Effect of acupuncture on pain intensity and grip strengh in symptomatic rhizarthrosis

EFFECT OF ACUPUNCTURE ON PAIN INTENSITY AND GRIP STRENGTH IN SYMPTOMATIC RHIZARTHROSIS PROSPECTIVE,RANDOMIZED, NON-BLINDED CLINICAL STUDY WITH WAITINGLIST DESIGN Christiane Grünecker Dissertação de Mestrado em Medicina Tradicional Chinesa 2014 EFFECT OF ACUPUNCTURE ON PAIN INTENSITY AND GRIP STRENGTH IN SYMPTOMATIC RHIZARTHROSIS PROSPECTIVE,RANDOMIZED, NON-BLINDED CLINICAL STUDY WITH WAITINGLIST DESIGN Dissertação de Candidatura ao grau de Mestre em Medicina Tradicional Chinesa submetida ao Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto Orientador – Dr. Henry Johannes Greten Categoria – Professor Asscociado convidado Filiação – Heidelberg School of Chinese Medicine Instituto Ciências Biomédicas Abel Salazar da Universidade do Porto Christiane Grünecker II DEDICATION To my wonderful husband Walter and to my sensational family Benjamin, Daniel, Joana, Lia, Nika Josua, Jeanne, Jaelle, Ilian, Johannes, Lisa and Tiger III IV Acknowlegdement I would like to thank : Prof. Greten for being an inspiring and motivating scientist Dr. Nuno Correia for being a hero Prof. Jorge Machado for keeping up the fight for TCM MSc. Maria Joao Santos for being a wonderful professor Dra. Petra Fröschen for always being on top of things organisation-wise Andrea Braun-Radnedge for successfully juggling with the technical aspects Dipl. Ing. August Grünecker for having been a person of excellence V VI Abbreviations ALT Algor Laedens Theorie DASH Disabilities of the Arm, Shoulder and Hand Questionnaire OA Osteoarthrosis TCM Traditional Chinese Medicine VAS Visual Analogue Scala TCM Traditional Chinese Medicine TMCjoint Trapeziometacarpal (joint) P Pulmo IC Intestinum crassum VII VIII Abstract Effect of Acupuncture on Pain Intensity and Grip Strength in Symptomatic Rhizarthrosis: a clinical research protocol. Christiane Grünecker1, Nuno Correia2,4, Henry Greten3,5 (1) TCM Master Programme, Abel Salazar Institute for Biomedical Sciences; Physiotherapy Department, Viana do Castelo Private Hospital, Portugal, (2) Acupuncture Clinic, Alfena Private Hospital, Portugal; (3) Abel Salazar Institute for Biomedical Sciences, University Porto, Portugal; (4) Internal Medicine, Emergency Department, Hospital Center São João, Porto, Portugal; (5) Heidelberg School of Chinese Medicine Introduction: Osteoarthrosis of the Trapeziometacarpaljoint or Rhizarthrosis: Occurs most frequently in middle-aged or postmenopausal women and affects at least 1 in 3 women over 65 and a quarter of men over 75. Rhizarthrosis is often bilateral . Etiology: Still very unclear. There is evidence that ligament laxity and trapeziometacarpal subluxation are important early events in the development of thumb arthrosis. Main Symptoms: Pain in the dorsoradial and thenar area of the hand and a loss of manual ability and grip strength. Great functional importance of the trapezometacarpaljoint explains that any pathological process that troubles its funcionality could lead to chronic social and occupational disability and have significant repercussions on everyday activity. Objective: To study the effect of suppletive acupuncture on pain intensity and grip strenght in symptomatik rhizarthrosis including a evaluation of its ongoing effect in the two weeks following end of intervention Methods: Ethics approval: The research protocol was approved by the Ethics Committee of the XV University of Porto. PROJETO Nº 073/2014 Study design: Prospective, randomized, non-blinded clinical study, with waitinglist-control Sample: n= 38 adults Inclusion criteria: diagnosis of rhizartrosis ,Eaton Stage < 3; age over 18 y.o, no surgery, no steroidinjection, no change of medication during the study; informed consent. Exclusion criteria: Rhizarthrosis Eaton Stage =/>3 rheumatologic diseases, anticoagulant treatment glucocorticoids, immunosuppressives; intra-articular injection or steroid injection in the 3 months before study. Interventiongroup n=38 (33 female), 46-75 y.o., randomly selected for Interventiongroup submitted to acupuncture, 4 sessions in 2 weeks, assessed before and after acupuncture. Waiting list Control group n= 15 (13 female) control group , 46-75 y.o., randomly selected for waiting list, stood there for two weeks, were assessed before and after this two weeks while standing by with no other treatment. XVI Follow-up group : In order to get an idea of the washout phase of suppletive acupuncture and its possible further evolution of symptoms, we extended the scope of the trial by one more serie of measurements two weeks after completion of treatments . A group of n=12 patients (10 female), aged from 46 years to 75 years, were recruited from the original Experimentalgroup Only the parameters VAS and Grip Strength were taken into account. Intervention: Patients were treated with classical suppletive acupuncture in a sequence of four treatments in two weeks. The selection of acupuncture points was based on potential local and segmental effects and followed the "the Heidelberg Model of Traditional ChineseMedicine" Manual acupuncture was performed with rotation of the needles until a sensation of numbness („DeQi“) was attended. Than needles remaind for 20 minutes Experimentalgroup was subject to four treatments in two weeks Measurements: Before and after the treatments, measurements were made by: DASH (Disability of Arm, Shoulder and Hand), VAS (visual analog scale) and GRIP STRENGHT (evaluation by means of a Martin vigorimeter). Results: Review of the recent literature indicates that acupuncture has effects on pain relief for different osteoarthrotic diseases and its analgesic mechanisms are well studied. In the proposed study, patients of Intervention group experienced a improvement in DASH 44,51%, Pain intensity improved in 40,54 %, Grip strength improved 19,21 % The Follow-up group showed an improvement of VAS of 52, 85% in total and Grip Strength had and improvement of 16,62% (after four weeks....two weeks intervention and two weeks followup without any intervention) In the waiting-list group the difference was: 1,67 % increase in VAS, 1,18% reduction in Grip Strength and 1,25 increase % in Dash. Discussion/Conclusion: We found no reliable published studies on acupuncture for Rhizarthrosis (Ostoearthrosis XVII of the Trapeziometacarpaljoint). Given the biological plausibility of acupuncture's effects and its clinical good outcomes already shown for other pathologies, it may be possible that acupuncture also has benificial effects on Rhizarthrosis. The study suggests: A: The results from the proposed prospective clinical study suggest that the effects of the chosen acupuncture points may be associated with a therapeutic benefit in the pathology of Rhizarthrosis However, controversy persists whether the observed effects are specific to acupuncture or merely nonspecific consequences of needling. Therefore, a future study could have the objective to determine the efficacy of different acupuncture treatment modalities. There could be compared verum and sham acupuncture (needling of non-specific points) in a prospective randomised trial with a double-blinded study design. If acupuncture shows good results it may then be an additional therapeutic tool for the multidisciplinary treatment of this common disease. B: The technique of suppletive needling seems to have a longer period of effect than expected. In order to avoid a carry-over effect in a future possible clinical study with cross-over design, we suggest further studies with exact mesurement of the wash-out phase after suppletive needling. Keywords Traditional Chinese Medicine, acupuncture, Heidelberg Model of TCM, osteoarthrosis, rhizarthrosis, trapeziometacarpal joint, grip strength XVIII 19 CHAPTER ONE Background Knowledge 20 1. Basic Knowledge 1.1. Functional anatomy of the trapeziometacarpal joint The basal joint of the thumb is formed by the articulation between the trapezium bone proximally and the first metacarpal bone distally. It is therefore called the trapeziometacarpal joint or the carpometacarpal joint of the thumb.(Fig. 1) The trapezium, a bone of the second carpal row, articulates with the scaphoid bone proximally, the trapezoid medially and the bases of the first and second metacarpal bones distally. The trapezium is on the palmar and radial side of the wrist. It is angled such that it projects towards the palmar side. It angles the first metacarpal bone (the most proximal bone of the thumb) radially and in a palmar direction. The articular facet of the trapezium with the first metacarpal is angled 35 degrees towards the palmar direction and 20 degrees radially. This results in the neutral position of the thumb being 35 degrees in a palmar direction and 20 degrees in a radial direction [11]. Fig. 1. Illustration of the trapeziometacarpal joint (TMC joint) of the left thumb. The first (M1) and second (M2) metacarpals, the trapezium (T), the trapezoid (TZ), the scaphoid (S) and the capitate (C) bones are illustrated. Illustration courtesy of Mr Donald Sammut, Consultant Hand Surgeon, The Hand Clinic, Windsor. The trapeziometacarpal joint is a saddle joint with wide mobility due to extensive articular surfaces. It is called a saddle joint because the trapezial articular surface is concave in a 21 dorsopalmar direction and convex in the radioulnar direction. The first metacarpal base is complimentary to the trapezial articular surface. The trapezium is compared to the saddle of a horse and the base of the first metacarpal bone may be compared to the horse rider as it is mobile. It is a synovial joint and is surrounded by a joint capsule that is strengthened by three ligaments. The most important of these is the ulnar beak ligament. This is a very thick and wide ligament that runs from the crest of the trapezium and attaches to the ulnar side of the base of the first metacarpal. This ligament maintains the stability of the thumb and is tense in abduction of the first metacarpal. The other two ligaments are less widely described as they are believed to be less important in the stability of the thumb. The radial ligament originates from the radial side of the trapezium and travels dorsally and medially to attach to the dorsal tubercle of the first metacarpal. A palmar wide ligament is also sometimes described [11, 12, 8]. A wide range of movement is permitted at the trapeziometacarpal joint: flexion, extension, abduction, adduction, opposition and retroposition. 1.1.1.Common problems of the trapeziometacarpal joint 1.1.1.1.Rhizarthrosis : Arthrosis of the trapeziometacarpal joint Apart from disorders of the innert structures, rhizarthrosis (RA) is a common, painful and debilitating condition. It is more common in women and most commonly presents in Caucasian women in their late forties [10]. It affects approximately 16-20% of women over 45 years old and 6% of men over this age [1]. It is the site most frequently operated on in the upper extremity for primary osteoarthritis. [7]. Pain is the main presenting symptom. It is often brought on by writing, by opening jars and using the hand for a long time, particularly in pinching movements and there is difficulty in performing these activities. The patients often have weakness due to the pain that may affect their ability to work, perform activities of daily living and follow leisure pursuits. They may also have an adduction deformity of their thumb. Signs include tenderness over the carpometacarpal joint at the base of the thumb,thenar wasting, reduced pinch grip strength and crepitus on moving the thumb [10, 3]. The severity of basal thumb rhizarthrosis can be graded according to the Eaton stages. Eaton Stage I basal thumb rhizarthrosis indicates joint pain and symptoms but no joint space-narrowing or cartilage degeneration shown on Xray. Eaton stage II is classified as joint space narrowing seen on X-ray with osteophytes present of less than 2mm in size. An osteophyte is a small outgrowth of bone which 22 occurs at joints in association with degeneration of joint cartilage. Eaton Stage III rhizarthrosis is characterised by osteophytes of greater than 2mm in size being present on x-ray and significant destruction of the joint. Instage IV basal thumb OA there is significant degeneration of the scaphotrapezial joint in addition to the trapeziometacarpal joint [2]. (Fig. 2) Fig. 2 Stages I – IV of rhizarthrosis 23 1.1.1.2. Pathophysiology of Rhizarthrosis Many authors have described theories on how rhizarthrosis of the base of the thumb occurs. There is often degeneration of the ulnar beakligament due to recurrent stress and overuse which leads to ligament and joint instability. With increased laxity there may be abnormal translation of the first metacarpal on the trapezium. This can result in excessive shear forces between the joint surfaces [9, 6, 5]. In addition there is articular degeneration. This may be secondary to instability which leads to joint surface incongruity. The incongruity may result in areas of high contact stress developing in the joint. This then causes cartilage erosion and the symptoms and signs of rhizarthrosis [1]. It has been shown that articular degeneration occurs on the palmar side first and gradually progresses to dorsoradial cartilage degeneration in the later stages of rhizarthrosis of the joint [7, 4]. Radiological studies looking at the angle of the trapezium comparedto the second metacarpal have shown that there is an increased radial trapezial tilt in Eaton stages III and IV compared to Eaton stages I and II rhizarthrosis of the base of the thumb [1, 5]. Studies have also shown accessory tendons of abductor pollicis longus inserting into the radial side of the metacarpal base in some people. These pull the metacarpal base radially and hence have a tendency to cause joint instability and may contribute to the development of rhizarthrosis [12]. 1.1.1.3. Conservative Treatment of Rhizarthrosis The treatment that is chosen depends on the stage of the arthrosis and the functional disability of the joint. Classically, conservative treatment of osteoarthritis of the trapeziometacarpal joint includes analgesics, joint protection, strengthening exercises of the intrinsic and extrinsic muscles of the thumb, and splints.[16] Surgical management is recommended to relieve intractable pain. In early arthrosis, deep transverse friction to the anterior and lateral aspect of the capsule can cause the pain to cease but does not influence mobility. Later in the course of the condition, intra-articular triamcinolone can be tried. It usually has a temporary result only. An open label trial found that steroids had no benefit on carpometacarpal pain at 26 weeks,while a randomized controlled trial evaluating steroids against placebo injection showed that steroids had no benefit in moderate to severe trapeziometacarpal osteoarthritis at 24 weeks.[17] (Table 1) 24 among "barefoot doctors" [110] in order to provide basic medical care for the population in China which at that time was a developing country. Fig. 4: Pseudo Philosophy of TCM (Greten 2008). The sheng or ko-cycle originates in the 3rd century bC. Feature constellations of clinical signs were arranged according to “elements” and balanced against each other. In the 1950s to 70s the theory of TCM started to be based on this representation that largely reduced acupuncture diagnostics in order to provide a tool of basic medical care for masses and a rapid distribution of pragmatic concepts. Therefore, “Traditional Chinese Medicine” (TCM) originally describes the modern practice of CM as a result of widespread reforms that resulted in a certain reduction of the theoretical and diagnostical background. The term “Classical Chinese medicine” (CCM) often refers to medical practices that are based on theories and methods dating from before the fall of the Qing Dynasty (1911) [6]. The apparent irrationality of the shortened versions of TCM exported after the 1950's from China can give rise to misunderstanding which is against a comprehensible theoretical basis for this medical system [3]. On the basis of the pioneering works of the medical-sinologist Prof. Manfred Porkert [120-125], the Heidelberg Model was developed by Prof. Greten [129] as a scientific model to allow rational access to Chinese medicine. 31 1.2.2. The Heidelberg Model of Traditional Chinese Medicine An “Integrated Chinese Medicine” or integrated TCM refers to more comprehensive recompilations based on TCM and the current status quo of methodologies. The theoretical basis of such recompilations such as. the “Heidelberg Model of TCM” [2, 4] are mathematical models on vegetative regulation inherent in the classical corpus medicus. In this approach, certain technical terms like yin, yang and the phases can be translated as vegetative functional terms. This can be considered crucial for the integration of TCM in Western health care systems and research. . Since Prof. Porkert devised a systematic account of Chinese Medicine theories, based on primary Chinese sources, he used a precise terminology in Latin, which better defines the original Chinese concepts at a philological level (e.g. the latin terms calor or algor, meaning “heat/cold”). Accordingly, the Heidelberg Model makes use of this terminology. Based on the already cited ‟ analysis of the I Ging (“The Book of Changes”), Prof. Greten developed a novel recompilation of the central ideas of Chinese Medicine, thereby explaining it as a logical model of system biology based on a mathematical language [119]. There is evidence that in classical China, even before the Yellow Emperor‟s Classic, these regulatory fluctuations were described by circulatory functions in a simplistic manner resembling a sinus wave. This wave is part of the so-called monad (Leibniz) or Taiji sign. (Fig. 5) Fig. 5 The Taiji sign 32 1.2.2.1. The guiding criteria: four different physiological levels In TCM four main descriptive models have evolved to organize the complex relationships of body regulation. These central ideas are condensed in the theory of the so-called guiding criteria (bagang). In essence these models describe the guiding criteria in the regulation of the human body at four different physiological levels, which together constitute a complex regulatory network model. (Fig. 6) Fig. 6 The Heidelberg Model of TCM establishes a parallelism between TCM concepts of disease and physiological processes at four levels of regulation: neurovegetative, humorovegetative, neuroimmunological, and cellular level. These four levels of control are: the neurovegetative level, humorovegetative level, the neuroimmunologic level, and the cellular level. (Table 3). The guiding criteria are considered to be an extension of the vegetative regulatory curve on processes such as microcirculation (“heat/cold”), defense mechanisms (theory of six stages of the Shan Han Lun) and the relation of the amount of the cell population and the respective regulatory processes (the yin, “substance”) [126]. 33 Table 3 . The Heidelberg Model of TCM establishes a parallelism between TCM concepts of disease and physiological processes at four levels of regulation: neurovegetative, humorovegetative, neuroimmunological, and cellular level. 1.2.2.2. The orbes: physiological patterns The laws of regulation indicate that most of the regulatory processes are based on periodic fluctuations of the actual value around a target value of regulation. Applying this model of regulation of Chinese Medicine to the vegetative system it results in the categorization of symptoms in organ patterns or orbes (= orbs). “Organs patterns” can be understood as physiological patterns of vegetative origin allowing to translate ancient Chinese physiology in terms of western vegetative physiological knowledge [126]. 34 The technical and regulatory dimension of Yin/Yang and the phases (elements) i.e., Wood, Fire, Earth, Metal, Water, can be seen in an analogous example of the regulation of temperature in a water basin by a thermostat system. Due to the inherent fluctuations, the actual temperature value moves around the set point approximately in a sinus wave. (figure 7). Fig. 7. Regulation as a technical process. The temperature profile of the pool is not constant (straight line), but rather sinusoidal. Temperature is on the y-axis, time on the xaxis, which corresponds to the desired temperature. 1.2.2.3. Sinusoidal-pattern of phases Almost all biological systems are regulated. in such a sinusoidal course. TCM has developed its own language to describe such changes around the set point, which could be applied to the regulation of the autonomic nervous system in the human body: Yangstates are above the set point; Yin-states are below the set point. The phases designate the sections (quadrants) of this sinusoid curve. A sine curve can also be seen as a circular function. as in the Fou qi character who has the basic mathematical meaning of the description of a circular motion. (Fig. 8). 35 Yang includes the wood and fire phases; yin includes metal and water phases. This model also illustrates very clearly the concept of Yin-deficiency and the six-stage theory of the “Shang Han Lun” [119]. Fig. 8 fou qi emblem: a symbol for the regulatory meaning of yin, yang and the phases The sinusoid wave is a circular function around a shall-be value in biological systems. Yin and yang are terms of regulation that can be further differentiated in phases ( wood, fire metal water ) The shall-be-value is associated with the central phase of earth. 36 1.2.3. Analogies of the phases with neurohormonal mechanisms The Heidelberg Model hypothesises a relation between this sinusoidal-pattern of phases and the differential activity of the autonomic nervous system and its major molecular effectors (e.g. hormones, neurotransmitters, etc) (Fig. 9). Fig. 9 Vegetative activity Postulated assignment of phases of Chinese medicine into the autonomic nervous system with respective analogies between the phases and the neurohormonal mechanisms. W – Wood phase. F – Fire phase. M – Metal phase. Scientific proof of efficacy based on this model has been reached by a novel double and even triple blinded assay of evaluation in acupuncture research. [119] have shown that in double or triple 37 blinded study design, acupuncture based on this reconstruction of classical theory is almost double as effective as current “western” acupuncture . Analogue data has been shown for polyneuropathy [127], in congestive heart failure[128, 129], pain following sternotomy in heart surgery, respiration after heart surgery, pain after tonsillectomy [120], walking distance and peripheral arterial occlusive disease [126]. Nevertheless more studies are needed to support this model. 1.2.4. Diagnosis according to the Heidelberg Model of TCM Along the lines of this model, the Chinese Medicine functional diagnosis is composed of four steps (Fig. 10): (A) the constitution; (B) the agent (pathogenic factor); (C) the “orb”, (D) the guiding criteria. Fig. 10 Schematic representation of the TCM methodology of diagnosis 1.2.4.1. Constitution Refers to the individual functional properties and the inner nature of the patient based in his/her phenotype. It describes the vegetative reaction type of the patient including a behavioural and emotional typology (the “inner nature” of the patient). Constitution significantly determines expressivity (including pain experience), body tension,conflict processing patterns, the guidance of joints by connective tissue (e.g. in hyper mobile spine), relationship and bondage intensity up to bondage addiction, co-addiction and 38 tendency to particular forms of compulsion (pulmonary and renal compulsions). 1.2.4.2. Agent Agent is regarded as a functional power (vector) that changes the individual functional properties (caused by the constitution), produces clinical signs of its own and induces groups of diagnostically relevant signs called “orb” (vegetative patterns). Agents may be divided into: Exterior agents :wind (ventus), cold (algor), dryness (ariditas), summer heat (aestus), glow (ardor). Exterior agents are vegetative reaction types of the defence type against cold, draught, humidity etc. Interior agents :(Ira (“anger”); Voluptas (“lust”); Maeror (“grief”), Timor (“anxiety”); Pavor (“shock”); Solicitude (“worriedness”); Cogitation (“thinking”). Interior agents are emotions Neutral agents: overwork, physical effects, poisoning. The agent as pathogenic factor is the „trigger of disease“ that causes the symptomatic state of a patient. The agent primarily determines the modalities of pain, such as worse on cold, worse on change of weather, worse in draught etc. Each agent is defined by key symptoms (Table1) and is accompanied by typical forms of general condition and typical tongue and pulse patterns. (Table 4) 39 Table 4 The agents 1.2.4.3. The Orbes The orb is the clinical manifestation of a phase, named after a region of the body. It consists of a group of diagnostically relevant signs indicating the functional state of a body island that correlates with the functional properties of a phase. (Dr. Greten 2007) It is the current disturbance pattern which also includes the current main symptom. Symptoms are considered to be part of a group of pre-defined diagnostic signs. These signs, “organ patterns”, “functional circles” or (latin) orbes are an expression of body regulation named after organ regions (body islands) which can become symptomatic within the overall pattern.The orb (e.g. the hepatic orb) manifests a vegetative functional tendency which is called phase (e.g. wood). 40 orb controls the extima on the whole. Actually it is believed that the puimonary orb, which we roughly translate as the many effects of the breathing movement, also rules the defensive qi. This defensive qi is not located in the conduits but in the surrounding tissue in the whole body. It is especially important in the extima where for natural reasons the defence must be strong, as it is the protective wall of the body. The breathing movement is stimulating the extima. The pulmonary orb controls and distributes the defensive qi. If this qi is low, external agents can invade more easily. Many patients with chronic pain syndromes or recurrent infections like children have an improper breathing. The spatial patterns of stimulation and de-activation of tissues that come by the breathing movement may help us to understand how pain is generated. Chinese Medicine states that spatial distribution pattems of activation (qi flow) are blocked when pain comes. This can be explained by a lack of spatial distribution of the effect of breathing, the spatial wave of vegetative activation. In this sense, the pulmonary orb acts as-a wiper of the human windscreen. Breathing has a cleaning effect on the whole conduit system according to the core statements of Chinese Medicine. When the transition of this vegetati ve is blocked for whatever reason, this may lead to non-transition of the wave from one part to the other of the body. So the transition trom one tissue to the next of this vegetative action does not take place. Accordingly, the orveractivating effect is seen in the tissue which is located before the site of transition. In Western terms, neuro-impulses, which should evenly distribute over the tissues, then concentrate on one tissue, a site of the body that finally is felt as painful. The threshold for the feeling between over-activation and pain varies individually. But if there is overstimulated tissue, this is, according to our experience, correlating with repletive pain. This kind of pain becomes worse under pressure. and we, use dispulsive needling to cure it. Dispulsive needling therefore could be explained as lowering the sympathetic activation pattern within a tissue that depends on a certain point. On the other hand, depletive pain may be due to a lack of stimulation. This kind of pain is also believed to be produced by blocks of qi. It may be explained, in a Western sense, by 47 the fact that after the site of blocked transition of the spatial wave of neuro-activation there is a lack of sympathetic action and a relative over-representation of vagal and deactivating stimuli. Letting a needle reside in a certain point is called suppletion. This effect may be explained by a stronger perception of the dependent area by the central nervous system. Like this, the sensation of stimulation is directed to the area. This is why the subconscious “focuses” on this area resulting in a regulation of the feedback mechanism of vegetative impulses' This is consistent with the finding that oniy thinking of an acupoints can have an effect. Acupuncture as a reflex ttherapy can therefore be regarded as a functional vegetative therapy. Western medical language calls this vegetative spatial distribution of impulses whereas the Chinese explanation is qi flow. Therefore we believe that most of the effects that are thought to be caused by qi are simply neurovegetative in origin. This supports the Heidelberg Model which argues that the core termini of Chinese Medicine - the phases and yin and yang - and the patterns which we call orbs are vegetatively explainable by the cybernetics of the phases that we teach. The spatial distribution of neurovegetative impulses therefore causes sensations of pain and the question arises how this is generated. Chinese Medicine says that external agents contribute significantly to this block of qi. The present understanding of the external agents is that these agents in fact do not invade the body like "wind" enters the body, but that vegetative reflex pattern are elicited that are similar to the influence of draught on the body, of cold and therefore represent vegetative reflex patterns, too. Ventus, e.g., may be explained by the effect of substance P on mast cells and by eliciting motion patterns which may be derived from evolutionary swimming movements. "Cold" (han, algor) e.g. can be explained by shutting the capillary flow in certain areas. We could therefore postulate that these disturbing patterns may be so strong locally that the normal spatial distribution of neuronal stimuli is not possible and overlaid by he physiological reaction and reflex pattern which is called an agent. There are stages of pain origin in Chinese Medicine that we have referred to previously: a 48 block of qi flow, xue stagnation and xue stasis. Block of qi flow, as explained, naturally shows a combination of pain sensation and dysfunctional tissue behaviour. Of course, lack of stimulation or over-stimulation of a certain tissue will also affect the capillary flow. The capillary flow, as we have seen above. is largely due to the breathing movement which is called pulmonary orb, he pump of qi and xue within the body in Chinese Medicine. Activated tissue will need more oxygen and more blood flow in the capillaries, de-activated tissue will show less blood flow. This is why repletion corresponds to calor and sometimes even to ardor and depletion corresponds to cold patterns. Stagnation of xue is comparable to a slight venous congestion of the microcirculation and the clinical signs according to Chinese Medicine are livid tissues and tissues that show dark blood flow out of the point into which a needle was insertedyou have inserted a needle. The flow of blackish blood is therefore a sign of xue stagnation in the dependent tissues. Stagnation of xue, according to Chinese Medicine, can accumulate and ascend to real acute stasis. The symptom of this is acute pain of stabbing nature. Outflow of'red blood from punctured sites is an important sign of this acute stasis. We can therefore postulate that capillary flow is intended to be augmented by the body which we call reactive calor. Most probably the mechanism by which stagnation of xue turns into stasis of xue is that the stagnation of blood flow, of xue, is enhanced. So we have something like a microcapillary microthrombosis. Therefore, the reaction of the surrounding tissue is to dissolve this microthrombosis, this intravascular coagulation. Some arguments may be put up to underline this. l. Disseminated intravascular coagulation (DIC) is one of the key features in sepsis and shock. These are also believed to be reactive calor which finally leads to collapsing yang. In Western medicine DIC goes along with high mortality which is an analogue process. 2. In Chinese Medicine micro-bloodletting in acupoints is a common technique. It is believed that the most pain improves when you hit the acupoints that lets out blackish blood (venous congestion). The preceding acupoints on the conduit normally show reddish blood. When you hit the point of stagnation and the blackish blood comes out, the outflow of blood from the other points is suddenly enhanced and all colour of the outcoming blood is then coming to normal and is equal in both the formerly blackish and 49 reddish points. These congestions therefore may be stagnation of xue and may lead to acute stasis by blocking surrounding capillary flow, whether this is directly caused by coagulation or just be blowing up capillaries by congestion so surrounding capillaries are pressed. This remains a field of research. 1.2.4.8. Bi-Syndrome, the TCM diagnosis of chronic pain in the trapeziometacarpal joint A: Bi-Syndrome = Painful Obstruction Syndrome is the TCM diagnosis for :musculoskeletal disorders causing chronic pain in the the TCM joint (with no correlated radiographic or other verifiable or mesurable diagnostic findings B: Bi-Syndrome of bone is the TCM diagnosis for : rhizarthrosis or osteoarthrosis of the TCM joint ad A: Musculoskeletal Disorders : According to traditional Chinese medicine Bi-Syndrome refers to stiffness and blockage of circulation of Qi and blood in the energy leading conduits. Bi-syndrome involves pain in muscles, tendons, bones and joints as well as difficult movement or deformation of these structures. Bi-syndrome involving the musculoskeletal system is a result of invasion from wind, cold, damp and heat. Musculoskeletal Bi-Syndrome can be divided into excess patterns associated with wind= ventus, cold = algor, damp= humor and heat= calor Wind Bi = ventus-Bi Wind Bi-Syndrome is also called wandering Bi and the patient shows signs of migrating pain. There is invasion of wind-colddamp, but primarily wind from the exterior. The wind obstructs Qi and blood flow in the muscles, bones and conduits which cause pain.There is a rapid onset of clinical signs of pain in the joints. The pain gets worse when the patient is exposed to wind. The tongue is pale with a thin coating and the pulse is superficial. The treatment principle is to eliminate the wind and invigorate the channels, eliminate cold and disperse damp. 50 Cold Bi = algor-Bi Cold Bi-Syndrome is also called painful Bi and the patient shows signs of severe pain. The primary pathogen is cold and in addition, there is a combination of wind and damp. The coldness obstructs Qi and Blood flow. The joints are painful and there is restriction in their movements. The pain gets worse when the patient is exposed to cold and there is pain relief with heat exposure. The tongue is purple with a slight pale coating and the pulse is wiry and slow. The treatment principle is to eliminate the cold and warm the channels and also clear the wind-damp. Damp Bi = humor-Bi Damp Bi-Syndrome is also called fixed Bi and the patient shows signs of marked joint stiffness. The primary pathogen is damp and in addition there is a combination of wind and cold. The damp obstructs the flow of Qi and blood. There is more stiffness than pain. The pain gets worse when the patient is exposed to cold and damp conditions and there is pain relief with heat and dryness. The tongue is pale with a greasy coating and the pulse is soft and slow. The treatment principle is to eliminate the Damp and the WindCold. Heat Bi = calor-Bi Heat Bi-Syndrome is also called febrile Bi and the patient shows signs of acute onset of local inflammation. The primary pathogen is heat. The wind-cold-damp causes stagnation which turns into heat. The patient has acute inflammation of the muscles or joints and this shows clinically as pain, redness, swelling and heat. The patient may have a fever. The tongue is red with a yellow coating and the pulse is strong and fast. The treatment principle is to clear the heat and eliminate the wind-damp. Bi yndrome of Bone is a deficiency pattern which includes kidney Qi, Yin and Yang. Bony Bi is the most advanced condition and the affected joints have chronic osteoarthritis. ad B: Rhizarthrosis or Osteoarthritis of the TCM joint The term ‘osteoarthritis’ did not exist in ancient Chinese medical texts, although there were descriptions of diseases that were very similar in terms of clinical characteristics. In 51 general, OA is usually categorised as ‘Bi-Syndrome’ (painful obstruction syndrome), and more specifically, ‘Bi-Syndrome of bone’. In modern texts, the term ‘Bi-Syndrome’ describes conditions of pain, soreness or numbness of muscles, tendons and joints as a result of invasion of external pathogenic wind, cold and/or dampness (290, 292). However, the term ‘bi’ is an ancient concept with broad meaning. In the Huang Di Nei Jing Su Wen (Yellow Emperor’s Inner Classic Plain Questions), one of the key ancient texts of Chinese medicine that is likely to have been compiled during the Han Dynasty, the word ‘bi’ translates as ‘blockage’ (293). Unschuld (2003) explains how within the Su Wen there is evidence of several changes in conceptualisation of the concept of ‘bi’, from a more basic reference to mechanical blockage of the urethra, to its conceptualisation as a disease caused by excessive wind, cold and/or dampness. In modern CM, ‘bi’ is now used to describe a disease, a set of signs and symptoms, or a term in pathology (293). With respect to Bi as a disease name, this is further specified in terms of the predominant pathogenic factor/qi involved, for example ‘wind block’, or the location of pathology, for example ‘bone block’ or ‘liver block’. Since pathological changes associated with Bi-Syndrome usually occur in joints and muscles, pain associated with OA typically occurs with joint usage and/or stiffness (294, 295). Other symptoms and signs of Bi-Syndrome include joint disability and/or oedema and numbness (296). In mild cases, there may be pain in the limbs and joints that becomes more pronounced with changes in the weather and, in severe cases, more pronounced soreness and pain, deformities and decreased range of movement (297). However, some patients with radiologic evidence of OA have no symptoms (298). Lack of pain in some OA sufferers is not inconsistent with descriptions of ‘bi’ in the Su Wen of blocks affecting the bones, sinews, vessels, flesh and skin that do not cause pain (293). In the two official clinical guidelines from the People's Republic of China, OA and degenerative arthrosis are both classified as ‘Bi-Syndrome of bone’ (299, 300). Aetiology, pathogenesis and treatment of OA. OA has generally been considered to be a type of BiSyndrome caused by depletion of the kidney and liver yang, which invites invasion of exogenous pathogenic factors. Such invasion obstructs the conduits, leading to impaired qi and blood circulation and, consequently, pain. In the majority of cases, the external causes of Bi-Syndrome are a combination of three pathogens: wind =ventus, cold=algor and dampness=humor (296). 52 Impairment of the transformation of body fluids over long periods (due to spleen depletion) leads to stagnation of non-substantial phlegm =pituita. Blood (xue) and phlegm = pituita stagnation become secondary pathogenic factors that accumulate in the joints and further exacerbate the problem (301), with phlegm =pituita condensing to form bone growths (290). The kidney has traditionally been considered the primary organ involved in the development of Bi-Syndrome, with the liver secondary (302). There are logical reasons for this within CM theory. The kidney is said to dominate bones. The kidney essence (jing) (a vital substance responsible for the formation of bone, growth and development) declines with age, which causes the qi of the organs to become depleted, the bones to become frail, tendons to stiffen and consequently movement to become impaired (292). Osteophytes - outgrowths of bone - are often associated with OA. The liver is said to store blood and control the sinews (tendons, cartilages and ligaments) through its nourishing and moistening functions. kidney yin is the foundation of liver yin and blood. The spleen is also involved by virtue of its actions of controlling the muscles and limbs, and transforming and transporting fluids and qi. Spleen depletion can lead to deficiency of qi and blood (since the spleen produces qi), further reinforcing deficiency of kidney jing and liver blood. In addition, the spleen is easily affected by external dampness (292). 1.2.4.8.1. TCM treatment concept for osteoarthrosis The treatment strategy for OA logically follows the diagnosis and understanding of its pathogenesis. General treatment principles give consideration to the ‘ben’ or root cause of a condition and the ‘biao’ or branch (which relates more to the symptoms and signs). Bi-Syndrome is considered to be a condition where the root is deficient (deficient kidney jing and liver blood), allowing invasion of pathogenic factors and contributing to the pathogenic development of blood and phlegm stagnation. The branch, on the other hand, is often excessive (referring to qi/blood/phlegm stagnation and invasion of external pathogenic factors that cause painful obstruction) . As a consequence of this understanding of the pathogenesis of the condition, the treatment strategy of CM has traditionally been to tonify the kidney and liver, nourish qi and blood, expel wind-cold, remove dampness, promote blood circulation and remove 53 obstruction from the conduits and collaterals. The majority of Chines Herbal Medicine formulas used to treat OA follow this basic pattern identification, and emphasise tonifying the kidney and liver, promoting blood circulation, expelling wind and resolving dampness (303). Acupuncture has been widely used for treatment of OA of the knee and chronic knee pain (304; 305), and, at least in China, commonly in conjunction with other techniques including electronic stimulation (electro-acupuncture) (306; 307; 308; 309), moxibustion, electrical heat lamps and other special electromagnetic therapeutic apparatus (310; 311; 312), acupoint injection, cupping, physical exercise and herbal medicine (oral, external and/or ionotherapy methods) (313; 314; 307; 308; 309). The technique of ‘warm needling’ is the most popular treatment modality for OA (315; 316; 317; 318), in keeping with the idea that OA is due to kidney deficiency and invasion of cold and damp (319). Laser therapy is also used for OA treatment in China (320). Arguments about the classification of OA and emerging theoriesThe main reason for classifying OA as Bi-Syndrome centres on the key symptom of pain. It is not difficult to understand the reasoning behind the primacy of the kidney in the pathogenesis of OA, given the previously outlined theoretical rationale. However, some researchers have argued that OA should be categorised as a disease of the sinews rather than ‘Bi-Syndrome of bone’ (301). The arguments for this include the fact that pathogenic changes of OA occur in articular cartilage and the tissue around joints - which are classified as ‘sinews’ in TCM and considered to be an extension of the liver. Inability to bend or straighten a joint properly, or overcompensation in order to do so is a sign of tendon degeneration (292). Consideration of the function of liver blood suggests a potential pathomechanism: if liver blood is deficient the sinews will lack moistening and nourishment, which may cause contraction, spasm, impaired flexion, numbness of the limbs, tingling and muscle cramps. In addition, if there is stasis of liver blood, the sinews will lack suppleness and the person may experience stiffness, rigidity and pain of the joints (291).A relatively recent emergent theory is that OA should be considered a combination of wei syndrome and Bi-Syndrome, with wei syndrome considered the fundamental disorder and Bi-Syndrome secondary. Thus greater emphasis is placed on the role of the liver in the pathogenesis of OA, rather than the kidney. A key proponent of this theory is Professor Shi Yinyu of Shanghai 54 Shuguang Hospital. Wei syndrome is defined as progressive weakening or degeneration of the limbs caused by a deficiency of qi, blood, body fluids and/or jing. It manifests as flaccidity of the sinews or muscles and, in severe cases, loss of voluntary movement of the limbs (322). The following quote from Chapter 44 of the Su Wen clearly links the notion of blockage (described in other parts of the Su Wen in relation to Bi-Syndrome) and muscle flaccidity, a key symptom of wei syndrome: Signs and symptoms of OA in the initial stage are indicative of ‘painful obstruction’ (BiSyndrome), although the clinical manifestation of advanced OA is atrophy of the muscles of the limbs (from lack of use) - a major feature of wei syndrome - along with muscle weakness. Other symptoms such as numbness may be shared by both Bi-Syndrome and wei syndrome. According to TCM theory, by fifty-six years the liver energy weakens causing the tendons to stiffen (292). Chapter one of the Su Wen states that the kidney qi begins to decline over the age of 40 years (292). Indeed, the kidney jing and liver blood are understood to have a common source. Therefore the decline in function of the liver and kidney with increasing age, as described in TCM theory, is in keeping with the epidemiology of OA: that approximately 40 per cent of adults over 70 years old are affected by OA of knee, 80 per cent of whom have limitations of movement and 25 per cent of whom cannot perform the major daily activities of living (323). For these reasons, it has been argued by some that OA should be considered a combination of Bi-Syndrome and wei syndrome (324; 322). This has important consequences in terms of treatment, The treatment principles that follow this reasoning emphasise soothing and nourishing the liver (in particular the liver blood), soothing the sinews and eliminating exogenous pathogenic factors (321). Other authors such as Guo et al. (2002) support the notion that in a chronic disease such as OA, comprehensive treatment strategies are required, and suggest that treatment strategies should encompass tonifying the kidney, soothing the liver, invigorating the spleen and removing blood and phlegm stasis. 55 1.2.4.8.2. The scientific evidence base of Chinese medicine in OA treatment In comparison with rheumatoid arthritis, OA has historically not been a priority area for research (325). Studies have found that Chinese Acupuncture is cost-effective and can reduce the burden of OA (326), which was estimated as costing Australia AUD$ 1090 million in 2001 (327). To understand the scientific evidence base for the treatment of OA with TCM a literature search of clinical studies was made that investigated the efficacy of acupuncture and Chinese Herbal Medicine in treating OA of the knee, a common location for OA. Literature search revealed 33 clinical trials that have investigated the efficacy of acupuncture in the treatment of OA of the knee (328). Twenty-seven of the studies were conducted in China, all of which found that acupuncture was effective. One meta-analysis concluded that the clinical improvements due to acupuncture may be due to placebo or expectation effects (329). Another systematic review found acupuncture superior to sham (placebo) acupuncture for treating chronic knee pain in both the short and longer term (295). Systematic reviews of acupuncture studies in OA indicate that there were no associated adverse events (329; 295) and that acupuncture is a relatively cost-effective therapy for OA patients (330). 1.2.4.8.3. Conclusion How OA is understood and treated in CM is vastly different to Western medicine, which is unsurprising given the very different paradigms of these two systems of medicine. OA is usually categorised as Bi-Syndrome, 1.2.5. Generalities of acupuncture research 1.2.5.1. General proposed mechanisms of action of acupuncture Multiple physiologic models have been proposed to explain the effects of acupuncture. Various models have implicated cytokines, hormones (e.g., cortisol and oxitocin), biomechanical effects, electromagnetic effects, the immune system, and the autonomic and somatic nervous systems. For many proposed models, the data have been either too inconsistent or inadequate to draw significant conclusions. 56 back pain, “an exercise programme, a course of manual therapy, or a course of acupuncture” should be recommended at the early stage.[283] In addition, trials on neck pain, headache, and osteoarthritis in the knee have all shown that acupuncture not only reduces pain but also improves patients’ physical function in the long term. 63 64 65 CHAPTER TWO Clinical Research Protocol 66 2. Clinical Research Protocol The Influence of Acupuncture on Pain Intensity and Grip Strength in Symptomatic Rhizarthrosis – a prospective, non-blinded, randomized clinical study with waiting list control 2.1. Academic and medical background This clinical research project was developed as part of the Master Programme in Traditional Chinese Medicine (TCM) of the Abel Salazar Institute of Biomedical Sciences – University of Porto (ICBAS-UP), 2012-2014th edition. The research will be performed in order to obtain the Masters degree in TCM by the student Christiane Grünecker, main researcher of the current project. Rhizarthrosis remains a difficult pathology for the treatment through Western medicine therapeutical strategies. As a governement licensed German naturopath and student of TCM, the main interest of the author is to evaluate the possible benefit of integrating acupuncture into the conventional treatment of Rhizarthrosis. 2.2. Background The trapeziometacarpal joint (TMC) is a specialized saddle-shaped joint, that allows the thumb to have a wide range of motions, including up, down, across the palm, and the ability to pinch. The thumb accounts for up to 40% of hand function and the functional importance of this joint explains that any pathological process that changes it could lead to chronic social and occupational disability and have significant repercussions on everyday activities. 2.2.1. Study-Focus Rhizarthrosis To the present date, we have found no reliable published studies on acupuncture for Rhizarthrosis. Given the biological plausibility of acupuncture’s effects and its clinical good outcomes already shown for other pathologies, it may be possible that acupuncture has beneficial effects on this pathology. However, this hypothesis has yet to be 67 scientifically corroborated. Rhizarthrosis appears in postmenopausal women after the age of 50 in more than 30% of women. It is ten times more frequent in women than in men. The etiology is multifactorial and the exact mechanism is unknown. Frequent symptoms are: pain at the base of the thumb, difficulty with tasks (such as opening jars, turning a key), stiffness of the thumb, hyperextension of the middle thumb joint, pain at rest and pain during the night. Eaton and Glickel described the radiographic severity of basilar joint arthritis, and these stages are often used to dictate treatment. Restoration of thumb function with a pain-free, stable, and mobile joint with preserved strength are the main goals of treatment of painful arthritis of the thumb. Conservative measures to address symptoms include oral anti-inflammatory medications, activity modification and splinting, and intraarticular corticosteroid injections. Surgical treatment of rhizarthrosis is indicated in progression of the symptoms and increase of functional restriction despite conservative treatment Surgical interventions include beak ligament reconstruction, arthroscopic synovectomy, arthroplasty, and finally arthrodesis of the affected articulations. Although short-term results from synovectomy and arthroplasty seem promising, long-term data are not yet available. Several surgical measures are available to us and require differentiated establishment of the indication. Trapezectomy with and without tendon interposition enables an improvement of symptoms. However, the increasing shortening of the thumb and the weakness and limitation to movement associated with this is to be regarded as disadvantageous. Arthrodesis of the metacarpophalangeal and interphalangeal joints yields a stable yet functional thumb with reliably good pain relief. 2.3. Justification of the study Despite the conventional medical and surgical treatments, in many cases of rhizarthrosis, neither conservative treatment nor standard surgical techniques can successfully solve all the symptoms. Overall, the results of conventional treatments are many times unsatisfactory to patients that remain with pain and limitations in their daily life activities. 68 Acupuncture has effects on pain relief for different musculoskeletal diseases (e.g. back pain; osteoarthritis of the knee) and its analgesic mechanisms are well studied. The present state of the scientific evidence of acupuncture is such that is has in fact been approved as a “medical competence” by the Portuguese Medical Association since 2002. 2.4. Research team 2.4.1. Main investigators Christiane Gruenecker Government Licenced Naturopath (Germany). Student of the Master in Traditional Chinese Medicine – ICBAS, UP. Nuno Correia Specialist in Internal Medicine – Serviço de Urgência, Hospital São João, Centro Hospitalar São João, Porto. Master in Traditional Chinese Medicine at Abel Salazar Institute for Biomedical Sciences Invited Assistent Professor of General Pathology – Escola Superior de Enfermagem, Universidade do Porto. 2.4.2. Research supervisors Main supervisor: Prof. Doutor Henry Johannes Greten. Director of the TCM Master Programme – ICBAS, UP. Head of the Heidelberg School of Traditional Chinese Medicine; President of the German Society of Traditional Chinese Medicine (DGTCM), Heidelberg, Germany. Co-supervisor: Prof. Doutor Jorge Machado – Director of Physiology Laboratory and Codirector of TCM Master Programme, ICBAS-UP. 2.5. Study hypothesis Will acupuncture improve grip strength in patients with chronic pain in the trapeziometacarpal joint including patients with symptomatic rhizarthrosis ? 69 2.6. Methods 2.6.1. Study population This study focuses on patients between 40 and 90 years-old with symptomatic Rhizarthrosis Eaton Stage <3. 2.6.2. Study design Prospective, randomized, non-blinded clinical study with waiting list control . 2.6.3. Randomization to intervention groups The selected 38 patients will be randomly assigned to the experimental (intervention) group or control (waiting list) group by the method of the coin flip. 2.6.4. Outcomes and measurements 2.6.4.1. Main outcomes Pain intensity: as evaluated by Visual Analogue Scale (0-10) Grip strength: as measured by a Martin Vigorimeter Fig. 12 The Martin Vigorimeter 70 2.6.4.2. Secondary Outcomes Daily activities and pain will be assessed with the “Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH score). 2.6.5. Eligibility criteria Inclusion criteria: diagnosis of Rhizartrosis of Eaton Stage <3, age over 18 years, no surgery ,no steroid injection, no change of medication during the study; informed consent. Exclusion criteria: Under anticoagulant treatment; under medication with glucocorticoids or immune suppressives, chronic polyarthritis, rheumatoid arthritis and other rheumatologic diseases, intra-articular injection of steroids in the 3 months before study. Rhizarthrosis = Eaton Stage < 3 2.6.6. Sampling and recruitment procedures A convenience sample will be selected based on the review of clinical files of patients with Rhizarthrosis Eaton Stage <3 and listed according to eligibility criteria. The main researchers will contact the potential participants, explaining the study, asking questions regarding eligibility requirements and inviting them to participate. On the first day, subjects will sign the written informed consent. 2.6.7. Experimental procedures Intervention group is submitted to 4 sessions of manual acupuncture during 2 weeks. Pain intensity, Grip strenght will be measured before and after each session of acupuncture. DASH is evaluated before and after the two intervention weeks. Follow-up : 12 patients of the interventiongroup are submitted to a third measurement of VAS and Grip two weeks after end of treatment, in order to evaluate the washout effect of the suppletive needling technique. Control group: continues with usual care without any medical intervention while being in the waiting list control group for two weeks. Pain evaluation (VAS) DASH and the grip strength measuring will be assessed in the beginning and at the end of the two weeks. 71 Acupuncture points and technique : The selection of acupuncture points is based on potential local and segmental effects: Lung= Pulmo = P P9 = vorago major P 10 = linea piscis P 5extra (heidelberg Model) IntestinumCrassum = IC IC 10 = vicus tertius manus IC 4 = valles conjuntae Extrapoint on the hand EX 14 octo heteropathias thumbsides Suppletive manual acupuncture will be performed with rotation of the needles until a sensation of “DeQi” is attained. Sample: n= 38 adults Interventiongroup: n=38 (33 female), 46-75 y.o, submitted to acupuncture, 4 sessions in 2 weeks. Waitinglist controlgroup: n = 15 (13 female), 46-75 y. were assessed before and after two weeks while standing by Followup group: n=12 (10 female) 46 -75 y, randomizly recruited from Interventiongroup. In order to get an idea of the possible further evolution of symptoms, and thereby evaluate the needed wash-out period for future cross-over studies, comparing suppletive acupuncture to bloodletting acupuncture (Leopard spot technique of the HeidelbergModel of TCM) one more series of measurements of the parameters VAS and Grip Strength were taken two weeks after completion of treatments . 72 Fig. 15 Study results – Intervention group - improvement 79 Fig. 16: Study results – Waiting list group - improvement Fig. 17 Study results – Intervention group – evolution Fig. 18 Study results – Waiting list group - evolution 80 81 Fig. 19 Study results – Follow-up group – improvement baseline vs 4 weeks Fig. 20 Study results – Follow-up group – improvement 2 weeks vs 4 weeks 3.1 Conclusion We found no reliable published studies on acupuncture for Rhizarthrosis (Ostoearthrosis of the Trapeziometacarpal joint) Given the biological plausibility of acupuncture's effects and its clinical good outcomes already shown for other pathologies, it may be possible that acupuncture also has benificial effects on Rhizarthrosis. The study suggests: A: The technique of suppletive needling seems to have a longer period of effect than expected. In order to avoid a carry-over effect in a future possible clinical study with cross-over design, we suggest further studies with exact mesurement of the wash-out phase after suppletive needling. A interesting follow-up study might be the compairing use of classical suppletive needling to the Leopard spot technique to relieve reactive calor in Rhizarthroses as proposed by The Heidelberg Model of TCM 82 Fig. 21 Study results – improvements between groups – baseline vs 2 weeks B: The results from the proposed prospective clinical study suggest that the effects of the chosen acupuncture points may be associated with a therapeutic benefit in the pathology of Rhizarthrosis However, controversy persists whether the observed effects are specific to acupuncture or merely nonspecific consequences of needling. 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If you did not have the opportunity to perform an activity in the past week, please make your best estimate on which response would be the most accurate. It doesn’t matter which hand or arm you use to perform the activity; please answer based on your ability regardless of how you perform the task. THE 114 113 117 112 111 Please rate your ability to do the following activities in the last week by circling the number below the appropriate response. NO MILD MODERATE SEVERE UNABLE DIFFICULTY DIFFICULTY DIFFICULTY DIFFICULTY 1. Open a tight or new jar. 12345 2. Write. 12345 3. Turn a key. 12345 4. Prepare a meal. 12345 5. Push open a heavy door. 1 2 345 6. Place an object on a shelf above your head. 12345 7. Do heavy household chores (e.g., wash walls, wash floors). 12345 8. Garden or do yard work. 12345 9. Make a bed. 1 2 3 45 10. Carryashopping bag or briefcase. 1 2 3 4 5 11. Carry a heavy object (over 10 lbs). 12345 12. Change a lightbulb overhead. 12345 13. Wash or blow dry your hair. 12345 14. Wash your back. 12345 15. Put on a pullover sweater. 12345 16. Use a knife to cut food. 12345 17. Recreational activities which requirelittle effort (e.g., cardplaying, knitting, etc.). 12345 18. Recreational activities in which you take some force or impact through your arm, shoulder or hand (e.g., golf, hammering, tennis, etc.). 12345 19. Recreational activities in which you move your arm freely (e.g., playing frisbee, badminton, etc.). 12345 20. Manage transportation needs (getting from one place to another). 123 45 21. Sexual activities. 12345 DISABILITIES OF THE ARM, SHOULDER AND HAND 114 118 113 112 NOT AT ALL SLIGHTLY MODERATELY QUITE EXTREMELY ABIT 22. During the past week, to what extent has your arm, shoulder or hand problem interfered with your normal social activities with family, friends, neighbours or groups? (circle number) 12345 NOT LIMITED SLIGHTLY MODERATELY VERY UNABLE AT ALL LIMITED LIMITED LIMITED 23. During the past week, were you limited in your work or other regular daily activities as a result of your arm, shoulder or hand problem? (circle number) 12345 Please rate the severity of the following symptoms in the last week. (circle number) NONE MILD MODERATE SEVERE EXTREME 24. Arm, shoulder or hand pain. 12345 25. Arm, shoulder or hand pain when you performed any specific activity. 12345 26. Tingling (pins and needles) in your arm, shoulder or hand. 12345 27. Weakness in your arm, shoulder or hand. 1 2 345 28. Stiffness in your arm, shoulder or hand. 1 2 3 4 5 NO MILD MODERATE SEVERE SO MUCH DIFFICULTY DIFFICULTY DIFFICULTY DIFFICULTY DIFFICULTY THAT I CAN’T SLEEP 29. During the past week, how much difficulty have you had sleeping because of the pain in your arm, shoulder or hand? (circle number) 12345 STRONGLY NEITHER AGREE STRONGLY DISAGREE DISAGREE NOR DISAGREE AGREE AGREE 30. Ifeel less capable, less confident or less useful because of my arm, shoulder or hand problem. (circle number) 12345 DISABILITIES OF THE ARM, SHOULDER AND HAND ADASH scoremay not be calculated if therearegreater than 3 missing items. DASH DISABILITY/SYMPTOM SCORE =[(sum of n responses) - 1] x 25, where n is equal to the number of completed responses. n 115 119 114 113