Applications in Musculoskeletal Disorders - part 7 docx

7 Extracorporeal Shock Wave Application in the Treatment
of Chronic Calcifying Tendinitis of the Shoulder
Introduction
Calcific tendinitis as a source of shoulder pain
initially was described more than 100 years
ago as Maladie de Duplay. The disease usually
is self-limiting and the natural history still is
contradictory. (Rupp et al. 2000, Uhthoff and
Loehr 1998).
Reports concerning the incidence of the dis-
ease are inconsistent. Tendon calcifications
have been observed in 2.7–20% of patients
without pain in their shoulders; calcifying
tendinitis has been observed in as many as
17% of shoulders of patients with chronic
periarthritis (Bosworth 1941, Hedtmann and
Fett 1989, Rowe 1988). Bosworth (1941)
describes progressive vanishing of the depos-
its in 9.3% of patients within 3 years after the
initial diagnosis. Wagenhäuser (1972) reports
that deposits disappeared in 27.1% of his
patients after 10 years.
Treatment of patients with calcific tendon-
itis typically is conservative (Farin et al. 1996).
If the pain becomes chronic or intermittent
after several months of conservative treat-
ment, surgical removal has been recom-
mended (Uhthoff and Loehr 1998). Success
rates above 80% have been reported (Loehr
and Uhthoff 1996).
Recently, extracorporeal shock wave ther-

apy (ESWT) has shown encouraging prelimi-
nary results in the treatment of calcific depos-
its (Loew et al. 1995, 1999, Rompe et al. 1995,
1998b). The goal of the current study was to
compare the efficiency of open surgery and
extracorporeal shock wave application
(ESWA) in patients with chronic, symptomatic
calcifying tendinitis of the supraspinatus ten-
don (Rompe et al. 2001b).
Materials and Methods
Prospectively 79 consecutive patients with a
chronic calcifying tendinitis of the supraspi-
natus tendon were recruited between 1996
and 1998. All patients had been referred to the
author’s shoulder clinic for recalcitrant shoul-
der pain by local general practitioners or
orthopedic practitioners. All patients had a
clinical examination and anteroposterior (A-
P) radiographs, acromial outlet views, sonog-
raphy, and/or magnetic resonance imaging
(MRI) (Wirth et al. 1990). The patients were
informed about open surgical removal of the
deposit and about high-energy ESWT as a
nonsurgical alternative. All patients contacted
their health insurance companies and asked
for reimbursement of the shock wave therapy
(SWT). In 29 cases reimbursement was denied
and the patients had to undergo surgery. The
remaining 50 patients decided to receive SWT
after reimbursement had been offered. So the

assignment of the patients to either group
was carried out completely independent of
our institution.
Fig. 7.1aAnteroposterior (A-P) radiograph of a
Gaertner III calcium deposit. b Axial radiograph of a
Gaertner II calcium deposit. c A-P radiograph showing
spontaneous disintegration within 9 weeks.
a
b
c
Table 7.1 Methods of treatment before referral to the
hospital
1
Treatment Group I
(n = 29)
Group II
(n = 50)
Physiotherapy 29 50
Antiinflammatory drugs 29 43
Kryotherapy 29 38
Infiltration with local
anesthetic
29 45
Infiltration with steroids 24 23
Needling 918
Radiation therapy 48
1
Number of patients
Inclusion Criteria
Inclusion and exclusion criteria were identi-

cal. All patients reported in this study fulfilled
the following criteria.
Inclusion criteria were: calcareous deposit
on standardized A-P radiographs of a diame-
ter of at least 10 mm; the morphology of the
deposit had to be homogenous in appearance
and with well-defined borders (correspond-
ing to Type I in the Gaertner classification of
1993), or inhomogenous in structure with a
sharp outline or homogenous in structure
with no defined border (corresponding to
Type II in the Gaertner classification); shoul-
der pain for more than 12 months; clinical
signs of subacromial impingement (Hawkins
and Kennedy 1980, Neer 1972): unsuccessful
conservative therapy in the previous 6
months (Table 7.1); no evidence of bone-
related anatomical outlet impingement or
functional outlet impingement as seen on
radiographs or MRI scans.
Exclusion Criteria
Exclusion criteria were: cloudy and transpar-
ent appearance of the deposit (Type III
according to Gaertner 1993); radiological
signs of spontaneous resorption (Fig. 7.1); evi-
dence of a Type-III acromial morphological
feature according to Bigliani et al. (1982) on
the outlet view of the acromion; evidence of
acute subacromial bursitis; evidence of an
acromial spur or acromioclavicular osteophy-

tes on the A-P radiographs; evidence of rota-
7 Extracorporeal Shock Wave Application in the Treatment of Chronic Calcifying Tendinitis50
Fig. 7.2aA-P radiograph of a Gaertner III deposit.
b A-P radiograph of a Gaertner III after needling and
lavage. c Dissolved deposit.
a b
c
tor cuff tears on MRI scans; evidence of func-
tional impingement of the rotator cuff on
sonographs or Arthro-MRI scans or both; tears
of the glenohumeral ligaments of the labrum;
hypertrophy of the supraspinatus muscle;
dysfunction in the neck (spondylarthritis, cer-
vical disc herniation) or thoracic region
(hyperkyphosis, spondylarthritis); prior sur-
gery to the shoulder; local degenerative dis-
ease of the shoulder; rheumatoid arthritis;
neurological abnormalities of the upper
extremity with calcifying tendonitis; preg-
nancy; infection; tumor.
Group I
The patients in group I underwent surgery as
described below. Group I comprised 29
patients (20 women and 19 men), with a
mean age of 53 years (range: 31–68 years),
and a mean duration of pain of 36.1 ± 28.6
months (range: 12–60 months). There were 19
Type-I deposits and 10 Type-II deposits
according to the Gaertner (1993) classifica-
tion. The right shoulder was affected in 54% of

the patients.
Thepatientwasinabeachchairposition
with a towel placed under the scapula. With
the patient under general anesthesia the rota-
tor cuff was exposed through a 5–6 cm–long
anterior incision as for an acromioplasty. The
deltoid was split parallel to its fibers for no
more than 5 cm distal to its acromial attach-
ment to prevent damage to the axillary nerve.
After partial subdeltoid bursectomy, the rota-
tor cuff was exposed. Following identification
of the calcium deposit in the supraspinatus
tendon either macroscopically or by fluoros-
copy, the tendon was incised longitudinally
and the calcium was removed by curettage
(Fig. 7.3). The defect was closed by means of
slowly resorbable sutures. The anterior acro-
Materials and Methods 51
Fig. 7.3 Open removal of the calcific deposit. a Skin incision and division of the deltoid muscle ( 5cm).b Partial
resection of the subdeltoid bursa. c Longitudinal incision of the supraspinatus tendon. d Extracted deposit.
a
c
b
d
mial edge was smoothed with a rasp and a
drain inserted. Then the deltoid and its fascia
were reapproximated with a resorbable vicryl
suture, the subcutaneous tissues were closed,
and a subcuticular nonresorbable suture was
applied for the skin. A sterile dressing was

applied. After the operation, the arm was sup-
ported by a sling, and pendulum exercises
were started after removal of the drain the
day after surgery. Passive assisted exercises
were performed on the following 3 days, then
assisted active motion was done for 4–6
weeks with no limitation on the range of
motion (ROM).
Group II
The patients in group II underwent ESWT.
Group II comprised 50 patients (28 women,
22 men), with a mean age of 49.6 ± 7.5 years
(range: 31–63 years) and a mean duration of
pain of 52.6 ± 54.4 months (range: 12–66
months). There were 28 Type-I deposits and
22 Type-II deposits according to the Gaertner
classification. The right shoulder was affected
in 56% of the patients.
7 Extracorporeal Shock Wave Application in the Treatment of Chronic Calcifying Tendinitis52
Method of Treatment
High-energy ESWT was performed using an
experimental device (Siemens AG, Erlangen,
Germany), characterized by the integration of
an electromagnetic shock wave generator in a
mobile fluoroscopy unit. Once the calcium
deposit was situated in the center of the C-
arm (Fig. 7.4a), the shock wave unit was
docked to the shoulder by means of a water-
filled cylinder. Standard ultrasound gel was
used as a contact medium between cylinder

and skin (Fig. 4b). Three thousand impulses of
0.60mJ/mm
2
were administered under regi-
nal anesthesia. Only one therapy session was
undertaken with each patient. No cold ther-
apy or nonsteroidal antiinflammatory drugs
(NSAIDs) were allowed after the procedure.
Active exercises began as an outpatient treat-
mentthedayafterSWTfor4–6weeks.
Fig. 7.4aDeposit in the reticule of the fluoroscopy unit of the shock wave device. b High-energy SWA using a
fluoroscopy guided shock wave device in plexus anesthesia with the patient under permanent control of an anes-
thesiologist.
a b
Method of Evaluation
Follow-up evaluations were done indepen-
dently of the treating orthopedic surgeon at 12
months and at 24 months.The University ofCal-
ifornia at LosAngeles score for painand function
of the shoulder (Kay and Amstutz 1988) was
used to grade each patientbeforetreatment and
at each follow-up. According to this protocol,
pain and function are each rated on a scale of
1–10 points, with 1 point being the worst and
10 points being the best score. The range of
active forward flexion and strength in forward
flexion were scored from 0–5 points; and the
patient’s satisfaction was scored from 0–5
points. The maximum score to be achieved was
35 points. The outcome score was as follows:

Excellent = 33 points
Good = 29–33 points
Poor = 29 points.
Method of Evaluation 53
Table 7.2 Points
1
according to the University of California at Los Angeles Rating System
Group I Group II p-value
Follow-up
(months)
Total Gaertner
I
Gaertner
II
Total Gaertner
I
Gaertner
II
Total Gaertner
I
Gaertner
II
0 17.8±4.0 18.0±3.4 17.4±4.7 19.0±3.3 18.7±3.2 19.2±4.8 – – –
12 30.3±3.2 29.3±3.8 31.7±4.5 28.3±6.9 26.7±3.6 30.6±4.3 – .01 –
24 32.4±2.9 32.0±4.1 33.1±3.9 29.1±4.2 26.7±3.6 31.9±4.7 .001 .0001 –
1
Mean±standard deviation
Radiological Evaluation
An A-P view (Kilcoyne et al. 1989) and an out-
let view of the acromion were obtained 1 day

before surgery or ESWT and at 12 months
after either treatment. On the A-P views,
resorption was graded as none, partial, or
complete by the author’s colleagues from the
local Department of Radiology, who were
blinded as to the treatment status and ante-
cedent studies.
Statistics
Statistical analysis was done by the local Insti-
tute of Medical Statistics and Documentation.
Differences between the groups regarding
pain, function, flexion, strength, and total out-
come were tested by using the Wilcoxon test
for two independent samples. The Fisher
exact test for 2 × 2 contingency tables was
used for the analysis of satisfaction and out-
come, and its extended version was used to
test the removal of the calcific deposits and
thetimeuntilthepatientsreturnedtowork.
Thecomparisonofpreoperativedatawith
data from the 12-month and 24-month
follow-up was done by means of the Wilcoxon
signed rank test for pain, function, flexion,
strength, and total outcome. Differences in
time concerning the patients’ satisfaction and
the outcome were done by the McNemar test.
Dependencies between removal of the
deposit, return to work, and outcome were
tested with the Fisher exact test and its exten-
sion. Differences in total outcome scores

according to different radiological outcome
and removal of the deposits were shown with
the Wilcoxon test. The level of significance
was set at 95% for each test; therefore p-
values 0.05 were considered to be signifi-
cant. All tests were calculated two-sided;
multiple adjustment was not done.
Results
Rate of Follow-up
At 12 months, 20 patients in group I and 45
patients in group II were examined. At 24
months, 20 patients in group I and 39 patients
ingroupIIwereexamined.Theremaining
patients were lost to follow-up. Regarding the
epidemiolgical data, the patients who were
lost to follow-up did not differ from the
patients included in the current study.
Clinical Outcome in the University
of California Los Angeles Score
The total outcome in the University of Califor-
nia Los Angeles score is shown in Tables 7.2
and 7.3. The comparison of the two groups
regarding point values or regarding “Excel-
lent” and “Good” outcomes showed no signifi-
cant difference at 12 months. At 24 months,
point values were significantly higher in
group I than in group II (32.4 and 29.1 points,
respectively; p 0.001), and there were sig-
7 Extracorporeal Shock Wave Application in the Treatment of Chronic Calcifying Tendinitis54
Table 7.3 Outcome according to the University of California at Los Angeles Rating System

1
Group I Group II p-value
Total Gaertner I Gaertner II Total Gaertner I Gaertner II
Follow-
up (mo)
E
2
G
3
P
4
EGPEGP EGPEGPEGP Total Gaertner I Gaertner II
0 ––100––100––100 ––100––100––100 – – –
12 50 25 25 42 33 25 63 12 25 40 20 40 28 20 52 55 20 25 – .01 –
24 55 35 10 50 42 8 63 25 12 46 18 36 43 10 47 56 28 16 .05 .0001 –
1
Percentage of patients
2
Excellent
3
Good
4
Poor
Fig. 7.5aA-P radiograph showing a Gaertner I cal-
cium deposit (homogenous structure with well-
defined borders). b A-P radiograph showing complete
disintegration 12 months after SWA.
a
b
nificantly more “Excellent” and “Good” results

in group I than in group II (90% and 64%,
respectively; p 0.05).
Radiological Outcome
Table 7.4 shows the extent of calcium elimina-
tion in relation to its radiomorphological fea-
tures.
Group I: At 12 months, the calcium deposit
had disappearded in 85% of the patients; in
15% of the patients only minor particles were
observed.
Results 55
Table 7.4 Elimination rates of the calcific deposit
Group I Group II
Elimination of
deposit
1
Gaertner I
(n=12)
Gaertner II
(n= 8)
Gaertner I
(n=25)
Gaertner II
(n=20)
Complete 84% 88% 28% 70%
Partial 16% 12% 36% 30%
None –– 36%–
1
12-month follow-up
Fig. 7.6aA-P radiograph showing a Gaertner II

deposit (inhomogenous structure with well-defined
border). b A-P radiograph showing complete disinte-
gration 12 months after SWA.
a
b
Group II: At 12 months, complete resorption
was observed in 47% of the patients (Figs. 7.5,
7.6) and partial resorption of the calcium
deposit was observed in 33% of the patients.
In 20% of the patients there was no change in
the radiomorphological features at all.
The calcium deposit was no longer detect-
able radiologically in significantly more
patients in group I than in group II
(p 0.0001). Complete disintegration of the
calcium was found significantly more often in
Gaertner Type-II deposits than in Gaertner
Type-I deposits after SWT (70% and 28%,
respectively; p 0.0001).
Radiomorphological Features and Clinical
Outcome
In group I Gaertner Type-I patients achieved
29.3 points at 1 year and 32.0 points at 2
years; Gaertner Type-II patients had 31.7
pointsat1yearand33.1pointsat2years.
IngroupIIGaertnerType-Ipatients
achieved 26.7 points at 1 year and at 2 years.
Gaertner Type-II patients had 30.6 points at 1
year and 31.9 points at 2 years.
Gaertner Type-I patients showed signifi-

cantly better point values in the University of
California at Los Angeles score in group I than
in group II at both follow-ups (all p 0.0001).
There was no significant difference between
Gaertner Type-II patients in group I and group
II (Table 7.2).
In group I patients with a Gaertner Type-I
deposit had “Excellent/Good” outcomes in
75% of cases at 1 year and in 92% at 2 years.
Patients with a Gaertner Type-II deposit
showed “Excellent/Good” results in 75% of
cases at 1 year and in 88% at 2 years.
In group II 48% of the patients with a Gaert-
ner Type-I deposit had “Excellent/Good” out-
comesat1year,andin53%ofcasesat2years.
7 Extracorporeal Shock Wave Application in the Treatment of Chronic Calcifying Tendinitis56
Fig. 7.7 Hematoma after high-energy ESWT in the
contact area of shock wave device and skin.
Patients with a Gaertner Type-II deposit
achieved “Excellent/Good” outcomes in 75%
of cases at 1 year, and in 84% at 2 years.
At both follow-ups there were significantly
more “Excellent/Good” outcomes in Gaertner
Type-I patients in group I than in group II (12
months: p 0.01; 24 months: p 0.0001).
There was no significant difference concern-
ing Gaertner Type-II patients between group I
and group II (Table 7.3).
Hospital Stay
Patients in group I remained in hospital for an

average of 12 ± 4.5 days; patients in group II
for3.1±0.65days.Sotheperiodofhospital-
ization was significantly shorter in group II
(p 0.0001),resultinginanaveragecost
advantage in group II of US$ 2970 per patient.
Absence from Work
After dismissal from the hospital it took
patients in group I an average of 9.1 ± 11.6
weekstoreturntowork,andpatientsingroup
II 2.5 ± 3.0 weeks. Absence from work was sig-
nificantly shorter in group II (p 0.01), result-
ing in an average cost advantage of US$ 9240
per patient.
Complications
Although one deep wound infection was
observed in a patient from group I, no side
effects except for transient subcutaneous
hematomas were observed in patients from
group II (Fig. 7.7). Lesions in the rotator cuff
were ruled out after SWT by MRI or through
ultrasonography.
Subjective Rating
At 24 months 55% of the patients in group I
reported a complete relief from pain and 29%
a significant reduction in pain. Five percent
and 11% of the patients observed only slight
or no improvement, respectively.
In group II there 43% of patients were with-
outpainand24%withasignificantreduction
in pain. Four percent and 29% of the patients

had a slight relief or no reduction in pain,
respectively. With the numbers available we
could not detect a significant difference
between group I and group II.
Discussion
The usual conservative treatment of the
chronic or subacute phase of calcifying tendi-
nitis comprises physical therapy, infiltration
with local anesthetics or corticosteroids, or
both, and needling and lavage. Success rates
reported vary between 30% and 85% (De
Palma and Kruper 1961, Gaertner 1993, Har-
mon 1958, Lapidus 1943, Pfister and Gerber
1994, Reichelt 1996, Wainner and Hasz 1998).
In a series of 100 patients treated conserva-
tively, Litchman et al. 1968 report only one
patient who had to undergo surgery. The
effect of ultrasonic energy is questionable
(Griffin and Karselis 1982). Radiation therapy
is not an acceptable mode of treatment
accordingtostudiesbyChapman(1942),
Young (1946), and Plenk (1952).
Open surgery is regarded as a dependable
and quick method to relieve the deposit.
Vebostad (1975) report excellent and good
results in 34 out of 43 patients (79%), and
Gschwend et al. (1981) report excellent and
Discussion 57
good results in 25 out of 28 patients (89%).
Rubenthaler and Wittenberg (1997) observed

88% excellent and good results. Rochwerger et
al
.
(1999), also using the open procedure,
report an increase of the Constant score val-
uesfrom52to89pointsafterafollow-upof
23 months.
The endeavor to avoid damage to the del-
toid muscle led to the development of mini-
mally invasive techniques, guided by arthros-
copy (Ellman 1987, Ellman and Kay 1991, Esch
et al. 1988, Gartsman et al. 1988). This techni-
cally demanding procedure has proved to be
successful in prospective studies (Altchek et
al. 1990, Ark et al. 1992, Ellman and Kay 1991,
Habermeyer et al. 1998, Sachs et al. 1994). Ark
et al. (1992) observed 50% excellent results.
Mol´eetal
.
(1993) report 82% of their patients
to be satisfied with the postoperative out-
come. Similar to Jerosch et al. (1998) and Re
and Karzel (1993), the authors show an
improvement in results with an associated
acromioplasty. All authors, with the exception
of Tillander and Norlin (1998), stress the
importance of complete removal of the cal-
cicfic deposit; subacromial decompression
was thought to be of minor importance.
In a preliminary study, Loew et al. (1995)

discuss the potential disintegrating capability
of extracorporeal shock waves regarding cal-
cific deposits of the rotator cuff. They pro-
posed that increasing pressure within the
therapeutic focus caused fragmentation and
cavitation effects inside the amorphic calcifi-
cations and led to disorganization and disinte-
gration of the deposits. A breakthrough of the
calcific masses into the adjacent subacromial
bursa or local resorptive reaction of the sur-
rounding tissue induced by extracorporeal
shock waves possibly led to the disappearance
of the deposits. The exact working mechanism
remains unclear. In an in vitro study, Perlick et
al. (1999b) put artificial concrements in the
rotator cuff of a pig and reported that it took
at least 2000–3000 impulses of an energy flux
density of 0.42 mJ/mm
2
to achieve a disinte-
gration of the deposit.
Clinically, Loew et al. (1995) report signifi-
cant improvement of symptoms in 14 out of
20 patients (70%) after two applications of
2000 shock waves of an energy flux density of
0.3 mJ/mm
2
. Radiologically, there were seven
cases of complete resorption and five cases of
partial disintegration. However, the follow-up

was at only 12 weeks. Radiologically, these
results are much better than the data reported
in the author’s first preliminary series (Rompe
et al. 1995) in which complete elimination of
the deposit was observed in only 15% of 40
patients who were treated once with 1500
impulses of an energy flux density of 0.28 mJ/
mm
2
. Daecke et al. (1997) showed an influ-
ence of two applications versus one applica-
tion of 2000 shock wave impulses of an
energy flux density of 0.3 mJ/mm
2
in 115
patients. Complete elimination of the deposit
was seen on radiographs in 54% of patients
(two treatments) and in 33% of patients (one
treatment), and partial disintegration was
seen in 23% of patients (one treatment) and
14% of patients (two treatments). The differ-
ences in the radiological findings were signifi-
cant in favor of two applications. Clinically,
54%ofpatientsversus45%ofpatientsdidnot
have pain after 6 months, and 75% of patients
versus 65% of patients attained at least 75% of
the age- and gender-dependent values of the
score of Constant and Murley (1987). How-
ever, the differences between the two treat-
ment groups were not statistically significant.

Krischek et al. (1997) observed 50 patients for
1 year after one application of 3000 shock
waves of an energy flux density of 0.28 mJ/
mm
2
. Thirty-four percent of the patients were
satisfied and 18% of patients were moderately
satisfied. Radiologically, deposits had been
eliminated completely in eight patients,
whereas 21 patients had a partial disintegra-
tion. According to the Gaertner classification,
they observed changes of the radiomorpho-
logical features in 88% of Type-II deposits, but
in only 44% in Type-I deposits. Clinically, the
Constant and Murley score values improved
from 60 to 76 points. Therefore, by doubling
the number of applied shock waves compared
with previous studies, neither an increase in
the elimination rate nor an improvement in
the clinical outcome was achieved. Eighteen
7 Extracorporeal Shock Wave Application in the Treatment of Chronic Calcifying Tendinitis58