Applications in Musculoskeletal Disorders - part 5 ppt

Fig. 4.8 Semiquantitative radiological grading of
bone growth 5 weeks after SWA. 0: Osteolysis; 1:
Unchanged; 2: Positive reaction; 3: Complete bridging;
N.S.: Not significant.
Fig. 4.9 Semiautomated image analysis of the histo-
logical sections. N.S.: Not significant.
Table 4.1 Radiological evaluation of osseous reaction after creating a defect following ESWT
Subgroups Grade a
1
b
2
c
3
Bridging 3 0 3 0
Positive bony reaction 2 4 13 0
No reaction 1 12 40 13
Osteolysis 0 4 0 7
Mean grade
4
0.9 2.0 0.7
Standard deviation 0.7 0.6 0.5
1
3000 impulses of 0.08 mJ/mm
2
2
3000 impulses of 0.28 mJ/mm
2
3
(Control group) received no SWT
4
Comparison of Group I and Group II showed p 0.05. Comparison of Group I and Group III showed no significant

difference. Comparison of Group II and Group III showed p 0.01.
Discussion
At the beginning of the 1990s, first reports on
the use of ESWT were published that went
beyond the already established disintegration
of kidney stones and gallstones. Valchanou and
Michailov (1991), and Schleberger and Senge
(1992) introduced shock waves to the treat-
ment of delayed union and nonunion of frac-
tures describing phenomena of local decortica-
tion. Noncontrolled, nonrandomized clinical
studiesreportedsuccessratesbetween52%
and 91% (Russo et al. 1995, Vogel et al. 1997).
Unlike in pulsed ultrasound, where excellent
prospective clinical studies have demonstrated
an acceleration of bone healing in fresh frac-
tures and pseudarthrosis (Frankel et al 1996,
Heckman et al. 1994, Kristiansen 1990, Xavier
and Duarte 1987), the published examinations
on shock wave therapy (SWT) did not meet this
quality standard. Accordingly, the results of
SWT must be viewed with caution.
Whereas in pulsed ultrasound the osteoge-
netic effect was clearly related to a piezoelec-
Discussion 29
Table 4.2 Experimental data on ESWA on bone
Author Species Effect
Graff Rabbit Damage to osteocytes,
bone marrow necrosis
Yeaman Rat Epiphyseal dysplasia

Seemann Rat Delay in bone healing
Augat Sheep Reduction in mechanical
stability
Forriol Sheep Delay in fracture healing
tric effect and a low-level mechanical force to
the fracture area, resulting in an increase in
vascularization, in development of soft callus,
and faster enchondral ossification (Pilla et al.
1990), the mechanism of shock waves on bone
is not yet understood.
Histological studies did produce evidence
forstimulationofosteogenesis,butnoquanti-
tative analysis has been presented so far
(Delius et al. 1995, Forriol et al. 1994, Graff et
al. 1988, McCormack et al. 1996, Seemann et
al. 1992). Most disconcerting were reports on
disturbance of bone healing after SWT of
experimentally produced defects (Augat et al.
1995, Ikeda et al. 1999, Yeaman et al. 1989)
(Table 4.2). Recently, Schmitz (2001) reported
on cellular and molecular investigations after
SWA to the noninjured, intact, distal rabbit
femur. 1500 impulses of 0.1, 0.35, 0.5, 0.9, and
1.2 mJ/mm
2
were applied. After fluochrome
labeling, periosteal bone growth was
observed regularly after application of energy
flux densities of 0.5 mJ/mm
2

and more, the
amount of periosteal reaction increasing with
higher energy flux densities. No endosteal
bone growth was observed; no cortical dam-
age was found. However, while there were
only minor signs of collateral damage to the
adjacent quadriceps tendon up to 0.5 mJ/mm
2
,
asignificantdamagetothetendonwasfound
after application of 1500 impulses of an
energy flux density of 0.9 or 1.2 mJ/mm
2
.
The inconsistency of results related to stim-
ulation of bone growth may be attributed to
thefactthatthelithotriptermachines
employed cannot be compared. Ideally, shock
wave generators should be classified by
means of acoustic measurements. Theoreti-
callytheycanbedefinedbytherisetime,
peak positive and negative pressure, duration
of impulse, spectrum of frequencies, size of
focal area, and acoustic energy of every
impulse. At present there are no standardized
hydrophones availabe to produce reliable
measurements of these parameters. Another
reason for the large variation in results is the
use of different animal models (dog, sheep,
rabbit) with various kinds of osteotomies and

subsequent fixation.
In the current study, a defect of 5 mm was
created in the middle to proximal third of the
fibular shaft. We did not observe any bridging
of the gap in the control group radiologically.
On the contrary, on the radiographs we not
only saw no tendency towards bony bridging,
but rather further osteolysis in 30%. After the
application of 3000 impulses of a low energy
density (0.08 mJ/mm
2
)wesawapositivebony
reaction in 20%. This rate quadrupled to 80%
after 3000 high-energy shock waves (0.28mJ/
mm
2
). In histopathology, we did not discover
any signs for deletary effects of the shock
waves, but found significant development of
soft callus and enchondral ossification. In his-
tomorphometry, bone coverage related to the
defect area was significantly higher after the
application of high-energy shock waves.
Of course, the timing of the shock wave
application is critical (Forriol et al. 1994). We
chose the fourteenth postoperative day for the
beginning of treatment because we feared
that earlier treatment would disrupt hema-
toma formation and that later treatment
mighthavenoeffectonnewlyformedbone.

We cannot rule out that an earlier date for
treatment might result in a more propitious
effect on bone healing.
Thesameappliestothenumberofimpulses
and amount of energy flux density adminis-
tered. From clinical studies, however, we had
strong hints for the effectiveness of the cho-
sen parameters. Vogel et al. (1997) performed
only one treatment session because of the
anesthesia required. Since bone repair occurs
by cellular proliferation and differentiation
over a period of several weeks, repeated
4 Dose-Dependent Effects of Extracorporeal Shock Waves in a Fibular-Defect Model in Rabbits30
applications over the course of a few weeks
might have a beneficial effect that we do not
yet know about.
The timing of follow-ups will also influence
the results. Bony healing of an osteotomized
rabbit fibula can be expected after 4 weeks
(Pienkowski et al. 1994). Of course, this will
not be the case after producing a 5 mm defect.
For reasons of sequential labeling and to allow
comparison of the osteotomy and of the
defect group, we chose an identical posttreat-
ment follow-up of 5 weeks, expecting a bony
reaction in the area of the fibular defect.
The aim of the current study was not to
evaluate mechanical stability and possible
acceleration of bone healing. This would have
required sacrificing the animals at various

periods after the SWT, the latest at the six-
teenth postoperative day when a rabbit fibu-
lar fracture is most responsive to stimulation
and stiffness is greatest (Friedenberg et al.
1971). This would, of course, have interfered
with the desired evaluation of sequential
labeling. In our study mechanical testing was
useless 7 weeks after the operation as only
three out of 30 fibulae with a defect osteo-
tomy showed consolidation at this point and
would have been usable for mechanical exam-
ination.
The current results cannot be compared
with pulsed ultrasound in a comparable ani-
mal model (Pienkowski et al. 1994, Pilla et al.
1990, Wang et al. 1994). In these studies non-
displaced osteotomies or fractures were
treated beginning only a few days after opera-
tion. In this ideal situation an impressive
stimulation of bone growth and fracture heal-
ing, as measured with biomechanical testing,
was described.
The current study produced no information
on the biomechanical aspect of the healing of
bone but addressed the issue of a bony reac-
tion to shock waves. Although radiographic
and histological results correlated well, there
was no correlation made with the biomaterial
properties of the healing defects. Further
studieswillhavetorelatethefindings

observed on radiographs and those occurring
in the tissues to the acquisition of load bear-
ing properties, which, of course, is the most
important outcome of fracture or bone defect
union.
Discussion 31
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5 Shock Wave Application for Plantar Fasciitis
Introduction
Plantar fasciitis is one of the most common
painful foot conditions (Atkins et al. 1999,
Crawford et al. 2000, Leach et al. 1983, Young
et al. 2001). The specific pathological features
of this clinical entity are not well understood
(Leach et al. 1983, Ogden et al. 2001). The pain
classically is present when the patient first
stands on his/her feet after awakening; it per-
sistsorisworsenedbyeverydayactivities.
The use of conservative methods will alleviate
the condition in most patients (Pfeffer et al.
1999, Probe et al. 1999, Schepsis et al. 1991,
Sobel et al. 1999, Wagner and Sharkey 1991).
Heel elevation to achieve reduction of loading
of the plantar fascia is being controversially
discussed (Kogler et al. 2001). Steroid injec-
tions into the painful area also have been used
(Martin et al. 1998), but are associated with a
significant risk of subsequent rupture of the
plantar fascia (Leach et al. 1983).
Plantar fasciotomy is not without signifi-

cant risk and may be associated with pro-
longed healing and postoperative rehabilita-
tion (Barrett and Day 1991, Benton-Weil et al.
1998, Blanco et al. 2001, Henricson and West-
lin 1984, Tomczak and Haverslock 1995, Ward
and Clippinger 1987).
Since 1996 several publications have exhib-
ited promising results following extracorpo-
real shock wave application (ESWA) (Chen et
al. 2001, Krischek et al. 1998, Maier et al.
2000a, Ogden et al. 2001, Perlick et al. 1998,
Rompe et al. 1996b). Randomized, controlled
studies and observational trials reported com-
parable treatment effects in 50–60 % of
patients for various entities (Benson and
Hartz2000,Concatoetal.2000).Thethera-
peutic mechanism involved remains specula-
tive (Heller and Niethard 1998, Loew et al.
1999). Ogden et al. (2001) described shock
waves directed at controlled internal fascial
tissue microdisruption that initiates a more
appropriate healing response within the fas-
cia and a better long-term capacity to adapt to
biological and biomechanical demands.
The clinical study described in the following
evaluated effects of extracorporeal shock
waves on the chronic painful heel in runners.
Materials and Methods
The study was planned as a placebo-
controlled trial to determine the effectiveness

of three applications of 2100 impulses of low-
energy shock waves to long-distance runners
with intractable plantar fasciitis.
Runners covering distances of more than 30
miles per week and suffering from chronic
plantar fasciitis for more than 12 months were
screenedandrandomizedintooneoftwo
treatment groups:
Group I Active treatment: energy flux den-
sity 0.16 mJ/mm
2
, 2100 impulses, three
times at weekly intervals.
Fig. 5.1 Radiologically proven heel spur.
Fig. 5.2 Infection at the insertion of the plantar fascia
after repeated corticosteroid injections (a Bone scin-
tigraphy; b MRI).
a
b
Group II Placebo treatment: sham treat-
ment using a sound reflecting pad, energy
flux density 0.16 mJ/mm
2
,2100impulses,
three times at weekly intervals.
Inclusion Criteria
For the current study, chronic heel pain was
definedassymptomsofmoderatetosevere
heel pain in the involved foot at the origin of
the proximal plantar fascia on the medial cal-

caneal tuberosity (Fig. 5.1).
The pain had to have persisted for at least
12 months before enrolling in the study, in
patients covering a running distance of at
least 30 miles per week before symptoms
occurred. All patients had failed to respond to
at least three attempts at conservative treat-
ment, including at least two prior courses of
intervention with physical therapy, the use of
orthotics, and at least one prior course of
pharmacological treatment, over a period of
more than 6 months.
Exclusion Criteria
Exclusion criteria were: dysfunction in the
knee or ankle, local arthritis, generalized poly-
arthritis, rheumatoid arthritis, ankylosing
spondylitis, Reiter syndrome, neurological
abnormalities, nerve entrapment syndrome,
history of previous plantar fascial surgery, age
under18years,pregnancy,infections(Fig.5.2)
or tumors, history of spontaneous or steroid-
induced rupture of the plantar fascia, bilateral
heel pain, participation in a workman’s com-
pensation program, receiving systemic thera-
peutic anticoagulants, and receiving nonste-
roidal antiinflammatory drugs (NSAIDs) for
any chronic conditions.
Group I
Group I, receiving a total of 6300 impulses of
an energy flux density of 0.16 mJ/mm

2
,con-
sisted of 10 women and 12 men, with a mean
age of 50 years and a mean duration of pain of
20 months.
Group II
Group II, receiving sham treatment, consisted
of 13 women, and 10 men, with a mean age of
50 years and a mean duration of pain of 18
months.
5 Shock Wave Application for Plantar Fasciitis34
Table 5.1 Laser-hydrophone data on the shock wave device
1
Physical Value Unit Energy level 1 Energy level 2 Energy level 3
(Treatment level)
Peak positive pressure P
+
MPa 5.5 7.9 11
–6 dB focal extend in x,y,z
direction
f
x(−6dB)
f
y(−6dB)
f
z(−6dB)
mm
mm
mm
6.0

6.0
58
5.7
5.7
57
5.5
5.5
56
5MPafocalextent,lateral f
x(5 MPa)
f
y(5 MPa)
mm
mm
2.2
2.2
3
3
5
5
Positive energy flux density ED
+
mJ/mm
2
0.016 0.04 0.07
Total energy flux density ED mJ/mm
2
0.04 0.09 0.16
Positive energy of –6 dB focus E
+(−6 dB)

mJ 0.38 0.7 1.1
Total energy of –6 dB focus E
(−6 dB)
mJ 1.1 2 3
Positive energy of 5 MPa focus E
+(5 MPa)
mJ 0.5 0.7 1
Total energy of 5 MPa focus E
(5 MPa)
mJ 1.8 2 3
Positive energy of 5 mm focal
area
E
+(5 mm)
mJ 0.24 0.5 0.9
Total energy of 5 mm focal area E
(5 mm)
mJ 0.63 1.3 2
1
Sonocur Plus provides eight user-selectable energy levels. The physical data listed in the table are typical values
for the energy levels used in this study. All measurements were made using a laser hydrophone.
Method of Treatment
The extracorporeal shock wave therapy
(ESWT) was applied using a mobile therapy
unit especially designed for orthopedic use
(Sonocur Plus, Siemens AG, Erlangen, Ger-
many), with the shock wave head suspended
by an articulating arm for flexible movement
of the head in three planes. The shock wave
head was equipped with an electromagnetic

shock wave emitter. Shock wave focus guid-
ance was established by inline integration of
an ultrasound probe—a 7.5 MHz sector
scanner—in the shock head. The physical out-
put parameters of the device, measured using
a laser hydrophone, are listed in Table 5.1.
Both groups were treated under the same
conditions and the patients were treated sin-
gly to avoid them influencing one another.
Each study subject assigned to active treat-
ment underwent shock wave application
(SWA) for a total of 6300 shocks in three treat-
ment sessions, with a one-week interval in
between, at an energy flux density of 0.16 mJ/
mm
2
and at a frequency of 4 Hz, without local
anesthesia. Ultrasound coupling gel was used
between the treatment head and the heel. The
shock tube head was applied under inline
ultrasound control, fine adjustment to the
most tender region was performed by palpa-
tion and interaction with the patient. For
those patients assigned to placebo therapy a
sound reflecting polyethylene pad was inter-
posed between the coupling membrane of the
treatment head and the heel to absorb the
shockwavesbythepresenceofmultipleair
cavities.
Method of Treatment 35

Method of Evaluation
Follow-ups were done 3 months after the last
application of the ESWT by an independent,
treatment-blinded observer. The actual study
procedure was done by a second physician
who was aware of the treatment.
Results
Follow-up
Twenty-two and 23 patients were random-
ized consecutively to either group.
At 3 months, one patient in each of the two
groups denied further cooperation because
shock wave therapy (SWT) had not improved
their condition, leaving 21 patients in Group I
and 22 patients in Group II.
Improvementfromthebaselineat3months
posttreatment in the American Orthopaedic
Foot and Ankle Society’s (AOFAS) Ankle–-
Hindfoot Scale was evaluated. This strictly
clinical score has a maximum of 100 possible
points (pain: 40 points; function: 50 points;
alignment: 10 points).
Regarding the AOFAS Ankle–Hindfoot Scale,
an increase was observed in both groups
(from 52.7 81.7 points in Group I, and from
49.8 to 62.7 points in Group II). While the pre-
treatment difference was not significant
between Group I and Group II, it was signifi-
cant after 3 months (p = 0.0039).
Before the ESWT started all patients rated

their pain condition themselves as “four” in a
subjective four-step scale (1 = excellent; 2 =
good; 3 = fair; 4 = poor). There was no differ-
ence between the groups at this point in time.
On the four-step scale an improvement was
seen in both groups from 4.0 to 2.3 points in
Group I, and from 4.0 to 3.0 points in Group II
(p = 0.0179).
Complications
Low-energy ESWT was felt as unpleasant by
all patients, though not as unpleasant as the
local infiltration all patients had received dur-
ing the various and unsuccessful treatment
regimes prior to the current study. No patient
discontinued the shock wave procedure
because of severe pain. No side effects were
seen at any follow-ups. There were no hema-
tomas, infections or abnormal neurological
findings.
Discussion
In patients with chronic heel pain, magnetic
resonance imaging (MRI) regularly shows
involvement of the calcaneal insertion of the
plantar aponeurosis (Berkowitz et al. 1991,
Grasel et al. 1999, Steinborn et al. 1999). The
diagnosis of plantar fasciitis is straightfor-
ward,evenmoresowhenaninferiorcalca-
neal spur has been detected. However, the
spur may be an incidental finding (Lapidus
and Guidotti 1965). Clinically, the field is wide

open for discussion (Pfeffer et al. 1999, Probe
et al. 1999). Atkins et al. (1999) and Crawford
et al. (2000) found only 11 randomized con-
trolled trials with low methodological assess-
ment scores carried out since 1966. There was
limited evidence for the effectiveness of topi-
cal corticosteroids administered by iontopho-
resis; there was limited evidence for the effec-
5 Shock Wave Application for Plantar Fasciitis36
Table 5.2 Overview of prospective studies on use of ESW for the treatment of plantar fasciitis
Author Journal n EFD
1
Anesthesia RCT
2
FU
3
(Mo) Success (%)
Rompe JD Arch Orthop Trauma Surg 1996 36 L
4
No Yes 6 +
6
Krischek O Z Orthop Ihre Grenzgeb 1998 50 L No Yes 12 58
Perlick L Unfallchirurg 1998 83 H
5
Yes No 12 61
Maier M J Rheumatol 2000 48 L No No 19 75
Wang C J Formos Med Assoc 2000 41 H Yes No 3 81
Hammer DS Arch Orthop Trauma Surg 2000 44 L No No 6 70
Ogden JA Clin Orthop 2001 235 H Yes Yes 3 47
Chen HS Clin Orthop 2001 80 H Yes No

Buch M Lecture 2001 150 H Yes Yes 3 70
Rompe JD J Bone Joint Surg [Am] in press 112 L No Yes 6 57
1
Energy flux density
2
Randomized controlled trial
3
Follow up
4
Low
5
High
6
Improvement compared with control group. No specific percentage mentioned in publication
tiveness of dorsiflexion night splints; and
there was limited evidence for the effective-
ness of low-energy ESWT.
A previous study from the presenting author
had shown comparable short-term results for
patients with plantar fasciitis and heel spur
(Rompe et al. 1996b). In the meantime, this
positive outcome has been confirmed in vari-
ous clinical studies (Krischek et al. 1998, Per-
lick et al. 1998, Sistermann and Katthagen
1998). Maier et al. (2000) obtained good or
excellent results according to the Roles and
Maudsley score in 75 % of 48 heels 29 months
after applying low-energy shock waves with-
out local anesthesia three times at weekly
intervals. The clinical outcome was not influ-

enced by the length of follow-up periods. No
negative side effects were reported. Wang et
al. (2000) reported 33 patients out of 41
patients to be either free of complaint or sig-
nificantly better at 12 weeks after SWT. Ogden
et al. (2001) published a randomized placebo-
controlled study with 119 patients in the treat-
ment group and 116 patients in the placebo
group. Twelve weeks after a single application
of 1500 high-energy shock waves under local
anesthesia success was observed in 47% of the
patients. After sham treatment the success
rate was only 30 %. Buch et al. (2001) reports
early results of a randomized placebo-
controlled study involving 150 patients. Ther-
apy was applied once, with 3800 high-energy
impulses under local anesthesia. After 3
months 70% of the patients in the treatment
group fulfilled the success criteria, as did 40 %
of the placebo group.
Most recently, Rompe et al. (in press)
reported a randomized controlled trial on 112
patients. Group I received 1000 impulses of a
low energy flux density three times; Group II
received 10 impulses on three occasions over
a period of 2 weeks. Comparing the rates of
good and excellent outcome in a four-step
score in the two groups, there was a signifi-
cant difference of 47 % in favor of Group I
treatment at 6 months. At 6 months pressure

pain had dropped for patients in Group I from
77 points to 19 points on a Visual Analogue
Scale (VAS). In Group II the ratings were sig-
nificantly worse: from 79 points to 77 points.
In Group I walking became completely free
from pain in 25 out of 50 patients, compared
with 0 out of 48 patients of Group II. By 5
years, comparing the rates of good or excel-
lent outcomes in the four-step score, the dif-
ferenceofonly11%infavorofGroupIwasno
longer significant; pressure pain was down to
9 points in Group I, and to 29 points in Group
II. Meanwhile, 5 out of 38 patients (13%) had
undergone an operation of the heel in Group I,
compared with 23 of 40 patients (58 %) in
Group II (Table 5.2).
Discussion 37
In the current study better results were
observed 3 months after low-energy SWA of
2100 impulses compared with placebo treat-
ment. Cointerventions remained on a compa-
rable, low level in both groups. No side effects
have so far been noticed with low-energy
ESWA compared with calcification after ste-
roid injections or postsurgical development of
wound infections, hypertrophic sensitive
scars or calcaneal fractures (Conti and Shinder
1991, Schepsis et al. 1991). Our clinical experi-
ence is in accordance with histological and
MRI-based studies (Maier et al. 2000, Rompe

et al. 1998a). High-energy shock waves, also in
use for the treatment of heel pain (Perlick et
al. 1998, Sistermann and Katthagen 1998), on
the other hand may produce side effects such
as periosteal detachments and small fractures
of the inner surface of the cortex (Ikeda et al.
1990).
Although the Food and Drug Administration
of the United States Department of Health and
Human Services (FDA) recently approved a
shockwavedevicefortherapyofheelpain
(Henney 2000), as long as the therapeutic
mechanism involved remains speculative
(Heller and Niethard 1998, Loew et al. 1999)
further studies should verify the results of the
studies available.
5 Shock Wave Application for Plantar Fasciitis38