The
Relative Effectiveness of Manipulation versus a combination of Manipulation and
oral Traumeel-S in the Treatment of Mechanical Neck Pain
[Graeme
John Harpham]
According to
the recent literature the application of non-steroidal anti-inflammatory drugs
(NSAIDS) is the mainstay and first line of conventional treatment for many
types of pain, including that
of spinal
origin (DiPalma and DiGregorio 1994/Dabbs and Lauretti 1995/Koes et al. 1997).
NSAID [= Nicht-steroidale Entzündungshemmer/haben
die folgenden Eigenschaften:
schmerzstillend
(analgetisch)
fiebersenkend (antipyretisch)
entzündungshemmend (antiphlogistisch)
z.T.
thrombozytenaggregationshemmend (z.B. Acetylsalicylsäure)] therapy has inherent
side effects (Goodman and Simon 1994), however, given the risks involved, they
are still of value as an
adjunct to
spinal manipulation (Crawford 1988), which has been shown to have less side
effects and be more effective than conventional NSAIDS (Dabbs and Lauretti
1995/Giles and Müller 1999).
A
homeopathic alternative to NSAIDS is Traumeel S, it fulfils all the criteria
for a locally acting therapeutic medication, with promotion of the natural
healing process, and minimum side effects
(Zell et
al. 1989). A study by Hepburn (2000) compared the relative efficacy of Traumeel
S against NSAIDS in the treatment of cervical facet syndrome. Hepburn concluded
that there was statistically
no
difference between the two therapies. It could therefore be inferred that
Traumeel S may be a valid alternative to NSAID therapy in the treatment of
cervical facet syndrome. This study tested this hypothesis by comparing the
effectiveness of spinal manipulation with the concurrent administration of oral
Traumeel S against spinal manipulation alone in order to assess the potential
benefit of combining Traumeel S with manipulation.
This
double-blinded randomised clinical controlled trial incorporated 38 volunteers
that met the inclusion criteria. Each subject was assigned randomly to either
the control group (manipulation + placebo) or the experimental group
(manipulation + Traumeel S) while maintaining the integrity of the
double-blinding.
The normal
clinical procedure of the DIT Chiropractic Day Clinic was observed. Both subjective and objective measures were
taken before treatment at each visit. The subjects were given a total of 4
treatments within a maximum of 3 weeks.
Evaluation
of the intra-group statistical results showed that both groups improved in a
statistically significant manner (p<0.001) in both the NRS pain rating scale
and CMCC neck disability index, the CROM (Cervical Range of Motion Instrument)
values showed that only flexion and left lateral flexion displayed improvement
(p=0.005 and p=0.003) in both groups. The algometer readings showed no
improvement over time in both groups, raising the question of appropriateness
of the measurement tool.
Evaluation
of the inter-group statistical results showed that the NRS results indicated no
treatment effect. The CMCC values showed no interaction between the two groups,
however there was evidence that showed that the placebo group was decreasing at
a faster rate than the active group, implying that if the study had continued
for longer the placebo group could have improved to a greater extent than the
active group. The CROM values were mixed, with some directions improving, some
staying the same, and some worsening. These results were therefore inconsistent
and so are unable to produce any valid conclusions from them.
The
algometer once again showed no change over time or interaction between time and
group implying the apparent inappropriateness the measurement tool.
According
to this study, there is no statistical benefit to the addition of Traumeel S
oral tablets in the Chiropractic treatment of acute +/o. sub-acute mechanical
neck pain (or facet syndrome) in terms
of
objective and subjective findings for a protocol of 4 treatments over a 3 week
period.
There is
growing concern about the safety of the application of NSAIDS, especially in
patients who are not on prescription NSAIDS but on large doses of
over-the-counter NSAIDS, which have
mostly
gastrointestinal side effects (Goodman and Simon 1994). Serious complications
occur fairly infrequently as a result of NSAID therapy, however, this being
said, it can be shown that an alternative treatment, such as spinal
manipulation, has less side effects and is more effective than conventional
NSAIDS (Dabbs and Lauretti 1995/Giles and Müller 1999). How ever, given the
risks involved with NSAID therapy they are still of value as an adjunct to
spinal manipulation (Crawford 1988).
A
homeopathic alternative to NSAIDS is Traumeel S, as it fulfils all the criteria
for a locally acting therapeutic medication, which are:
good
analgesic action,
fast
resorption of oedema and haematomas,
enhancement
of microcirculation with promotion of the natural healing process, and minimum
side effects (Zell et al. 1989).
Studies
using Traumeel S show that it is highly effective for a wide variety of
conditions and considered by physicians as necessary in daily practice (Ludwig
and Weiser 2001/Zenner and Metelmann 1992/Heel 1986).
A study by
Hepburn (2000) compared the relative efficacy of Traumeel S against NSAIDS in
the treatment of cervical facet syndrome. Hepburn concluded that there was
statistically no difference between the two therapies, it could therefore be
inferred that Traumeel S may be a valid alternative to NSAID therapy in the
treatment of cervical facet syndrome. Giles and Müller (1999) show that spinal
manipulation is the most effective method of treating spinal pain on its own. However,
the literature suggests that there is benefit in combining manipulation with an
“anti-inflammatory type” drug
(Serrentino
2003/Oberbaum 1998/Crawford 1988).
This study
tested this hypothesis by comparing the effectiveness of spinal manipulation
with the concurrent administration of oral Traumeel S against spinal
manipulation alone in order to assess the potential benefit of combining
Traumeel S with manipulation.
1.2
Aim and
Objectives
The aim of
this study is to investigate the efficacy of spinal manipulation alone versus
spinal manipulation with the concurrent administration of oral Traumeel S in
patients with mechanical neck pain in terms of objective and subjective
clinical findings.
The first
objective is to determine the relative effectiveness of spinal manipulation and
Traumeel S in terms of subjective pain perception and in terms of objective
clinical findings.
The second
objective is to determine the relative effectiveness of spinal manipulation and
placebo in terms of subjective pain perception and as compared to a spinal
manipulation alone in terms of objective clinical findings.
REVIEW OF
THE RELATED LITERATURE
2.1
Epidemiology
An
epidemiological study was conducted by Drews (1995) on patients with pain of
cervical origin, using information from 162 new patients at the Durban
Institute of Technology Chiropractic
Clinic
over a three month period. The results showed that 16.7% presented with neck
pain, 21.6 % with neck pain and headache, and 16.1% presented with neck pain
and arm pain.
Grieve
(1988) reported that the prevalence of neck pain among 2500 randomly selected
men and women was 16% and 20% respectively. Neck pain is costly in terms of
treatment, individual
suffering
and time lost from work (Jordan et al. 1998). One particular study showed that
5% of industrial workers were unable to work due to neck pain (Grieve 1988).
Lawrence
(1969) found that at any one time 12% of adult females and 9% of adult males
were suffering from neck pain and that 35% of the general population can
remember having had neck pain
at some
time.
2.2
Functional
Anatomy of
the Cervical Spine
The cervical
spine can be divided into two anatomically and biomechanically distinct
sections, the lower cervical spine incorporating C3 to C7 and the upper
cervical spine comprising C1 and C2 (Haldeman 1992/Reid 1992).
2.2.1
Lower
Cervical Spine
The region
from C3 to C7 basically resembles the architecture of the rest of the spinal
column. These vertebrae are small, with broad bodies that are slightly raised
laterally, forming uncinate processes
on the
upper surfaces. As in other regions of the spine, the vertebral bodies
gradually increase in size down to C7 which is in response to the increase in
weight-bearing load. The posterior arches
are sloped
backward and enclose a relatively large triangular shaped vertebral foramen. Perforating
each transverse process is a transverse foramen, through which pass the
vertebral artery (except at C7), the vertebral veins, and the sympathetic
nerves.
The
articular processes are stacked laterally on the bodies in the form of pillars,
on which the facet joints (or zygapophyseal joints) are located. These facet
joints are almost flat, and orientated in
a plane at
about 45° to the horizontal and 90° to the midline, the angle of inclination to
the horizontal plane however increases from the lower to the upper cervical spine.
Although the facet joints are relatively large in area compared to the
intervertebral disc, they are not primarily weight-bearing joints. The joint
capsules are lax and richly innervated which is associated with a greater
degree
of
kinaesthetic sense for the cervical region. (Windsor 2004/Porterfield and
DeRosa 1995/Haldeman 1992)
2.2.2
Upper
Cervical Spine
The upper
cervical spine (or occipitoatlantoaxial complex) consists of the occiput, the
atlas (C1), and the axis (C2) and the unique architecture of the complex is
directly related to its biomechanical
function.
The axis has a vertically orientated peg-like projection called the dens (or
odontoid process), onto which the ring-like atlas is eccentrically mounted via
a midline synovial articulation between
the
anterior arch of the atlas and the dens and re-enforced by the transverse
ligament. The rotation of the atlas around the dens is responsible for the
exceptional axial range of motion of the cervical
spine. Bony
masses on the lateral aspects of the atlas form the articulations between the
occiput and the axis. The superior facets of the atlas are ellipsoid in shape
and are cupped congruently to the occipital condyles and produce a
predominately biaxial direction of movement, the inferior facets tend to be
mildly convex in the anteroposterior direction and mildly concave in the
mediolateral
direction
and face inferior and medially to the corresponding facets of C2. The inferior
aspect of C2 resembles a typical cervical vertebra in appearance and
articulation.
(Windsor
2004/Porterfield and DeRosa 1995/Haldeman 1992)
2.2.3
Innervation
The
fibrous capsules of the synovial facet joints contain more mechanoreceptors
(type I, II, and III) than in the lumbar spine as well as free nerve endings. This
neural input from the facet joints may
be
important for proprioception and pain sensation and may modulate protective
muscular reflexes.
The facet
joints are innervated by both the anterior and ventral dorsal rami.
C0 - C1
and C1 - C2 joints are innervated by the ventral rami of the 1st and
2nd cervical spinal nerves, two branches of the 3rd
cervical spinal nerve dorsal ramus innervate C2 - C3 facet joint, while the
remaining cervical facet joints (C3 - C4 to C7 - T1) are supplied by the dorsal
rami medial branches one level above and below the joint. These medial branches
send off articular branches to the facet
joints as
they wrap around the waists of the articular pillars.
Any pain
sensations that one might experience are sent to the brain via the spinal cord
by unmyelinated C fibres, and to a lesser extent by myelinated A-delta fibres,
these fibres are mainly present in
the medial
branch of the posterior primary rami of the spinal nerves. (Windsor
2004/Haldeman 1992)
2.2.4
Ligamentous
Stability
The
anterior longitudinal ligament (ALL) and the posterior longitudinal ligament
(PLL) are the major stabilisers of the intervertebral joints. Both ligaments
are found throughout the length of the spine, however, the ALL is closely
adhered to the intervertebral discs while the PLL is not well developed in the
cervical spine.
The ALL
becomes the anterior atlantoocciputal membrane at the level of the axis, while
the PLL merges with the tectorial membrane. Both ligaments continue onto the
occiput.
(Windsor
2004/Porterfield and DeRosa 1995)
The
supraspinous ligament, interspinous ligament, and ligamentum flavum maintain
the stability between the vertebral arches. The supraspinous ligament runs
along the tips of the spinous processes,
the
interspinous ligament runs between the spinous processes, and the ligamentum
flavum runs from the anterior surface of the cephalad lamina to the posterior
surface of the caudad lamina.
The
interspinous ligament and especially the ligamentum flavum control excessive
flexion and anterior translation. The ligamentum flavum also connects to and re-enforces
the facet joint capsules on the ventral aspect. The ligamentum nuchae is the
cephalad continuation of the supraspinous ligament and has a prominent role in
stabilising the cervical spine. (Windsor 2004/Porterfeild and DeRosa 1995)
2.2.5
Cervical
Range of Motion
The types of
motion present in the cervical spine are flexion, extension, lateral flexion
(lateral bending), and rotation. The cervical spine is most flexible in flexion
and rotation, which occur most freely
in the
upper cervical area and get progressively more restricted towards the lower
levels. Cervical motion, however, hardly ever happens in isolation, it is always
coupled with another motion.
Rotation
around the Y axis is coupled to rotation around the Z axis and vice versa (i.e.
lateral flexion is coupled to rotation) (Schafer and Faye 1990).
Haldeman
(1992), states that, for the cervical spine, the approximate normal values for
extension are between 30° and 40°, 45° of flexion, between 30° and 45° of
lateral flexion to the left and right,
and 60° - 90°
of rotation to each side.
2.3
Mechanical
Neck Pain
Patients that
present with mechanical neck pain complain of neck pain, headaches, and limited
range of motion. The pain is described as a dull aching discomfort in the
posterior neck that sometimes radiates to the shoulder or midback regions
(Windsor 2004/Reid 1992).
Clinical
features that often are associated with cervical facet pain include tenderness
to palpation over the facets or paraspinal muscles, pain with extension and/or
rotation, and absent neurological abnormalities (Windsor 2004).
Schafer
and Faye (1990) also include the presence of asymmetries or misalignments that
are observed motion detected through motion palpation, and special orthopaedic
tests. Signs of cervical spondylosis,
narrowing of the intervertebral foramina, osteophytes, and other degenerative
changes are present equally in people with and without neck pain (Windsor
2004).
A study by
Bogduk and Marsland (1988) attempted to determine if the facet joints in
patients without objective neurological signs were the primary source of their neck
pain. Those with lower
cervical
spine pain underwent C5 and C6 medial branch blocks first (using bupivacaine),
if they did not find relief then the adjacent levels were blocked until the
pain was relieved. Those that had
upper neck
pain underwent third occipital nerve blocks, and C3 and C4 if necessary. 15 out of 24 patients had complete relief of
their neck pain, and repeat blocks had the same effect.
No
clinical or radiological features corresponded with the positive
responses. This finding suggests that
facet joints in the cervical spine can be a significant source of neck pain.
According
to Strasser (2004) the causes of mechanical neck pain include activities and
events that influence cervical biomechanics such as extended sitting,
repetitive movement, accidents, falls
and blows
to the body or head, normal aging and everyday wear and tear.
2.4
Chiropractic
Treatment of Mechanical Neck Pain
2.4.1
Spinal
manipulation
Haldeman
(1992) defines spinal manipulative therapy as “all procedures where the hands
are used to mobilise, adjust, stimulate or otherwise influence the spinal and
paraspinal tissues with the aim
of influencing
the patient’s health”.
Chiropractors
seek out areas in the cervical spine that have decreased movement that are
associated with neck pain using palpation.
Once
found, the affectedjoint/s are treated via manipulation to release the joint
and restore movement. The Chiropractic
adjustment is an effective way of providing the force necessary to facilitate
the
restoration of this movement (Schafer and Faye 1990). Cassidy et al. (1992) describes the
adjustment as a high velocity, low amplitude thrust directed beyond the passive
range of motion of the
spine and associated
with an audible „crack‟ caused by the cavitation of the underlying facet joint. Sandoz (1976) states that a Chiropractic
adjustment is a passive manual manoeuvre during which
the three-joint-complex
(intervertebral disc and facet joints) is suddenly carried beyond the normal
physiological range of movement without exceeding the boundaries of anatomical
integrity.
2.4.2
Effectiveness of
Spinal Manipulation in the
Management of Neck Pain
Cassidy et
al. (1992) produced a study in which 100 patients were either given a spinal
manipulation or mobilisation technique to treat mechanical neck pain.
It was
determined that a single manipulation is more effective than mobilisation in decreasing
pain in patients with mechanical neck pain, although both treatments did
increase range of motion in
the neck to
similar degrees.
A study by
Vernon et al. (1990) examined the effect of cervical manipulation versus
mobilisation on pressure pain threshold in the cervical spine measured 5 minutes
after the intervention.
Of the two
methods used, manipulation produced significantly higher increases in the
pressure pain threshold.
Yeomans
(1992) assessed the cervical intersegmental mobility before and after manipulative
therapy. Two systems of mensuration were
utilised in 58 case studies. The results
revealed that the post-
manipulative
mobility is significantly greater than the pre-manipulative data with the
exception of the C1 segment of both male and female treatment groups.
2.4.3
Risks of
Spinal Manipulation
The most
significant risk to spinal manipulation that has caught the media’s attention
is the risk of stroke following manipulation.
The literature, however, agrees that the risk of stoke
is 1 to 3
incidents per 100,000 treatments in patients receiving a course of treatments
per year, or 0.001% (Dabbs and Lauretti 1995).
The
estimated risk of death following spinal manipulation is 1 death per 400,000 patients
receiving a course of treatments per year, or 0.00025% (Dabbs and Lauretti
1995).
Manipulation
is well tolerated in the healthy spine, however pathological conditions already
present in the spine can lead to a risk of complication.
Such conditions
include infective processes, inflammatory processes such as rheumatoid
arthritis, metabolic disturbances such as osteoporosis, congenital defects or malformations,
severe trauma,
and neoplasia
(Haldeman 1992).
2.5
Treatment
Alternatives
According
to the recent literature the application of non-steroidal anti-inflammatory
drugs (NSAIDS) is the mainstay and first line of conventional treatment for
many types of pain, including that
of spinal
origin (Di Palma and DiGregorio 1994; Dabbs and Lauretti 1995/Koes et al. 1997). A meta-analysis of 26 published randomised
clinical trials evaluating NSAIDS for low back pain
showed
that they are effective in providing short-term relief from uncomplicated low
back pain, however are less effective in patients with sciatica +/o. nerve root
symptoms (Koes et al. 1997).
This
treatment is also used to treat neck pain (DiPalma and DiGregorio 1994/Dabbs
and Lauretti 1995).
Other
treatment alternatives include other forms of physical therapy including mobilisation,
soft tissue therapy, stretching, and ultra-sound therapy; inter-articular facet
joint injection; medial branch
blocks;
percutaneous radiofrequency neurotomy; and surgical intervention such as fusion
(Windsor 2004).
2.6
Safety
There is
growing concern about the safety of the application of NSAIDS, especially in
patients who are not on prescription NSAIDS but on large doses of over-the-counter
NSAIDS possibly on
the
recommendation (but not prescription) of their chiropractor, physiotherapist,
or other therapist (Goodman and Simon 1994).
The side effects of NSAIDS are documented as being particularly
harsh on
the gastrointestinal tract, predisposing to ulceration and bleeding from the
GIT possibly leading to abdominal pain, diarrhoea and possibly death (Goodman
and Simon 1994).
Other side
effects include renal injury and possible renal failure, interference with anti-hypertensive
drugs, CNS effects such as aseptic meningitis, psychosis, cognitive
dysfunction, dizziness and
headache,
effects on the foetus during pregnancy, anti-platelet activity, oedema, dry
mouth, rash and tiredness (Goodman and Simon 1994/Koes et al. 1997).
It
however, must be noted that the risks of serious complications following NSAID therapy
are only minimal, but alternative treatment such as chiropractic spinal manipulation
still has less side
effects (Dabbs
and Lauretti 1995) and is more effective (Giles and Müller 1999) than NSAID
therapy.
Given the
risks involved, NSAID therapy is still of value as an adjunct to spinal manipulation
due to its anti-inflammatory effects.
The value of NSAID’s was established by inducing inflammatory reactions
and controls in laboratory rabbits and then treating the lesions with NSAID's,
it demonstrated the value of applying NSAID’s topically when conservatively
managing an acute patient
(Crawford 1988). Studies by the Medical Scientific Department
at Biologische Heilmittel Heel GmbH in Germany (1986) on Traumeel S however,
display a side effect rate of only 130 out of
3,651,580
cases (0.0035%), all of which could be classified as allergic reactions.
2.7
Basic
Principles of Homeopathy
Homeopathy
is a self-consistent scientific system of medical therapy, which was founded by
Christian Friedrich Samuel Hahnemann in 1796.
It is
based on the observed biological fact that if a disease process disturbs an
organism’s bio-energetic state, it can be predictably restored to normal by
specially prepared medicinal stimuli that
need only
be administered in small doses, or more often in sub-physiological deconstructions
to which the body has an altered receptivity to (Gaier 1991). This receptivity
occurs provided that,
in a
healthy organism the medical agents chosen would produce symptoms and clinical
features like those of the disease, and that obstacles to cure have been
removed (Gaier 1991).
There are
three main principles that feature in Homeopathy, the first is “Like Cures
Like” which is also known as the Law of Similars which implies a match between
the primary symptoms of the
remedy and
the symptoms of the patient.
An example
of this would be the remedy for stings and histamine reactions being derived
from bees (Apis), or the remedy for insomnia being derived from the green
coffee bean (Coffea)
(Kayne 1997).
The
principle of “Minimal Dose” is quite unique to homeopathy, remedies are diluted
down to various degrees of dilution depending on the condition being treated,
acute conditions are treated
using
dilutions right down to 1 in 1060 and even further, due to the fact that the
potency of the remedies are increased, this dilution process is called
„potentisation‟.
However,
different conditions require different potencies to be effective, therefore only
the minimal amount of the remedy that is effective is used in treatment (Kayne
1997).
The
„Single Remedy‟ principle comes from the belief that Hahnemann had that the
body could not suffer from more than one disease at a time, and that any and all
diverse symptoms were linked
to a
single cause or disease process, Hahnemann therefore believed that only one
simple remedy was all the treatment necessary to provide relief (Kayne 1997).
It has
been found through clinical experience that some homeopathic remedies can be
mixed together and administered successfully as a complex, breaking away from
the „Single Remedy‟
philosophy.
Traumeel S
is such a complex.
Complex
remedies can be administered if the prescriber is unsure of which remedy is the
most appropriate, thereby increasing the chance of a correct prescription. Complexes
are also used to address multiple symptoms of a single condition at the same
time which saves time and is more convenient (Kayne 1997).
2.8
Traumeel S
2.8.1
Therapeutic
Criteria
A
homeopathic alternative to NSAIDS is Traumeel S, it fulfils all the criteria
for a locally acting therapeutic medication, which are:
good
analgesic action,
fast
resorption of oedema and haematomas,
enhancement
of microcirculation with promotion of the natural healing process, and a
minimum of side effects (Zell et al. 1989), but uses a completely different
method of action (Conforti
et al. 1997).
2.8.2
Method of
Action
Research
by Conforti et al (1997) suggests that the anti-inflammatory effects of Traumeel
S are not due to its action on a specific cell-type of immunomodulation cell
(e.g. on granulocytes) or due
to a
biochemical mechanism (e.g. platelet activity) associated with conventional
anti-inflammatory drugs. Instead, Traumeel S appears to inhibit the acute
neurogenic mechanisms of inflammation
at a local
level, regulated by the release of neuropeptides by sensitive nerve endings.
2.8.3
Components
of Traumeel S
Traumeel S
is a homeopathic complex that is available in various dosage forms (such as
drops, tablets, injection solution, and ointment), with the function of each of
the ingredients of Traumeel S
being:
Enhancement
of wound healing following blows, falls and contusions: Arnica montana, Calendula
officinalis and Symphytum officinale.
Analgesic
effects: Aconitum napellus, Arnica montana,
Matricaria chamomilla, Hamamelis virginiana, Hypericum perforatum, and Bellis perennis.
Haemostatic
effects: Aconitum napellus, Arnica montana, Hamamelis virginiana (venous
bleeding), and Achillea Millefolium (arterial bleeding) and Hepar (“sealing” of
blood vessels).
Anti-inflammation
and anti-viral: Mercurius solubilis Hahnemanni.
Stimulation
of body defence mechanisms: Echinacea purpurea and Echinacea angustifolia.
Ingredients:
Beinwell (Symphytum officinale)
Bergwohlverleih (Arnica montana)
Eisenhut (Aconitum napellus)
Gänseblümchen
(Bellis perennis)
Gemenge, das im wesentlichen Mercuroamidonitrat enthält (Mercurius
solubilis Hahnemanni)
Johanniskraut (Hypericum perforatum)
Kalkschwefelleber (Hepar sulfuris)
Kamille (Matricaria recutita)
Purpur-Sonnenhut (Echinacea purpurea)
Ringelblume (Calendula officinalis)
Schafgarbe (Achillea millefolium)
Schmalblättriger Sonnenhut (Echinacea)
Tollkirsche
(Atropa bella-donna)
Zauberstrauch (Hamamelis virginiana)
All rubor
(redness), tumor (swelling), calor (temperature changes), and dolor (pain)
symptoms which are the features of inflammation: Atropa Belladonna (Stock 1988).
2.8.4
Indications
and Side Effects
The main
indications for the application of Traumeel S are trauma and injury, inflammation
and soft tissue swelling, to increase the non-specific defence mechanism, as
well as degenerative processes
and
arthroses (Oberbaum 1998/Heel 1986). The preparation has no known toxic side
effects because its ingredients are diluted by several orders of magnitude
below toxic levels (Oberbaum 1998).
It should,
however, be noted that an increased flow of saliva may occur after taking this
medication and hypersensitivity reactions may occur in individual cases
(Biotherapeutic Index 2003).
There is
substantial anecdotal evidence that the administration of Arnica montana in low
homeopathic potencies (e.g. 6CH or lower) may induce the extravasation of blood
instead of producing
2.8.4
Indications
and Side Effects
The main
indications for the application of Traumeel S are trauma and injury, inflammation
and soft tissue swelling, to increase the non-specific defence mechanism, as
well as degenerative processes
and
arthroses (Oberbaum 1998/Heel 1986). The
preparation has no known toxic side effects because its ingredients are diluted
by several orders of magnitude below toxic levels (Oberbaum 1998).
It should,
however, be noted that an increased flow of saliva may occur after taking this
medication and hypersensitivity reactions may occur in individual cases
(Biotherapeutic Index 2003).
There is
substantial anecdotal evidence that the administration of Arnica montana in low
homeopathic potencies (e.g. 6CH or lower) may induce the extravasation of blood
instead of producing
the
required effect of reducing the extravasation (Hopkins 2003). The following reactions have been recorded as
potential side-effects in patients taking preparations containing
Rudbeckia.x (= Echinacea) (Biotherapeutic Index 2003).
2.9
Efficacy
A study by
Hepburn (2000) compared the relative efficacy of Traumeel S against NSAIDS in
the treatment of cervical facet syndrome, the study involved a double-blind,
comparative, clinical trial
using 50
consecutive patients at the Durban Institute of Technology Chiropractic Clinic
divided into two groups, and concluded that there was statistically no
difference between the two therapies.
However both
groups did improve significantly. It
could therefore be inferred that Traumeel S is a reasonable substitute to NSAID
therapy in the treatment of cervical facet syndrome according to
his
research.
Treatment
using Traumeel S for arthosis, myogelosis, sprains, periarthropathia
humeroscapularis, epicondylitis, tendovaginitis, and others, showed that 78.6%
of patients had complete and long-
term relief
from complaints or definite long-term improvement, 17.8% improved for a limited
amount of time, 3.5% showed no change, and 0.1% worsened (Zenner and Metelmann
1992).
Similarly,
pediatric (0 - 12 year old children) injuries treated with Traumeel S ointment rated
97% of patients as “good” or “very good” results, regardless of age or symptoms
(Ludwig and Weiser 2001).
Heel
(1986) conducted a survey of 3030 physicians of various disciplines of whom
2859 (94.3%) considered Traumeel S to be necessary in their daily practice.
Giles and
Müller (1999) showed that spinal manipulation on its own is the most effective
method of treating spinal pain. The
literature also seems to indicate Traumeel S as the drug of choice over
(or in conjuction
with) NSAIDS as an adjunct to spinal manipulation for neck pain due to its lack
of side effects and comparable anti-inflammatory action (Serrentino 2003/Oberbaum
1998).
2.10
Hypothesis
Therefore,
this study aims to test this hypothesis by comparing the effectiveness of
spinal manipulation with the concurrent administration of oral Traumeel S in patients
with mechanical neck pain
and spinal
manipulation along with placebo. This
would distinguish how much spinal manipulation would be enhanced as an intervention
by the addition of Traumeel S.
The study
design chosen was that of a double-blind, comparative, clinical trial that
involved two treatment groups, both groups received spinal manipulation with
each group receiving either a
homeopathic
remedy (Traumeel S) or placebo remedy respectively.
6.1
Conclusion
Evaluation
of the intra-group statistical results showed that both groups improved in a
statistically significant manor (p<0.001) in both the NRS and CMCC measures,
the CROM values showed that
only
flexion and left lateral flexion displayed improvement (p=0.005 and p=0.003) in
both groups, possibly due to those directions being manipulated more than the
others, or that the effect of
manipulation
on range of motion is short lived. A
reason for those particular directions being most improved is that during this
study, many subjects that suffered from mechanical neck pain worked
in the
office environment, thus factors such as computer mouse use, holding the
telephone between the ear and shoulder, and monitor placement would impact only
certain ranges of motion
rather
than others. The algometer readings
showed no improvement over time in both groups, raising the question of
appropriateness of the measurement tool.
Evaluation
of the intergroup statistical results showed that the NRS results indicated no
treatment effect. The CMCC values showed
no interaction between the two groups, however there was
evidence
that showed that the placebo group was decreasing at a faster rate than the active
group, implying that if the study had continued for longer the placebo group
could have improved to a
greater extent
than the active group, i.e. the Traumeel S had a detrimental effect on the subjects. The CROM values were erratic, with some directions
improving, some staying the same, and
some
worsening. These results were therefore inconsistent
and so are unable to produce any valid conclusions from them, the reason for
these inconsistencies could be attributed to the small sample
size and that
one direction of manipulation may have been treated more than another and was
not kept as standard. The algometer once
again showed no change over time or interaction between time
and group
implying the apparent inappropriateness +/o. of the measurement tool.
A flaw in
the research procedure could have been the combination of manipulation with
Traumeel S to determine its efficacy, the spinal manipulation is such a strong
treatment tool that it appears
to have
overwhelmed the effect of the Traumeel S and somay have resulted in misleading
results and statistics.
The aggravation
effect of homeopathic preparations could also have influenced the results, a longer
time-frame might have shown the active group “bouncing back” but there was no
statistical
evidence
of this, and studies have shown Traumeel S to work much faster (Ludwig and
Weiser 2001). The condition treated may
also have been incorrect, either Traumeel S is just not effective in
treating
mechanical neck pain, or that the level of inflammation present in the subjects
was too low for the Traumeel S to have had a significant measurable effect over
and above the spinal
manipulation.
There was also no trauma or definitive injury as such on which the Traumeel S
could have an action. A more accurate
objective measure of pain and inflammation is needed.
It is
therefore the researcher’s conclusion that, according to this study, there is no
statistical benefit to the addition of Traumeel S oral tablets in the
Chiropractic treatment of acute +/o. sub-acute mechanical neck pain (or facet
syndrome) in terms of objective and subjective findings for a protocol of 4
treatments over a 3 week period.
6.2
Recommendations
In the
opinion of the researcher, a large draw-back to this study was the small sample
size, a larger sample group would allow for a more representative slice of the
population.
A larger
sample size would have made the measurement of range of motion more
representative, and a type II error would have been avoided. The small sample size also allowed chance to
have a larger impact (e.g. people with less symptoms could have been
predominantly in one group), and the chance of incomplete randomisation would
be greater, therefore greater numbers would increase the power
of the
study.
However, if
this study were to be regarded as a pilot study, the statistical analysis
undertaken shows that if the sample size was increased it might have indicated
a detrimental effect of the active
treatment
relative to the placebo. Thus, these results would not indicate that further
larger studies should be undertaken.
In order
to remove the inconsistencies that occurred in the CROM readings, a more focused
approached would have proved more successful, this would mean limiting
treatment to only one direction
or pair of
directions. The CROM inconsistencies
could also have been as a result of the many office workers that were
incorporated into the study due to the fact they had neck pain, office
ergonomics
could predispose these subjects to certain fixations rather than others. To avoid this effect, the sample population
should be more homogenised, either including exclusively office workers
or removing
them from the subject pool.
Each
subject was responsible for taking the research tablets at home, away from the
researcher, patient compliance might have been an issue as some subjects might
forget to take them, or some people
may have
forgotten more often than others. Even
though the research subjects were instructed not to take any other pain
medication during the study, it is possible that they may have done so
without
notifying the researcher.
Homeopathic
remedies are also sensitive to the presence of strong flavours such as coffee
or peppermint (even toothpaste), if the Traumeel tablets were taken near such
things the effect of Traumeel S
may be
diminished.
As far as
possible, verification of compliance was undertaken at the end of each treatment
session verbally.
The lack
of statistical significance of the algometer leads the researcher to question
the appropriateness of the measurement tool.
A more significant effect of the Traumeel S tablets might have been
observed if the anti-inflammatory effects were more readily observable and
appropriately measured, thus a better +/o. more sensitive objective measurement
instrument is needed to measure
inflammation
and pain.
Different
results may have been observed if the measurements were taken immediately or
shortly after the treatment, showing a more pronounced effect.
In
retrospect, this study should have incorporated in the statistical analysis a mention
of whether the lesion was on the left or right sides and a note of occupational
influence on the subject group.
The sample
size should have been larger (60 subjects instead of 38), and the population
group should have been more homogenous.
A more accurate (or sensitive) measure of inflammation
should be
found to measure the effect of the Traumeel S, such as a blood test (ESR or
CRP).
Perhaps
more of an effect could be visualised if the subject population was more
symptomatic (i.e. post traumatic syndromes, whiplash, or arthritis). Traumeel S has different application methods,
in future
studies, using a different treatment regime may show different results, changes
such as different potencies, different dosages, and different application forms
such as treatment via an
injectable
solution, may prove more appropriate to this condition.