas of muscle spasm until a release of the barrier of resistance was felt. Release meaning the relaxation of the point of muscle spasm with a decrease in the sensitivity and muscle tone after re-palpating the area. Care was taken not to cause increased discomfort to the patient (to the level of pain tolerance). Longitudinal and transverse friction massage will be applied to the posterior tenomuscular junction of the infraspinatus muscle, the coracoacromial ligament (postero-inferior aspect) and the insertion of the supraspinatus on the greater tuberosity of the humerus. The friction massage application will be achieved by palpating the capsular or tendinous adhesions and frictioning over its surface with the practitioner's index finger. This will be maintained until friction anaesthesia is achieved and till the patient could not feel any discomfort. A new point will be chosen and the process repeated. Once again care will be taken to not cause excessive discomfort to the patient. At the end of the treatment sessions ice application is advised at a frequency of three applications of 15 minutes with two 20-minute breaks. Ultrasound phonophoresis will be applied to the areas that previously underwent friction massage with a topical corticosteroid [1%]. Ultrasound was applied with a continuous wave form for 7 minutes at a setting of 2.2 W/cm2 to the rotator cuff insertion on the anteriorinferior aspect of the humerus and posterior inferior aspect of the acromioclavicular joint. Peripheral thrust manual manipulation will be applied to the glenohumeral joints in external rotation (progressive) and inferiorly to the acromioclavicular joint and anterior to posterior to the sternoclavicular joint in all of the patients where a likely motion restriction was detected. Diversified spinal manipulations were used to manipulate the thoracic and cervical spines at the level of T3/4 and C5/6. All patients will be given a basic exercise program with initial emphasis on isometric strengthening of the supraspinatus and infraspinatus muscles. This was implemented once a reduction in pain and improved range of motion was noted at a frequency of 4 sets of 10 repetitions, 2–3 times per day. Theraband (extendable elastic) exercises were also implemented at the same frequency after the initial isometric strengthening period. This also included shoulder shrugs, wall push-ups and scapula retraction exercises33. GROUP 2: Control group; Conventional physiotherapeutic approach. The subjects will be instructed with self training program which includes active range of motion exercises, stretching and strengthening exercise program including rotator cuff muscles, rhomboids, levator scapulae and serratus anterior with an elastic band at home at least seven times a week for 10–15 min and the exercises were taught by physio.therapist. Same exercise program will be given to each patient as shoulder exercise brochure37, 18. C) Post- intervention measurement Post-intervention measurement will be performed in the same manner as pre intervention measurement for pain, range of motion and function. These measurements will be taken after 1 week of treatment and even after one month post treatment. 8. LIST OF REFERENCES: 1) Peter Lapner,MD, FRCSC, Presented at The University of Ottawa’s 57th Annual Refresher Course for Family Physicians,Ottawa, Ontario, April 2007. The Canadian Journal 80 of Diagnosis / May 2008. 2) Pope DP, Croft PR, Pritchard CM, Silman AJ. 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J Bone Joint Surg Am 2005; 87–A:824–831. 31) Nicholson GP, Goodman DA, Flatow EL, Bigliani LU. The acromion: Morphologic condition and age-related changes. A study of 420 scapulas. J Shoulder Elbow Surg 1996; 5:1– 11. 32) Tyler TF, Nicholas Sj, Roy T, Gleim GW. Quantification of posterior capsule tightness and motion loss in patients with shoulder impingement. Am J Sports Med 2000; 28: 668–673. 33) Mario Pribicevic and Henry Pollard; A multi-modal treatment approach for the shoulder: A 4 patient case series. Chiropractic & Osteopathy 2005, 13:20 doi: 10.1186/1746-1340-1320. 34) Wewers M.E. & Lowe N.K. (1990) A critical review of visual analogue scales in the measurement of clinical phenomena. Research in Nursing and Health 13, 227±236. 35) Michael J Mullaney (2010), Reliability of shoulder range of motion comparing a goniometer to a digital level. Physiotherapy Theory and Practice, 26(5):327–333, 2010. 36) John D. Breckenridge, James H. McAuley (2010) , central west orthopaedics and sports physiotherapy, sydney and the university of Sydney neuroscience research Australia(Neura), Randwick, Australia 37. )Baltac G (2003) Approaches in athletes with subacromial impingement syndrome: prevention and exercise programs. Acta Orthop Traumatol Turc 37(1):128–138. 38) Griffin JE, Echternach JL, Price RE, and Touchstone JC: Patients treated with ultrasonic driven hydrocortisone and with ultrasound alone. Phys Ther 1967, 47:594-60. 39) Aimie F. Kachingwe, Comparison of Manual Therapy Techniques with Therapeutic Exercise in the Treatment of Shoulder Impingement: A Randomized Controlled Pilot Clinical Trial, the journal of manual & manipulative therapy n volume 16 n number 4, 2008 , 238-248 9. SIGNATURE OF CANDIDATE SD/(KAVAN TK) 10. REMARKS OF GUIDE PRESENTED TO THE RESEARCH COMMITTEE AND APPROVED 11. 11.1 NAME AND DESIGNATION OF GUIDE DR.MARITTA BABY THOMAS ( ASSISTANT PROFESSOR) MPT (ORTHOPAEDIC AND MANUAL THERAPY) 11.2 SIGNATURE SD/- 11.3 CO-GUIDE (if any) 11.4 SIGNATURE 11.5 HEAD OF THE DEPARTMENT DR.MASIH MUHAMMAD KHAN MPT (MUSCULOSKELETAL DISORDERS AND SPORTS PHYSIOTHERAPY) 11.6 SIGNATURE SD/- 12 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL APPROVED AND FORWARDED 12.2 SIGNATURE SD/-