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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
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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
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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.
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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
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New insights in the pathophysiology of inflammation in
musculoskeletal disorders
Alex Scott PhD, Canada
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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.
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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
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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.
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Management of acute exacerbation of chronic injuries
Cathy Speed MD, UK
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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.
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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.
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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.
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The range of musculoskeletal disorders and the place
for a multi-target medication
Bernd Wolfarth MD, Germany
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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.
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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.
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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
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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.
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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
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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.
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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. ”