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The inflammation continuum from acute to chronic Optimizing patient outcomes by a multi-targeted approach Satellite Symposium at the Annual Meeting of EULAR, 2013 Thursday 13th June 2013, 17:30 – 19:00 N107 & N108, North Convention Centre, 1st floor, Feria de Madrid, Spain Sponsored by Biologische Heilmittel Heel GmbH 2 Agenda Symposium Co-chairs Bernd Wolfarth MD, Germany & Carlos González de Vega MD, Spain 17:30 Welcome & introduction Bernd Wolfarth MD, Germany & Carlos González de Vega MD, Spain 17:35 New insights in the pathophysiology of inflammation in musculoskeletal disorders Alex Scott PhD, Canada 17:50 Management of acute exacerbation of chronic injuries Cathy Speed MD, UK 18:05 The range of musculoskeletal disorders and the place for a multi-target medication Bernd Wolfarth MD, Germany 18:25 Ongoing and future research Luc Vanden Bossche MD, PhD, Belgium 18:45 Q & A 18:55 Summary and close Bernd Wolfarth MD, Germany 3 Your co-chairs Bernd Wolfarth is Assistant Professor at the Department for Preventive and Rehabilitative Sports Medicine at the University Hospital, Technical University Munich, Germany. His scientific interest lies in genetics, performance and trainability. In applied sports medicine, Dr Wolfarth currently serves as the Head Physician of the German Olympic Team (Summer and Winter) and, since 2011, as chairman for the medical advisory board of the German Olympic Sports Association. 4 Carlos González de Vega is a Professor at the Medical School of the Autonoma University of Madrid, and Medical Director and Chief Executive Officer of the MEDYR Clinic for Sports Medicine and Rehabilitation, Madrid, Spain. Hi is currently researching electrotherapy techniques and rehabilitation protocols. Dr González de Vega incorporates his rehabilitation experience from sports medicine to treat soft tissue injuries in a wide range of patient groups. Welcome On behalf of the faculty, we have pleasure inviting you to our symposium, focusing on inflammation and optimizing patient outcomes by using a multi-targeted approach. You will be able to hear about the role of multitarget medications in disease processes and how you can integrate new inflammation treatment strategies into your practice. The emerging role of inflammation, in conditions previously considered noninflammatory, will be explored and we will review methods to stratify patients according to their level of inflammation or stage of tissue reaction. We will also address and discuss the proactive management of chronic injuries, highlighting options for acute exacerbations, and their limitations. Finally, there will be an update on a current ongoing study, Traumeel in rotator cuff syndrome (TRARO), and its likely impact on everyday clinical practice. Bernd Wolfarth MD Carlos González de Vega MD Symposium Co-chair Preventive and Rehabilitative Sports Medicine, Technical University Munich, Germany Symposium Co-chair Rehabilitation and Sports Medicine, MEDYR Clinic and University of Madrid, Spain 5 New insights in the pathophysiology of inflammation in musculoskeletal disorders Alex Scott PhD, Canada 6 Alex Scott PhD, Canada Faculty of Medicine, Department of Physical Therapy, University of British Columbia, Canada Alexander Scott is the Assistant Professor at the Department of Physical Therapy, University of British Columbia, Vancouver, Canada. He is also the Principal Investigator in the Cartilage Tendon Muscle Unit at the Centre for Hip Health and Mobility, Vancouver Coastal Health and Research Institute, which is affiliated to the University of British Columbia. Dr Scott is qualified in Physical Therapy and in Human Kinetics, and gained a PhD in Experimental Medicine in 2008, from the University of British Columbia. His PhD focused on the mechanisms of tendinopathy. His research goal is to understand the influences of physiologic movement and inflammatory signals on tenocyte biology, and to incorporate this knowledge into new clinical strategies for tendinopathy. Dr Scott is currently investigating the role of tenocytes as an initiating factor in tendinopathies. 7 New insights in the pathophysiology of inflammation in musculoskeletal disorders Alex Scott PhD, Canada Historically, inflammation was defined by the cardinal signs of inflammation: heat, redness, swelling, pain and loss of function. However, as our understanding has increased, the mechanisms underlying inflammation have become clearer. Clinical reasoning is now enhanced by understanding of the interdependence of molecular, cellular, physiological and clinical levels of inflammatory reaction.1 In clinical practice, many chronic musculoskeletal pathologies are often considered mechanical or degenerative, rather than inflammatory. However, key aspects of the inflammatory response are activated in osteoarthritis, back pain and tendinopathies; conditions not generally regarded as inflammatory. Tendinopathy, in particular, has experienced shifting opinion on the contribution of inflammation. Before 1990, the term tendinitis was commonly used implying a large role 8 for inflammation in the pathological process. Opinion shifted over the last decade of the 20th century, until, in the 2000s tendinopathy was as attributed to an underlying state of degeneration without inflammation (tendinosis). However, evidence for the role of inflammation has continued to accumulate. Tendinopathy has several inflammatory features, including pain, swelling, crepitus and decreased function. There is also physiological evidence of increased blood flow, as well as evidence of cellular and molecular changes reflective of inflammatory processes.2 In the shoulder, the levels of an inflammatory mediator (substance P) correlate with pain.3 Color Doppler images have been used to quantify the level of inflammatory activity in tendinopathy.4 This imaging modality could provide a means to stratify patients’ levels of inflammatory activity, allowing inflammation to be quantified in deeper tissues that are not as easily assessed using the ‘cardinal signs’. 1. Scott A, Khan K, Cook J, Duroniol V. What is “inflammation”? Are we ready to move beyond Celsus? Br J Sports Med 2004;38:248–9. 2. Rees JD, Stride M, Scott A. Tendons – time to revisit inflammation. Br J Sports Med 2013 doi 10.1136/bjsports-2012-091957. Mechanical loading Necrosis Hypoxia Vibration Molecular Regulation of signalling molecules and enzymes Vascular trauma Modulation of cellular response Cellular Endothelium Gap junction remodelling Proliferation Migration Neovessel formation Neutrophils Diapedesis Migration Phagocytosis Smooth muscle Relaxation Proliferation Migration Neovessel maturation Fibroblasts Diapedesis Migration Proliferation Platelets Degranulation Aggregation Coagulation Lymphocytes Diapedesis Migration Proliferation Mast cells Degranulation Migration Neurones Sensitisation Depolarisation Axon sprouting Exocytosis Macrophages Diapedesis Migration Phagocytosis Coagulation Physiological Coagulation Local metabolism Axon potentials Vasodilation Increased and altered ECM Angiogenesis Vessel permeabilisation Muscle spasm Clinical Heat, Swelling, Redness, Pain ECM, extracellular matrix Scott A, Khan KM, Roberts CR, Cook JL, Duronio V. What do we mean by the term “inflammation”? A contemporary basic science update for sports medicine. Br J Sports Med. 2004 Jun;38(3):372–80. Review 3. Gotoh M, Hamada K, Yamakawa H, Inoue A, Fukuda H. Increased substance P in subacromial bursa and shoulder pain in rotator cuff diseases. J Orthop Res. 1998 Sep;16(5):618–2. 4. Krogh TP, Fredberg U, Stengaard-Pedersen K et al. Treatment of lateral epicondylitis with platelet-rich plasma, glucocorticoid, or saline: a randomized, double-blind, placebo-controlled trial. Am J Sports Med. 2013 Mar;41(3):625–35. doi: 10.1177/0363546512472975. Epub 2013 Jan 17. 9 Management of acute exacerbation of chronic injuries Cathy Speed MD, UK 10 Cathy Speed MD, UK Rheumatology and Sports Medicine, Cambridge University Hospital, Cambridge, UK Cathy Speed is a Consultant in Rheumatology, Sport & Exercise Medicine at the Cambridge Centre for Health and Performance, Cambridge, UK. She is Visiting Professor of Sports Medicine at University College, Suffolk and a Senior Physician at the English Institute of Sport. She has a special expertise in the management of sporting and non-sporting musculoskeletal injuries, chronic pain syndromes and in exercise medicine. 11 Management of acute exacerbation of chronic injuries Cathy Speed MD, UK There are many forms of interventions for soft tissue injuries. This section of the Symposium provides an overview of these interventions and integrated strategies for best practice in the management of acute exacerbations of chronic complaints. Differentiating between an acute exacerbation of a chronic injury and a de novo injury can be challenging and requires a detailed patient history as well as thorough physical examination. It is important to establish what triggered the current acute event, and relate this to the previous injury. In the event of an acute exacerbation of a chronic injury, as well as treating the immediate acute condition, it is important to consider the management of the underlying chronic condition. Should more intensive rehabilitation be instituted? Should preventive medication be used long term? Is the injury a result of noncompliance with rehabilitation or medication? An acute exacerbation can be used as an opportunity to emphasise the importance of following the prescribed regimen to prevent further injury. 1. Holmgren T, Bjornsson Hallgren H, Oberg B et al. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ 2012;344:e787. 12 2. Umer M, Qadir I, Azam M. Subacromial impingement syndrome. Orthopedic Reviews 2012;4:e18. 3. Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract 2005;55:224–8. Rotator cuff syndrome (RCS), or subacromial impingement syndrome, is a common cause of shoulder pain. Several structures, such as the subacromial bursa, the tendons of the rotator cuff, the acromion, the coraco-acromial ligament, and the caput longum tendon of the biceps brachii muscle, are involved in the pathogenesis.1 Conservative treatment is the first choice, often with corticosteroid injection or different physiotherapy interventions, or both. When conservative treatment fails, surgery is often performed accounting for about 30% of patients.1 There is only a limited evidence base for RCS treatments, however, there is strong evidence that shock wave therapy, moderate evidence that ultrasound therapy and limited evidence that laser are no more effective than placebo.2 There is evidence for the efficacy of subacromial injections of corticosteroid.3 Although accuracy of placing the injection, and the possibility of the corticosteroid causing tendon rupture have been raised as issues.4 There is also evidence that a specific exercise strategy for the scapula stabilisers can reduce pain and improve shoulder function in patients with persistent RCS, and this may reduce the need for surgery.5 However, there is still a need for alternative treatment options. 4. Bhatia M, Singh B, Nicolaou N et al. Correlation between rotator cuff tears and repeated subacromial steroid injections: a case-controlled study. Ann R Coll Surg Engl 2009;91:414–6. 5. Marder RA, Kim SH, Labson JD. Injection of the subacromial bursa in patients with rotator cuff syndrome: a prospective, randomized study comparing the effectiveness of different routes. J Bone Joint Surg Am 2012;94:1442–7. 13 The range of musculoskeletal disorders and the place for a multi-target medication Bernd Wolfarth MD, Germany 14 Bernd Wolfarth MD, Germany Preventive and Rehabilitative Sports Medicine, Technical University Munich, Germany Bernd Wolfarth is Assistant Professor at the Department for Preventive and Rehabilitative Sports Medicine at the University Hospital, Technical University Munich, Germany. Besides his clinical work, Dr Wolfarth teaches medical and sports science students in preventive and rehabilitative sports medicine. His scientific interest lies in genetics, performance and trainability. He has published more than 50 international original and review articles in the field of molecular genetics and sports medicine. In applied sports medicine, Dr Wolfarth currently serves as the Head Physician of the German Olympic Team (Summer and Winter) and, since 2011, as chairman for the medical advisory board of the German Olympic Sports Association. In addition, he is head physician of the German Ski Association and physician to the German biathlon and cross-country teams. 15 The range of musculoskeletal disorders and the place for a multi-target medication Bernd Wolfarth MD, Germany Despite the best efforts of clinicians, many individual patients will not respond to conventional treatment for their condition. Current strategies in cases of treatment failure will be reviewed for conditions in several musculoskeletal disorders. Strategies may include the use of novel treatments, electrotherapy, or enhanced rehabilitation strategies. The evidence base for these approaches will be reviewed. Some medications, commonly used in patients with musculoskeletal disorders, e.g. NSAIDs, can mask pain.1,2 This masking of pain has the potential to increase the risk of exacerbating existing injury. The ideal would be an agent that accelerates healing, reduces overall pain levels, but still allows patients to experience pain when they are generating further damage. Avoidance of pain masking has the potential to facilitate rehabilitation by allowing patients to work to maximum tolerance thresholds, without increasing the risk of further injury. There are also safety issues regarding the long-term use of NSAIDs.3 The potential role of multi-target therapies in managing inflammation, including the versatility of the multi-target medication Traumeel, will be discussed. These preparations are working differently to conventional anti-inflammatory drugs. They are containing several active ingredients that act synergistically to accelerate the healing process.4 For example Traumeel has an established evidence base proving efficacy and safety in a variety of musculoskeletal conditions.5 1. Orchard J, Best T. The management of muscle strain injuries: an early return versus the risk of recurrence. Clin J Sport Med 2002;12:3–5. 2. Orchard JW et al. The early management of muscle strains in the elite athlete: best practice in a world with a limited evidence basis. Br J Sports Med 2008;42:158–9. 3. Sullivan WJ, Panagos A, Foye PM et al. Industrial medicine and acute musculoskeletal rehabilitation. 2. Medications for the treatment of acute musculoskeletal pain. Arch Phys Med Rehabil 2007;88(Suppl 1):S10–S13. 16 4. Cesnulevicius K. The bioregulatory approach to work-related musculoskeletal disorders: Using the multicomponent ultra low-dose medication Traumeel to target the multiple pathophysiological processes of the disease. Altern Ther Health Med 2011;17(2 Suppl):S8–S17. 5. Wolfarth B, Gonzalez de Vega C. Make an impact on your daily practice: the potential role for a natural multi-target medication. Curr Med Res Opin 2013;29(suppl 2):15–9. Treatment Algorithm for Musculoskeletal Disorders (Traumeel) Specific Musculoskeletal Diagnosis Traumeel can be used from acute to chronic conditions Traumeel can be used as monotherapy, or in combination with other treatments Acute exacerbation of chronic condition Acute Treatment includes: ■ RICE, physiotherapy, and other nondrug therapies ■ Traumeel ■ Other natural anti-inflammatory agents ■ NSAIDs, analgesics, local injections such as corticosteroids and/or local anesthetic Chronic Treatment includes: ■ Rehabilitation and manual therapies ■ Traumeel ■ Supplements ■ NSAIDs, analgesics, local injections such as corticosteroids and/or local anesthetic, viscosupplements How to treat specific indications with Traumeel Developed by: Luc Vanden Bossche, Belgium; Andrey Garkavi, Russia; Charles Kahn, USA; Cathy Speed, UK; Carlos González de Vega, Spain; Bernd Wolfarth, Germany. RICE; rest, ice, compression, elevation. NSAIDs; non-steroidal anti-inflammatory drugs. Specific Musculoskeletal Diagnosis Developed by: Luc Vanden Bossche, Belgium; Andrey Garkavi, Russia; Charles Kahn, USA; Cathy Speed, UK; Carlos González de Vega, Spain; Bernd Wolfarth, Germany. RICE; rest, ice, compression, elevation. NSAIDs; non-steroidal anti-inflammatory drugs. ■ ■ ■ ■ ■ Muscle Bursa Tendon Myofascia Ligament ■ Joint related Soft tissue ■ Frequency1 Duration2 1 – 3 times per week 2 – 12 weeks Traumeel Tablets 3 × 1 tablet daily Acute: up to 12 tablets per day Up to 3 months Traumeel Topical 2 – 4 times daily Up to 3 months Traumeel Injection* Spine Articular 1. T he regimens should be tailored to individual requirements 2. Treatment may be continued long term following review and evaluation of the treatment plan 3. Intra-articular injection should not be given more than once per week There is a contraindication for known hypersensitivity to one or more of Traumeel’s ingredients. Traumeel has no known negative interactions with other medications based on pharmacovigilance. *Intra-articular,3 peri-articular, intra-lesional, peri-lesional 1. The regimens should be tailored to individual requirements 2. Treatment may be continued term following reviewdisorders and evaluation of the treatment Treatment algorithm forlong musculoskeletal (Traumeel). a) plan Traumeel in the treatment paradigm. b) How to treat specific indications with Traumeel. 3. Intra-articular injection should not be given more than once per week © Aspen Medical Media 2013. There is a contraindication for known hypersensitivity to one or more of Traumeel’s ingredients. Traumeel has no known negative interactions with other medications based on pharmacovigilance. Wolfarth B, González de Vega C. Make an impact on your daily practice: the potential role for a natural multi-target medication. Curr Med Res Opin 2013;29 Suppl 2:15-9 17 Ongoing and future research Luc Vanden Bossche, MD, PhD, Belgium 18 Luc Vanden Bossche, MD, PhD, Belgium Department of Physical and Rehabilitation Medicine, Ghent University Hospital, Belgium Professor Dr Luc Vanden Bossche, MD, PhD received his medical degree from the University of Ghent in 1993 and obtained his board certification in 1998. His PhD thesis was entitled New Insights into the Etiopathogenesis of Heterotopic Ossification. He was appointed head of clinic of the Ghent University Hospital Department of Physical and Rehabilitation Medicine and professor at Ghent University. Since 1994 he is a member of the medical staff of the Royal Belgian Soccer Association (KBVB) and since 2007 team physician of the firstdivision KAA GENT soccer team. In 2009, he was appointed assistant physician of the national A soccer team. Dr Luc Vanden Bossche is president of the Flemish Society of Sportsmedicine. His fields of interest are sports medicine, neurophysiology, musculoskeletal ultrasound, and diaphragm electromyography, with a special interest in heterotopic ossification and is widely published. 19 Ongoing and future research Luc Vanden Bossche, MD, PhD, Belgium Shoulder pain is the third most common musculoskeletal symptom, and rotator cuff disorders are the most common causes of shoulder pain. At present, with the exception of complete tears, many are conservatively treated. However, there is a need for further treatment options. Good results have been observed following the use of Traumeel injection for the treatment of rotator cuff syndrome such that further investigation was deemed warranted. 64 patients for the Traumeel and dexamethasone groups and 32 for the placebo group. Patients will undergo a washout and screening period of one week prior to commencing study medication. The primary outcome variable will be change from baseline in visual analog scale (VAS) for abductor rotation pain at day 22 (Traumeel versus dexamethasone). Secondary outcome measures will include functional and clinical efficacy parameters, as well as safety variables. TRARO (Traumeel in Rotator Cuff Syndrome) is designed to prove the superiority of local Traumeel injections against placebo and noninferiority to dexamethasone injections in patients with rotator cuff syndrome and bursitis. This randomized, double-blind, three-armed, active- and placebo-controlled multicenter trial will include one ultrasound-guided, subacromial injection per week for three weeks and 12 weeks follow-up. Dexamethasone has been chosen as a comparator because it is commonly used in rotator cuff syndrome, however, the evidence base for corticosteroids is limited and there are questions over the effectiveness and safety of this treatment.1, 2, 3 It is hoped that this study will show that Traumeel is an effective and safe treatment for rotator cuff syndrome. A total of 160 patients will be recruited, providing 20 Research on Traumeel is on-going, and an overview of other studies, in progress and planned, will be provided. Double-blind treatment 3 Weeks 12 Weeks screen randomization Traumeel® days n=64 Dexamethasone n=64 Placebo n=32 1 8 1 5 15 Noninferiority day 22 1 Week follow-up Superiority 22 105 Treatment period 1 ultrasound-guided subacromial injection/week ROM, Range of Motion DASH, Disability of Arm, Shoulder, and Hand VAS, visual analog scale PRIMARY VARIABLE Day 22 Change from baseline in VAS for abduction rotation pain: non-inferiority – Traumeel® injections vs. dexamethasone injections Secondary variables VAS pain comparison with placebo: superiority – Traumeel® injections vs. Placebo (Day 22). ROM, DASH score (Day 15). Patient’s / investigator’s global assessment (Days 22 and 105) TRARO: study design Multicenter, double-blind, randomized, controlled study in rotator cuff syndrome TRARO, TRAumeel ROtator cuff syndrome Trial ID: NCT01702233 1. Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract 2005;55:224–8. 2. Bhatia M, Singh B, Nicolaou N et al Correlation between rotator cuff tears and repeated subacromial steroid injections: a case-controlled study. Ann R Coll Surg Engl 2009;91:414–6. 3. Marder RA, Kim SH, Labson JD et al. Injection of the subacromial bursa in patients with rotator cuff syndrome: a prospective, randomized study comparing the effectiveness of different routes. J Bone Joint Surg Am 2012;94:1442–7. 21 Traumeel Summary of Product Characteristics Traumeel: Tablets • Injection solution • Ointment • Gel Compositions: Tablets: 1 tablet = 301.5 mg containing: Active ingredients: Atropa belladonna D4 75 mg; Aconitum napellus D3, Hepar sulfuris D8, Mercurius solubilis Hahnemanni D8, 30 mg each; Chamomilla recutita D3, Symphytum officinale D8 24 mg each; Achillea millefolium D3, Arnica montana D2, Calendula officinalis D2, Hamamelis virginiana D2, 15 mg each; Bellis perennis D2, Echinacea angustifolia D2, Echinacea purpurea D2 6 mg each; Hypericum perforatum D2 3 mg. Excipients: Lactose monohydrate 6.0 mg; Magnesium stearate 1.5 mg. Injection solution: 2.2 g containing: Active ingredients: Achillea millefolium D3, Arnica montana D2, Atropa belladonna D2, Calendula officinalis D2, Hepar sulfuris D6, Chamomilla recutita D3, Symphytum officinale D6, 2.2 mg each; Aconitum napellus D2 1.32 mg; Bellis perennis D2 1.1 mg; Mercurius solubilis Hahnemanni D6 1.1 mg; Hypericum perforatum D2 0.66 mg; Echinacea angustifolia D2, Echinacea purpurea D2 0.55 mg each; Hamamelis virginiana D1 0.22 mg. Excipients: Sodium chloride 19.4 mg, water for injections 2179.1 mg. Ointment: 100 g containing: Active ingredients: Arnica montana D3 1.500 g; Calendula officinalis Ø, Hamamelis virginiana Ø, 0.450 g each; Chamomilla recutita Ø, Echinacea angustifolia Ø, Echinacea purpurea Ø, 0.150 g each; Bellis perennis Ø, Symphytum officinale D4, 0.100 g each; Achillea millefolium Ø, Hypericum perforatum D6 0.090 g each; Aconitum napellus D1, Atropa belladonna D1, 0.050 g each; Mercurius solubilis Hahnemanni D6 0.040 g; Hepar sulfuris D6, 0.025 g. Excipients: Paraffin, liquid 9.342 g; cetostearyl alcohol (type A), emulsifying 8.007 g; white soft paraffin 9.342 g; water, purified 60.579 g; ethanol 96% (V/V) 9.335 g. Gel: 100 g containing: Active ingredients: Arnica montana D3 1.500 g; Calendula officinalis Ø, Hamamelis virginiana Ø, 0.450 g each; Chamomilla recutita Ø, Echinacea angustifolia Ø, Echinacea purpurea Ø, 0.150 g each; Bellis perennis Ø, Symphytum officinale D4, 0.100 g each; Achillea millefolium Ø, Hypericum perforatum D6, 0.090 g each; Aconitum napellus D1, Atropa belladonna D1, 0.050 g each; Mercurius solubilis Hahnemanni D6 0.040 g; Hepar sulfuris D6 0.025 g. Excipients: Water, purified 74.652 g; ethanol 96% (V/V) 18.653 g; carbomers 1.000 g; sodium hydroxide solution 18% m/m 2.300 g. Indications: Tablets, injection solution, ointment, gel: Traumatic injuries of all kinds such as sprains, dislocations, contusions, haemarthrosis and effusions into a joint; regulation of inflammatory processes in various organs and tissues, including in particular acute and chronic/degenerative disorders of the musculoskeletal system. Contraindications: Tablets, injection solution, gel: Known allergy (hypersensitivity) to one or more of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Matricaria recutita (chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy). Ointment: Known allergy (hypersensitivity) to one or more of the ingredients, including plants of the daisy family (Asteraceae) such as Arnica montana (arnica), Calendula officinalis (pot marigold), Chamomilla recutita (chamomile), Echinacea (coneflower), Achillea millefolium (yarrow), Bellis perennis (daisy) and emulsifying cetylstearyl alcohol. Special warnings and special precautions for use: Tablets: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Injection solution: None. Ointment: Cetylstearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Avoid contact with eyes, mucosae, open wounds or broken skin. Gel: Avoid contact with eyes, mucosae, open wounds or broken skin. Side effects: Tablets, ointment, gel: Allergic (hypersensitivity) skin reactions may occur in very rare cases (i.e. affects less than 1 in 10,000 users). Injection solution: Allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in very rare cases (i.e. affects less than 1 in 10,000 users). Interactions with other medication: Tablets, injection solution, ointment, gel: No interactions have been reported, and none are expected due to the homeopathic dilutions. Pregnancy and lactation: Tablets, injection solution, ointment, gel: For this product no clinical data on pregnancy and lactation are available. Homeopathic dilutions of the substances present in this medicament are not known to be toxic during pregnancy and lactation. No adverse effects have so far been reported. Effects on ability to drive and use machines: Tablets, injection solution: No effects on the ability to drive and use machines have been reported, and none are expected due to the homeopathic dilutions. Ointment, gel: Not applicable. Dosage: Tablets: Standard dosage: Adults (and children 12 yrs. and older): 1 tablet 3× daily; 6–11 yrs. 1 tablet 2× daily; 2–5 yrs.: 1 tablet 1–2× daily; below 2 yrs.: 1 tablet 1× daily. Acute or initial dosage: Adults (and children 12 yrs. and older): 1 tablet every ½ to 1 hr., up to 12×daily, and then continue with standard dosage; 6–11 yrs.: 1 tablet every 1 to 2 hrs., up to 8× daily, and then continue with standard dosage; 2–5 yrs.: 1 tablet every 1 to 2 hrs., up to 6× daily, and then continue with standard dosage; below 2 yrs.: 1 tablet every 1 to 2 hrs., up to 4× daily, and then continue with standard dosage. Method of administration: Preferably allow the tablet to dissolve in the mouth, and then swallow. For children it is possible to crush the tablet and add to a small amount of water. This medicine should be taken away from meals. Injection solution: Standard dosage: Adults (and children 12 yrs. and older): 1 ampoule 1 to 3× weekly. 6–11 yrs.: 2⁄3 of an ampoule 1 to 3× weekly; 2–5 yrs.: ½ ampoule 1 to 3× weekly. Acute or initial dosage: Adults (and children 12 yrs. and older): 1 ampoule daily, and then continue with standard dosage; 6–11 yrs.: 2⁄3 of an ampoule daily, and then continue with standard dosage; 2–5 yrs.: ½ ampoule daily, and then continue with standard dosage. Method of administration: Solution for injection may be administered by the s.c., i.d., i.m., i.a. or i.v. route. Ointment, gel: Standard dosage: Apply 2× daily, or more often if needed. Method of administration: For external use only. Apply generously to the affected area. Traumeel may be applied using mild compression bandaging and/or occlusive bandaging. Overdose: Tablets, injection solution: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions. Ointment, gel: No cases of overdose have been reported, and none are expected due to the homeopathic dilutions and external use. Package sizes: Tablets: Packs containing 50 and 250 tablets. Injection solution: Packs containing 10 and 100 ampoules of 2.2 ml each. Ointment, gel: Tubes containing 50 and 100 g of ointment. “ Soft tissue disorders are the most common source of musculoskeletal pain, and chronicity and recurrence are common. ” Speed C. Current treatment paradigms in the management of soft tissue disorders. Curr Med Res Opin 2013;29(suppl 2):7–9. Luc Vanden Bossche, MD, PhD Physical and Rehabilitation Medicine, Sports Medicine, Ghent University Hospital, Ghent, Belgium Carlos González de Vega, MD Rehabilitation and Sports Medicine, MEDYR Clinic, and University of Madrid, Spain Alex Scott, PhD Department of Physical Therapy, University of British Columbia, Canada Cathy Speed, MD Rheumatology, Sport and Exercise Medicine, Cambridge Centre for Health and Performance, Cambridge, UK Bernd Wolfarth, MD Preventive and Rehabilitative Sports Medicine, Technical University Munich, Germany Biologische Heilmittel Heel GmbH, Baden-Baden, Germany, www.heel.com [xxxxx] Date of preparation: May 2013 © 2013 Biologische Heilmittel Heel GmbH, Baden-Baden, Germany. “ In all cases, the underlying principle, besides controlling pain, should be to facilitate tissue repair so that rehabilitation results in full recovery. ”