ElectroNews Vol 4 Issue 4

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• From: pautrey2 <pautrey2@xxxxxxxxx>
• Date: Sun, 18 Oct 2009 18:33:45 -0700 (PDT)

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ElectroNews Vol 4 Issue 4



NEWS : ISEPA Web Pages Hosted

Some of you may recall that I have mentioned the formation of the
International Society for Electro Physical Agents (at a meeting in
February in Las Vegas). For the moment, the ISEPA web pages are hosts
on the www.electrotherapy.org site so you can freely access the
information available and follow what is happening. At some point in
the future, ISEPA will have its own web site probably linked with
WCPT, but until that time, I am happy to accommodate.



NEWS : Spanish edition of Electrotherapy : Evidence Based Practice

Elsevier have now done a translation of this text into Spanish full
details available on the web pages go to the BOOKS page from the main
menu. I gather that a Portuguese and possibly others are planned will
let you know as soon as I have any further updates.



NEWS : Microcurrent Review

I have mentioned Microcurrent Therapy in several previous issues and
have been looking at the literature on it sine I was looking at
endogenous bioelectric issues back in the late 1980s. A new paper out
by Leon Poltawski (one of my PhD students) and myself which I will not
review in detail in the normal sections of the newsletter has just
come out in Physical Therapy Reviews (Poltawski, L. and T. Watson
(2009). "Bioelectricity and microcurrent therapy for tissue healing -
a narrative review." Physical Therapy Reviews 14(2): 104-114). As the
title would suggest, the review looks specifically at the evidence for
(and against) the use of this therapy in relation to tissue repair it
is also used clinically for pain management but this aspect is not
covered in the review. This is an potentially underutilised therapy I
think because many practitioners think that current THAT small cant be
actually doing anything or maybe it is simple a matter of awareness?
Anyway, the review should prove interesting for those of you who
already use microcurrent type treatments, those wanting an overview of
what it does and those with an interest in endogenous bioelectrics and
their relation to tissue repair.



NEWS : NHS Evidence Web Site

Sure that this will not be news to many of the you in the NHS in the
UK, but for those of you overseas and for those of you not directly
employed by the Health Service, you may be interested to try the
following link : www.evidence.nhs.uk : which offers the facility to
search for evidence using key words or phrases. I know that there are
a lot of sites out there that do thins kind of thing, but you never
can have too many links to source the evidence . . .




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Contents :


General Electrotherapy Electrophysical Agents and the
Curriculum


Electrophysical Agents and the Evidence

Ultrasound Ultrasound and
Fracture Healing

Magnetic Therapy Magnetic Wrap and OA Knee

Magnetic
Field Therapy Review

PEMF Pulsed
Electromagnetic Fields and phantom limb pain

Shockwave Therapy Shockwave therapy and plantar
fascitis

Electrical Stimulation Dose responses with TENS :
A Review of Reviews

Electrical stimulation and OA knee

Muscle
stimulation and bone loss

Bioelectrics Mechanical
transduction and bioelectric field strength

Electrical
properties of acupuncture points and meridians

Vibration therapy Whole body vibration and
bone density

Whole body
vibration and physiological effects

Tissue and Repair Trigger point
inflammation

Achilles
tendinopathy : exercise and brace research

TA
microcirculation and cryotherapy

TA
microcirculation and tissue loading

Eccentric
exercises and Achilles tendinopathy


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There were several papers in a recent edition of Physical Therapy
Reviews to coincide with the ISEPA conference meeting in the USA
earlier this year. I mentioned a couple in the last edition, and a
couple more coming up here. The ISEPA web pages are currently hosted
on my own web site (till we have a web place of our own) : follow the
ISEPA link from the top menu.



Electro Physical Agents and the Curriculum
Lucy Chipchase whose name has appeared several times in this
newsletter - presents a paper in the journal looking at the
increasing complexity of the electro physical agents (EPAs) available
to therapists and how this might be rationalised with a crowded
curriculum, a difficult evidence base and current trends in clinical
practice (Chipchase, L. S. et al. (2008). "A framework for determining
curricular content of entry level physiotherapy programmes:
electrophysical agents as a case study " Physical Therapy Reviews 13
(6): 386-394). The authors argue that although EPAs were historically
a mainstay in physiotherapy, the increasing use of manual therapy and
exercise therapy in the clinical environment has resulted in a need to
rethink the EPA curriculum, primarily in terms of content. It does not
specifically deal with the complex issues of the style of delivery
which, I would suggest, deserves a similar evaluation at some point.



The paper provides a brief but interesting historical view of EPA use
in therapy as a component of core practice, going on to look at
teaching of EPAs in entry level education programmes. Although based
in Australia, a wider international perspective is taken where
possible. The next two sections provide some fascinating material
looking at the relationships between current clinical practice and the
curricula and then looking at the relationship between the research
evidence and the curricula, ending with some suggestions regarding a
way forward. This is a valuable paper for those involved not only with
EPA education, but also those in clinical practice considering the
relations between the evidence and practice. I have been banging on
about this stuff for ages, so I found it refreshing to read that
somebody else has looked at the issue, and come up with some great
material.



The authors also suggest, way back at the start of the paper, that
EPAs are used as an example in the paper the same principles could be
applied (and probably should be applied) in other therapy practice
areas. One of the suggestions in the way forward section is that an
international approach would be beneficial and indeed, I would suggest
that the recently formed ISEPA (International Society for Electro
Physical Agents) might just be able to fulfil that role.



Nice paper, great overview and well worth a read not just for those in
education many clinicians and especially those involved in the
education of students on practice would gain from a read I would
suggest.



Electrophysical Agents and the Evidence
Val Robertson who also gets mentioned in almost every issue provides
an interesting evaluation of some key issues when considering the
relationships between clinical practice with EPAs and the published
evidence for the same. The paper, (Robertson, V. J. (2008).
"Electrophysical agents and research: from instinct to evidence "
Physical Therapy Reviews 13(6): 377-385) only focuses on two
modalities ultrasound and microwave as examples to illustrate the
thesis that clinical practice is often based on not the evidence. If
you thought (from the title) that this paper was going to review the
whole topic well, it doesnt, and there is no way you could do that
given the limits of a journal paper one would struggle to get that
done in a whole book without having to leave some stuff out!



Anyway, the summary of the content goes something like this (though
Val makes a much more comprehensive and well argued case than my few
lines here!) : Microwave is rarely used in clinical practice, but
actually has a substantial amount of quality research to support its
application in some clinical settings. Ultrasound on the other hand,
is very widely used, yet is less strongly supported by clinical
evidence so the claims made by therapists that they are delivering
evidence based care is not so well founded as might be thought.



I might take issue with some of the finer details BUT in essence, I
spend a LOT of time looking through the breadth and depth of the EPA
literature (hence the newsletter), and I also spend a lot of time out
there talking to practicing therapists about EPAs and I absolutely
agree that current practice is not (generally) well founded on the
available evidence. It is based on historical norms, words of mouth
and a lot of anecdotal evidence. There is of course, nothing wrong
with anecdotal and experiential evidence it is important in any
practice so please dont think that I am saying that we should ONLY do
what is published in RCTs etc etc BUT there are some areas of EPA
usage which ARE evidenced but RARELY practiced. I would suggest that
microwave therapy is infrequently available (in the UK at least) based
on modality availability surveys. Robertson notes exactly the same
issue. Most therapists assume that the modality has been largely
abandoned in the physiotherapy world due to either (a) a lack of
evidence to support it or (b) no evidence is available neither of
which are in fact true.



Do read this paper. It makes a good argument and uses Ultrasound and
Microwave therapies as a means of illustrating the points made. I
find, in a similar way, that many therapists are shocked to hear of
the supportive evidence for some other interventions (like NMES for
example) which has some VERY supportive research evidence and yet many
therapists consider it to be old fashioned like the old application of
Faradism and rarely used in some practice areas. There is a disparity
between the published evidence and clinical practice. I would suggest
(Val refrains from doing so) that this is true in other practice areas
not just EPAs, but the argument and well presented, coherent, and
deserves consideration.



Ultrasound and Fracture Healing
Again, I get to mention this in most issues of the newsletter, and
when I put up a set of recent references on the web page looking at
the published evidence, most people were surprised just how much of it
there is out there so lets add another one! The lead author on this
particular paper (Rutten based in Holland) has published in this area
previously, as have some of the others on the authorship list. The
paper in a recent issue of the journal Bone (Rutten, S. et al. (2008).
"Low-intensity pulsed ultrasound increases bone volume, osteoid
thickness and mineral apposition rate in the area of fracture healing
in patients with a delayed union of the osteotomized fibula." Bone 43
(2): 348-54) looks at data obtained from a clinical RCT comparing the
progress of delayed union of the osteotomised fibula. Thirteen
patients were recruited, all of whom had a delay in the fibular union
following a high tibial osteotomy. The aim of the study was to try and
further identify the mechanism through which the LIPUS is effective
(something which remains poorly understood). The introduction,
although necessarily brief, actually provides a succinct summary of
the current state of the art and makes for a very useful 5 minute read
for anybody wanting to catch up with where we are in the knowledge,
and would rather read something from a group of experts in the field
rather than just the stuff on my web pages (where the is a LOT about
LIPUS for enhanced fracture healing).

The 13 patients were divided into n = 7 in the LIPUS group and n = 6
in the control group. All patients had a high tibial osteotomy (for
OA) and at the 6 month follow up, were recruited to the trial if the
fibula osteotomy (which is renown for delayed union) if radiological
healing was not evident. The control group in this case received a
sham LIPUS intervention (as opposed to nothing). The LIPUS was
delivered in the standard way (described in the paper and on the web
pages if you want it) but essentially was 20 minutes daily at 30mW
cm-2 @ 1.5 MHz using the Exogen device. Group allocation was blinded
and the intervention was of 5 months duration. Full details are
provided in the paper.



There were several outcomes employed, via a biopsy taken 2 4 months
following the start of the treatment. A 2.5mm drilled biopsy was taken
and subjected to histological analysis. (detailed provided). There
were several areas of interest namely, the new bone formation zone, an
area of cancellous and an area of cortical bone. The bone density and
metabolic activity was noted at each and in addition, the angiogenic
activity was noted by assessing the number of blood vessels in the
area.



There are a lot of results, but they summarise thus : There was a 47%
greater osteoid thickness in the treated samples compared with the
placebos and there was also an increased bone volume (by 33%) and
greater mineralised volume (34%) in the treated samples. There were no
more osteocytes in the treated samples. The rate of bone formation was
27% greater in the treated group (statistically significant), and the
blood vessel numbers were marginally greater in the treated smales,
but this was not statistically significant (8%). The cancellous areas
of the sample showed greater bone volume and mineralisation than the
controls whilst other values were not significantly different. In the
cortical bone sample, there were no major differences between treated
and controls, and those differences that were identified are detailed.



The discussion provides some interesting analysis and comment. The
results suggest that the mechanism of LIPUS in this clinical arena
includes increasing bone formation through increased osteoblast
activity. The new bone formation was significantly greater in the
treated group, though the number of blood vessels was not (the
angiogenic response) which would suggest (according to the authors)
that any increase in local blood flow is not directly related to new
vessel formation (this is a brief summary of an extensive discussion
go read the original it is worth it). The authors conclude that the
demonstrated advantage in the treatment group is achieved by
increasing osteoid thickness, the rate of mineral deposition and
greater bone volume. Increased stability and blood flow was apparent,
but probably not a marked difference in angiogenesis.



The laboratory and clinical evidence to support the use of LIPUS in
various types of fracture healing has been established over the last
10 15 years. This paper adds to the knowledge in this area by
clarifying the mechanism(s) through which the modality may be
operating.



Magnetic Therapy : Magnetic Wrap and OA Knee


There is a growing interest in the field of magnetic therapy, though
many remain sceptical that it is anything other than a placebo or
gimmick treatment method. I am not trying to either support or trash
this line of treatment, but report a couple of trial that might be of
interest. One of the biggest problems that I can see with magnetic as
a treatment, other than the lack of some decent trials, is the issue
of dose i.e. the amount of applied energy and under what conditions.
The first paper by a group from Taiwan (Chen, C. Y. et al. (2008).
"Effect of magnetic knee wrap on quadriceps strength in patients with
symptomatic knee osteoarthritis." Arch Phys Med Rehabil 89(12):
2258-64) considers the effect of a magnetic knee wrap for patients
with symptomatic OA knee (but I guess you could have spotted that from
the title!!). This was a clinical trial, and it was an RCT design
(which should tick a couple of good boxes for those of you out there
who worry about some quality control issues in electrotherapy
research). There were 50 patients recruited to the trial, , who
presented with mild or moderate OA knee (mean age of 66) though only
37 completed. The intervention period was for 12 weeks and patients
wee allocated to either a treatment (n=24) or a sham (n=26) group.
Although the main outcome measure was isometric strength of the quads,
secondary measures were taken using the Health Assessment
Questionnaire Disability Index (HAQ-DI) and the Health Assessment
Questionnaire Pain Scale. The authors argue that although various
electromagnetic field treatments have been shown to be effective with
this patient group, there are cost and access implications. The
alternative method is to use permanent magnets and thereby a static
magnetic field, and this is the area where I think that there is most
scepticism.



The inclusion and exclusion criteria are identified and rationalised.
The knee wrap (real or placebo) was worn over the affected knee for 12
weeks (using the worse knee if bilateral problem). The wrap was worn
while awake (except for bathing) and some basic compliance was also
recorded. Interestingly, exercise and other physical activity was
prohibited during the treatment phase I can appreciate why from an
experimental control perspective though it may seem irrational from a
clinical perspective. Physical activity and drug intake were kept as
constant as possible. The randomisation and blinding procedures are
detailed in the paper. The knee wrap used was a commercial device and
there is not a lot of detail provided with regards its technical
specification other than the magnetic field strength (measured rather
than manufacturers claim) which was at 35mT on the knee wrap surface.
This is a short distance field in that by 17mm from the wrap, the
field was no stronger than the ambient field. The application of the
outcome measures is described, with the isokinetic quadriceps strength
being tested with a Biodex device at both 30 and 60 degrees a second
angular motion. The group sizes were informed by an a priori power
calculation, and analysis was based on an intention to treat analysis
(detailed).



Although 13 patients withdrew from the trial (i.e. did not complete),
only 2 of these reported that it was because they thought the
treatment ineffective. The profile of those who withdrew was not
significantly different from those that remained. A consort type
diagram is included so that the reader can follow all subjects through
the process.



There was no significant difference between the groups at baseline
measure. There was a significant increase in the quadriceps strength
at both 30 and 60 degrees a second. The strength changes are detailed
in the results section, but the key issue is that there were no
significant strength changes in the control group, whilst in the
treatment group, the changes were already apparent by 1 week into the
trial. The changes in HAQ-DI scores decreased in both groups (i.e. got
better) but the changes were significantly greater in the treatment
compared with the control group at week 12. There was a trend for the
pain scores to be better in the treatment group at week 12, though
this did not reach statistical significance (p=0.063). The basic
compliance measures did not identify any significant differences in
use between the groups, though looking at the median and ranges for
the two suggest (to me) that the treatment group appear to have used
the wrap for less hours a day on average than the control group but
this was a very basic compliance outcome measure, and I would not
personally hold a lot of store by the results). There are some
additional and interesting results for which you will need to go find
the original paper.



There is a useful discussion with several interesting and valid points
raised. My own expectation was (before getting to the full results)
that the knee wrap would bring about a differential pain relief
between the treatment and sham groups, and this was likely if
anything, to explain the differences in quadriceps strength changes
measures. The fact that the quads changes appear to be of a greater
magnitude than the pain relief does not actually help to clarify the
mechanism for the clinically significant changes in patient status
observed in this trial. It certainly adds to the slowly growing body
of evidence that static magnetic therapy may have a real effect beyond
the placebo. Whether it is better than using electromagnetic fields as
a method to deliver the energy remain to be seen, but in circumstances
where resources are limited, this treatment option might enable
patients to take away a device which has a useful effect in mild and
moderate OA knee. There is plenty to be followed up on in this work,
and the authors acknowledge some of the trial limitations. The work
does however provide useful additional data to extend our existing
knowledge in this field.



Magnetic Field Therapy Review
Review papers are always welcomed in that somebody has the glorious
task of trawling through the literature and pulling together an
objective consideration of what is out there (this is something that I
actually quite enjoy doing, but I do appreciate that for many it is
simply too time consuming to be doing for topic after topic). Anyway,
Colbert et al (based in the USA) have had a review just published
which looks at static magnetic fields as a therapy and offers a
critical review of that old chestnut treatment parameters (Colbert, A.
P. et al. (2009). "Static magnetic field therapy: a critical review of
treatment parameters." Evid Based Complement Alternat Med 6(2):
133-9). As I mentioned in the previous section, static magnetic fields
get a critical and sceptical audience all hot under the collar in that
it is argued that they are not capable of having sufficient
therapeutic effect (unless dynamic, pulsed or in some other way made
to vary). The review (it is only 5 pages plus references and is freely
available so far as I can see no subscription needed) concentrates on
summarising research conducted on human subjects (leaves out the
animal, cellular and lab work) and includes both patient oriented and
normal subject related trials. Having searched a lot of databases etc,
the authors come up with 56 studies that they reviewed (42 patient
related and 14 healthy subjects). They describe their search and
review method, and their key information : the reported treatment
parameters. Here is another old favourite of this newsletter it is the
treatment parameters, machine output and various settings that are so
often incompletely reported certainly not adequate for replication of
the trial, but neither are the reports adequate to enable further meta-
analysis. This is a great shame if somebody goes to the effort of
conducting some research in an area, and then goes to the trouble of
getting it published, it would be SO much more useful if sufficient
data / parameters were included in the report to enable the work to be
taken further. In this case, almost two thirds of the reviewed papers
carry insufficient critical information.



Given the lack of sufficient detail, the authors work through an
analysis of 10 key treatment issues relating to magnetic field therapy
rather than working through the results of the trials which would be
all but impossible given the lack of detail. The paper was actually
written in 2007, so although it is a 2009 publication, the last couple
of years worth of data will be necessarily missing.



Papers were scored using a quality grading system (described) giving a
maximum score of 20. There were three reviewers (a clinician/
researcher a biophysicist and a product developer). Thirty nine
different clinical pathologies were identified from the 42 clinical
papers, with OA knee being the most popular. The majority of the
clinical trials were of an RCT type design. Only 2 studies of the 56
described all the parameters (10) in sufficient detail and therefore
achieved the max 20/20 score. It would seem that the worst reported
elements were associated with the magnetic device itself (field
strength etc) whilst the more clinically biased parameters (how many
sessions, duration etc) were more commonly reported.



The discussion provides some useful information and will be
particularly relevant to those doing research relating to static
magnetic therapy (gives a checklist of parameters that should be
recorded and reported) and also to those consulting the magnetic field
therapy literature it gives you some points to look for and to note if
they are not there.



I am sorry if this paper does not actually do what you were hoping for
a full evaluation of treatment parameters in this emerging therapeutic
field but I guess the reason for it not delivering is, as the authors
illustrate, in the main because there is insufficient information
available in the publications to make that a realistic possibility.
Read, enjoy and make the most of a lot of work done.




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Pulsed Electromagnetic Fields and phantom limb pain
This is a paper that was from last year, but I did not report it then,
so have taken the liberty of including it in this issue even though we
are half way through the year. Wilkes et al (from the USA) provide a
case study, and while it involves the application of radiofrequency
energy, this is not the type of application that most of you are
likely to be involved with this is a high dose application, and in
fact something that I have reported on a couple of times over the last
few years (Wilkes, D. et al. (2008). "Pulsed radiofrequency treatment
of lower extremity phantom limb pain." Clin J Pain 24(8): 736-9).



Phantom limb pain is widely reported post amputation and there are a
lot of pain management approaches employed (briefly outlined). TENS is
one that I do have some experience of, but the majority of treatment
approaches involve drug therapy or nerve blocks. There was one
fascinating piece of info in the introduction to this paper the
results from a survey of American veterans with phantom limb pain,
showing that only 1% reported sustained benefit from any treatment.
Maybe I was just unaware of the apparent lack of efficacy of treatment
for this problem.



Anyway, this care was from a 63 year old woman who ended up with an
above knee amputation (a revision following an earlier below knee).
The last surgery was 4 years prior to the currently described
intervention. She presented with a complex and ongoing pain history
(described), but essentially had both stump and phantom pain, stump
neuroma and significant disruption to her daily living activities.



Radiofrequency treatment was of the non destructive type which uses
short bursts of RF energy, resulting in a heat build up in the target
tissue which dissipates between pulses (very similar in that sense to
a pulsed shortwave application but at higher energy). The patients
ongoing management is summarised and discussed. Following a temporary
improvement with local nerve block, the pulsed radiofrequency
treatment was applied to her sciatic nerve (using 120 second duration,
temperature of 42 C using pulses of 20ms delivered at 2Hz. She
reported complete pain relief post procedure, and at 1 month follow up
remained free of the phantom limb pain and weaned herself off
medication. By 4 months there was some return and the procedure was
repeated.



Although this particular intervention is not one that is in the
repertoire of most therapists (it is effective classed as a medical/
surgical type intervention, it is (a) interesting to see how effective
it was compared with the normal treatment and (b) presents an
interesting opportunity to carry out some research with therapy type
pulsed shortwave devices to see if they can have a significant
clinical effect at even lower doses?



The discussion includes some review of current thinking on phantom
limb phenomena and also discusses the possible mechanism whereby the
pulsed radiofrequency treatment might be effective (the exact
mechanisms are certainly not yet known).



Shockwave therapy and plantar fasciitis
Another popular topic in terms of the newsletter and given the
increasing volume of evidence out there in relation to Shockwave as a
therapy, you may have found some of the summary info and pages that I
have now put up onto the web site (go the MODALITIES from the main
menu and scroll down from there). This paper from a research group
based in Germany describes a multicentered RCT looking at shockwave
therapy for chronic plantar fasciitis (Gerdesmeyer, L. et al. (2008).
"Radial extracorporeal shock wave therapy is safe and effective in the
treatment of chronic recalcitrant plantar fasciitis: results of a
confirmatory randomized placebo-controlled multicenter study." Am J
Sports Med 36(11): 2100-9).



The trial involved substantial patient numbers (n=245) and essentially
compared a treatment group with a placebo group. The initial
proposition is that although shockwave is considered to be effective,
there was a need for a large scale RCT style trial to provide better
quality evidence. Further more, it is argued that a high proportion of
this patient group recover either spontaneously or with conventional
therapy (cited at around 90%). It is the recalcitrant lesions that are
problematic, and they are the target of this research the most
problematic cases. There are several different types of shockwave
application, and this one (radial shockwave) has a smaller penetration
into the tissues than the focal shockwave treatments (summary on the
web pages if you want them).



The way to get these high patient numbers is to employ a multicentre
design (in this case 3 centres in the USA and 5 in Europe. The patient
allocation, randomisation and blinding (patient and researcher doing
the assessments) are described. All patients had at least a 6 month
history and a condition that had not responded to conventional
treatment. There is a comprehensive flowchart of all recruits and
participants (page 2102) which is a quick and easy way to follow the
trial from recruitment to final follow up. Group allocations were 129
in the treatment group and 122 in the placebo group. There were 3
treatment sessions (real or placebo) 2 weeks apart, and patients were
followed up at 12 weeks post final treatment and then again at a year
post final treatment so we have decent numbers and a useful follow up
period.



The details of the applied shockwave are included in the paper, but
essentially, this involved 2000 shocks per session delivered at 8
shocks per second. The placebo unit was designed to look identical,
and importantly, make the same noise as the real thing. Some shockwave
treatments (the high powered ones) need a local anaesthetic, but this
intervention was an outpatient treatment without anaesthetic delivered
either by an orthopaedic surgeon or podiatrist.



The outcome measures are fully detailed in the paper, and I will
briefly summarise them here : The primary outcome was based on a
composite VAS pain score (3 elements heel pain on first steps in the
morning, heel pain on daily activity, heel pain in response to a
standard local pressure) which is decribed in detail together with
missing data management. These measures were taken at the 12 week and
the 12 month follow ups. Treatment success was also recorded, and the
patients that were followed through to the 12 month period were those
who were deemed to have achieved a successful outcome at 12 weeks
(allowing those who did not get a good result to pursue other
treatments). There were a raft of secondary outcomes which included
the Roles and Maudsley score, SF-36, the investigators judgement of
effectiveness, patient view of treatment satisfaction and whether they
would recommend the treatment to a friend (which I thought was an
interesting one). There is a useful section on statistical analysis,
power (90% on primary outcome) and data management processes.



The results showed that the two groups were no different in terms of
demographics or clinical condition at baseline. The VAS scores showed
a significant reduction in pain for the treatment group over the
placebo group at 12 weeks and at 12 months. For example, at 12 weeks,
the treatment group had a 72% reduction in pain score compared with a
45% reduction in the placebo group. At the 12 month stage these were
scored at 85% reduction in the treatment group and 43% reduction in
the placebo group. All primary and all secondary outcomes were
significantly better in the treatment group compared with the placebo
group. Over 90% of the treatment group patients would recommend the
intervention to a friend (I do like that outcome think I might use it
in future for something . . . .). The reported adverse effects seem to
concentrate on pain and/or discomfort during the treatment and for a
limited period thereafter (minutes rather than anything worse than
that).



There is a well constructed discussion with some useful comparison
with previous work and results. The big differences between this work
and some previous trials appears to be (a) the application of the
therapy at the point of maximum tenderness as opposed to application
at a fixed point for everybody and (b) the application of the radial
shockwave therapy requiring no anaesthesia which appears to be more
effective than the stronger shockwave needing local anaesthetic.
Finally, the study WAS sponsored but a company that make the shockwave
device and some of the authors were supported by that company BUT
there are clear declarations of these associations and a categorical
statement that the company did not influence data collection, analysis
or publication.



This is a quality trial in my view. It is strongly supportive of the
therapy over a placebo intervention. The authors have been careful in
their design and have also been careful in their reporting of the
process and their research method including the bits that people often
miss out like how they handled missing data etc. There are criticisms
that one could make, but this is good evidence coming from a well
constructed piece of research and a must read for those with an
interest in plantar fasciitis, shockwave or recalcitrant lesions or
for those who want to read how a well done RCT can be presented.



Dose responses with TENS : A Review of Reviews
There seem to be an increasing number of systematic reviews in the
field of TENS, and somebody commented in a recent discussion that we
will soon have more reviews that we have original RCT papers! This is
a review of systematic reviews presented by Claydon (from NZ) and
Chesterton (from the UK). It raises some interesting points and also
highlights some issues that I am very pleased to see in print at last
namely that some systematic review methodology could be flawed in that
it does not take any account of the applied dose of the intervention
in other words an RCT could score VERY highly on an RCT score system
(because they describe all the right things) BUT if they delivered an
ineffective dose, there is no account taken in the review method so
you could end up with a highly ranked paper which delivered what is in
effect a totally ineffective treatment dose. The result is (in my
view) that the systematic review can come to the conclusion that TENS
is ineffective but that might not be the right conclusion. I know I am
not alone in these concerns, and it would appear that Claydon and
Chesterton are expressing something similar (Claydon, L. S. and L. S.
Chesterton (2008). "Does transcutaneous electrical nerve stimulation
(TENS) produce 'dose-responses'? A review of systematic reviews on
chronic pain " Physical Therapy Reviews 13(6): 450-463).



OK, so back to the paper which sets out to review the existing
systematic reviews which look at the efficacy of TENS for chronic pain
relief with a particular emphasis on dose related effects.

The results (in short) were that they identified 6 reviews, two of
which identified that high intensity TENS was more effective than low
intensity TENS when compared with placebo application, though the
authors raise some points about existing trial quality and review
methodology which need to be taken into account when designing future
RCTs or systematic reviews.



This review of reviews type activity has been carried out previously
(the often cited paper by Sloka and Walsh in 2003 for example) but
have been largely inconclusive due the methodological issues with the
reviewed trials. Given that more evidence has been published in the
period since the 2003 paper, Claydon and Chesterton set out to include
the more recent materials.



The inclusion and exclusion rationale is identified together with the
applied methodology for the review. 6 review papers were identified
though as previously, it was noted that the wide range of outcome
measures employed makes meta-analysis problematic. The VAS and NRS
pain scales are the preferred method of assessing pain as a clinical
phenomenon in chronic pain studies, and if researchers want/need to
use other recording methods, one might be so bold as to suggest that
they should be done in addition to the VAS/NRS systems. The score of
the trials included in the reviews was not that impressive (ranging
from 1.9 to 3.5 out of 5) though none of the trials appear to have
been excluded on the basis of low methodological quality. It appears
the the reviews were equally split between positive and negative
findings. The papers reviewing TENS for chronic pain, chronic low back
pain and rheumatoid arthritis were inconclusive (this may have
something to do with the recent NICE decision not to support TENS in
the management of low back pain). The other three reviews (looking at
chronic musculoskeletal pain and OA knee) concluded that there was a
positive effect of the therapy.



This (Claydon and Chesterton) paper goes on to look at specific
clinical problems and TENS (RA hand, chronic low back pain, OA knee
and Chronic pain). They also go on to look in some considerable detail
at the breakdown between positive and negative trial outcomes against
the high and low quality trial methodology.



The discussion is useful and is a MUST read for anybody involved in
TENS (or similar) research and for those looking at RCT methodology
issues (even if you do not agree with all the ideas and conclusions).
For example, only 5 of the 24 RCTs reported in all the reviews had a
sample size which gave adequate statistical power to detect a large
treatment effect this is critical. It is great to do research in the
clinical arena, but to go to the effort of setting up an RCT and then
not to recruit adequate patient numbers is a great shame. The results
are under powered and the conclusions may not be entirely correct. The
fact that these underpowered trials are then included in the
subsequent systematic reviews further compounds the error. It is
pointed out (in case you think that I am trying to hide it) that of
the high quality trials that had sufficient power (n=5) showed
negative results. The smaller (underpowered) trials had a greater
tendency to provide positive findings.



This review paper then goes on to look at outcome measure issues and
dose responses, again looking at the differences in outcomes between
low and high quality trials and between underpowered and sufficiently
powered papers. In the dose response section, the authors suggest that
when looking at sufficiently powered trials (RCTs), both high
intensity, high frequency TENS applied locally and low frequency, high
intensity TENS applied at a remote location produce a large
hypoalgesic effect.



There are SO many problems with the research methodology (of the
original trials and the subsequent systematic reviews) that the only
(obvious) conclusion is that more work is needed BUT the additional
work needs to be of sufficient quality and power to enable safe
conclusions to be reached. The authors of this paper have made
considerable effort to analyse not only the original trials but also
the quality of the systematic reviews carried out to date. The point
that they make is that a systematic review can come to an unsafe
conclusion (my words, not theirs) but not taking into account all the
relevant factors, and hence one should remain cautious when reading
such a review. There are serious implications for researchers and
methodologists which are worthy of consideration.



Electrical stimulation and OA knee
SO, lets move away from reviews of reviews, and even RCTs, and have a
look at a series of case reports looking at the effectiveness of
electrical stimulation for OA knee (Fary, R. E. et al. (2009).
"Effectiveness of pulsed electrical stimulation in the management of
osteoarthritis of the knee: Three case reports." Physiotherapy Theory
and Practice 25(1): 21-29). The research group (based in Australia)
look at the effect of sub sensory pulsed electrical stimulation (which
they term PES) taking into consideration symptoms and functional
change.



The authors argue that although one can use electrical stimulation
effectively with OA knee, the majority of the work done so far has
been primarily concerned with pain relief. There is a suggestion from
the growing body of experimental literature that it may be possible to
have an effect on the disease process (i.e. not just the pain) but
that this would involve long term stimulation, and therefore these
case studies were undertaken in order to establish whether there were
short term symptomatic results and to also consider compliance and
comfort issues as a means of trying to establish whether longer term
stimulation (months) would be a viable option.



The treatment in these cases was delivered over a 16 week period for
n=3 patients (2 x F; 1 x M) all aged over 60 with confirmed OA knee.
Two of the patients had a bilateral presentation, and they were asked
to select their worse joint . Some background data on each of the
three patients is provided in the paper.



The stimulation was delivered using a commercially available, portable
(battery powered) device which has been used in previous studies. The
machine output (described by the manufacturers not sure whether these
authors actually tested the output) is : a pulsed monophasic
stimulation with an exponentially decaying pulse of 2ms duration. The
stimulation is delivered at 100Hz using skin surface electrodes and
conductive gel. The electrodes are held in place with a Neoprene wrap,
with one electrode (cathode) placed over the anterior patella and one
(anode) over the anterior thigh. The intensity was determined by
turning up to a sensory level and then reducing until the sensation
was no longer felt. Patients were advised to use the device for at
least 8 hours a day, and it was advised to do this at night (for
convenience). A compliance meter built into the device recorded actual
usage.



Outcome measures were numerous, recorded at baseline, 4 and 16 weeks
(pain, function, global assessment and quality of life) whilst others
were recorded less frequently (ambulatory activity levels (0 and 16
weeks) and global perceived effects (16 weeks only). Pain was recorded
using a VAS scale. Function with a questionnaire, though there was no
comment regarding its derivation or established validity/reliability
with this population. Patient global assessment used an established
scale as did quality of life (QoL) the SF36 and the perceived global
effect scale. A small accelerometer was used to measure physical
activity, and this has also been previously employed in such trials.



Even though this was a small study (with n=3) there are a lot of
results (detailed in the paper). In summary, two of the three patients
reported being considerably better after the 16 weeks of therapy,
whilst one patient reported no overall change in condition. Clearly
much more detail is available in the results section.



The usage (compliance) is recorded at between 562 and 915 hours over
the 16 week period (8 hours a day for 16 weeks gives just under 900
hours use). No problems were reported with machine use and tolerance
appears to be good.



The trial did not set out to establish whether this was an effective
therapy or whether it achieved disease modification.. It did set out
to see whether there was any benefit (on multiple scales) and whether
there was patient compliance and tolerance. The intervention did
appear to be effective in 2 of the three patients. Its was well
tolerated and therefore there appears to be a justification for
running a well controlled RCT something which one looks forward to
reading all about.



Muscle stimulation and bone loss
I get frequently asked about the potential value of various
electrotherapy modalities in terms of osteoporosis and associated bone
loss problems and at the moment, there is a raft of evidence, but
nothing conclusive that I have seen in the clinical research
literature (though, as ever, I may have missed it). Anyway here we
have a fascinating report concerned with the potential benefit of
electrical muscle stimulation as a means of limiting bone loss though
it is a lab study on rats so dont get THAT excited about treating your
osteoporotic patients it may well work, but this is not a clinical
trial in humans but never the less, this is interesting and
potentially valuable stuff.



The researchers (based in New York) have published in Bone (Lam, H.
and Y. X. Qin (2008). "The effects of frequency-dependent dynamic
muscle stimulation on inhibition of trabecular bone loss in a disuse
model." Bone 43(6): 1093-100) and I will provide a brief summary of
their work. Their stated objective was to evaluate the effect of
dynamic muscle stimulation on disuse atrophy of trabecular bone and
furthermore to look at the effect (if any) of different stimulation
parameters (frequency). The work was completed using rats, and an
established model for bringing on a disuse atrophy (using hindlimb
suspension). 56 rats were divided into 7 groups. One (the control) got
only the hindlimb suspension. The others received muscle stimulation
at varying frequencies (1, 20, 50 or 100Hz) for 10 minutes a day, 5
days a week for 4 weeks. Analysis was performed of both metaphysis and
epiphyseal regions of the distal femur using tomography and
histomorphology.



The authors pain a succinct but useful background picture
rationalising why this approach might be useful and a summary of some
of the key previous work in this field (worth a reads in its own
right).

The method for the hindlimb suspension method is described. The groups
(4 of them) which received the stimulation were anaesthetised during
the 10 min stim period, and electrodes were applied to upper and lower
lateral quads. The stim (at the appropriate frequency) was applied in
a 2 sec on : 8 sec off protocol to minimise fatigue. The stimulation
itself was very simple (1ms square wave pulse) at 1 or 20 or 50 or
100Hz. The animals were sacrificed at 4 weeks and the lower femur was
subjected to both tomographic and histomorphologic testing (full
details provided I will not replicate them here) though there were 3
different metaphyseal test zones and one epiphyseal test area. There
was a significant body weight loss in all the test groups, but it was
no different in the suspension without stimulation vs the suspension
with stimulation groups.



In the metaphyseal regions of the distal femur, there was significant
trabecular bone loss (quality and quantity) in the control groups. The
animals in the stimulation groups showed highly significant
improvement in bone state, though this was much less apparent with the
1Hz stimulation, and although the 100Hz stim group were better off
than the controls, this was not significant. Looking at all the bone
regions tested, the 50Hz stimulation appears to have produced the best
results of the 4 stimulation options. The data showed therefore that
what the authors call mid range stimulation (the 20 and the 50Hz) was
capable of preserving bone mass, trabecular number and connectivity.
There is a useful consideration of the mechanism in the discussion. It
is strongly possible (from this and other studies that I have read)
that the induced muscle contraction produces a physical force on the
bone and this is the likely mediator of the observed effect. There are
some limitations of this particular work mainly that they looked at
bone formation and did not look at bone reabsorption (authors
acknowledged) but at the end of the day, this provides some very
useful lab based data looking at the potential benefit of muscle
stimulation as a means of tackling osteopenia. I can think of a dozen
clinical trials as a follow up to this one and I am sure that we will
see some coming through in the reasonably near future.



Mechanical transduction and bioelectric field strength
For those of you who have heard me talk on the tissue repair study
days or who have read some of the stuff that I have published on
tissue bioelectrics, will know of my ongoing interest in this field.
This paper (which you may have missed unless you were going hunting
for it) from Hart in the USA (Hart, F. X. (2008). "The mechanical
transduction of physiological strength electric fields."
Bioelectromagnetics 29(6): 447-55) looks at endogenous bioelectric
signals, mechanics and glycoproteins. This may not instantly grab you,
but if you are delivering electric fields to the tissues, it is argued
that they have effects on cells, and that these effects have a
mechanical intracellular component. One has to consider how the
applied field can result in mechanical changes a transduction process
and this paper takes a comprehensive look at just such a thing. There
MAY be another element in that if you are applying mechanical stress
in the first place (manual therapy, exercise, manipulation,
mobilisations etc etc) there might be an important bioelectric
consequence of your therapy and the bioelectric intervention model
(something that I am currently working on) might just be partly
responsible for how your therapeutic effects are achieved so dont jump
over this one even if you do not like the maths and the modelling!



Hart argues that the mechanical transduction of electric fields is a
plausible mechanism for electric field effects i.e. that the applied
electric field can bring about intracellular mechanical effects via a
glycoprotein structure. Hart argues that this effect is most likely to
be important at low frequencies (below 10Hz) and at higher
frequencies, it should be less apparent. Hart does not suggest that
this mechanotransduction effect replaces voltage gated models already
written about indeed, he proposes quite clearly that this is likely to
be an additional component rather than as a replacement for existing
explanations. I do appreciate that most of you will not find this
stuff that exciting, but if you are into trying to identify how
applied electric fields might be able to have their physiological and
hence, therapeutic effects, then this paper might just be for you. It
needs further development, and has some limitations (which are
acknowledged), but there are a range of possibilities that open up IF
this effects is substantiated in further experimental work.



Electrical properties of acupuncture points and meridians
Another paper from Bioelectromagnetics (a great journal in my books)
and another topic that comes around every now and again acupuncture
points, meridians and bioelectric properties. This one is a systematic
review from a group predominantly based in the States (Ahn, A. C., A.
P. Colbert, et al. (2008). "Electrical properties of acupuncture
points and meridians: a systematic review." Bioelectromagnetics 29(4):
245-56).



Both acupuncture points and meridians are widely held to be points of
low electrical resistance on the skin surface (though of course, this
is a very Western approach to the TCM philosophy) and many devices
claim to identify the location of these points and meridians by
finding the points of low resistance. This is the first systematic
review I have seen in this field though I think I have seen most if
not all the papers to which it refers. This review aimed to review and
summarise the studies which have looked at acupuncture points and
meridians to see if there is any substantive evidence that they are
electrically different or distinct.



A search strategy was employed (identified in the text) and limits
were placed (such as English language papers which is a bit of a
limiter in this field, no animal studies, clinical significance
papers, no controls etc). A review methodology was developed (by a tem
of people covering a wide range of research, clinical and academic
skills) and the employed method is described. The original number of
papers (over 1600) was swiftly reduced to 320 of primary interest and
after further evaluation, 16 papers (representing 18 studies) were
fully evaluated.



There are several pages describing the reviewers findings and it would
be both impossible and inappropriate to fully replicate their work
here this is intended to provide a straightforward overview. Each
section (acupuncture points and meridians) is dealt with firstly by
looking at the data obtained and secondly offering an interpretation
of that data.



In terms of the acupuncture points, most of the trials were of low
quality with small sample sizes (the mean was n=13). Most of the study
participants were non injured (healthy) volunteers, and the actual
measurements taken using DC or low frequency currents (hence the
resistance or impedance/conductance was what was measured). Five of
the 9 studies in this group showed an association between acupuncture
points and lowered electrical resistance or impedance BUT the higher
quality studies (as judged by the review specific criteria) failed to
demonstrate such an association. There were differences in methodology
(there are two basic ways of doing this (a) find the points and then
measure the electrical characteristics at that point or (b) to scan
for points of low resistance/impedance and then look to see if they
correlate with an acupuncture point. There are problems with both
approaches (discussed). In view of the diversity of test methods
employed, it is difficult, if not impossible to carry out any real
meta-analysis. There is considerable debate, even within the
acupuncture community about the size, location and relative
distribution of these points, and there is just as much debate between
researchers in this field. The authors of this review take some
trouble to look at these differences and try to rationalise why
different experimental protocols may have come up with very different
and even conflicting results. They do not proffer definitive answers
(in my view) but they do make a valuable contribution to the debate.



In terms of the acupuncture meridians, the studies appear to be of
generally higher quality with more subjects recruited and in terms of
the methodology appear to be more sophisticated. Severn of the 9
studies showed a positive association (one was mixed and one showed no
relationship). Once again the studies involved normal healthy
subjects. The results are more complex than that, and those of you
with an interest in acupuncture or tissue bioelectrics will
undoubtedly want to look at them in a whole lot more detail. Generally
though, lower impedance measures seem to be the order of the day far
more consistently with the meridian studies than for the point
studies. Even with the better studies for the meridians, the authors
of this paper suggest that the evidence is inadequate to conclusively
state that the meridians are sites of lower impedance and higher
capacitance compared with non meridian skin.



As with almost all systematic review (that I get to see anyway), the
main conclusions were that there was no definitive evidence one way or
the other, and in part this may be due to small sample size, weak
methodology and of limited scope (mainly upper limb in normal
subjects). The evidence supporting the concept that the meridians are
different is stronger than the evidence to support the same claim for
the acupuncture points. Better studies are needed and if nothing else,
this review highlights the points that need to be addressed in order
to raise the quality of future work. This is a good review paper. You
may not find yourself in agreement with the reviewers, and you may
feel that the limitations of this systematic review limit the strength
of the conclusions, but it does make for an interesting read (but I
almost always say that!) and provides a platform from which further
work can be planned and undertaken.



Whole body vibration and bone density
Another recurrent and emerging theme in the newsletter is concerned
with vibration as a therapy so here is a paper from Sweden (Rehn, B.,
P. Nilsson, et al. (2008). "Effects of whole-body vibration exercise
on human bone density - systematic review " Physical Therapy Reviews 13
(6): 427-433) which looks at vibration exercise and bone density and
it is another systematic review (such joined up planning in this
edition!). There is a LOT of talk around out there about the
beneficial effects of the combination of exercise and whole body
vibration, but many practitioners are unsure of the validity of this
approach they are sceptical and to a large extent, this might relate
to the public awareness and PR work in this developing area.



The reviewers review both the lay and the scientific rationale for
combining exercise and vibration normally involving light exercise on
a vibrating plate or platform. The effectiveness of this therapy on
muscle strength, especially in the lower limb has been previously
identified. This review looks at it from the perspective of bone
health and particularly, bone density. The review only looks at work
in humans and is only concerned with studies where bone density was a
primary issue. Literature was identified through standard searching in
various databases, but also looking through the grey literature to be
commended. Each paper was reviewed and analysed by two reviewers and
scored against a Pedro scale (widely used and cited though it has been
criticised as a method). In addition to the Pedro score, a whole body
vibration exercise (WBVE) scale ws employed which specifically
considered the intervention parameters. 169 papers were initially
identified, 26 of which were of interest and 9 of these were
eventually selected for review.



The results (in brief) showed that 8 out of the 9 studies demonstrated
a positive effect for WBVE on bone density compared with either a
control condition or a weight bearing system. Five of the positive
studies produced significant results whilst the other three showed
improvement, but that it was not statistically significant. The
increases in bone density were shown in differing locations in
different studies. Bone density increases in the back, hip and
proximal tibia were shown as were cortical changes in the tibia (most
used DEXA as the primary outcome measure). The vibration parameters
fell into a relatively confined range with vibration frequency
typically being between 12 and 45Hz and vibration amplitude in the 0.7
4.2mm range, and the majority of the selected studies using primarily
a vertical displacement. Five of the selected studies considered the
effect in post menopausal women whilst the others looked at various
combinations of young people (often girls) with and without
concomitant health problems.



The evidence summarises into a moderate category, and furthermore, the
authors conclude that the improvement in bone density for post
menopausal women is not superior with WBVE compared with weight
bearing and resistance training methods (though some would argue with
this stance I have no doubt). There are further areas where more
detailed work is needed (as you might expect) and amongst these are
the best parameters for the vibration platform. The authors do
conclude that there IS moderate evidence for the use of WBVE as a
training modality to increase bone density in post menopausal women.
There are many further options for investigation (possibly as a
preventative intervention, maybe as a treatment for those with
generalised osteoporosis the sedentary elderly for example), and hence
further work is needed. For those of you who have not delved into this
literature thus far, the review would be a very useful introduction
and summary of the current (2008) evidence. For those who already have
an interest in this field, it will provide a reasonably comprehensive
consideration of the literature.



Whole body vibration and physiological effects
Following on from the previous review paper, here is another one
concerned with whole body vibration exercise but considering both
young and older people, and from what I can see, it was not included
in the Rehn review most probably because it explicitly did not look at
bone density changes (Cochrane, D. J. et al. (2008). "A comparison of
the physiologic effects of acute whole-body vibration exercise in
young and older people." Arch Phys Med Rehabil 89(5): 815-21). The
research team are based in NZ and the UK. 12 healthy young people
(mean age 21) and 12 healthy older people (mean age 69) were recruited
for this work which was conducted in a lab (university) setting in the
UK. This study was not looking at bone density per se though the
background arguments are to a great extent the same as those provided
in the preceding review. One of the key differences between this study
and others is that each subject undertook a series of 9 difference
test conditions in a static ½ squat position with varying loads
applied (described in the methods section). The order of exposure was
randomised as one might expect. Each intervention was of 4 minutes
duration followed by a 30 second rest. The tests were conducted over 2
visits with at least 24 hours between sessions and a maximum of 5 test
conditions on a visit.



Given the 9 different test combinations, the method would take too
much space to detail here but at least Archives Phys Med Rehabil
should not be too difficult for most of you to access if you want the
detail.



The outcome measures were related to various physiological parameters
and several peripheral measures (such as normal activity during a
week. Various anthropometric measures (height, weight, skinfold
thickness, limb length) were taken plus VO2, heart rate, blood
pressure and a rating of perceived exertion during the activities.



At the end of the day, both vibration and load increased the VO2
scores in older and younger groups with the vibration increasing VO2
by almost 20%. The WBV also increased heart rate (as did load). There
are a lot more results than this go grab the original for the detail.



The authors summarise the findings thus : It is suggested that in both
young and older people, VO2 was significantly enhanced with vibration
and an additional load. The WBV was found to affect VO2 in older and
younger people in a very similar way but that the metabolic response
to vibration appeared to be slightly lower in the older subjects than
in the younger subjects.



There are some issues and limitations with this paper the authors
identifying some of them. The older people being tested were certainly
not a classic sedentary group they appear to have beeen somewhat more
active than average and that may have influenced the results. I was
also surprised by the ½ squat position for the testing though I can
certainly appreciate why, from a methodological viewpoint it was
advantageous most similar studies use a variety of standing positions
though with the knees bent so there are some similarities. Anyway,
this adds useful data to the evidence pot.



The last papers in the edition are concerned with various aspects of
tissue injury and repair . . . . .



Trigger point inflammation
Here is the first one which strictly is neither tissue injury or
repair but it does look at inflammatory markers at myofascial trigger
points in a complex study on normal subjects and is certainly of
interest in this regard. The research team (from the USA) undertook
the study in an attempt to determine the presence and concentrations
of numerous biochemical markers in samples taken from active, latent
and non trigger points (trapezius and gastrocs) and have come up with
some interesting results (Shah, J. P. et al. (2008). "Biochemicals
associated with pain and inflammation are elevated in sites near to
and remote from active myofascial trigger points." Arch Phys Med
Rehabil 89(1): 16-23).



It is suggested that MTPs (myofascial trigger points) are very
frequently present in patients who experience chronic pain disorders.
They are tender, sensitive and not only present as a sign on
assessment but also used by many therapists as a part of their
treatment programme (not what this paper is about - I am just making
an observation). The research team have previously developed a needle
based sampling system which enables the collection of tissue fluid
whilst being minimally invasive. The aim of this study was to look at
the biochemical milieu of substances associated with pain and
inflammation in an active MTP in upper fibres of trapezius and further
to compare the data with samples from latent (non active) UFT trigger
points, samples from the UFT where trigger points are absent, and also
from samples obtained from a remote (uninvolved) site in the upper
medial gastrocnemius. Interesting proposition . . . . so read on.



Nine subjects were recruited from a normal population. The recruitment
and exclusion (both important issues) are detailed in the paper.
Subjects were divided into 3 groups based on assessment findings :
ACTIVE (MPT present, idiopathic cervical pain <3 months, n=3
subjects) : LATENT (MTP present, no cervical pain, n=3 subjects) :
NORMAL (MTP absent, no cervical pain, n=3 subjects). The procedure
involved the use of this novel instrument using a variation on a theme
of a 30 gauge needle (detailed in this and previous publications).VAS
pain scales and pressure algometry (pressure pain threshold PPT) were
taken at set points. The penetration of the needle into the point is
detailed in the paper (too much information for most readers here). 22
samples were taken from the trapezius and a further 10 from the
gastrocnemius and were then subjected to several biochemical assays
looking for 9 different chemicals [bradykinin, substance P, calcitonin
gene related peptide, tumour necrosis factor alpha, interleukin 1B,
interleukin 6 and 8,serotonin and norepinephrine and also the pH of
the fluid (sorry for those who want to see all the abbreviations and
symbols for these chemicals I can do it on my computer but GUARANTEE
by the time I e mail the newsletter to you, it will end up as a
garbles mess).



There are some predictable and some surprising results. The active
group had higher pain scores on the VAS (that is predictable) and they
also had lower pressure pain thresholds (as you might expect) BUT they
were also lower when taken over the gastrocnemius point not just the
UFT area though the PPT differences were not significant (all leg
pathology and pain had been ruled out at baseline screening so it was
not a local event).



In terms of the biochemical screening, there were lots of tests from
lots of samples, so the results are long with lots of plots in the
original paper (though they are easy to read) Some of the active group
data was combined with data from a previous experimental study as
there were no statistical differences in the separate results. The
concentration of all markers were significantly higher in the active
than in the latent or normal subjects with the exception of pH which
was lower. There was no overall difference between the latent and the
normal group data. There were also differences in the gastrocnemius
data between the three groups. Similar to the trapezius results, the
concentrations were higher in the active than the latent and the
control groups and once again, the pH was significantly lower in the
active group. Further statistical testing showed that the
gastrocnemius concentrations were lower in the gastrocnemius than in
the trapezius samples. There were some minor variations, but this is a
reasonable summary of the data. For the full set, as ever, head for
the original paper and see the tables and plots for yourself.



In conclusion that authors have demonstrated that chemicals associated
with pain and inflammation are significantly raised in the vicinity of
active MTPs, confirming previous results. The inclusion of
interleukins 6 and 8 (not tested previously) is a new result. The data
also suggest that the raised levels of these chemicals is not confined
to the local area given that they were also raised in the
gastrocnemius of the active group compared with the normal and latent
groups though these levels were not elevated to the same extent as in
the trapezius test data. There are some interesting links drawn
between this test data and the more clinical models put forward (by
Simons for example) and if you use trigger points in either assessment
or therapy, you would be well served to consider the discussions
points made. Links are (potentially) made between the raised
gastrocnemius concentrates and central sensitisation, though given
that central sensitisation was not assessed, this remains a
hypothetical (though interesting) proposal. The study has limitations,
and the most obvious one, which the authors acknowledge, is the very
small sample sizes though they do defend this on the basis of having
achieved a significant result even under these circumstances.



Although one might be able to criticize the experimental approach on
several levels, this remains, in my view, a fascinating paper and one
that will be looked at over and over (I suspect) by those working more
intimately with trigger points. My own interest, in the biochemistry
of the inflammatory events, was certainly fired up by this data and I
look forward to further studies along these lines.



Achilles tendinopathy : exercise and brace research
A brief summary of the last few papers I am running out of time and
space here though it is certainly not because they are uninteresting
research publications! Petersen et al (mentioned previously in this
publication) have published the results of an RCT comparing the effect
of eccentric training and an Air Heel brace on patients with Chronic
Achilles Tendinopathy (Petersen, W. et al. (2007). "Chronic Achilles
tendinopathy: a prospective randomized study comparing the therapeutic
effect of eccentric training, the AirHeel brace, and a combination of
both." Am J Sports Med 35(10): 1659-67). This is a 2007 paper, but it
is included her as I have not mentioned it before, though I should
have done so, and because it fits with the Achilles tendinopathy
papers put together in this final section.



The basic structure of this RCT was to take a group of patients with
chronic Achilles tendinopathy (n=100) and divide them into three
groups. One group were managed with an eccentric exercise programme,
one group with the AirHeel Brace and one group with both
interventions. Measurements were taken at baseline and then at 6
weeks, 12 weeks and 54 weeks so we have an RCT with decent numbers and
with a long enough follow up to provide useful data.



The outcomes included the VAS pain score, and ankle score based on the
AOFAS hindfoot scale and an SF-36 for quality of life issues plus an
ultrasound scan. The short version of the results indicates that there
was significant improvement in all three groups, and after analysis,
there was actually no significant differences between the improvement
obtained. The fact that the AirHeel Brace is as effective as the
eccentric exercise programme might be a surprise to some but that is
what these results would suggest. It is also shown that combining the
brace with the eccentric programme does not seem to add anything of
significance to the outcome. The AirHeel brace is a specifically
designed brace for this patient group and it provides a pulsing
compression via two interconnecting air sacs which, it is proposed,
heals to reduce both swelling and discomfort though to date this has
not be unequivocally established through any reported trial. All the
patients in this study were recruited through local paper adverts and
all had a problem with a minimum duration of 3 months.



The eccentric training programme is described. Patients were
instructed in these exercises, were provided a written instruction and
they were checked at 6 weeks to make sure they were doing them
correctly. Exercises were to be done 3 times daily, 7 days a week for
the 12 week period. Those using the brace were instructed to wear it
during the daytime



There are more results than I have intimated here. In addition to
those mentioned, it was noted that there was no change in tendon
diameter (based on the ultrasound scans) from the baseline measurement
in any of the three groups. Although the official results indicate no
gross difference between the three groups, there were some outcomes
and some time points where the combined group had an apparent
advantage even though it may not have been statistically significant.
There are two key issues in my mind here. One is that the eccentric
group did not demonstrate as good an outcome as has been reported in
some previous trials something noted by the authors, but not really
explained. Secondly, that the AirHeel brace used alone, appears to
have had just as good an effect on the outcome. Both issues need
further work, but for those with an interest in this field of therapy,
the results should be of interest. Chronic Achilles tendinopathy has
certainly been shown to be one of the most problematic and most
recalcitrant lesions which therapists are asked to manage, (Poltawski,
Watson and Byrne 2008) and anything which contributes to our knowledge
of effective treatment programmes is to be welcomed.



TA microcirculation and cryotherapy
Knobloch et al have been cited in previous Electrotherapy Newsletters
(Vol 2 Issue 2 and Vol 2 Issue 4), so they are certainly not newcomers
in this research field. They have a paper from last year which, as the
title suggests, presents the results of a lab study which evaluates
microcirculation changes in the mid portion of the Achilles with ice/
compression combined against the effect of cryotherapy alone
(Knobloch, K. et al. (2008). "Midportion achilles tendon
microcirculation after intermittent combined cryotherapy and
compression compared with cryotherapy alone: a randomized trial." Am J
Sports Med 36(11): 2128-38).



This study involved n=60 subjects who were uninjured volunteers,
divided at random into two groups : one receiving cold therapy alone
(using the KoldBlue system, previously reported in this publication)
and one receiving cold therapy combined with compression (using a
CryoCuff system which will be familiar to most of you even if you have
not used it). The introduction to the paper briefly discusses the
salient issues including the microcirculatory issues associated with
Achilles midportion and insertional tendinopathy, cold therapy and
previous research evidence. It also introduces the key outcome measure
(O2C) which evaluates capillary blood flow, tendon oxygen saturation
and postcapillary venous filling pressures (again, all of which I have
commented on in this newsletter on previous occasions).



The paper includes a clear CONSORT diagram which enables the reader to
follow all recruits through the trial process. These subjects were
recruited from sports clubs and from the university of the lead
author, and were effective healthy normals (i.e. not chronic
tendinopathy patients). The profile for participants including
baseline and demographic data are reported, and they seem to be
consistent with equivalent data obtained from previous studies.



The outcome measures were centered around the use of the O2C system
which combines laser Doppler and flowmetry to measure microcirculation
changes in both the deep (8mm) and superficial (2mm) tissues and the
reliability of this system has been previously evaluated, giving no
more than 5% variability within subjects. There is (in my view) a lack
of some methodological detail in this paper regarding the actual
application of the therapy. Certainly, whichever group the
participants were in, they got 3 x 10 minutes application of the
therapy each followed by a 10 minute rest period. The treatment were
delivered with cold water/ice mix at 15 degrees C one delivering just
the cold and one the cold combined with a pressure (the CryoCuff). The
treatments were applied to the ankle such that the midportion of the
TA was included I the treatment zone. The total test time was for 60
minutes and the participants were supine throughout. The O2C probe was
applied at a fixed (measured) point on all subjects (which one might
argue with in that if you are 2.5m or 1.8m tall, then a point 4cm
proximal to the distal attachment of the TA is not the same equivalent
position). In addition to the O2C system, participants were also asked
to report their cold perception score (scale 0 10) as a subjective
outcome.



The results in the main paper are detailed, and (as ever) I will
summarise for the sake of brevity and of copyright! Subjectively, the
participants felt the maximal cold sensations at slightly different
times during the three interventions and with the different
applications, but typically between the first and second minute of
application, and the amount of cold felt looks pretty similar with
both applications. The recovery appears to be slightly faster with the
CryoCuff applications. In terms of the capillary flow, there was no
significant difference between the two applications (deep or
superficial) during the interventions. There was however a significant
difference during the recovery period, with the CryoCuff participants
recovering faster (deep and superficial).



The oxygen saturation results are a bit more complex (though fully
detailed), but in summary the saturation levels decreased during each
application period (more so for the CryoCuff) and there was a recovery
(greater than baseline) during the recovery phases this too was
significantly greater in the CryoCuff group. The postcapillary filling
pressures decreased during the cold application (deep and superficial,
both applications), with a recovery during the rest intervals, which
appreas to be a stronger response in the CryoCuff group.



Overall then the responses for the CryoCuff group appear to be
stronger both during the applications and in the recovery phases and
therefore the authors argue that the CryoCuff gave the better response
to treatment, and therefore conclude that 3 x 10 minute intermittent
applications of cold therapy using the CryoCuff system is superior to
applying cold alone (i.e. no compression). There are limitations with
the study (discussed) and it needs to be noted that this particular
RCT was carried out on healthy volunteers not patients, and none of
the participants had either an injury or any kind of TA problem so it
would be interesting to see how the results transfer to a patient
population. In the meantime however, the knowledge base has been added
to and more is known abut the differential effects of different
methods of cold application.



TA microcirculation and tissue loading
Carrying on with a similar story, Malliaras et al (doing some
excellent work in tendon issues) have looked at TA blood flow with
loading (though this time in an athletic population) (Malliaras, P. et
al. (2008). "Achilles tendon Doppler flow may be associated with
mechanical loading among active athletes." Am J Sports Med 36(11):
2210-5).



The recent considerations that TA blood flow may in fact be a
contributor to pain and discomfort in some patients is still under
discussion (beyond the scope of this newsletter) but the bsic idea in
this care goes like this : it has been suggested from previous work
that flow changes have been demonstrated in the region of abnormal
imaging for between 50 and 100% (depends on the trial) of patients
with TA pain, leading to the use of sclerosing injections to try and
deal with the problem. In athletes some with painful TAs have shown
circulation problem and it is suggested by the authors that this might
be a load related phenomenon. The primary aim of this work was
therefore to look at tendon blood flow, using a ultrasound Doppler
technique and to look at the association between presenting pain and
the flow in a group of active athletes. The second aim was to look at
the association between flow and activity levels (my paraphrase).



The participants in this study were Badminton players (mixed ability
some at national level and some at club level), who played at least 1
x weekly. They were assessed using both ultrasound imaging including
colour Doppler and pain measures together with an index of their
activity levels. Pain levels and function were assessed using the VISA-
A (8 item questionnaire previously reported in the newsletter) which
has previously been shown to be reliable. The ultrasound scanning
technique that was employed is detailed in the methods section. The
participants were scab=nned following a badminton activity (of varying
duration, depending on their level). Tendons were categorised as to
their normality and any abnormality was recorded. Colour Doppler was
used to assess tendon vascularity, counting the number of vessels.
Full details are described.

Sixty one players were recruited (24 elite and 37 recreational). 13 of
the 61 self reported TA pain and 2 of these had bilateral issues
(giving 15 tendon problems in the total group).



The results (abbreviated) showed that there was no significant
association between blood flow changes and pain and this was not
influenced by the players level. There sis appear to be a relationship
between the lower scores on the VISA-A questionnaire and the presence
of Doppler flow changes. The number and length of the visualised blood
vessels did not vary with reported pain. The US scans showed abnormal
findings in 12 of the 13 tendons with midportion Doppler changes, and
there was a significantly greater AP dimension of the tendon in those
with Doppler changes.



In terms of reported badminton activity and Doppler changes, those who
had been playing for longer were significantly more likely to have the
Doppler changes. Age, gender, level of play or hours of badminton a
week did not demonstrate significant association with the Doppler
changes.



There are more results plenty of table data and more statistical data
than I have reported here, but this will give you the main trust of
what was found. The strongest findings were that the longer a player
had been playing, the more likely they were to have the Doppler flow
changes, and there was a (non significant) trend for there to be a
link between hours a week played. Only just over 20% of the tendons
evaluated in this study showed a Doppler flow and only 20% of these
were associated with TA pain. The authors suggest that the presence of
Doppler flow may be a sign of adaptation to increased mechanical
loading rather than being linked to the pain findings. Given the
complexity of the vascularity / pain / tendinopathy etc discussions
which are ongoing, this study adds to the debate, but from my point of
view, does not actually provide sufficient information to resolve the
issue not that it was a bad piece of work in any way just that the
results do not allow the issue to be resolved yet . . . . . . . .



Eccentric exercises and Achilles tendinopathy
The final paper for this issue (the next 30 are already lined up!)
looks at eccentric training for patients with chronic insertional
Achilles tendinopathy though it reports the outcome of a pilot study
rather than a full blown trial (Jonsson, P. et al. (2008). "New
regimen for eccentric calf-muscle training in patients with chronic
insertional Achilles tendinopathy: results of a pilot study." Br J
Sports Med 42(9): 746-9). The group (mainly from Sweden with
Australian overtones) argues that although eccentric training
programmes have been shown to be effective for patients with
midportion TA problems, it appears to be less effective for those with
insertional TA presentations. They aimed to evaluate the effectiveness
of a new type of eccentric training for this latter group.



27 patients with a total of 34 painful insertional TA problems were
recruited. All had a long standing problem (mean of just over 2 years)
and undertook a new programme of eccentric exercise that did not load
into dorsiflexion (the current normal). The exercises were performed 3
x 15 repetitions, twice a day, 7 days a week for 12 weeks. Pain and
return to activity were the primary outcomes. The results suggest that
some two thirds of the patients were satisfied with the outcome and
were back to their previous activity, with a mean pain reduction from
almost 7/10 to just over 2/10. Nine patients (11 tendons) were not
satisfied (pain from 7.7 down to 5.8. The new exercises appear to be
more effective, but clearly need to be followed up with a larger scale
trial. The exercise (my brief description) involved a heel raise
(using the non painful side), followed by an eccentric phase with a
return to plantargrade standing (i.e. NOT into a dorsiflexion range).
If no pain was experienced, then a load was applied using a backpack
and dead weights. There is a bit more to the programme than that, but
it covers the essentials as ever, see the full paper for the full
details as indeed you are encouraged to do when it comes to the
results which I have severely abbreviated in my comments above. Given
that just under a third of patients in previous studies have shown a
good response to eccentric training with the exercise taken into a
dorsiflexed position, the two thirds improvement in this pilot is a
good outcome, and would be worth following up (not sure whether this
is planned or not). For those of you treating patients with an
insertional Achilles tendinopathy in the meantime, it might be worth a
try if (as ever) you can get the patients to actually comply with the
regime!



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That will do for now folk. I hope that something in here has been of
some value to somebody . . . . . .

If there are papers that you are aware of (or indeed, have written)
please do let me know and I will do my best to get them included if I
can. The next Issue is scheduled for September 2009.

Regards

Tim

Professor Tim Watson
School of Health & Emergency Professions
University of Hertfordshire
UK

E Mail : t.watson@xxxxxxxxxxx


http://www.electrotherapy.org/index.htm
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