The immediate effect of acupuncture on improving pain and range of motion in patients with shoulder pain

The Immediate effect of acupuncture on improving pain and range of motion in patients with Shoulder Pain Master Thesis Dissertation in Traditional Chinese Medicine Mário Francisco Barbosa Costa 2014 1 Mário Costa 2 Mário Costa Mário Francisco Barbosa Costa The Immediate effect of acupuncture on improving pain and range of motion in patients with Shoulder Pain Dissertação de Candidatura ao grau de Mestre em Medicina Tradicional Chinesa submetida ao Instituto de Ciências Biomédicas de Abel Salazar da Universidade do Porto. Supervisor – Dr. Gonçalo Borges, Physician Affiliation – Hospital da Prelada, Santa Casa da Misericórdia do Porto Co-supervisor – Maria João Santos, Lecturer at Master Program of TCM, ICBAS, UP Affiliation – Abel Salazar Institute for Biomedical Sciences (ICBAS), UP Co-supervisor – Jorge Machado, Professor at ICBAS, UP Affiliation – Abel Salazar Institute for Biomedical Sciences (ICBAS), University of Porto, Portugal LabiomepPorto Biomechanics Laboratory – University of Porto 3 Mário Costa DEDICATIONS AND ACKNOWLEDGEMENTS To my parents, for all humility, example, support and hard work they transmitted me; To my grandparents for what they represented to me and their legacy of perseverance; To my son and daughter, for their support, sincere and unconditional love, and above all, their constant smile; To my wife for supporting me and the family while doing this thesis; To all those who direct or indirectly, in person or remotely, participated in this work, particularly Bruno Ramos for all his help in the statistic work. 4 Mário Costa “Mutation is the only constant in life!” Costa “The natural healing force within each one of us is the greatest force in getting well.” Hipocrates 5 Mário Costa ABSTRACT Title: Immediate effect of acupuncture on pain and range of motion in patients with Shoulder Pain (SP) Background/Introduction The shoulder pain (SP) it is a frequent condition that leads to functional impairment, as well as high individual and social costs. There is a worldwide prevalence of 7 to 25% of SP which represents 12% of chronic pain in Portugal. Acupuncture is widely used against chronic pain with low cost and little side effects. We were interested in a comparison of two acupuncture regimens in order to optimize treatment. Objectives The purpose of this study is to assess the immediate effect of acupuncture in the shoulder pain and range of motion. Methodology 32 patients were divided in 2 groups by random. Subjective perception of pain was assessed by VAS and objective measurement of the amplitude of abduction was carried out before and 5 minutes after acupuncture to assess its clinical effects. Group A received acupuncture on C3 and It11 and group B on F21 and an extra point located 5 tsun above elbow. Pain reduction and ROM was assessed and statistically compared by Student’s t test. The study included male or female patients, aged between 18-85 years old, with pain in shoulder and limitation of shoulder abduction movement, diagnosed by an independent physiatrist with no previous experience of acupuncture and the TCM diagnosis of a yang maior Syndrome. Exclusion criteria involved patients with shoulder pathologies without pain in abduction, patients with neurological or oncological pathologies, pregnant and infants Identical depth and intensity of stimulation of acupuncture were applied in both groups using Leopard-spot technique. Results 1. Before acupuncture both groups showed similar demographic and clinical characteristics; 2. In group A pain improved 39.01%, resulting in a statistically significant pain reduction (p<0,001). The amplitude improved by an average of 28,57 degrees, showing statistically significant data; 3. The comparison of group A and B revealed that pain reduction was significant in group A and has increased in group B. The ROM improvement in EG was twice the one of the CG. Conclusion Acupuncture according to the Heidelberg (HD) Model resulted in significantly immediate pain reduction. Also the ROM doubled in the HD model rather control group. Acupuncture is a technique with immediate effect in painful shoulder. 6 Mário Costa RESUMO Título Efeito imediato da acupuntura na melhoria da dor e amplitude de movimento em pacientes com dor no ombro Introdução A dor no ombro (DO) é uma condição frequente que leva à incapacidade funcional, com altos custos sociais e individuais. Há uma prevalência mundial de 7 a 25% e representa 12% da dor crónica em Portugal. A acupuntura é amplamente utilizada na dor crónica, com baixo custo e bons resultados. Estávamos interessados na comparação de dois regimes de acupuntura, a fim de otimizar o tratamento. Metodologia 32 Pacientes foram divididos em dois grupos de forma aleatória. A Perceção subjetiva da dor foi avaliada pela Escala Visual Analógica (EVA) e a medida objetiva da amplitude de abdução foi realizada antes e após 5 minutos da acupuntura para avaliar os seus efeitos clínicos. O grupo A recebeu acupuntura nos pontos C3 e It11 e grupo B no F21 e num ponto extra localizado a 5 tsun acima do cotovelo. A redução da dor e amplitude de movimento (AM) foram comparadas pelo teste Student’s t test (para amostras emparelhadas). O estudo incluiu pacientes masculinos e femininos, com idades entre 18-85 anos, com dor e limitação dos movimentos de abdução do ombro, diagnosticadas por um médico da medicina convencional, não tendo tido contacto prévio com a acupuntura. A dor na abdução corresponde à patologia Yang Maior no diagnóstico da medicina chinesa. Os critérios de exclusão envolveram pacientes com outras patologias do ombro, sem dor em abdução, os pacientes com patologias neurológicas ou oncológicas, gestantes e bebês. A profundidade e intensidade de estimulação na acupuntura aplicada foram idênticas em ambos os grupos, utilizando a técnica “Leopard Spot”. Resultados 1. Antes da acupuntura, ambos os grupos apresentaram características demográficas e clínicas semelhantes; 2. No grupo A a dor melhorou 39,01%, o que resulta numa redução estatisticamente significativa da dor (p <0,001). A amplitude melhorou numa média de 28,57º, revelando dados estatisticamente significativos; 3. No grupo B a acupuntura resultou numa redução da dor de 4,42%, não sendo estatisticamente significativa (P = 0,624); 4. A comparação dos grupos A e B revelou que a redução da dor foi significativamente melhor no grupo A do que no grupo B. A melhoria da amplitude de movimento no grupo A foi o dobro da do grupo B. Conclusão A acupuntura de acordo com o modelo de Heidelberg (HD) resultou na significativa redução imediata da dor. Também a AM duplicou no modelo HD face ao grupo de controlo. A acupuntura é uma técnica com efeito imediato no ombro doloroso. 7 Mário Costa CONTENTS CHAPTER 1 (Introduction) …………………………………...……………………………………...… 11 INTRODUCTION …………………………………………...……………………………………. 12 STATE OF ART ………………………………………………………………………………….. 13 EPIDEMIOLOGY …………………………………………..……………………………………. 15 ECONOMIC IMPACT …………………………………………..……………………………….. 16 CHAPTER 2 (The Western Approach of Shoulder Pain) …………………………………………. 17 SHOULDER ANATOMY ……………………………………………….……………………….. 18 Joints of the shoulder complex ……………………………………………………….. 19 ACTIVE MOVEMENT OF THE SHOULDER COMPLEX …………...………………………. 23 SHOULDER PAIN ……………………………………………..………………………………… 23 Summary of common impairments with RC disease and impingement Syndromes …………………………………………………………………….………… 25 DIAGNOSIS AND EVALUATION …………………………………….………………………... 26 PHYSICAL EXAMINATION …………………………………………………………………….. 27 Provocative tests ……………………………………………………………………….. 27 Diagnostic Laboratory Tests ………………………………………………………….. 27 Conventional Treatments ……………………………………………………………… 29 THE PAIN …………………………………………………………………..…………………….. 32 CHAPTER 3 (Traditional Chinese Medicine // The Heidelberg Model) …………………………. 33 TRADITIONAL CHINESE MEDICINE ………………………………………………………… 34 THE HEIDELBERG MODEL OF TCM ………………………………………………………… 35 Phases as a circular process of vegetative functions ……………………………… 36 Yin, Yang and the three treasures of TCM: Qi, Xue and Shen ……….………….. 38 8 Mário Costa The channels of Qi circulation: the conduits ………………………………………… 41 DIAGNOSE ……………………………………...……………………………………………….. 43 How balance can be affected: “how to become sick” ………………………………. 43 The agents ……………………………………………………………………………… 44 The Algor Laedens Theory (ALT) as a diagnostic system for immune-vegetative mechanism (3 rd ) ………………………………………..………. 46 CHAPTER 4 (Acupuncture) ……………………………………………………………………………. 50 The Acupuncture Physiology …………………………………………………………. 51 Why use Acupuncture …………….…………………………………………………… 53 Specificity of Acupoints ……………………….……………………………………….. 54 Leopard Spot Technique ……………………………………………………………… 55 THE SP BY THE HD MODEL AND THE POINTS SELECTION …………………………… 58 The points ………………………………………………………………………………. 59 CHAPTER 5 (Methodology) ……………………………………………………………………………. 61 STUDY OBJECTIVE ……………………………………………………………………………. 62 RESEARCH TEAM …………………………………………………………………………….... 62 SETTING …………………………………………………………………………………………. 63 RESULTS ………………………………………………………………………………………… 69 CHAPTER 6 ……………………………………………………………………………………………….. 72 DISCUSSION ……………………………………………………………………………………. 73 LIMITATIONS & FUTURE DIRECTIONS …………………………………………………….. 77 CONCLUSION …………………………………………………………………………………... 78 REFERENCES …………………………………………………………………………………... 79 APPENDIXES ……………………………………………………………………………………. 83 15 Mário Costa Guerra et al (2003) in a 201 cases observational study for five different acupuncture techniques (auriculotherapy, body acupuncture, moxibustion, cupping, EA), found that body acupuncture was the second most frequently used treatment and that altogether reached a good outcome: 59,7% were clinically resolved and 33,8% got a remarkable improvement [4]. Pirotta (2007), referring a Cochrane review in Australia, considering nine trials involving 500 patients, found no short term improvement in shoulder pain. Comparing ACP with placebo in shoulder function, also conclude that in the first 4 months there was significant differences, but after those differences were no lost their significance. This results were corroborated by Urruela et al. However this last author refers a German trial with statistically significant difference between acupuncture and placebo for the treatment of chronic SP (more than 4 weeks duration) [2, 7]. Doenitz et al (2012) found that it is possible no enhance microcirculation. Once some injuries of shoulder (like Supraspinatus tendon) may be related to a decrease of local circulation, ACP can be a good instrument no restore structures nutrition [8]. He et al (2005) studied intense ACP effect in 24 women with neck and SP, comparing real points with sham acupuncture, and also evaluating the social and psychological effect. The study shown good results, not only in physical symptoms but specially in the emotional and social aspects: quality of sleep, anxiety, depression and satisfaction with life [9]. Regarding the effect of ACP vs the type of technique applied to the control group, MacPherson et al (2014) reported the influence of control group (CG) and/or the type of needle used in the experimental group (EG). He found that acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles [10]. The AP have specific localizations and specific effects, not corresponding to the spinal nerve segment, but to the meridian. This specificity allows to compare the effects of the true AP with the false AP [11]. A good trust of general practitioners and physiotherapists (73%) in the short-term effect of ACP are common [12]. 16 Mário Costa EPIDEMIOLOGY Chronic SP is the third most common type of musculoskeletal pain [13]. It is consensus among several authors that the prevalence of SP is uncertain. It can fluctuate between 4 to 34%, according to different studies in different countries [2, 4, 1316]. The SP is common in much of the world population interfering with daily life activities and with the active rehabilitation of other pathologies[17]. The SP has a direct relationship with age, increasing its prevalence with the aging, being one of the causes of chronic pain (CP). The CP and consequent dysfunctions, with heterogeneous distribution and high prevalence, is recognized as a major public health problem, with physical, psychological, family and high economic impact implications in different countries [18]. Being the SP, usually, a chronic condition, and to avoid discrepancies, we decided to focus on its prevalence in Portugal, housed in studies of chronic pain, whose include the shoulder pain. The prevalence of chronic pain in Portugal is around 34%, in which shoulder pain is present in 12% of the affected population [19, 20] (see table 1) Table 1 – pain characteristics and pain impact in subjects with chronic pain, opioid users and opioid nonusers. Adapted from Azevedo et al (2013) [20] 17 Mário Costa ECONOMIC IMPACT A common worker decreases his productivity and/or probability to work when has pain in the back or articulations. Such fact impairs socio-cultural development and represents a big expense for all society, by direct and indirect costs. At a time that we all have to work hard and longer, the inability to work, as well as the need of medical care, will surely complicate the country evolution and future global needs. In Portugal it is estimated that the indirect costs of chronic back pain and other joints (which includes the shoulder) for disability in the short and long term are of € 739.85 million [19]. Also, insurers do not escape this reality, since approximately 18% of capitals payments for disability are made to patients with neck and shoulder disorders, which are often related [21]. In a large trial, ACP plus routine care was associated with marked clinical improvements at a cost of €10,526 (approximately $13,000) per quality-adjusted life-year (QALY), representing very good cost-effectiveness [22]. 18 Mário Costa CHAPTER 2 The Western Approach of Shoulder Pain 19 Mário Costa SHOULDER ANATOMY Talking about the shoulder we are talking about the most complex articular segment of the human body. The human shoulder anatomy is the mechanical base for a special capacity that is the hand movement and its fine motor activity. Much of the human survival competency is based on the capability to the detail, being the hand the finest tool, to heel or to destroy. The design of the shoulder girdle allows for mobility of all the upper extremity. As a result, the hand can be placed almost anywhere within a sphere of movement. The combined mechanics of its joints and muscles provide and control the mobility. Figure 1 – Plans and axis of shoulder movements, adapted from Kapanji (2000) [23]. In the shoulder girdle complex, the only bony attachment to the axial skeleton, is made by the Sternoclavicular (SC) joint. In which the clavicle articulates with the sternum via the small SC joint. That results in a considerable mobility in the upper extremity, stabilized by an intricate balance between the scapular and glenohumeral (GH) muscles and the structures of the joints in the shoulder girdle [24, 25]. 20 Mário Costa Joints of the shoulder complex There are 5 joints that compose the shoulder girdle complex: glenohumeral, Acromioclavicular (AC), Sternoclavicular, Scapulothoracic (ST), subacromial [24]. Figure 2 – Bones and joints of the shoulder girdle complex, from Kisner et al (2007) [24]. Glenohumeral joint The GH joint is an incongruous, ball-and-socket (spheroidal) triaxial joint with a lax joint capsule. It is supported by the tendons of the rotator cuff (RC) and the GH (superior, middle, inferior) and coracohumeral ligaments. Some congruence is given by the concave bony partner of the glenoid fossa, by the glenoid labrum (a fibrocartilagenous lip that deepens the fossa and serves as the attachment site for the capsule), and the orientation of the glenoid fossa (that faces anteriorly, laterally, and upward). However, because of the convex bony shape of the humerus head, only a small portion of it comes in contact with the fossa at any one time, allowing for considerable humeral movement, but potential instability [24]. The structural relationship of the bony anatomy, ligaments, glenoid labrum and the adhesive and cohesive forces in the joint provide static stability. But dynamic stability is provided by the coordinated response of the muscles of the cuff and tension in the ligaments, depending on the position and motion of the humerus. Also, the long head of the biceps and the long head of the triceps branchy reinforce the capsule with their attachments. Functionally, the dynamic coordination is dependent of the neuromuscular control, including movement awareness and motor response [24] (see Fig. 3). 21 Mário Costa Figure 3 – Lateral aspect of the glenoid fossa, showing attachments of the glenoid labrum, capsule and their relationship to the RC and long head of the biceps branchy musculature, from Kisner et al (2007) [24]. Acromioclavicular joint The AC joint is a plane, triaxial joint that may or may not have a disk. It is reinforced by the superior and inferior AC ligaments. The lateral end of the clavicle represents the convex part, and the acromion of the scapula represents the concave part. It movement is a slide movement, in the direction which the scapula moves. The AC capsule, the coracoclavicular and the coracoacromial ligaments represent the static stability. Once there’s no muscles crossing directly this joint, no dynamic support is given [23-25]. Sternoclavicular joint The SC joint is an incongruent, triaxial, saddle-shaped joint with a disk that helps the congruence. The static stability is given by the interclavicular and costoclavicular ligaments. Also, once there are no muscles crossing it there’s no dynamic stability. The SC moves as a result of the scapular and humerus motions, not being able to perform motion isolated [23-25]. 22 Mário Costa Scapulothoracic articulation The ST articulation it’s not a pure anatomic joint, because there isn’t connection between the two bone parts, but it is considered a physiologic joint. The soft tissue mobility and flexibility allows the scapula to slide along the thorax, and participate in the shoulder motions. The ST movements are: elevation/depression, protraction/retraction, up/down rotation. However, it is of extreme importance in the quality of shoulder motion, as well as in the spine posture. The scapula is stabilized by the balance of forces. Those forces are created by the anatomical structures, as the arm weight, and by muscles (see table 2). ST plays an important role in all arm movement, because the scapula function in synchrony to stabilize and control the position of the scapula so the scapulohumeral muscles can maintain an effective length–tension relationship as they work to stabilize and move the humerus. Without the positional control of the scapula, the efficiency of the humeral muscles decreases. T able 2 – static and dynamic stabilizers of the scapula and GH joint, adapted from Kisner et al (2007) [ 24 ] Description Static Stabilizers Dynamic Stabilizers Scapula Weight of upper extremity creates downward rotation and forward tipping moment on the scapula - Cohesive forces of the subscapular bursa Upper trapezius and serratus anterior middle trapezius and rhomboids Glenohumeral joint In dependent position: if scapula is in normal alignment, weight of arm creates as adduction moment on the humerus - S uperior capsule and suprahumeral ligament are taut - Adhesive and cohesive forces of synovial fluid and negative joint pressure hold surfaces together - Glenoid labrum deepens fossa and improves congruency Rotator cuff, deltoid and long head of biceps branchy When the h umerus and the scapula is rotating upward - Tension placed on static restraints by the rotator cuff - Glenohumeral ligaments provide interior of humeral head Rotator cuff an deltoid, elbow action brings in two-joint muscle support - Long head of biceps stabilizes against humeral elevation - Long head of triceps stabilizes against inferior translation 23 Mário Costa Subacromial articulation Subacromial articulation is considered another physiologic joint, composed by the acromion and coracoacromial ligament, forming the coracoacromial arch (see fig. 4). This arch overlaps the subdeltoid bursa, the supraspinatus (SE) tendon, and portion of its muscle. Important for the pathophysiology, a compromise of this space from faulty muscle function, faulty postural relationships, faulty joint mechanics, injury to the soft tissue in this region, or structural anomalies of the acromion lead to impingement syndromes and related injuries, such as RC tear [24]. Figure 4 – Left shoulder: lateral view. Detail of the acromial insertion of the coracoacromial ligament, adapted from Giacomo et al (2008) [26] 24 Mário Costa ACTIVE MOVEMENT OF THE SHOULDER COMPLEX The shoulder complex in is whole, allows the following active movements, with its respective limitations: flexion/extension, abduction/adduction, external/internal rotation, horizontal flection/extension (see fig. 5) [23-25, 27]. The showed movements respect the shoulder anatomical axis. However, the abduction movement achieves is best performance and movement quality when performed in the scapula angle: 30º of horizontal flection. This angle allows the balance and uniform contraction of all deltoid and SE fibers, as well as the uniform tension is the shoulder ligaments, avoiding adverse proprioceptive actions and muscles synergies [23, 25]. Figure 5 – movements of the shoulder complex. A – range of motion of the shoulder; B – axes of the arm, adapted from Magee (2006) [25] SHOULDER PAIN The SP can be defined as a pain and functional limitation due to the involvement of static and dynamic shoulder structures, as ligaments, capsule and muscles [15]. It is one of the most common complaints affecting the locomotor system, and frequently takes the patients to primary healthcare centers and specialists. The usual complications are pain, restricted movement and strength and loss of shoulder functionality [28]. It is regarded as a multifactorial pathology, whose pathophysiology is related to mechanisms of extrinsic and intrinsic order [4]. 31 Mário Costa Ultrasound Therapy [38, 39] US are sound waves of high frequency inaudible to the human ear, a device produced by the piezoelectric effect and transmitted to the skin for a vibrating probe through which penetrate the body. Must be using a conductive product, typically a gel, but also water may be used. Can be applied in continuous or pulsed mode. The resulting mechanism for applying a kinetic or mechanical energy that, when absorbed by the body, turns inside in a different energy. The US manifest the following effects: improvement of ionic exchanges, increased temperature (hyperemia), improvement of cellular nutrition, improvement of cell polarization, increased activity of local metabolism, improving lymphatic circulation and decreased pain. Besides being trusted for a large part of the clinicians, Johansson et al (2002) did not find significant evidence in its use [6]. Chock-wave therapy The high energy shock wave therapy (>0:28mJ/mm 2 ) is effective (moderate to strong evidence) in the treatment of calcified tendinopathy of the RC in the medium and long term. However, in non-calcified tendinopathy the effect is not so evident. Focusing of shock waves in the deposits of calcium is more effective (moderate evidence) that focus on large humeral tuberosity. Laser Therapy [38, 39] The laser (Light Amplification Stimulated Emission Radiation) comprises applying energy to the body of the electromagnetic spectrum, in the form of light, to facilitate their biochemical activity. This light is applied to the body in a modified and controlled way, well measured so as not to cause cellular damage manner. Typically, a monochrome light is used, composed of a single wavelength, thereby controlling and isolating the light which is intended to emit. Its application is made directly to the affected region is very well tolerated and has immediate effects. The effects are: improvement of protein synthesis, increased ion exchange, enhance the generation of new organic molecules used in the regeneration 32 Mário Costa and energy intake. Fundamentally, the laser favors the intercellular environment and facilitates assisted exchanges between the active cells and their extracellular environment. Massage Massage is the manipulation of soft body tissues and is usually carried out manually. With benefits like, improvement of large and micro circulation, improvement of lymphatic flow, improvement of interstitial permeability, control of scar tissue formation, release of adhesions and fibrous tissue, improve the muscle flexibility, action in nervous tissues (special in pain peripheral terminations) it releases pain [40]. The massage can be very important not only in the injured tissue, but in the surrounding tissues, like muscles, improving mobility and range of motion, as well as releasing muscle tension. According to Cyriax (2001) deep transverse massage, breaks down scar tissue adhesions created by successive tendon injuries, relieving symptoms and preventing relapses. The therapist performs a digital friction on the exact site of the lesion and transversely to the direction of the affected fibers [35]. Administration of Sub-acromial corticosteroid. Consists of a suprascapular nerve block with bupivacaía. Well tolerated, sees its best effects in arthritis and/or degenerative joint disease [33]. Suprascapular nerve block may be more effective than placebo at reducing pain in people with frozen shoulder, but not in improving shoulder function (measured by Simple Shoulder Test) or ROM. However, it improves pain, disability, and ROM in people with rheumatoid arthritis, degenerative disease, or both [21]. NSAIDs Murphy et al (2009) in his revision, found that oral NSAIDs compared with placebo in people with RC disease Oral NSAIDs may be more effective than placebo at reducing pain at 7 to 14 days in people with acute-onset shoulder tendonitis, subacromial bursitis, or both, and at reducing pain at 14 days in people with acute shoulder pain of less than 96 hours' duration. But he couldn’t find if oral NSAIDs are more effective than placebo at improving pain or abduction at 4 weeks in people with RC tendinitis of more than 72 hours' duration [21]. 33 Mário Costa Corticosteroids The infiltrations of corticosteroids to reduce inflammation and pain may have a significant therapeutic effect and facilitate mobility and function [41]. However, the adverse effects of oral corticosteroids are well documented and include a wide array of problems affecting many body systems. Common or serious adverse effects include: osteoporosis, diabetes, dyspepsia, weight gain, and impaired healing. These effects can be minimized by using the lowest effective dose for the minimum period possible [21]. Both this chemical treatments gather the highest preference of clinicians (89-94%). However, due to his side effects and sometimes the constrains of some patients to take them, they cannot be always used. Surgical Treatment While responding positively to the conservative treatment, there are cases where surgery may be considered as a solution. The timing for surgery is often difficult for the practitioner. So, it must be taken into account the desired performance for the joint, the state of injury, the age and comorbidities of the patient. If in a young patient, the main goal is to maximize strength and function in an older, the main purpose is pain relief. In general, the absolute surgical indications are acute loss of strength, posttraumatic, in young and active without previous dysfunction of the RC. The surgical indications are relative refractory pain or muscle weakness for adequate conservative therapy for 3-6 months [33]. THE PAIN According to the International Association for the Study of Pain (IASP), pain is defined as "an unpleasant experience multi-dimensional, involving not only a sensory component but also an emotional component and which is associated with a real or potential tissue damage, or is described in terms of such damage". By current knowledge, pain does not generate any measurable biological indicator, whereby the intensity of pain is becomes the one that the patient relates, and thus a subjective data [42]. 34 Mário Costa CHAPTER 3 Traditional Chinese Medicine The Heidelberg Model 35 Mário Costa TRADICIONAL CHINESE MEDICINE (TCM) TCM is a system of diagnosis and health care that has evolved over the last three thousand years. The first records found report for the year 1000 BC the Chang Dynasty, which at the time already addressed sophisticated problems of medicine [43]. The first known book on the subject of Chinese Medicine, the Huangdi Neijing - the Yellow Emperor Cannon of Internal Medicine - dates back to the years 475–22 BC and documents human structure and physiology as well as disease pathophysiology and treatment procedures. TCM is recognized by the World Health Organization (WHO) (2010) as variety of therapies and medicinal practices employed in China for the last two millennia, developed from clinical experience and recorded in classical ancient scripts. The TCM is based on a holistic and systematic theoretical structure of a philosophical nature, focusing his study and action in respect of the yin/yang, the five elements theory and in the circulation system of energy through the meridians of the human body. There are seven main treatment methods of TCM [44]: − Tui Na ou Tuiná (推拿) (massage); − Acupuncture (針疚); − Moxibustion (艾炙); − Vacuotherapy (拔罐); − Fitotherapy (中药); − Dietetics/Nutrition (食療); − Physical Practices: integrated meditation exercises, breathing and circulation of energy, such as Qi gong (氣功) or Tai ji quan (太極拳). Under the upgrade, systematization and universalization of concepts, practices and teaching, in the 1950’s, these principles were modernized in order to integrate many anatomical and pathological notions with modern scientific medicine. In the I Ging (“The Book of Changes”, the oldest book of mankind), the yin and yang signs are presented as a mathematical expression of numbers. This binary numbering system developed by Leibniz enables to describe circular processes, the monad, bigram and trigram [45]. 36 Mário Costa Following this new approach, a new system began to be studied and developed: the Heidelberg (HD) Model. In this model, homeostasis and their regulation, plays a key role in the understanding and balance of the human body. Thus the functioning of the human body and its physiological adjustment processes derive from the fact that state of balance is a constantly changing process and not a stationary process. If this balance is disturbed, symptoms are developed. THE HEIDELBERG MODEL OF TCM According to the HD School of Chinese Medicine (Greten 2011), TCM is a system of findings and sensations, designed to evaluate the functional vegetative state of the body, further treated by a set of tools such as Chinese dietetics, TCM psychotherapy, TuiNa massage technique, Chinese phytopharmacology, QiGong and ACP [46]. Being a scientific model, the HD Model explains TCM in a logical and systematic manner. Based on the work of Leibniz, who decoded the I Ging (the mutations book) in a binary language, the human physiology can be described as a circular process. Like in mathematics and physics, the human body can be analyzed using the trigonometric measurements and respective force and direction vectors. Body homeostasis or regulation, may best be understood through the thermodynamic study of the water when heated. Imagining a water container, a heat source, and a controller (thermostat), and establishing a standard temperature like 37ºC (target value), we can recognize the processes of homeostasis. Water as our internal environment, the heat source as the different stimuli to which the body is subjected and the thermostat as the monitoring mechanisms and regulation. The analogy with this system tells us that our body does not hold our target value as we expected. For when we cut the supply of heat to the water, this takes a while to cool down until it reaches the target value. The same happens when we supply heat to the water, it does not heat up immediately. That makes our regulation system working in an up and down movement forming a sinus wave (see fig. 8). 37 Mário Costa Figure 8 – Model of the “Water basin”, adapted from (Greten, 2011) [46] Phases as a circular process of vegetative functions TCM considers a parallel between living organisms and their surroundings, the Nature. Thus, for example, the environment is divided into four seasons, the functioning of the human body is also divided in cyclic processes, the vegetative functions. Given the circular and chained character of regulatory processes, HD designates as phases the following commonly called elements: Wood (related to spring); Fire (related to summer); Metal (related to autumn); Water (related to winter) and fifth the Earth. Defining phase as: a cybernetic or regulatory term, part of a circular process, a vegetative functional tendency which is manifested in a specific body part by means of clinically relevant signs and symptoms named orbs. An orb, according to HD model, may be considered as: − “clinical manifestation of a phase, named after a region of the body (body island)”; − “a group of diagnostically relevant signs indicating the functional state of a body island (body region), which correlates with the functional properties of a conduit”. Although it may show similarities with the designation of human organs according to Western medicine, an orb is an organ pattern or the signs manifested by that organ. 38 Mário Costa The Scientific HD model of Chinese Medicine is based on a simplified model of body regulation. In this model, the vegetative functions are expressed cyclically, resulting in a sinusoidal curve whose vectors have reference to a baseline value, which represents the homeostasis (horizontal line). Figure 9 – Sinusoidal curve representing the circular process of phases, adapted from Greten (2012) [47] The regulatory model leads us to understand better how to express phases. Just as one season comes threaded in before, with new features, temperature, color, influence on the planet; phases arise in a regular thread, manifesting vegetative functional tendencies. Thus the phase transitions give the following sequence: wood-fire-earth-metal-water. Here, the phase earth has a role of up-regulation or down-regulation, working as a vector which supports the transitions between phases. As Greten’s (2011) advocates that below the base line, are the yin phases in which parasympathetic stimuli is more expressed. On the other and, above the base line are the yang phases, where the sympathetic nervous system prevails. Phases Wood and Fire are characterized by a hyper-tone and hyper-dynamic vegetative state, when compared to Metal and Water, that are respectively more hypotonic and hypo dynamic [46] (see fig. 10). 39 Mário Costa Figure 10 – the phases with respective Western medicine features, adapted from Greten (2012) [47] Yin, Yang and The three treasures of TCM: Qi, Xue and Shen Yin and Yang Yin and yang are probably the most familiar words of TCM. In fact they are the basis of his understanding. Are fundamental principles and complementary opposites that interact with each other and help the perception and understanding of various contradictions in anatomy and physiology of the human body, as well as diagnosis and treatment. Having been first time reported in the I Ging, in the form of continuous and broken lines, forming the trigrams and hexagrams also formed a possibility encoding and systematization of philosophical concepts. The Yin is defined according to Porkert (1999), as the structural part, something static, the physiological somatization, and the Yang is action, is alterations, modifications and can disappear or destroy, or even emerge as something dispersed [48]. 40 Mário Costa According to Greten (2011), they are a pair of terms to describe functional relations in chinese culture and language. Philosophically they derive from the simple observation of nature, showing an interdependence between all that exists. For example, when the sun lays his sun-rays over a mountain, defines one sunnier side and one shadow side. However, if on the sunnier side we put a house, it will have a bright and shady side, thus creating shade in the light, creating yin within yang. So everything that happens in the Universe has two opposite and interdependent aspects and yin and yang is a way to express that thought. For Jia J. (2004), yin and yang are relative terms to express the polarity and not static, but dynamic, constantly changing, meaning that there is only cold and heat, but heat becoming cold and cold transforming into heat [49]. According to HD and framing the yin and yang in a regulatory context of homeostasis, they may have the following meanings: Yin Yang Below target value Above target value Descending values, such as in downregulation Rising values, such as in upregulation Lack of substrate causing instable regulation Functional, primarily regulatory problem Adapted from Greten 2012 [ 47 ] If we put these terms in the medical context, we identify them with the following main meanings: Yin Yang Less vivid, less qi More vivid, more qi Colder Warmer Outside, exterior Inside, interior Function structure Adapted from Greten (2012) [47] 47 Mário Costa Figure 12 – the four components of TCM diagnosis, by HD model, Greten (2011) [46] The Algor Laedens Theory (ALT) as a diagnostic system for immunevegetative mechanism (3rd) The ALT, also known as "Shang Han Lun", the model of six stages, also known as the theory of six layers of energy, describes the processes by which the agent cold can affect the body and the counter-action of the body to this agent. It is a prerequisite for the application of the ALT theory is that you need to have the signs of algor (tearing pain, hyaline coating of the tongue, pulse diagnosis, among others). The TCM calls these mechanisms of counter-action the reactive calor, a general increase in microcirculation that is itself a regulatory process. If in each stage, the mechanisms of counter-action fail, the algor invades the body. The six stages can are divided in [47]: − Three extimal stages, Yang − Three intimal stages, Yin. The algor in Western terms, might be translated like a lack of circulation, or decreased regional microcirculation that affect primarily the conduit that contains more xue than qi, 48 Mário Costa and may be caused by defensive reflexes to cold or virus (adhesion molecules, complement system, coagulation). Figure 13 – scheme of the six stages with the corresponding forms of energy, adapted from Greten (2011) [47] Each layer has a specific functional power that, when attacked by algor, produces the characteristic signs and symptoms. The six energy layers comprise six different forms of energy which technically are [47]: I. Defensive qi (or Wei Qi), resides within the extima, outside the conduits and creates a first defensive barrier against external attacks; II. Qi of the conduit, is the qi within main conduits (the "cardinal conduits"). If the agent blocks the qi flow, primarily may result in pain and secondarily in dysfunction of the respective orb. III. Xue of the conduit, driven by the conduit qi, it warms the conduits, while nourishes and moisturizes the tissues. This heat banishes the agent algor. IV. Qi of the body island, is the qi in the intima (whole body’s interior), where the functions of the orbs are generated in their respective parts of the body “islands”; 49 Mário Costa V. Xue of the body island, is a substantial part of the of the body islands with body heat, thus activating and enhancing functional properties; VI. Yin, which is the functional tissue, like a subpopulation of cells, the substrate from which the functions (yang) develop. The Algor is a Yin agent with functional properties of deprivation. The Algor-induced signs and symptoms of orbs involved are categorized into 6 stages of clinical signs: I. Yang major, when the agent invades the skin, “attacks” the defensive qi. The defensive qi does not remain in the conduits but in the skin surrounding the conduits and in all other tissues. Symptoms may vary, but the clinically most decisive symptom, may be a general feeling of chills. The Orbs that are affect are the Vesical and the Tenuintestinal; II. Splendor Yang, when the agent algor enters the conduits, it creates a regional block of the flow of qi and Xue. Once flow of qi is more easily blocked than the flow of Xue as the qi is what moves the Xue, the phases and orbs that more depend on qi, are those more prone to this problem. In this stage the affected Orbs are the Stomachal and the Crassintestinal; III. Yang minor, if the agent algor dominates the flow of Xue in the conduit, this may lead to a reverse flow of Xue to the interior, leading the algor to the interior, causing a feeling of internal cold. Often, the inside Xue (yin) will be mobilized against the agent causing the sensation of internal heat again, or if the Algor is expelled out, even heat temporarily abroad. The struggle algor vs xue, expelling each other repeatedly is called the “Tom and Jerry” stage. Here Felleal and Tricalorical Orbs are involved; IV. Yin major, from this stage forward, the main symptoms do not come from the conduits, but more frequently from the interior (the intima), the “body island” and it respective functions. When an agent affects the qi of the “body island”, Earth and the Metal (as phases) are sensitive to the decrease of the qi activity, the Lienal and the Pulmonary Orbs are the most affect; V. Yin flectens, when the Algor affects Xue in the inside, the functions of the Orbs which depend on Xue are more easily affected than the others. By their straight 50 Mário Costa relation with the xue, signs and symptoms of Hepatic and Pericardial orbs may appear; VI. Yin minor, the Yin is the structural condition to the yang development. Consequently, also the yin (functional tissue) is a technical form of energy. When this energy is affected by Algor, Renal symptoms are more likely to develop. As the Yang drift from the Yin, a similar process is the development of the Ascending Yang Qi which is in connection with the Cardial Qi. 51 Mário Costa CHAPTER 4 Acupuncture 52 Mário Costa The Acupuncture Physiology ACP is one of the main forms of treatment in TCM. It involves the use of sharp, thin needles that are inserted in the body at very specific points. This process is believed to adjust and alter the body's energy flow into healthier patterns, and is used to treat a wide variety of illnesses and health conditions. The beneficial effects are created by the needles itself, without injection of any kind of drug. In 1972, the National Institutes of Health gave its first grant to study acupuncture. The study reported that ACP was not hypnosis [53]. In 1997, a conference organized by the National Institutes of Health in the USA, a Consensus Panel reported that there was “clear evidence for acupuncture’s”. Also, ACP efficacy was evaluated as being suitable for a certain number nominations. The WHO (2002), indicates ACP for several medical conditions, specially involving pain [53, 54]. In countries like Germany, the investment in TCM is increasingly with a growth rate estimated between 20 and 22%. There is a socioeconomic element between users of TCM because it finds most fans among the wealthier layers, with more training and conservative than among the poor and who have less training (Greten, 2006). In Portugal, ACP is recognized by the Medical Council as a "Medical Competency" as a result of reflections of the Portuguese Society of Medical Acupuncture and the approval of the National Executive Council on 14/05/2002. Nevertheless, recent legislation allows other Health Professionals to practice ACP, since they gadder the conditions to obtain a professional certificate. Regarding the eastern definition of how ACP works, using specific points connected, forming a Channel (conduit) with specific effect in the body, Western medicine has tried hard to find anatomical, histological or electrophysiological evidence to support it. However, so far, in contrast to the points, there has been no identification of anatomical basis. Nevertheless, certain findings allow the Western medicine observer to assume with great probability that the postulation of channels might be correct [55]: 1. Needles can induce sensations in the patients at sites very distant from the site of insertion. The sensations described, for example, starting in the hand and rising along the arm and up to the face, often corresponding to the description of a traditional channel. The Chinese doctors call it a “propagated sensation along the channel”; 53 Mário Costa 2. Considerable dermatology literature describes different eczemas, atopic dermatitis, or similar complains which correspond exactly to the path of traditional described channels; 3. TCM movement therapies and meditation, like qi gong, produce sensations in many patients, in pathways corresponding to the energy-flow channels; 4. In a French study, a radioactive tracer 99m Tc was injected into particular acupuncture points on the leg and its spread was followed by a gamma-ray camera. Remarkably, after hours, the spread was observed to occur thru the paths of the channels. Despite this facts, Western investigations have proposed different theories on the mechanism of ACP [5, 53, 55-57]. a) Neurotransmitter Theory – ACP effects higher brain areas, stimulating the secretion of β-endorphins and encephalin in the brain and spinal cord, which influences the immune system and the anti-nociceptive system; b) Autonomic Nervous System Theory – ACP stimulates the release of several types of opioids like norepinephrine and acetylcholine. That affects changes in their turnover rate, normalizing the autonomic nervous system and reducing pain; c) Gate Control Theory – ACP activates no nociceptive receptors that inhibit the transmission of nociceptive signals in the dorsal horn, “gating out” painful stimuli; d) Vascular-interstitial Theory – ACP manipulates the electrical system of the body by creating or enhancing closed circuit transport in tissues. This facilitates healing by allowing the transfer of material and electrical energy between normal and injured tissues; e) Blood Chemistry Theory – ACP affects the blood concentrations of triglycerides, cholesterol and phospholipids suggesting that ACP can both rise and diminish peripheral blood components, thereby regulating the body toward homeostasis; Nevertheless, a good explanation based on the neurophysiologic studies of the analgesic effect of ACP, is given by Hempen et al (2012) referring (Pomeranz et al) in the following steps [55]: I. Peripheral stimulation with as ACP needle stimulates afferent nerve cells of type 2 and 3. A real stimulation only takes place when the qi sensation generated is 54 Mário Costa accompanied by sensations such as numbness, dull pain, and feelings of pressure or distension; II. The stimulation at the periphery transits impulses to the spinal cord; III. Peripheral pains (skin, joints, organs) are directly linked to the spinal cord; IV. In the posterior horn area of the spinal cord, the switch is made to a second neuron, which transmits the stimulation on to the thalamus and the cerebral cortex; V. In the spinal cord, ACP stimulation causes the release of encephalin or dynorphins (but endorphins are not released here). The substances released cause a blockage of the pain transmission in the spinal cord and thus produce an analgesic effect. Various peptides are involved in this process: cholecystokinin, somatostatin, neurotensin, calcitonin, and angiotensin; VI. Impulses are transmitted from the area of the spinal cord to the cerebellum. Here, as the result of the influence of encephalin, there is a release of monoamines. Being serotonin and norepinephrine as the most important, which are capable of having a feedback influence on the cells of the spinal cord and of preventing further transmission of pain. VII. In the hypothalamus, beta-endorphin and adrenocorticotropic hormone are released. That hormone stimulates de effect on the adrenal cortex and leads to the release of cortisol. As all cells producing beta-endorphins are located in the hypothalamus, the substances are then distributed via the vascular system, producing a systemic effect. Western neurophysiology plays an important role explaining analgesia as well as one of many effects of ACP. Obviously the release of endorphins, monoamines, and cortisone has a special feature in some ACP treatments. However, this cannot in any way explain the range and immense variability of the effects of ACP. Furthermore, this approach to finding an explanation would suggest that the precisely differentiated localization of AP would not be necessary, which contradicts the specificity of ACP appliance. Why use Acupuncture? For its analgesia, ACP is a very popular treatment, with results sometimes surprising in acute and chronic pain. It is shown as a reference for the treatment of chronic pain, since in many studies, the results obtained were more effective than in the placebo and treatment with false ACP (sham ACP) [1, 3, 4]. 55 Mário Costa ACP treatment is low cost and highly effective in the treatment of pain. By previous studies and by clinical experience acupuncture's efficacy proved to be immediate with a medium and long term effect. Address the concerns and objectives of the WHO and the "National Strategic Plan for Prevention and Control of Pain" of the Direção-Geral da Saúde ACP is a therapeutic tool of great usefulness and should be placed at the disposal of the population [58, 59]. Specificity of Acupoints The Western theories proposed to explain the workings of ACP rely on spinal nerve segments and the reflex action of the nervous system. However, the conduits do not always correspond to nerve or dermatome pathways. We also know that the AP’s, albeit close, have specific locations and different effects. One question that can be raised is whether using a false point near the genuine, even if outside the conduit it will have the same effects. Studies using functional Magnetic Resonance Imaging (fMRI) shows that does not. Byung et al (2009) studied the effect of point F34 and a false point situated 2 inches from this point, but out of felleal conduit, using EA as a stimulus and fMRI as evaluation. The fMRI allowed to observe that the regions activated by EA at the point F34 were different from those activated with the sham point. In addition, the results demonstrated that real EA at F34 had a greater effect and broad neuromatrix responses that involved limbic-related brain structures (see fig. 13). 56 Mário Costa Figure 14 – fMRI images from the regions activated by acupoint F34 and by its sham point. Adapted from Byung et al (2009) [11] In conclusion, we may say that EA at an AP and in its sham point, in the same spinal segment, induced specific cerebral response patterns, which provides evidence for neuronal specificity of an AP. It has also been showed that EA at F34 may be more related to motor function than EA at its sham point, which is correlated with the clinical indications for acupoint F34. Leopard Spot Technique (LST) The LST is as a special technique to influence qi and xue. Due to the lack of evidence, this technique is difficult to explain in modern terms. However, many acupuncturists have informally stated that they get dramatic results from this treatment method. In the ancient times, the first applications of ACP consisted of bleeding, as a method to make out the "bad blood" as well as the perverse qi, especially in lesions and fevers. Only later the needles were used as a way of regulating qi, abolishing the need of "releasing" something from the body. 63 Mário Costa STUDY OBJECTIVE Facts to consider The pathologies of the shoulder beyond its impact on patient's life can trigger other conditions, such as neck pain. ACP has proven to be an effective therapeutic tool in SP. The model of HD has their own vision of TCM, particularly in the diagnosis and choice of points. The LST is a technique rarely used in research, although widely used in clinical practice. The immediate effect of ACP can be very helpful to achieve good therapeutic intervention. Objetives − To study is to access the immediate effect of ACP in the shoulder pain and range of motion; − To assess the viability and effectiveness of the research protocol for a future clinical trial. RESEARCH TEAM Main investigator Mário Costa, Physiotherapist Master student in Traditional Chinese Medicine – ICBAS-UP Co-investigators Maria João Santos, Lecturer at Master Program of TCM, ICBAS, UP Abel Salazar Institute for Biomedical Sciences (ICBAS), University of Porto, Portugal 64 Mário Costa Jorge Machado, Professor at ICBAS, UP Abel Salazar Institute for Biomedical Sciences (ICBAS), University of Porto, Portugal LabiomepPorto Biomechanics Laboratory – University of Porto Research Supervision Gonçalo Borges, Physician Physical Medicine and Rehabilitation Service of Hospital da Prelada, Santa Casa da Misericórdia do Porto SETTING Pre Experimental Procedure - Recruitment and Design Sample and Recruitment This study was focused on Portuguese patients, aged between 18 and 85, diagnosed with Painful Shoulder Syndrome by a Conventional Medicine Doctor. Patients were provided by the Department of Physical Medicine and Rehabilitation of Hospital da Prelada, da Santa Casa da Misericórdia, located in Porto. A previous, non-definitive convenience sample was selected based on the patient’s clinical file and eligibility criteria (refer to table 5). 65 Mário Costa Inclusion Criteria Exclusion Criteria I. Male or female patients aged between 18 - 85 years old, with pain in shoulder and limitation of shoulder abduction movement, diagnosed by a doctor of conventional medicine*; II. Have no previous experience with acupuncture. * which corresponds to ALT stage I – Yang minor in the TCM diagnose I. Patients with shoulder pathologies without pain in abduction; II. Patients with neurological or oncological pathologies; III. Pregnant and infants; Table 5 – Eligibility criteria After the initial screening, potential participants were contacted, or when necessary, their families. After explained the study by the telephone, an interview was scheduled at a day and time to better explain the procedure and when understood and granted, proceed with it. Before positive feedback, informed consents were presented and their agreement was asked. Sample randomization After recruitment, a serial number was attributed to each participant. The sample was then randomly divided into two groups using the method of papers on a bag. The two groups created were: Experimental Group (EG) and Control Group (CG). Outcome assessment Initially for each patient, will be verified if abduction movement is painful and/or limited. By our clinical experience we have observed, as some authors argue that the most committed and painful shoulder movement is abduction. Such a movement happens to be involved in most activities of daily living (particularly those involving raising the arm), is also the main movement of the most frequently affected muscle, the supraspinatus. Nevertheless, the remaining muscles of the RC are involved in the abduction, sometimes directly in their implementation, even partially by some of its beams, either by its stabilizing component and/or holding the GH joint during abduction. For this reason, the abduction movement in the plane of the scapula (30 following a bending axis perpendicular to the plane of the blade) was chosen as the test movement [4, 23, 24, 27]. 66 Mário Costa To evaluate the pain it was used the Visual Analogic Scale (VAS), because it has been shown to be a relevant tool for measuring pain, particularly in SP [14]. For this purpose, a line of 10 cm, with the numbers 0 and 10 drawn on opposite ends was used, meaning, respectively, the minimum and the maximum pain ever felt. In this scale, the participants drew a line where they considered that their pain was located [42]. For the assessment of ROM, it was used the manual goniometer as a measuring device. The goniometer was chosen because it is an instrument easy to use and their low economic cost as a measuring device. Despite, it still is considered a good and reliable method for amplitudes evaluation, especially when the same physical therapist takes these measurements [67-69]. Study design The study was designed as a prospective, controlled, non-blinded, preliminary trial. Collected patients data At Baseline (T0) After confirm patient personal data, shoulder involved, inclusion and exclusion criteria, patients were asked to execute the movement of abduction in the plane of the scapula, until pain or movement limitation prevent further movement of the shoulder. The maximum amplitude attained was measured by the investigator. Immediately following ROM measure, patients were asked to register the pain felt in the VAS. After intervention (T2) After 5 minutes of the acupuncture intervention, the same procedures as in T0 were performed, concerning to ROM and VAS. 67 Mário Costa Figure 16 – flowchart of research Experimental procedure – Intervention The experimental protocol was based on the clinical experience from the HD. Clinic of Chinese Medicine workgroup. With the patient seated, the acupoints were located and the area of intervention has been disinfected, using for the purpose gloves, sterile gauze and ethyl alcohol. Then, LST of ACP, known as ancestral ACP technique that is characterized by rapid insertion of the needle 5 times, from the point has been applied, causing its dispersion through bleeding very slight (1 to 5 small drops of blood), was applied to both groups. A mesotherapy needle 27G ½ "0,4x13mm, brand BD Microlance TM 3, sterile single-use was used. True ACP protocol, consisting of the points C3, (Shao hai) located in a recessed muscle midway between epitróclea the humerus and the medial end of the elbow crease and It 11 (Tian Zong) located in the center of the infra-spinous fossa of the scapula, was applied to the EG. "False" points of ACP (for this clinical picture) were applied to the CG. We used the points F21 (Jian jing), located in the suprascapular region, midway between the tip of the acromion process and below the spinous process of the seventh cervical vertebra (C7), and an extra false point, located 5 cun above the elbow crease between the Crassintestinal conduit and the Pulmonal conduit. (Figures 16 and 17) [11, 48, 66]. 68 Mário Costa Figure 17 – points used in experimental group l Figure 18 – points used in control group The targeted areas were again disinfected and placed a sterile dressing for protection. 69 Mário Costa Ethical considerations, protection of human rights and safety issues All patients voluntarily decided to be a part of the present study. Participants were not given or promised any warranties regarding their heath after or during the study. The study was conducted in accordance to the 1964 Helsinki Declaration and international standards of Good Clinical Practice requirements and it was granted approval from the Ethical Committee (EC) of the Hospital da Prelada, Santa Casa da Misericórdia do Porto. All subjects were provided a consent form describing the study with precise information, in order to exert an informed decision about their participation in the investigation (see attached annex 2). Subjects and/or families were briefed about the goals, methods, expected benefits, and potential risks or discomforts, as well as it was their right to decide to withdraw or discontinue the experiment at any moment during his/her participation. They were also notified that no prejudice would result in cases of refusal to participate or withdrawal from the study. The trial would stop if the investigators believed that there was an unacceptable risk of serious adverse events. Confidentiality All data collected in the scope of the present study is confidential, and identification of participants was preserved at all moments. Data was only maintained during the necessary time to produce the present paper. Participants Exemption No pre-established agreement existed that obliges participants to take part in the study. Both patients and other participants were free, at any given moment, to abandon the investigation if this was their desire. 70 Mário Costa Financing and Conditions This study is independent and as such, not financed by any institution. Participants were voluntarily a part of it, without any promise of financial or other form of compensation. The resulting costs of investigation were fully supported by the investigator. Conflicts of Interest None of the individuals that were part of the present study is involved in any conflicting activity. Research Supervisor Feedback The present study started after receiving positive feedback from Prof. Henry J. Greten and from Dr. Gonçalo Borges. Study Location The study was carried out in: Hospital da Prelada, Santa Casa da Misericórdia do Porto. RESULTS At baseline, the patients and the controls shared similar demographic and clinical characteristics. The Kolmogorov Smirnov test was performed, which confirmed the normal distribution of data, (p=0,881) for goniometry and (p=0,558) for VAS. Our study included 32 patients; 25 females and 4 males with a mean age of 64.33 years (min 44, max 80). Four of these patients were excluded for a diagnosis of oncological diseases, resulting in a 29 participants sample. To assess the ROM and the VAS we choose the Student’s t test (For paired samples). This test is commonly used to compare two small sets of quantitative data when data in each sample set are related. The EG had highly statistically significant results (p<0.001) for the two dependent variables (Goniometry and VAS). The CG although the applied ACP protocol has had statistical significance (p=0.033) in the goniometer, it was less than the significance of the EG. Since the VAS parameter of the CG had no significant difference (p=0.624) between the application of corresponding acupuncture protocol and the baseline. In terms of mean 71 Mário Costa percent improvement, the EG achieved an improvement percent of 43.70% in the goniometer, while the CG got a mean percent improvement of 23.71%. In the VAS parameter, the EG achieved percentage improvement of 39.01%. Table 6 – percentage of ROM and VAS improvement Goniometry VAS Experimental Control Experimental Control Mean % 43,70 23,71 -39,01 -4,42 Median % 42,02 9,09 -42,86 0,00 Min % 0,00 -4,76 -16,67 0,00 Max % 100,00 100,00 -33,33 100,00 Graphic 1 – degrees representation of goniometry evolution, between experimental and control group 0,00 5,00 10,00 15,00 20,00 25,00 30,00 Experimental Controlo Goniometry Evolution 72 Mário Costa Graphic 2 – percentage representation goniometry evolution, between experimental and control group Graphic 3 – VAS evolution in experimental and control group 0,00 10,00 20,00 30,00 40,00 50,00 Experimental Controlo % DIFFERENCES OF ROM IMPROVEMENT 0 1 2 3 4 5 6 Experimental Control VAS Before After 79 Mário Costa CONCLUSION Current literature data supports a plausible effect of ACP in SP. The used protocol, via HD model of diagnose, had a significant effect in immediate pain and ROM of painful shoulder. By its simplicity, in implementation and evaluation, the protocol might be a therapeutic tool to consider in SP, supposedly allowing the application of other therapeutic techniques. 80 Mário Costa REFERENCES 1. Jung Ah Lee, P., et al., Acupuncture for Shoulder Pain After Stroke: A Systematic Review. THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, 2012. 18(9): p. 818823. 2. Urruela, M.A. and M.E. Suarez-Almazor, Acupuncture in the Treatment of Rheumatic Diseases. COMPLEMENTARY AND ALTERNATIVE MEDICINE, 2012. 14: p. 589-597. 3. Andrew J. Vickers, D., et al., Acupuncture for Chronic Pain: Individual Patient Data Metaanalysis. American Medical Association, 2012. 172(19): p. 1444-1453. 4. Guerra, J., et al., Acupuncture for Soft Tissue Shoulder Disorders: A Series of 201 Cases. ACUPUNCTURE IN MEDICINE, 2003. 21(1-2): p. 18-22. 5. Lin, J.-G. and W.-L. Chen, Acupuncture Analgesia: A Review of Its Mechanisms of Actions. The American Journal of Chinese Medicine, 2008. 36(4): p. 635-645. 6. Johansson, K., et al., A combination of systematic review and clinicians’ beliefs in interventions for subacromial pain. British Journal of General Practice, 2002. 52: p. 145152. 7. Pirotta, M., Acupuncture in musculoskeletal disorders, in Australian Family Physician. 2007. p. 447-448. 8. Doenitz, C.A., et al., Can heat and cold be parameterized? Clinical data of a preliminary study. Journal of Chinese Integrative Medicine, 2012. 10(5): p. 532-537. 9. He, D., et al., Effect of intensive acupuncture on pain-related social and psychological variables for women with chronic neck and shoulder pain – an RCT with six month and three year follow up. ACUPUNCTURE IN MEDICINE, 2005. 23(2): p. 52-61. 10. MacPherson, H., et al., Influence of Control Group on Effect Size in Trials of Acupuncture for Chronic Pain: A Secondary Analysis of an Individual Patient Data Meta-Analysis. PLOS ONE, 2014. 9(4): p. 1-8. 11. Na, B.-j., et al., An fMRI study of neuronal specificity of an acupoint: Electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neuroscience Letters, 2009. 464: p. 1-5. 12. Johansson, K., et al., A combination of systematic review and clinicians’ beliefs in interventions for subacromial pain. British Journal of General Practice, 2002: p. 145-152. 13. Fu, Q.-N., et al., Acupuncture at local and distal points for chronic shoulder pain: study protocol for a randomized controlled trial. Trials Journal, 2014. 15(130). 14. Garzedin, D.D.d.S., et al., PAIN SEVERITY IN PATIENTS WITH PAINFUL SHOULDER SYNDROME. ACTA ORTOP BRAS, 2008. 16(3): p. 165-167. 15. Zanelatto, A.P., Avaliação da acupressão auricular na Síndrome do Ombro Doloroso: estudo de caso. Rev Bras Enferm, 2013. 66(5): p. 694-701. 16. Y., G.L., et al., EFFECTIVENESS OF ELECTROACUPUNCTURE AND INTERFERENTIAL ELECTROTHERAPY IN THE MANAGEMENT OF FROZEN SHOULDER. J Rehabil Med, 2008. 40: p. 166-170. 17. Azevedo, L.F., et al., Epidemiology of Chronic Pain: A Population-Based Nationwide Study on Its Prevalence, Characteristics and Associated Disability in Portugal. The Journal of Pain, 2012. 13(8): p. 773-783. 18. Luís Filipe Azevedo, M., et al., Chronic Pain and Health Services Utilization. Is There Overuse of Diagnostic Tests and Inequalities in Nonpharmacologic Treatment Methods Utilization? Medical Care, 2013. 00(00): p. 1-11. 19. Gouveia, M. and M. Augusto, Custos indirectos da dor crónica em Portugal. Rev Port Saúde Pública, 2011. 29(2): p. 100-107. 81 Mário Costa 20. Azevedo, L.F., et al., A population-based study on chronic pain and the use of opioids in Portugal. PAIN, 2013. 154: p. 2844-2852. 21. Garcia, J.B.S., Shoulder Pain. 2009, Sociedade Brasileira para o Estudo da Dor – SBED. 22. KELLY, R.B. Acupuncture for Pain. 2009; Available from: www.aafp.org/afp. 23. KAPANDJI, A.I., PHYSIOLOGIE ARTICULAIRE 1 Membre Supérieur. 2000, Paris, France: MALOINE. 24. Kisner, C. and L.A. Colby, THERAPEUTIC EXERCISE Foundations and Techniques. 5th ed. 2007, Philadelphia, PA: F. A. Davis Company. 25. Magee, D.J., ORTHOPEDIC PHYSICAL ASSESSEMENT ENHANCED EDITION. 4th ed. 2006, St. Louis Missouri 63146: SAUNDERS ELSEVIER. 26. Giacomo, G.D., et al., Atlas of Functional Shoulder Anatomy. 2008, Italy: Springer. 27. Pabst, R. and R. Putz, Sobotta atlas de anatomia humana. 2 ed. 2000: Guanabara Koogan. 28. Vas, J., et al., Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial. BMC Complementary and Alternative Medicine, 2005. 5(19): p. 1-10. 29. Witte, P.B.d., et al., Study protocol subacromial impingement syndrome: the identification of pathophysiologic mechanisms (SISTIM). BMC Musculoskeletal Disorders, 2011. 12(282): p. 1-12. 30. Frias, D.M.P.e., PATOLOGIA DA COIFA DOS ROTADORES Abordagem Clínica, Diagnóstico e Tratamento, in Medicina. 2013, Instituto de Ciências Biomédicas Abel Salazar, Universidade do Porto. p. 36. 31. Lehman, C., et al., The incidence of full thickness rotator cuff tears in a large cadaveric population. Bull Hosp Jt Dis, 1995. 54(1): p. 30-31. 32. Bilal, R., et al., Rotator Cuff Pathology. Medscape, 2011. 33. Frias, D.M.P.e., SÍNDROME DO OMBRO DOLOROSO - PATOLOGIA DA COIFA DOS ROTADORES. ABORDAGEM CLÍNICA, DIAGNÓSTICO E TRATAMENTO, in Instituto de Ciências Biomédicas Abel Salazar. 2013. 34. Petty, N.J., Exame e avaliação neuro-músculo-esquelética. Um manual para Terapeutas. 3 ed. 2007, Reino Unido: LUSODIDACTA. 35. Cyriax, J.H. and P.J. Cyriax, Manual Ilustrado de Medicina Ortopédica de Cyriax. 2 ed. 2001: Manole. 36. Turtelli, C.M., Avaliação do ombro doloroso pela radiologia convencional. Radiol Bras, 2001. 34(4): p. 241-245. 37. Roy, J.-S., et al., Impact of movement training on upper limb motor strategies in persons with shoulder impingement syndrome. Sports Medicine, Arthroscopy, Rehabilitation, Therapy & Technology, 2009. 1(8): p. 1-11. 38. Martín, R., Electroterapia en Fisioterapia. 2 ed.: Editorial Medica Panamericana. 39. Kitchen, S., Electrotherapy - Evidence-Based Practice. 11 ed. 2003: Manole. 40. Fritz, S., Fundamentals of therapeutic massage. 4 ed. 2009, Missouri: evolve elsevier. 41. Silva, R.M.e., Infiltrações e punções em traumatologia do desporto - II. Rev Medic Desp in forma, 2010. 1(4): p. 29-30. 42. dor, D.-G.d.S.C.n.d.c.d., Dor como 5º sinal vital: registo sintomático da intensidade da dor, D.-G.d. Saúde, Editor. 2011: Lisboa, Portugal. 43. COIMBRA, N.R., Tratamento dos Distúrbios da Articulação Temporo-Mandibular através da Medicina Chinesa – método de tratamento por medicina complementar. 2011, ICBAS - Instituto de Ciências Biomédicas Abel Salazar: Porto. 44. Figueiredo, J.M.A., Avaliação da Eficácia da Acupunctura no Tratamento da Enxaqueca segundo o Modelo de Heidelberg, in Medicina Tradicional Chinesa. 2010, ICBAS. 45. Pais, I., Efeito da acupunctura nas células NK em doentes com cancro colorectal submetidos a quimioterapia, in Medicina Tradicional Chinesa. 2013, ICBAS. 46. Greeten, H.J., Clinical Subjects - Scientific Chinese Medicine - The Heidelberg Model. 2011. 82 Mário Costa 47. Greeten, H.J., Understanding TCM, Scientific Chinese Medicine - The Heidelberg Model. 2012: Heidelberg School, Heidelberg School Editions. 48. Porkert, M., et al., Classical Acupuncture: The Standard Textbook. 1999 Laurier Books, Limited. 49. Jia, J.E., Ch'an Tao. Conceitos Básicos: medicina tradicional chinesa, Lien Ch´i e meditação. 2 ed. 2004, Brasil: Icone editora. 50. He, Y. Hun, and N.Z. Ba, Teoria básica de Medicina Tradicional Chinesa. 1999: São Paulo. 51. Wei, L.Y., Scientific advance in acupuncture. Am J Chin Med, 1979. 52. Guan-Yuan Jin, M., L.Ac; Jia-Jia X. Jin OMD, and M. L. Ac; Louis L. Jin, BS, Contemporary Medical Acupuncture - A Systems Approach. 2007, China: Higher Education Press. Springer. 53. Ulett, G.A., J.S. Han, and S. Han, Tradicional and Evidence-Based Acupuncture: history, mechanisms, and present status. Southern Medical Journal, 1998. 91(12): p. 1115-1120. 54. Organization, W.H., "Acupuncture: Review and analysis of reports on controlled clinical trials.". 2002. 55. Hempen, C.-H. and V.W. Chow, Pocket Atlas of Acupuncture. 2012, Germany: Thieme. 56. Levy, B., The Acupuncture Approach to the Hypothalamus-Pituitary-Adrenal Axis and Its Interaction With the Sympathetic and Parasympathetic Systems. Journal of Biomedical Therapy, 2009. 3(1): p. 22-25. 57. Cho, Z.H., et al., Neural substrates, experimental evidences and functional hypothesis of acupuncture mechanisms. Acta Neurol Scand, 2006. 113: p. 370-377. 58. Hopwood, V. and C. Donnellan, Acupuncture in Neurological Conditions. 2010: Churchill Livingstone ELSEVIER. 59. Organization, W.H., Traditional Medicine Strategy 2014-2023. 2013. 60. Bonica, J.J., Anatomic and physiologic basis of nocicepcion and pain. In: The management of pain. 2 ed. 1990, Philadelphia: Philadelphia, Lea & Febiger. 61. Hwang, Y.C., Anatomy and classification of acupoints. 1992, Problems in Veterinary Medicine. 62. Anjos, A., OBJECTIVE ASSESSMENT OF ACUPUNCTURE EFFECTS BY MICROCIRCULATIONRELATED PARAMETERS IN PATIENTS WITH PROXIMAL FEMUR FRACTURE, in Medicina Tradicional Chinesa. 2011, Abel Salazar Institute for Biomedical Sciences. 63. Strittmatter, B., Ear Acupuncture. 2 ed. 2008: Thieme. 64. Hu, J.H., The neural basis of meridians and acupuncture points. 1975: Am J Acupunct. 65. Sun, K., et al., Acupuncture for frozen shoulder. Kwong Wah Hospital, 2001. 7(4): p. 381391. 66. Porkert, M., M. Chinese Medicine - A science in its own right. 1997: Eastern Horizon. 67. Riddle, D.L., J.M. Rothstein, and R.L. Lamb, Goniometric Reliability in a Clinical Setting: Shoulder Measurements. PHYSICAL THERAPY, 1987. 67(5): p. 668-673. 68. Andrade, J.A., et al., Estudo comparativo entre os métodos de estimativa visual e goniometria para avaliação das amplitudes de movimento da articulação do ombro. ACTA FISIÁTRICA, 2003. 10(1): p. 12-16. 69. Andrews, A.W. and R.W. Bohannon, Decreased Shoulder Range of Motion on Paretic Side After Stroke. Physical Therapy, 1989. 69(9): p. 768-772. 70. Hopton, A.K., et al., Acupuncture in practice: mapping the providers, the patients and the settings in a national cross-sectional survey. BMJ Open, 2014. 2. 71. Freedman, J., An Audit of 500 Acupuncture Patients in General Practice. ACUPUNCTURE IN MEDICINE, 2002. 20(1): p. 30-34. 72. Zhang, J., et al., Acupuncture-related adverse events: a systematic review of the Chinese literature. Bulletin of the World Health Organization 2010. 88: p. 915-921. 73. Wang, Y.J., Analysis of clinical efficacy of combination therapy of small needle knife and Daqinjiu Tang in treatment of periarthritis of shoulder. Zhongguo Zhong Yao Za Zhi, 2013. 38(23): p. 4164-4167. 83 Mário Costa 74. Ping, Z., Essentials forAcupuncture Treatment of Periarthritis of Shoulder. Journal of Traditional Chinese Medicine, 2006. 26(2): p. 108. 75. Koel, G., Anti-impingement Therapy? Journal of the American Physical Therapy Association, 2006. 86: p. 143-144. 76. Takakura, N., et al., Double-blinding with a new placebo needle; a further validation study. Acupunct Med, 2010. 28(3): p. 144-148. 77. Jia, X., et al., Does a positive Neer impingement sign reflect rotator cuff contact with the acromion. Clin Orthop Relat Res, 2011. 469: p. 813-818. 78. Gomoll, A.H., et al., Rotator Cuff Disorders. Recognition and Management Among Patients With Shoulder Pain. ARTHRITIS & RHEUMATISM, 2004. 50(12): p. 3751-3761. 84 Mário Costa APPENDIXES Annex 1 - Table with tests for the shoulder pain, adapted from [32, 77, 78] TEST DESCRIPTION RESULT (positive test if) Sensitiv ity IMPINGEMENT TESTS (do not localize the injury) Neer’s test The examiner stands behind the sitting patient. With one hand prevents rotation of the scapula, and the other executes a shoulder front elevation of the patient. This movement causes the decrease of the interval between the greater tuberosity of the humerus and the anterior-inferior portion of the acromion Pain and suggests an anterosuperior compression 89% Hawkins - Kennedy test Behind the patient , the examiner performs passive shoulder flexion at 90°, followed by repeated movements of internal rotation Pain resulting from contact between the RC (on the side of the synovial pouch) and coraco-acromial ligament and/or the articular surface of the tendon and the anterior superior edge of the glenoid cavity. The contact between the tendon and sub-scapular muscle and the coracoid apophysis can also occur. 87% Yocum test The patient places a hand on the contralateral shoulder and is asked to raise the elbow without raising the shoulder Pain caused by contact of the tendon of the RC and the coraco-acromial ligament and possibly the lower surface of the acromion-clavicular joint, suggesting an anterior-superior or anterior-internal PSS 78% The sensitivity of this three tests listed above, when combined , is 100 %, showing the relevance of their systematic execution Posterior impingment test Patient in the supine position . The examiner makes 90-100º abduction together with maximum external rotation. Posterior pain caused by compression of the articular side of the tendon of the RC between the greater tuberosity of the humerus and the posterior superior margin of the glenoid cavity/joint capsule 90% TESTS THAT ALLOW TO LOCATE THE INJURY SE impingment test Shoulder and elbow at 90° of flexion , while palpating the supraspinatus tendon, the examiner makes internal rotation Pain is caused 86% Empty can test Shoulder in the plane of the scapula ( 90° of abduction and 30° of horizontal adduction) and maximum internal rotation: thumb Pain is caused Unknow n 85 Mário Costa pointing down . Examiner pushes downwards and the patient must resist the force. Test for isolation of infraspinatu s 0° shoulder elevation , elbow at 90° of flexion and 45° of internal rotation, leaning against the hip. Patient performs external rotation against resistance Pain is caused Unknow n Patte’s test The examiner holds the patient's shoulder at 90° of anterior elevation while he is asked to perform external rotation against resistance. Pain is caused 92% Gerber’s test Patient places his hand on his back , with 90 º of elbow flexion. The examiner's move’s the hand about 5-10 cm away from the back, keeping the angle of the elbow. The patient must maintain position without examiner’s help If the patient is unable to maintain position, the subscapularis is involved 100% if there is rupture of the subsca pularis Gerber’s resisted test Same as above, but the patient must perform internal rotation against resistance TEST FOR THE BICEPS LONG PORTION Speed test Shoulder at 90° of flexion, full extension and supination of the elbow. Perform arm flexion against resistance Pain reveals involvement of the long head of the biceps 63% 86 Mário Costa Annex 2 – consent form C ONSENTIMENTO I NFORMADO , L IVRE E E SCLARECIDO PARA PARTICIPAÇÃO EM P ROJETOS DE D OCÊNCIA E / OU I NVESTIGAÇÃO de acordo com a Declaração de Helsínquia 1 e a Convenção de Oviedo 2 Por favor, leia com atenção a seguinte informação. Se achar que algo está incorreto ou que não está claro, não hesite em solicitar mais informações. Se concorda com a proposta que lhe foi feita, queira assinar este documento. Título do estudo: Efeito imediato da acupuntura na melhoria da dor e amplitude de movimento em pacientes com dor no ombro Enquadramento: No âmbito da tese de Mestrado de Medicina Tradicional Chinesa do Instituto de Ciências Biomédicas Abel Salazar Explicação do estudo: este estudo visa estudar o efeito da acupunctura na dor e na limitação da amplitude da articulação do ombro. Será escolhida uma amostra de indivíduos de ambos os géneros, com idades entre os 18 e os 85 anos, com as condições clínicas bem específicas, descritas e diagnosticadas por um médico de medicina convencional. Da amostra serão excluídos os indivíduos com todas as outras patologias que não a do estudo, as grávidas ou lactentes, e patologias do foro neurológico e oncológico. A amostra será dividida em 2 grupos: o de teste e o de controlo. No grupo de teste será aplicada uma técnica de acupunctura (Leopard-spot) em pontos verdadeiros definidos para a patologia, no grupo de controlo será aplicada a mesma técnica em pontos de acupunctura não indicados para essa condição clínica (sham acupuncture). No primeiro momento (T0 – avaliação de linha de base) a amostra será avaliada quanto à dor e a amplitude, usando para o efeito, respetivamente, a Escala Visual Analógica e o Goniómetro. No mesmo momento, será aplicada a acupunctura, usando uma agulha de mesoterapia 27G ½” 0,4x13mm, da marca BD Microlance TM 3, esterilizadas de uso único, e nova avaliação (T1) logo após a intervenção. Os dados recolhidos serão tratados estatisticamente. Esperam-se como resultados, que a acupunctura reduza a dor e melhore a amplitude do ombro , apresentando resultados estatisticamente significativos na dor e amplitude do ombro com patologia Note que não se espera que a acupunctura prejudique o tratamento convencional a que será sujeito nem haverá qualquer interferência no seu plano de tratamento habitual. Todas as agulhas de acupuntura são esterilizadas e descartáveis (ou seja, de uso único). Antes da inserção das agulhas, a pele será desinfetada com uma solução antisséptica alcoólica. Os riscos associados a acupunctura são mínimos. Poderá sentir algum grau de dor ou desconforto e formigueiros no local das picadas com as agulhas de acupunctura. Mais raramente, poderá sentir tonturas, ansiedade ou náuseas. É possível que após o tratamento possam surgir ligeiros sangramentos, em particular se estiver a tomar a tomar medicamentos anti-agregantes (ex.: Aspirina, ácido acetilsalicílico) ou hipocoagulantes (ex.: Varfine ® (varfarina); Sintrom ®, acenocumarol) e/ou aparecerem ligeiros hematomas num local onde foram inseridas as agulhas que se resolverá espontaneamente. Caso esteja a tomar a medicação acima referida deverá informar a equipa de investigação. Condições e financiamento: O presente estudo será realizado sem qualquer custo para o paciente. Todos os custos serão suportados pelo Instituto de Ciências Biomédicas Abel Salazar da 1 http://portal.arsnorte.min-saude.pt/portal/page/portal/ARSNorte/Comiss%C3%A3o%20de%20%C3%89tica/Ficheiros/Declaracao_Helsinquia_2008.pdf 2 http://dre.pt/pdf1sdip/2001/01/002A00/00140036.pdf 87 Mário Costa Universidade do Porto (ICBAS-UP). A sua participação é voluntária e terá o tempo que necessitar para ponderar sobre a sua participação neste estudo. É livre de consultar a opinião dos seus familiares ou amigos. Caso decida aceitar, poderá posteriormente a qualquer momento recusar continuar no estudo, sem quaisquer tipos de prejuízos assistenciais ou outros, caso não queira continuar a participar. Confidencialidade e anonimato: Todos os dados recolhidos para o presente estudo asseguram uma total confidencialidade e anonimato dos participantes, os seus nomes nunca serão tornados públicos. Todos os resultados obtidos serão devidamente codificados; os dados serão apenas do conhecimento do investigador principal e dos orientadores do estudo. Agradecimentos e identificação do/a investigador/a e da pessoa que pede o consentimento, se for diferente: Mário Francisco Barbosa Costa, Fisioterapeuta, trabalha em unidade privada de Fisioterapia. Assinatura(s): ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Declaro ter lido e compreendido este documento, bem como as informações verbais que me foram fornecidas pela/s pessoas/s que acima assina/m e que considero suficientes. Foi-me garantida a possibilidade de, em qualquer altura, recusar participar neste estudo sem qualquer tipo de consequências. Desta forma, aceito participar neste estudo e permito a utilização dos dados que de forma voluntária forneço, confiando em que apenas serão utilizados para esta investigação e nas garantias de confidencialidade e anonimato que me são dadas pelo/a investigador/a. Nome: ______________________________________________________ Assinatura: Data: __ /__ /_____ E STE DOCUMENTO , COMPOSTO DE 2 PÁGINA / S , É FEITO EM DUPLICADO : UMA VIA PARA O / A INVESTIGADOR / A , OUTRA PARA A PESSOA QUE CONSENTE