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doi: 10.2522/ptj.20110252Originally published online June 28,
2012
2012; 92:1376-1385.PHYS THER. Cacchio and Valter
SantilliAttanasi, Teresa Venditto, Marila Servidio, Angelo
Francesco Ioppolo, Maria Tattoli, Luca Di Sante, CarmineClinical
Trial Comparing Two Different Energy LevelsSupraspinatus Calcifying
Tendinitis: A Randomized Extracorporeal Shock-Wave Therapy for
http://ptjournal.apta.org/content/92/11/1376found online at: The
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Physical Agents/Modalities Injuries and Conditions: Upper
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Extracorporeal Shock-Wave Therapyfor Supraspinatus
CalcifyingTendinitis: A Randomized ClinicalTrial Comparing Two
DifferentEnergy LevelsFrancesco Ioppolo, Maria Tattoli, Luca Di
Sante, Carmine Attanasi,Teresa Venditto, Marila Servidio, Angelo
Cacchio, Valter Santilli
Background. Extracorporeal shock-wave therapy (ESWT) represents
a validintervention in the treatment of people with supraspinatus
calcifying tendinitis (SCT),but there is limited evidence for the
useful range of ESWT doses.
Objective. The aim of this study was to compare 2 different
ranges of energy fluxdensity in treatment of SCT with ESWT.
Design. This study was designed as a single-blind randomized
clinical trial.
Setting. This study was performed in a university hospital.
Patients. Forty-six patients with SCT were randomly assigned to
2 groups thatreceived different therapeutic energy doses of ESWT:
(1) group A received ESWT atan energy level of 0.20 mJ/mm2, and (2)
group B received ESWT at an energy levelof 0.10 mJ/mm2.
Intervention. The treatment protocol consisted of 4 sessions
performed once aweek.
Measurements. The change in mean Constant Murley Scale (CMS)
scores at 3and 6 months was the primary endpoint. The change in the
mean visual analog scale(VAS) scores from baseline to 3 and 6
months after the intervention and radiographicchange in size of
calcium deposits were evaluated as secondary endpoints. At
12months, pain relief was assessed using a numeric rating
scale.
Results. Significant clinical improvement based on mean CMS
scores was observedafter 6 months in group A (X79.43, SD10.33)
compared with group B (X57.91,SD6.53). Likewise, after 6 months, a
significant decrease in VAS scores was foundin group A (X2.09,
SD1.54) compared with group B (X5.36, SD0.78). Calcificdeposits
disappeared in the same percentage of patients in both groups.
Limitations. The small sample size and lack of a control group
were limitationsof the study.
Conclusions. In ESWT for SCT, an energy level of 0.20 mJ/mm2
appears to bemore effective than an energy level of 0.10 mJ/mm2 in
pain relief and functionalimprovement.
F. Ioppolo, MD, PhD, PhysicalMedicine and Rehabilitation
Unit,Azienda Policlinico Umberto I,School of Medicine, La
SapienzaUniversity of Rome, Rome, Italy.
M. Tattoli, MD, PhD, Departmentof Biomedical Sciences andHuman
Oncology, MedicalSchool, University of Bari AldoMoro, Bari, Italy,
and Depart-ment of Physical and Rehabilita-tive Medicine, School of
Medicine,La Sapienza University of Rome.
L. Di Sante, MD, PhD, PhysicalMedicine and Rehabilitation
Unit,Azienda Policlinico Umberto I,School of Medicine, La
SapienzaUniversity of Rome, Piazzale AldoMoro 5, 00185 Rome,
Italy.Address all correspondence toDr Di Sante at:
[email protected].
C. Attanasi, MD, Department ofPhysical and Rehabilitative
Medi-cine, School of Medicine, LaSapienza University of Rome.
T. Venditto, MD, Department ofPhysical and Rehabilitative
Medi-cine, School of Medicine, LaSapienza University of Rome.
M. Servidio, MD, Department ofPhysical and Rehabilitative
Medi-cine, School of Medicine, LaSapienza University of Rome.
A. Cacchio, MD, PhD, Depart-ment of Health Sciences,
PhysicalMedicine and Rehabilitation Unit,School of Medicine,
Universityof LAquila, LAquila, Italy, andDepartment of Physical and
Reha-bilitative Medicine, School ofMedicine, La Sapienza
Univer-sity of Rome.
Author information continues onnext page.
Research Report
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Supraspinatus calcifying tendini-tis (SCT) represents an acuteor
chronic disease caused byinflammation around calcium depos-its
situated upon tendons, with par-ticular involvement of the
supraspi-natus tendon in its proximal portionof the humerus. It is
most commonamong people between 30 and 50years of age.1 The
prevalence of SCThas been reported to range from 7%to 36% of the
population,2 and theincidence is estimated to be between2.5% and
20%.1,3 Clinical features ofthis disease are pain-triggering lossof
muscular strength, decrease inrange of motion (ROM), and
disabil-ity of the shoulder. Furthermore,pain localized in the
deltoid region ismore often present during the night,when calcium
undergoes reabsorp-tion.4 This phase can last from 2weeks in its
acute form to up to 3months in its chronic form.5
According to Bosworth et al,6 cal-cium deposits can be divided
into 3categories according to size and clin-ical impairment: tiny
(0.5 cm),medium (0.51.5 cm), and large(1.5 cm). Gartner and
Simons7
classified these calcifications in rela-tion to their
radiological features:(1) type 1pasting and not clear
inradiographs, (2) type 2pasting andclear in radiographs, and (3)
type3without clear limits and with ahigh tendency toward
spontaneousresolution. The mechanisms underly-ing the etiology of
intratendinousdeposits of carbonated apatite arenot fully
understood.8
Uhthoff et al5 demonstrated that SCTis a dynamic phenomenon in
whichcalcium goes through a cyclical pro-cess of formation,
reabsorption, andremodeling. Treatment of peoplewith SCT may be
conservative orsurgical.9 Conservative treatment10
includes therapeutic exercise,11 anal-gesic and nonsteroidal
anti-inflammatory drugs, transcutaneouselectrical nerve
stimulation,12 steroid
injections,13 and shock-wave therapy(SWT).1417 During the
chronic state,arthroscopic-guided surgical resec-tion of the
calcification is indi-cated.18 Shock waves, defined as asequence of
single sonic pulses char-acterized by high peak pressure (100mPa),
a fast rise in pressure (10nanoseconds), and a short life cycle(10
microseconds), are conveyed byan appropriate generator to a
spe-cific target area. Short-wave therapycan be classified
according to itsenergy levels.19,20 A simpler classifi-cation
distinguishes between low-energy SWT, having an energy fluxdensity
(EFD) of less than 0.12mJ/mm2, and high-energy SWT, hav-ing an EFD
between 0.12 and 0.38mJ/mm2.1921
During the last 10 years, extracorpo-real shock-wave therapy
(ESWT) hasbeen used successfully in peoplewith tendon and muscle
tissue dis-ease.14,15,22 It was found that ESWTinduces a long-term
tissue regenera-tion effect in addition to having amore immediate
antalgic and anti-inflammatory outcomes.23 A wash-out of chemical
inflammation medi-ators, a trigger to neovascularization,and a
nociceptive inhibition (gatecontrol theory) have been reportedas
the main biological effects ofESWT on tissues.24,25
To date, various molecular workingmechanisms of shock waves
havebeen demonstrated.23,2628 Twophysical effects are produced
byshock-wave application: (1) thestress-related phenomenon
inducedby an ultrashort rise time of about5 nanoseconds and (2)
cavitationbubbles produced at the interfacebetween the solid and
the surround-ing liquid.29 The latter effect inducesvessel rupture
and angiogenesis insoft tissues. In in vitro studies, ESWTat an EFD
lower than 0.09 mJ/mm2 isreported to produce a neoangio-genic
effect by increasing expressionof vascular endothelial growth
factor
V. Santilli, MD, Department of Physical andRehabilitative
Medicine, School of Medicine,La Sapienza University of Rome.
[Ioppolo F, Tattoli M, Di Sante L, et al. Extra-corporeal
shock-wave therapy for supraspi-natus calcifying tendinitis: a
randomizedclinical trial comparing two different energylevels. Phys
Ther. 2012;92:13761385.]
2012 American Physical Therapy Association
Published Ahead of Print: June 28, 2012Accepted: June 21,
2012Submitted: June 13, 2011
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(VEFG) and its receptor Flt-1.30 Sev-eral studies have shown
that thereis a direct relationship betweendose and effect for
ESWT.3133 Gotteet al34 also demonstrated that ESWTinduces a
nonenzymatic productionof nitric oxide and a subsequent
sup-pression of NF-B (nuclear factor-kappaB) activation responsible
forthe clinically beneficial action on tis-sue inflammation.
The number of cells destroyed (vac-uolization) after ESWT
increases in away that is dose and number depen-dent. It would seem
that the destruc-tion of cells is a short-term effectof high
shock-wave doses, whereascells stimulation is a
medium-termeffect.35 On the other hand, a disor-ganization of
matrix structure andchanges in degraded collagen levelshave been
described in normal ten-dons after EWST and might repre-
sent the trigger for repair in chronictendinopathy.28
Furthermore, side effects have beenreported as consequences of
theeffect of ESWT on tissues.25,36
Indeed, an EFD between 0.04 and0.22 mJ/mm2 has very few
sideeffects, such as pain, local soft tissueswelling, cutaneous
erosions, ery-thema, and local subcutaneoushematomas.22,37 Only one
casereport of osteonecrosis of thehumeral head has been
published.38
To date, it is not yet clear whichenergy level is the most
effectivein pain relief and clinical improve-ment of shoulder
function afterESWT.24,3941 Indeed, Gerdesmeyeret al15 found that 2
sessions of 1,500high-dose impulses (0.32 mJ/mm2)appeared to be
superior to 2 sessionsof 6,000 low-dose impulses (0.08
mJ/mm2) in terms of pain reduction,clinical improvement, and
radiologi-cal calcium deposit resorption,although they stated that
thresholdenergy has yet to be defined.Schofer et al42 found an
increase inshoulder function and a reduction ofpain in 2 groups
treated with 6,000impulses in 3 sessions. They used anenergy level
of 0.78 mJ/mm2 in thefirst group and an energy level of0.33 mJ/mm2
in the second group,but did not observe any differencebetween
groups.
Therefore, treatment parameters ofESWT remain empirical
becausethere is no consensus on appropriatesessions and
doses.16,18,22,39 In ourstudy, 2 different protocols weredesigned:
one protocol bounded bythe upper limit of low dose (0.040.12
mJ/mm2) and the other proto-col bounded by the lower limitof high
dose (0.12 mJ/mm2). Wetested low-energy procedures in ourstudy
because they do not requireany kind of anesthesia, which gener-ally
was applied when high-energyprotocols were used.43 Moreover,it
recently has been demonstratedthat local anesthesia
substantiallyalters the biological responses ofESWT.25,44 It also
been shown thatboth high- and low-energy protocolprocedures are
similarly effective ifthe total energy applied is approxi-mately
the same. Thus, with thelow-energy protocol, more impulseshad to be
applied in more treatmentsessions to achieve a similar
result.44
However, in our study, we chose tocompare the effects of the 2
treat-ment protocols using the sameimpulses and number of
sessions.
MethodDesign OverviewA single-blind randomized clinicaltrial
with assessment at baseline(admission to the clinic) and at 3,
6,and 12 months after the end of thetreatment was conducted.
The Bottom Line
What do we already know about this topic?
Several studies suggest the effectiveness of extracorporeal
shock-wavetherapy (ESWT) as an intervention for reducing pain and
improvingshoulder function in people with supraspinatus calcifying
tendinitis(SCT); however, there is limited evidence about the
useful range of ESWTdoses.
What new information does this study offer?
This study contributes to the standardization of treatment of
SCT and canhelp clarify the most appropriate energy flux density
(EFD) levels, numberof sessions, and number of impulses of shock
waves in SCT treatment. Inthis study, 2 different energy levels
were tested: 0.10 mJ/mm2 in the firstgroup, and 0.20 mJ/mm2 in the
second group. The group that received thehigher energy level showed
a greater reduction in pain and a greaterimprovement in shoulder
function than the other group. The study alsorevealed that the
clinical improvement of patients was not related to thereabsorption
of or a decrease in size of calcific deposits.
If youre a patient, what might these findings meanfor you?
If you have SCT, the destruction of calcifications is not
necessary toreduce your pain and improve your shoulder
function.
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Setting and ParticipantsConsecutive outpatients of theDepartment
of Physical and Rehabil-itative Medicine (School of Medi-cine, La
Sapienza University ofRome) with clinical and radiologicalfeatures
of SCT from November2008 to June 2010 were invited toparticipate in
the study.
All patients had a current episode ofshoulder pain that had been
in prog-ress for at least 4 to 6 months. A totalof 68 consecutive
patients affectedby shoulder pain (40 women and 28men) were
screened for eligibility.If they had undergone previous
con-servative treatment with no visibleclinical benefits, they were
includedin the study. Patients with mediumand large calcific
deposits accordingto the Bosworth classification6 andwith type I
and II calcific depositsaccording to the Gartner classifica-tion7
were included. Individualswith clinical signs of partial or
com-plete tear of the rotator cuff (evalu-ated with Jobe and full
can tests)45
were excluded. Dinnes et al46
reported that clinical examinationhas a sensitivity of 90% and a
speci-ficity of 54% in the detection of rota-tor cuff tears. Four
patients weresubjected to magnetic resonanceimaging to eliminate
doubts aboutsupraspinatus tendon tears.
Moreover, patients with the pres-ence of tiny calcific deposits
accord-ing to the Bosworth classification6
and type III calcific deposits accord-ing to the Gartner
classification7
were excluded because of the highprobability of spontaneous
resolu-tion.47 Further exclusion criteriawere: age of less than 18
years, dia-betes, coagulation diseases or under-going anticoagulant
therapy, tumors,bone infections, previous shouldersurgery,
pregnancy, use of a pace-maker, acute bursitis demonstratedby
ultrasound imaging, rheumatoidarthritis, or other connective
tissuediseases.48
At the end of the evaluation, 46patients (31 women and 15
men;mean age54.3 years, SD14.8,range2978) fulfilled the
selectioncriteria. They agreed to participate,signed informed
consent statements,and were enrolled in the study. Theright
shoulder was affected in 70% ofthe participants, and the left
shoul-der was affected in 30%. The meanduration of condition at
time of treat-ment was 7.1 months (SD1.16,range69). The enrolled
patientsdid not receive any conservativetreatment in the 4 weeks
beforeESWT, and this was the first time thatthey received ESWT. A
flow diagram
of participant recruitment and reten-tion is shown in Figure
1.
Randomization andInterventionsUpon consenting to be involved
inthe study, patients were asked byan interviewer blinded general
ques-tions regarding age, symptom dura-tion, current medicine
intake, andaverage pain intensity over the pre-vious week. A
research assistant ran-domly assigned participants to studygroups
by the use of a computer-based 1:1 randomization
scheme.Participants were randomly assignedto receive 1 of 2
treatment protocols:(1) group A received ESWT at an
Randomized(n=46)
Excluded (n=22) because of: Coagulation disease (n=4) Acute
bursitis (n=5) Previous shoulder surgery (n=4) Connective acute
diseases (n=3) Refused to participate (n=6)
Assessed for eligibility(n=68)
Allocated to energylevel of 0.10 mJ/mm2
(n=23)
Allocated to energylevel of 0.20 mJ/mm2
(n=23)
23 completed6-month assessment
20 completed12-month assessment
16 completed12-month assessment
23 completed3-month assessment
23 completed6-month assessment
23 completed3-month assessment
Figure 1.Flow diagram of participants in the study.
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energy level of 0.20 mJ/mm2, and(2) group B received ESWT at
anenergy level of 0.10 mJ/mm2. Bothgroups received 2,400 pulses
once aweek for 4 weeks. Baseline measure-ments were taken by a
second inter-viewer who was blinded to ESWTdosage, and the
participants com-pleted the questionnaire adminis-tered. Treatment
allocation wasconcealed in a numbered, opaqueenvelope, which
subsequently wasopened by the physician.
Participants were instructed to useoral nonsteroidal
anti-inflammatorydrugs (dexibuprofene, 400 mg) 1hour before
treatment to providepain relief during treatment. Localanesthesia
was not administered, asin previous studies.25,49
We utilized an ESWT device (Modu-lith SLK system, Storz Medical,
Tager-wilen, Switzerland), with an electro-magnetic extra-corporeal
shock-wavegenerator equipped with an in-lineultrasound positioning
system onthe target zone. Participants under-went ESWT by lying on
a bed withthe affected arm positioned in adduc-tion, the elbow
flexed at 90 degrees,and the hand on the abdomen(Fig. 2).
Outcome and Follow-upThe Constant Murley Scale (CMS)50
and a visual analog scale (VAS)51
were administered before treatmentand at 3 and 6 months after
the endof the ESWT. The primary endpointwas the change in mean CMS
scoresfrom baseline to the 3- and 6-monthfollow-ups. Secondary
endpointswere the change in VAS scores frombaseline to the 3- and
6-monthfollow-ups and the numerical ratingscale (NRS) score at the
12-monthfollow-up, as well as radiographiccalcific deposit size at
the 6-monthfollow-up.
The CMS evaluates shoulder functionwith high accuracy,
test-retest reli-ability (intraclass correlation coeffi-cient.80),
and reproducibility.52 Itis a cumulative scale, consisting ofa
100-point scoring system, withassessment of patient-reported
painand function accounting for up to35 points and quantitative
assess-ment of ROM and strength account-ing for up to 65 points.
Its emphasisis on symptoms and functional diffi-culties, and the
patient-report com-ponent documents pain and diffi-culty in
activities of daily life, work,sports, and sleep. Higher
scoresreflect an improvement in shoulderfunction.
Shoulder pain was assessed using theVAS, which represents a
valid mea-sure of acute pain with a good con-struct validity.53 It
consists of a10-cm horizontal line (with 0 cmreferring to no pain
and 10 cmreferring to worst pain ever) onwhich participants were
invited tomark a line indicating pain intensity.The distance is
measured, and painis recorded on a 10-point scale.54 Inthe acute
pain setting, the VAS hasbeen shown to have very good test-retest
reliability (intraclass correla-tion coefficient.99).55
Dworkin et al56 suggested that rawscore changes of approximately
1point or percentage changes ofapproximately 15% to 20%
representthe minimal clinically important dif-ference (MCID) for
the VAS and sim-ilar NRS measures (010) for painintensity. All
outcomes before ESWTand at the scheduled 3- and 6-monthfollow-ups
were assessed by a thirdblinded independent observer.
To further assess pain relief in bothgroups, at 12 months, the
third inter-viewer, who was blinded to theenergy level of
treatment, adminis-tered an 11-point NRS (group A:n20; group B:
n16) by telephone.The NRS usually is an 11-, 21-, or(rarely)
101-point scale, with num-bers in boxes that are anchored with2
extremes at the ends of the scale.57
The 11-point scale NRS consists ofintegers from 0 through 10,
with 0representing no pain and 10 repre-senting worst imaginable
pain.The NRS recently has been demon-strated to possess good
psycho-metric properties. High correlationswere observed between
the NRS andVAS scores. The patient acceptablesymptomatic state
(PASS) was 3.3.58
Calcifications of each patient werefirst detected in a previous
visit byradiography or ultrasound beforetreatment with a
standardized tech-nique in terms of position of theshoulder and
arm, distance from
Figure 2.Participants underwent extracorporeal shock-wave
therapy while lying on a bed withthe affected arm positioned in
adduction, the elbow flexed at 90 degrees, and the handupon the
abdomen.
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the radiographic film, and exposure.The size of the calcific
deposit wasdefined as the difference in measure-ments at the
6-month follow-up com-pared with baseline values.
Statistical AnalysisStatistical analysis was performedaccording
to the principle of inten-tion to treat, with missing dataimputed
with the last observationcarried forward technique. All anal-yses
were performed with SAS statis-tical software, version 9.1 (SAS
Insti-tute Inc, Cary, North Carolina).Computed P values were
2-sided,and P.05 was used to determinestatistical significance.
Two-wayanalyses of variance (ANOVAs) forrepeated measures of CMS
and VASscores were performed with group(treatments) as the
between-subjectsfactor and time and group interac-tions time as the
within-subjectsfactors.
Preplanned time-repeated contrastswere done. Two-tailed unpaired
ttests and the Fisher exact test wereapplied when appropriate. The
par-ticipants baseline characteristics areshown in the Table.
Sample SizeSample size and power calculationswere performed with
nQuery Advi-sor 7 statistical software (StatisticalSolutions,
Saugus, Massachusetts).We computed that a sample size of46
participants achieved a powerover 80% to detect a 15% differencein
CMS score. The statistical level ofsignificance was set at
alpha.05,and the assumed standard deviationwas set at 17.7 points
based on theresults of a study by Loew et al.24
Role of the Funding SourceThis study was supported by a
grantfrom La Sapienza University ofRome.
ResultsAll patients participated in the 3- and6-month
follow-ups. As shown inthe Table, the baseline clinical
anddemographic characteristics of theparticipants were homogenous
inthe 2 groups.
Repeated-measures 2-way ANOVAsfor CMS and VAS scores showed
asignificant effect of treatment (CMS:F1,4425.04, P.000; VAS:
F1,4432.39, P.000) and a significanttreatment-time interaction
(CMS:F2,8820.14, P.000; VAS: F2,88
46.23, P.000). A significant changein test performance over time
alsowas observed in both groups (CMS:F2,8872.52, P.001; VAS:
F2,88337.48, P.000).
Using preplanned contrasts, weobserved a significant increase
inCMS values compared with baselinevalues at 3 months in both
treatmentgroups (time effect: F1,4484.24,P.000), with no
significant differ-ence between treatment groups(interaction
effect: F1,440.18,P.672). A further improvement
Table.Baseline Demographic and Clinical Characteristics of
Participants With ChronicSupraspinatus Tendinitis in Groups A and
Ba
CharacteristicGroup A(n23)
Group B(n23) P
Age (y) .21b
X 57.09 51.65
SD 16.40 12.23
Range 2778 3178
95% CI 50.0064.18 46.3656.94
Time since onset of pain (mo) .44b
X 6.95 7.22
SD 1.06 1.20
Range 69 610
95% CI 6.497.41 6.697.74
Sex (female/male) 15/8 16/7 1.00c
Treatment side (right/left) 16/7 14/9 .76c
Type of calcificationd
I 5 6 1.00c
II 18 17 1.00c
CMS score .62b
X 49.26 47.70
SD 8.56 12.23
95% CI 45.4652.96 42.4152.99
VAS score .68b
X 8.45 8.36
SD 0.67 0.78
95% CI 8.178.74 8.038.69
a Group A received extracorporeal shock-wave therapy (ESWT) at
an energy level of 0.20 mJ/mm2, andgroup B received ESWT at an
energy level of 0.10 mJ/mm2. 95% CI95% confidence
interval,CMSConstant-Murley Scale (0100 points), VASvisual analog
scale (010 points).b As determined by an independent 2-sample t
test.c As determined by Fisher exact test.d Gartners
classification.7
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over the time at the 6-monthfollow-up was observed (time
effect:F1,4411, P.000); however, theimprovement was present in
groupA but not in group B (interactioneffect: F1,4442.01, P.000)
(Fig. 3).
The effect on pain relief was percep-tible at the 3-month
follow-up versusbaseline in both groups (time effect:F1,44174.92,
P.000), although itwas more evident in group A than ingroup B
(interaction effect: F1,446.04, P.018). Comparing scoresobtained at
the 6-month follow-upwith those obtained at the 3-monthfollow-up,
the effect was still moreobvious in group A (time
effect:F1,44151.58, P.000; interactioneffect: F1,4445.69, P.000)
(Fig. 4).
Furthermore, statistical analysis(2-tailed unpaired t test) of
NRSscores obtained at 12 monthsshowed a significantly lower level
ofpain (P.045) in group A than ingroup B (group A: X 2.60,
SD2.1,95% confidence interval [95% CI]1.62 to 3.58; group B:
X4.56,SD3.5, 95% CI2.69 to 6.44).Moreover, 7 participants in group
Aand 10 participants in group B hadNRS scores greater than 3.3, and
13participants in group A and 6 partic-ipants in group B had NRS
scoreslower than 3.3.
The complete disappearance of cal-cification deposits was
observedafter 6 months in approximately 50%of the patients treated
in bothgroups. In particular, we found thatcalcifications had
disappeared in23 (50%) of the 46 participants. Ofthese, 11 (47.8%)
were in group A,and 12 (52.2%) were in group B. Fur-thermore, there
was no difference(t-test value.22) between treat-ments in mean
change of calcificdeposit size at 6 months from base-line (group A:
X135.91, SD71.69, 95% CI100.37 to 166.29;group B: X109.73,
SD75.73,95% CI50.69 to 134.44). No
Time (mo)
Group AGroup B
80
70
60
50
40
630
CM
S M
argi
nal M
eans
Figure 3.Time course of Constant Murley Scale (CMS) scores at
baseline (0) and at 3- and6-month follow-ups. Data are expressed as
marginal means. A significant increase inCMS values with respect to
the baseline at 3 months in both treatment groups (timeeffect:
F1,4484.24, P.000), with no significant difference between
treatment groups(interaction effect: F1,440.18, P.672), was
observed using preplanned contrasts. Afurther improvment at the
6-month follow-up was observed in group A (time effect:F1,4411,
P.000) but not in group B (interaction effect: F1,4442.01,
P.000).
Group AGroup B
8
6
4
2
VAS
Mar
gina
l Mea
ns
0 3 6Time (mo)
Figure 4.Time course of visual analog scale (VAS) scores at
baseline (0) and at 3- and 6-monthfollow-ups. Data are expressed as
marginal means. Using preplanned contrasts, thedecrease of pain was
present at the 3-month follow-up versus baseline in both
groups(time effect: F1,44174.92, P.000), although it was more
evident in group A than ingroup B (interaction effect: F1,446.04,
P.018). At the 6-month versus 3-monthfollow-ups, the effect was
still more obvious in group A (time effect: F1,44151.58,P.000) than
in group B (interaction effect: F1,4445.69, P.000).
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correlation between clinical improve-ment and calcium deposit
changewas observed in either treatmentgroup. Finally, no side
effects wereobserved in participants after treat-ment or reported
by participantsafterward.
DiscussionAccording to the literature, whenprevious conservative
treatment isnot effective, ESWT is a valid alterna-tive in the
management of SCTbecause it reduces pain andimproves the function
of the shoul-der joint.39,59 There is no consensusas to the
appropriate EFD, number ofsessions, and impulses of SWT, andit is
not known whether and, if so,to what degree a correlation
existsbetween decreased pain and func-tional recovery, on the one
hand,and the resorption of calcific depos-its, on the other.
Peters et al22 reported that therapywas more effective in the
high-energy group (0.44 mJ/mm2) thanin the low-energy group
(0.15mJ/mm2) in achieving clinicalimprovement and dissolving
calcifi-cations at 6 months from the end oftreatment. Gerdesmeyer
et al15 alsoobserved a better clinical responsein the high-energy
group (0.32mJ/mm2), with a rate of completedisappearance of
calcific depositsof 60% at the 6-month follow-up and86% at the
12-month follow-up. Bycontrast, in the low-energy group(0.08
mJ/mm2), the rate of dissolu-tion was 21% at 6 months and 25% at12
months.
Albert et al60 observed that a high-energy level of ESWT
significantlydecreased symptoms in individualswith SCT at a 3-month
follow-up,but the results of our study indicatedthat clinical
improvement was notrelated to resorption of calcificdeposits.
Indeed, the calcific depos-its disappeared from the radiographsat 3
months in only 15% and 5% of
the patients in the high-energy andlow-energy groups,
respectively.
The results of our study showed thatthe improvement in mean (SD,
95%CI) CMS scores was higher in groupA: 79.43 (10.33, 74.9783.90)
thanin group B: 57.91 (6.53, 55.0960.74) at 6-month follow-up.
Indeed,the change from baseline in 6-monthCMS scores was 61% in
group A:49.26 (8.56, 45.5652.96) and21% in group B: 47.70
(12.23,42.4152.99).
To date, there are no studies provid-ing data on the MCID for
CMS scores.However, assuming a 30% increasein CMS score from
baseline as clini-cally relevant improvement,18 wecould speculate
that only an EFD of0.20 mJ/mm2 induced a clinically rel-evant
improvement of shoulder func-tion over time.
Both treatments produced a reduc-tion of pain, although
varyingaccording to dose. At 6 months, theVAS score mean (SD, 95%
CI) changewas 75% in group A: 2.09 (1.54,1.422.76) and 37% in group
B: 5.36(0.78, 5.035.70), from the respec-tive baseline values
(group A: 8.45[0.67, 8.178.74]; group B: 8.36[0.78, 8.038.69]),
which was bothstatistically (P.001) and clinicallysignificant.
Indeed, as described byDworkin et al,56 a reduction inchronic pain
intensity of at least 10%to 20% appears to reflect
minimallyimportant changes. Furthermore,group A showed better
effects forlevel of pain than group B at 12months, assuming that an
NRS scorelower than 3.3 points is related to anacceptable state of
pain.
Moreover, we found that clinicalimprovement was not related to
thedisappearance or reduction in size ofcalcifications, according
to the cur-rent data,61 because they were stilldetectable in
approximately 50% ofour participants in both groups after
6 months. Although some authorshave emphasized the potential
effectsof ESWT for disintegrating calcifieddeposits upon the
supraspinatustendon, the real mechanisms remainunknown.62,63
The exact biological effects bywhich ESWT acts are still in
ques-tion. A study conducted on rabbitsshowed that ESWT increases
neovas-cularization at the tendon-bonejunction through release of
angio-genetic growth and proliferating fac-tors such as VEFG and
endothelialnitric oxide synthase, which stimu-late increased blood
flow in tendonsand seem to relieve shoulder symp-toms.28 Another
study carried outon rabbits showed some short-termtendon
pathologies associated withESWT energy levels of at least
0.6mJ/mm2.64 However, neither ten-dons nor the cartilage of joints
havebeen found to be injured by shockwaves lower than this energy
level.Despite a previous report,42 theenergy level used in our
study wasranged in doses suitable for softtissue diseases.1921 We
did notobserve any side effects in the par-ticipants in our
study.
It also should be emphasized thatthese results were obtained
usingenergy levels below those reportedin the literature because we
wantedto compare the effectiveness of 2energy levels, ranging in
the low lev-els. It can be hypothesized, on thebasis of our
findings, that at the low-energy level used in our study
(0.10mJ/mm2), the ESW produces imme-diate analgesic and
anti-inflammatoryeffects, washing out the inflamma-tory mediators
and turning off theassociated neoangiogenesis process.This efficacy
possibly could beexplained by an increased synthesisof nitric
oxide, which has beenshown to be produced in vitro by anEFD of 0.03
mJ/mm2.27 At 0.20mJ/mm2, ESWT probably led to inte-grated
anti-inflammatory and regen-
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erative actions on the different tissuecomponents, and these
combinedmechanisms could explain the betterclinical results
observed in group Ain our study. However, the limita-tions of the
present study include thesmall sample size and the lack of acontrol
group receiving a placebo.The efficacy of this therapy is betterand
longer lasting in patients treatedwith an energy level of 0.20
mJ/mm2
than in those treated with an energylevel of 0.10 mJ/mm2.
So far, from what we know from theliterature, this is the first
study thatused the same number of impulsesand number of sessions in
the rangeof low-energy levels in order to stan-dardize a
therapeutic protocol withbetter clinical results for SCT ther-apy.
Certainly, it must be taken intoaccount, as already stated, that
thepresence of a control group, as wellas a larger sample size,
would haveallowed us to confirm the obtainedresults.
Nevertheless, in clinical practice theresults of this study
could be helpfulto clarify the most appropriate EFD,number of
sessions, and impulses ofshock waves in SCT treatment, sur-passing
what is currently the mostused empirical approach in
clinicalpractice. In addition, many patients,and even some
physicians, believethat the effect of treatment withEWST is due to
the destruction ofcalcific deposits. On the contrary,our results,
in line with those of thestudy by Albert et al,60 showed thatthe
destruction of calcifications isnot necessary to reduce pain
andimprove function.
Further studies are needed to con-firm the most appropriate
energythreshold in ESWT to obtain the bestresults in reducing pain
and improv-ing shoulder function. The results ofthe present study
are promising, butstudies with larger samples, longer
follow-up, and possible comparisonwith a control group are
needed.
Dr Ioppolo, Dr Tattoli, Dr Di Sante, Prof Cac-chio, and Prof
Santilli provided concept/idea/research design. Dr Ioppolo, Dr
Tattoli,Dr Di Sante, Dr Venditto, Dr Servidio, andProf Cacchio
provided writing. Dr Tattoli andDr Di Sante provided data
collection. Dr Tat-toli, Dr Di Sante, and Dr Attanasi provideddata
analysis. Dr Ioppolo, Dr Attanasi, andProf Santilli provided
project management.Dr Attanasi and Dr Venditto provided
facili-ties/equipment. Dr Di Sante, Prof Cacchio,and Prof Santilli
provided consultation(including review of manuscript
beforesubmission).
This study was approved by the local ethicscommission.
This study was supported by a grant fromLa Sapienza University
of Rome.
ClinicalTrials.gov Identifier: NCT01602653.
DOI: 10.2522/ptj.20110252
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doi: 10.2522/ptj.20110252Originally published online June 28,
2012
2012; 92:1376-1385.PHYS THER. Cacchio and Valter
SantilliAttanasi, Teresa Venditto, Marila Servidio, Angelo
Francesco Ioppolo, Maria Tattoli, Luca Di Sante, CarmineClinical
Trial Comparing Two Different Energy LevelsSupraspinatus Calcifying
Tendinitis: A Randomized Extracorporeal Shock-Wave Therapy for
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