| Medicine Section - Extracorporeal Shock Wave
Treatment for Plantar Fasciitis and Other Musculoskeletal
Conditions
| Topic: Extracorporeal Shock
Wave Treatment for Plantar Fasciitis and Other Musculoskeletal
Conditions |
Date of Origin: 04/2001 |
Section: Medicine
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Policy No: 90 |
Approved Date: 02/10/2009
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Effective Date: 03/01/2009 |
Next Review Date: 03/2010
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IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
Description
Extracorporeal shock wave treatment (ESWT)
Extracorporeal shock wave treatment, also known as
orthotripsy, has been available since the early 1980s
for the treatment of renal stones, and has been widely
investigated for the treatment of biliary stones. Shock
waves create a transient pressure disturbance, which
disrupts solid structures, breaking them into smaller
fragments, allowing spontaneous passage and/or removal
of stones. The mechanism by which ESWT might have an
effect on musculoskeletal conditions is not well defined.
Chronic musculoskeletal conditions, such as tendinitis,
can be associated with a substantial degree of scarring
and calcium deposition. Calcium deposits may restrict
motion and encroach on other structures such as nerves
and blood vessels, causing pain and decreased function.
One hypothesis is that disruption of these calcific
deposits by shock waves may loosen adjacent structures
and promote resorption of calcium, thereby decreasing
pain and improving function.
Other functions are also thought to be involved. Physical
stimuli are known to activate endogenous pain control
systems, and activation by shock waves may "reset" the
endogenous pain receptors. Damage to endothelial tissue
from ESWT may result in increased vessel wall permeability,
causing increased diffusion of cytokines, which may
in turn promote healing. Microtrauma induced by ESWT
may promote angiogenesis and thus aid in healing. Finally,
shock waves have been shown to stimulate osteogenesis
and promote callous formation in animals, which is
the rationale for ESWT in delayed union or non-union
of bone fractures.
Both high-dose and low-dose protocols have been investigated.
A high-dose protocol consists of a single treatment
of high energy shock waves (1300mJ/mm2). This painful
procedure requires anesthesia. A low-dose protocol
consists of multiple treatments, spaced one week to
one month apart, in which a lower dose of shock waves
is applied (1405mJ/ mm2 over three sessions). This
protocol does not require anesthesia.
There are currently five ESWT devices approved by
the U.S. Food and Drug Administration (FDA):
Device Name |
Type |
FDA Approved
Indication(s) |
OssaTron® device (HealthTronics,
Marietta, GA) |
High-dose - Electrohydraulic
delivery system |
Chronic proximal plantar fasciitis
for patients with symptoms of plantar fasciitis
for 6 months or more that has failed to respond
to conservative management.
Chronic lateral epicondylitis (tennis elbow)
that has failed to respond to conservative
treatment. |
Epos™ Ultra (Dornier, Germering,
Germany) |
High-dose - Electromagnetic delivery
system |
Treatment of chronic plantar
fasciitis for patients with symptoms of plantar
fasciitis for 6 months or more and a history
of unsuccessful conservative therapy. |
SONOCUR® Basic (Seimens,
Erlangen, Germany) |
Low-dose - Electromagnetic delivery
system |
Treatment of chronic lateral
epicondylitis (commonly referred to as tennis
elbow) for patients with symptoms of chronic
lateral epicondylitis unresponsive to conservative
treatments for more than six months. |
Orthospec™ Extracorporeal
Shock Wave Therapy Device |
High-energy – Electrohydraulic/Spark
Gap |
Treatment of chronic proximal
plantar fasciitis with or without heel spur in
patients 18 years of age or older who have had
symptoms for 6 months or more and a history of
unsuccessful conservative therapies to relieve
heel pain. |
Orbasone™ Pain Relief System |
High-energy – sonic wave |
Treatment of chronic proximal
plantar fasciitis in patients 18 years of age
or older that has failed to respond to conservative
therapy. Chronic proximal plantar fasciitis
is defined as heel pain in the area of the insertion
of the plantar fascia on the medial calcaneal
tuberosity that has persisted for six months
or more. |
Another type of ESWT, radial ESWT (rESWT) received
pre-market approval (PMA) in May 2007. The FDA-approved
device is the Doloclast (spelled Dolorclast in the
PMA summary) from EMS Electro Medical Systems, Nyon,
Switzerland. Radial ESWT is generated ballistically
by accelerating a bullet to hit an applicator, which
transforms the kinetic energy into radially expanding
shock waves. Other types of ESWT produce focused shock
waves that show deeper tissue penetration with significantly
higher energies concentrated to a small focus. Radial
ESWT is described as an alternative to focused ESWT
and is said to address larger treatment areas, thus
providing potential advantages in superficial applications
like tendinopathies.
Plantar Fasciitis
Plantar fasciitis is a very common ailment characterized
by deep pain in the plantar aspect of the heel, particularly
on arising from bed. While the pain may subside with
activity, in some patients the pain may persist, interrupting
activities of daily living. On physical examination,
firm pressure will elicit a tender spot over the medial
tubercle of the calcaneus. The exact etiology of plantar
fasciitis is unclear, although repetitive injury is
suspected. Heel spurs are a common associated finding,
although it has never been proved that heel spurs are
the cause of the pain. It should be noted that asymptomatic
heel spurs can be found in up to 10% of the population.
Conservative therapy of plantar fasciitis is successful
in the vast majority of cases. Rest or minimization
of running or jumping is the cornerstone of therapy.
Heel cups are sometimes helpful in alleviating symptoms,
presumably by padding the heel and absorbing the impact
of walking. Nonsteroidal anti-inflammatory drugs are
also helpful in acute cases. If the above measures are
ineffective, a local injection of steroids may be effective.
Improvement is frustratingly slow and gradual, taking
up to a year in some cases. For refractory cases, either
open or endoscopic plantar fasciotomy may be considered.
Tendinitis of the Shoulder
Tendinitis of the shoulder results from strain of the
shoulder girdle muscles, most commonly the muscles of
the rotator cuff. These small muscles control rotation
of the shoulder and are prone to injury and inflammation
due to their location and relative weakness. Calcific
tendinitis refers to a condition in which clinical signs
and symptoms of tendinitis are accompanied by calcium
deposition at the site of the affected tendon. This
most commonly occurs at the origin of the supraspinatus
muscle but may also involve other muscles of the rotator
cuff. The cause of calcium deposition is not well understood,
and there is not a clear correlation between clinical
symptoms and the presence or extent of calcific deposits.
Many patients with chronic tendinitis do not have calcium
deposition, and less than half of patients with calcific
deposition on x-ray exhibit clinical symptoms.
Initial therapy consists of rest, anti-inflammatory
medications, physical therapy, and/or local corticosteroid
injections. Response to conservative therapy varies,
but it is common for shoulder tendinitis to become chronic,
especially when the muscles of the rotator cuff are
involved. When conservative treatment fails, a number
of invasive techniques are available for both calcific
and non-calcific tendinitis of the shoulder. For example,
needle irrigation can be performed for calcific tendinitis,
during which calcium deposits are localized and disrupted
by needling under fluoroscopic guidance. Following disruption,
irrigation and aspiration removes loose calcium particles.
Approximately 10% of patients with chronic shoulder
tendinitis undergo surgery, usually performed arthroscopically.
Tendinitis of the Elbow (Lateral Epicondylitis)
Lateral epicondylitis is the most common form of tendinitis
of the elbow, and results in lateral elbow pain and
functional limitations. The disorder is caused by overuse
or injury of the tendons that attach the arm muscles
to the elbow, such as commonly occurs from playing
tennis (“tennis elbow”). However, only
a minority of cases are caused by playing tennis, the
majority occur from other activities that involve repetitive
extension of the wrist. Overuse of the extensor muscles
lead to microtears at their insertion point, which
incites an inflammatory response. Repetitive cycles
of injury and inflammation lead to tendinosis, degeneration
of the tendon structures, and disorganized healing.
The diagnosis of lateral epicondylitis is made by characteristic
pain and tenderness at the lateral aspect of the elbow,
in conjunction with typical activities or injury that
accompany this condition. Radiologic imaging is not
necessary for diagnosis, but may be useful in ruling
out other causes of lateral elbow pain, such as fracture,
dislocation, degenerative joint disease, and other bony
or soft tissue pathologies. Imaging is usually normal
in lateral epicondylitis, although occasionally calcium
deposition can be seen. Conservative treatment consists of rest, activity modification,
anti-inflammatory medications, and/or physical therapy.
Corticosteroid injections and orthotic devices can also
be tried as adjuncts to conservative measures. A number
of surgical treatments are available for patients who
do not respond to conservative treatment; approximately
5%–10% of patients with tendinitis of the elbow
require surgery. Surgery may be performed as open or
laparoscopic procedures. The general approach is to
debride any degenerative or nonviable tissue and to
repair tears or other structural abnormalities.
Note: ESWT for Peyronie's disease
is addressed in a separate Regence policy, Medicine
No. 109.
Policy/Criteria
Extracorporeal shock wave treatment, using either
a high- or low-dose protocol, is considered investigational
for all musculoskeletal indications, including
but not limited:
- Avascular necrosis of the femoral head
- Delayed union and nonunion of fractures
- Lateral epicondylitis (tennis elbow)
- Plantar fasciitis
- Stress fracture
- Tendinopathies including calcific tendinitis of
the shoulder
Scientific Background
This policy is based in part on 2003 and updated 2004
BlueCross BlueShield Association Technology Evaluation
Center (TEC) Assessment (2-4), which evaluated the
cumulative literature on ESWT for musculoskeletal conditions,
and focused on three conditions: plantar fasciitis,
tendinitis of the shoulder, and tendinitis of the
elbow.
The most clinically relevant outcomes of ESWT are
improvements in pain and/or function. Both of these
outcomes can be influenced by nonspecific effects, placebo
response, natural history of the disease, and regression
to the mean; therefore, they need to be evaluated in
randomized, controlled trials that maintain satisfactory
blinding of the treatment assignment. Both the 2003
and 2004 TEC Assessments focused on double-blind studies,
as the observed placebo effect in double-blinded trials
of ESWT for plantar fasciitis was substantially greater
than in single-blind trials. Pain outcomes require quantifiable
pre- and post-treatment measures, which are most commonly
measured with a visual analogue scale (VAS). Collectively,
the pain measurement literature cautions against using
only statistical significance of difference in mean
change in scores to determine clinical significance.
More meaningful to patients and clinicians is the correlation
of improvement in pain scores with improvement in function
and quality of life. Thus, quantifiable pre- and post-treatment
measures of functional status are also necessary. Although
there is a lack of validated instruments for many indications,
in some cases the SF12 and SF36 (instruments for measuring
health status and outcomes from the patient’s
point of view) may be employed for this purpose. Also
used in some studies were the Roles and Maudsley score,
the Maryland Foot score, and the American Orthopedic
Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale.
Plantar Fasciitis and Heel Pain
The 2004 TEC Assessment on ESWT for the treatment
of chronic plantar fasciitis (3) focused on five randomized,
double-blind studies reporting on 878 patients, all
of which were judged to be of high quality based on
specific criteria (5-11):
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HealthTronics Surgical Services,
Inc/Ogden et al (5,6) |
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293 patients with symptoms for at least 6 months’
duration and failure to respond to at least three
prior treatment interventions were enrolled in
this trial. Patients were randomized to either
sham or active treatment, and both groups demonstrated
improvement at 12 weeks post-treatment. Two outcomes
met statistical significance: patient reported
improvement in pain on first walking in the morning
and improvement in the investigator assessment
of pain caused by applying pressure to the heel.
However, the percent of patients who had a 50%
improvement in pain was not statistically significant
(60% vs. 48%, p=0.13). There was no significant
difference between ESWT and placebo in the patients’
self-assessments of the distance and time they were
able to walk without heel pain, and pain medication
use was similar in both groups. The HealthTronics
report notes “none of the primary or secondary
outcome measurements demonstrated differences as
pronounced as the [blinded] investigator assessment.” (5) |
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It should be noted that Ogden and colleagues
subsequently reported additional follow-up
data from the above 12-week results (36), however,
randomization was not preserved after 12 weeks,
making the ability to draw conclusions from the
data problematic. |
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Buchbinder et al (7) |
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This trial enrolled 166 patients, who were randomized
to either active or sham ESWT. Three treatment
sessions of low-energy ESWT were given at weekly
intervals. Study measures included overall, morning,
and activity pain measured on a VAS scale, the
Maryland Foot Score, and quality of life using
SF36. Outcomes were assessed at 6 and 12 weeks.
Improvements of a similar magnitude were reported
for both groups on measures of pain and functioning.
There were no significant group differences for
any of the outcome measures. |
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Haake et al (8) |
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In this trial, 272 patients with a 6-month history
of plantar fasciitis were randomized to three treatments
of medium-energy ESWT or sham ESWT, with treatment
scheduled every two weeks. The primary outcome
measure was the percentage success rate after 12
weeks based on the Roles and Maudsley score, where
success was defined as a score of 1 or 2. Although
both groups improved at 12 and 52 weeks, the differences
between the two groups were not statistically significant
for either primary or secondary outcomes. The success
rate at 12 weeks was 34% in the ESWT group and
30% in the placebo group, and differences remained
nonsignificant at the 1-year follow-up. |
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Rompe et al (9) |
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In this study, 45 patients who ran 30 or more
miles per week and who had plantar fasciitis for
at least 12 months were randomized to three treatments
of either medium-energy or sham ESWT. Treatment
success was defined as 50% improvement in self-assessment
of morning pain. At six months follow-up, the ESWT
group had greater improvement on self-assessment
of morning pain (p<0.001, the AOFAS Ankle-Hindfoot
scale (p<0.001), and the Roles and Maudsley
Scale (p<0.01) compared to the placebo group.
Treatment success was 60% for the ESWT group and
27% for the placebo group (p=0.06). |
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Theodore et al/Dornier Medical Systems, Inc.
(10,11) |
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There were 150 patients enrolled in this study.
All had a six month history of moderate-to-severe
heel pain and had failed at least three attempts
at conservative management. Patients were randomized
to a single treatment of high-energy ESWT or to
placebo. Treatment success was defined as the percent
of patients achieving at least 60% improvement
in morning pain. At three months, treatment success
was 56% in the ESWT group and 45% in the sham group
(p=0.19), a nonsignificant difference. The ESWT
group had greater improvement in the average rating
of morning pain (3.4 vs. 4.1, p=0.04) and greater
percentage of patients scoring excellent/good on
the Roles and Maudsley score (62% vs. 40%, p=0.03).
Group differences on the remaining outcomes were
nonsignificant, and post-treatment scores were
not reported. |
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| Also mentioned in the 2004 TEC Assessment
were several other published studies that were
deemed to be of lower quality due to disproportionate
dropout rates between study groups, lack of double-blinding
or other limitations. (12-14) |
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| It should be noted that although
the above studies employed differing treatment
protocols (high-dose versus low-dose), there are
no controlled clinical trials that test the relative
efficacy of differing techniques for shock wave
dosage or delivery. Specifically, the effect of
different dosage protocols on physiologic measures,
magnitude of treatment effect, and/or adverse effects
has not been determined in humans. |
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| In summary, the evidence included
in the 2004 TEC Assessment concerning ESWT for
the treatment of chronic plantar fasciitis demonstrated
a statistically significant effect on between-group
difference in morning pain measured on a 0–10
VAS score. However, the clinical significance of
the change was uncertain as the absolute value
and effect size were small. The most complete information
on the number needed to treat (NNT) to achieve
50%–60% reduction in morning pain was derived
from the three studies of high-energy ESWT, combined
NNT =7 (95% CI: 4–15). Improvements in pain
measures were not clearly associated with improvements
in function. Effect size for improvement in pain
with activity was non-significant, based on reporting
for 81% of patients in all studies and 73% of patients
in high-energy ESWT studies. Success in improvement
in Roles and Maudsley score was reported for fewer
than half the patients and although statistically
significant, confidence intervals were wide. Where
reported, improvement in morning pain was not accompanied
by significant difference in quality-of-life measurement
(SF-12, physical and mental scales) or use in pain
medication. Therefore, TEC concluded that
the technology assessment criteria were not met. |
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| Since publication of the TEC Assessment,
results were reported to the FDA from trials delivering
ESWT with the Orthospec™, Orthopedic ESWT,
and Orbasone™ Pain Relief System as follows: |
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Orthospec™ (15) |
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Efficacy was examined in a multicenter, double-blind,
sham-controlled trial involving 172 participants
with chronic proximal plantar fasciitis failing
conservative therapy. Patients were randomized
to ESWT or sham treatments in a 2 to 1 ratio. At
3 months, the ESWT arm had less investigator-assessed
pain with application of a pressure sensor (0.94
points lower on a 10-point VAS, 95% CI: 0.02 to
1.87). However, there was no difference in improvement
in patient-assessed activity and function between
ESWT and sham groups. |
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Orbasone™ (16) (33) |
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In a multicenter, randomized, sham-controlled,
double-blind trial, 179 participants with chronic
proximal plantar fasciitis were randomized to active
or sham treatment. At 3 months, both active and
sham groups improved in patient-assessed pain on
awakening (by 4.6 and 2.3 points respectively on
a 10-point VAS; crude difference between groups
at 3 months of 2.3, 95% CI: 1.5 to 3.3). While
ESWT was associated with statistically significant
more rapid improvement in a mixed-effects regression
model, insufficient details were provided to evaluate
the analyses. |
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| While approved by the FDA for treatment
of chronic plantar fasciitis and examined for efficacy
in apparently well-designed, randomized, double-blind,
controlled trials, the weight of evidence remains
consistent with the conclusions of the 2004 TEC
Assessment. Definitive, clinically meaningful
treatment benefits at three months were not apparent,
nor was it evident that the longer-term disease
natural history was altered. |
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| A 2005 meta-analysis conducted
by Thomson and colleagues included results from
six randomized, controlled trials, involving 897
participants. (17) For the endpoint of morning
pain assessed using a VAS, they concluded that
although statistically significant, the effect
size was very small. Furthermore, excluding the
two poorest quality trials from the meta-analysis
resulted in a statistically insignificant effect. |
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An updated search of the MEDLINE
database through October 2008 identified the
following additional published randomized, controlled,
double-blind clinical trials. |
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| Kudo and colleagues reported a statistically
significant difference in improvement in mean pain
score on first walking in the morning between the
active treatment and placebo (18) There were no
significant differences in other measures. It should
be noted that the placebo group also reported significant
improvement in pain from baseline. Intention-to-treat
analysis was not reported in this study, and there
was a significant difference between groups in
blinding verification, with more active treatment
patients reporting that they believed they received
the active treatment, thus potentially biasing
results. Malay and colleagues randomized 172 patients
at a 2:1 ratio to either active ESWT (n=115) or
sham (n=57). (19) Subjects and assessors were blinded,
while nonblinded investigators administered the
single treatment session. Follow-up was three
months. Both groups reported improvement
from baseline, with significantly more responders
(decrease from baseline of 50% or more with a visual
analog scale (VAS) score =4) in the active
ESWT group than in the sham group (42.9% and 19.6%,
respectively; p=.003). Between-group differences
in reduction in heel pain reached statistical significance
for both blind assessor’s objective and participants’ subjective
assessment (p=.045 and p<.001, respectively). The
reduction in pain was statistically significantly
greater in the treatment group than in the sham group
in the absence of heel spur (p=.012) but not when
heel spur was present (p=.96). The reduction
in the use of pain medication was also significantly
greater in the treatment group (p<.001). It
is interesting to note that despite the report of
greater reduction in pain in the treatment group
there was no significant between-group difference
in self-assessment of activity and functional levels.
This study adds to the number of randomized controlled
clinical trials reporting significantly greater symptom
improvement with active treatment compared with sham. However,
conclusions related health outcomes cannot be reached
due to the short-term follow-up period, the 2:1 patient
ratio and the administration of treatment by nonblinded
investigators. In addition, it is difficult
to compare these results with other studies due to
differences in treatment protocol and patient selection
methods. |
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| Gerdesmeyer and colleagues reported
on a multicenter double-blind randomized controlled
trial (RCT) of radial ESWT (rESWT) conducted for
FDA premarket approval (PMA) of the Doloclast (spelled
Dolorclast in the PMA summary) from EMS Electro
Medical Systems. In this study, 252 patients were
randomized, 129 to rESWT and 122 to sham treatment.
(41) These patients had heel pain for at least
six months, and failure of at least two nonpharmacological
and two pharmacological treatments prior to entry
into the study. Three treatments at weekly intervals
were planned, and more than 90% of patients in
each group had all three treatments. One patient
required local anesthesia which was allowed by
the study protocol. Outcome measures were composite
heel pain (pain on first steps of the day, with
activity and as measured with Dolormeter), change
in individual visual analog scale (VAS) scores,
and Roles and Maudsley score measured at 12 weeks
and 12 months. (The PMA summary indicates that
VAS scores were adjusted if rescue pain medications
or other treatments were used by adding two points
to the VAS score at the affected visit. This was
not noted in the published article; no further
details on the use of analgesics were provided
in the publication.) Success was defined as at
least 60% improvement in two of three VAS scores
OR, if less pain reduction, then patient had to
be able to work and complete activities of daily
living, had to be satisfied with the outcome of
the treatment, and must not have required any other
treatment to control heel pain. Patients who did
not achieve success at 12-weeks follow-up were
allowed to withdraw and their results were carried
forward for the 12-month analysis. (For this reason,
results at 12 months are not discussed in this
section.) A value of P<0.025 (1-sided) for between
group difference was considered significant. A
number of secondary outcomes were also measured
at 12 weeks including changes in Roles and Maudsley
score, SF-36 physical percent changes, SF-36 mental
percent changes, investigator’s judgment
of effectiveness, patient’s judgment of therapy
satisfaction, and patient recommendation of therapy
to a friend. At 12-week follow-up rESWT was followed
by a decrease of the composite VAS score of heel
pain by 72.1% vs 44.7% after placebo (P=.0220);
although the final VAS scores were not provided. Success
rates on individual VAS scores were as follows:
heel pain when taking first steps in the morning,
60.8% for ESWT vs 48.31% for placebo (P=0.0269 – not
significant), heel pain during daily activities,
60% for ESWT vs 40.68% (P=0.0014), and heel pain
after application of Dolormeter, 52.85% vs. 39.66%
(P=.0216). The success rate for the composite score
was 61% vs. 42% (P=0.002). Statistically significant
differences were noted on all secondary measures.
On SF-36 physical, the percent change was -44.1
for ESWT and -23.9 for placebo and on SF-36 mental
the change was -22.8 vs -14.3. Just over
half (58.4%) of the ESWT group and 41.52% of placebo
group had good or excellent Roles and Maudsley
scores. Patient global judgment of therapy
satisfaction was very or moderately satisfied in
63.16% of ESWT and 46.36% of placebo patients.
There are a number of limitations concerning this
published study that prevent definite conclusions
from being reached including the following: the
limited data concerning specific outcomes (e.g.,
presenting percent changes rather than actual results
of measures); inadequate description of prior treatment
(or intensity of treatment) provided before referral
to the study; use of the composite outcome measure;
and no data on the use of rescue medication. In
addition, the clinical significance of changes
(and relative changes) in outcome measures is uncertain
from this publication. There are also questions
about the adequacy of patient blinding regarding
treatment. |
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| In a smaller single-center double-blind
trial in Germany 40 patients were randomized to
receive either focused ESWT provided by the Duolith® SD1
device or sham treatment. (42) (The Duolith SD1,
from Storz Medical, is a small, mobile shockwave
device that provides either electromagnetic focused
ESWT or radial pressure wave. It does not have
FDA approval.) Anesthesia was not used. Outcome
measures were the same as described in the paper
by Gerdesmeyer et al. In this study, active ESWT
resulted in a 73% reduction in composite heel pain
at 12-week follow-up, a 33% greater reduction than
achieved by sham treatment. Between-group differences
in reductions in composite and individual VAS scores
were not statistically significant. Marks and colleagues
(43) described a small (25 subjects) double-blind
RCT of low energy ESWT for plantar fasciitis. Outcome
measures were pain on VAS, and Roles and Maudsley
scores before ESWT, early after treatment and six
months later. They reported that there appeared
to be a significant placebo effect with ESWT and
there was lack of evidence of efficacy compared
to sham treatment. |
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| In summary, evidence from more recently
published data fail to alter the conclusions reached
in the 2004 TEC Assessment. The balance of
evidence concerning ESWT for the treatment of chronic
plantar fasciitis remains inconclusive. |
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| Tendinitis of the Shoulder |
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| In the 2003 TEC Assessment (2), four
studies enrolled a total of 199 patients with tendinitis
of the shoulder. Two were randomized, double-blind
controlled trials, comparing ESWT to sham ESWT
(15,16); and two were nonrandomized, unblinded
controlled trials (20,21). Only the study by Schmidt
was rated as "good," meeting all of the
quality criteria. (22) In this study, both treatment
and sham groups showed similar improvements on
pain and functional status measures, with no significant
group differences. |
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| The remaining three studies were
rated as "poor"
due to several serious methodological limitations.
Two studies were nonrandomized studies and did not
use blinding, which were considered fatal flaws in
the TEC Assessment. (20,21) Although the study by
Speed and colleagues was randomized and double-blinded,
there was an unacceptably large loss to follow-up of
32% for the primary endpoint
— also considered a fatal flaw. (23) |
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| The TEC Assessment concluded there
was not sufficient evidence to permit conclusions
concerning whether ESWT improved outcomes for patients
with tendinitis of the shoulder. The highest quality
evidence, two placebo controlled trials, including
one rated "good"
quality, suggested that there is no benefit in health
outcomes for this indication. |
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| An updated search of the MEDLINE
database through October 2008 identified four additional
double-blinded, randomized studies published since
completion of the TEC Assessment: |
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Gerdesmeyer and colleagues compared the effectiveness
of high-energy and low-energy ESWT to sham treatment
in patients with calcific tendonitis. (24) Although
patients and evaluators were blinded to the treatment,
all patients underwent 10 sessions of physiotherapy
following ESWT, which introduced a co-intervention.
This study demonstrated statistically significant
improvements in VAS scores between active and sham
treatments at 6 and 12 months; however, there was
a significant dropout rate at 12 months. While
the findings of this study indicate there may be
a treatment effect from ESWT (particularly high-energy
EWST), the authors stated that their findings need
to be confirmed in high-quality randomized clinical
trials with different treatment protocols and treatment
parameters. They also stated that further studies
were necessary to analyze long-term treatment effects. |
| |
|
| • |
Pleiner and colleagues randomized 43 patients
with calcific tendonitis to sham or active ESWT,
the latter of which consisted of two treatment
sessions of high-energy ESWT, two weeks apart.
(25) There was a high overall loss to follow-up
of 23%; dropouts were counted as treatment non-responders
in the analysis. This study reported a larger decrease
in pain scores for the active ESWT group, but the
difference was not statistically significant. Similarly,
more patients had complete resolution of their
calcific deposits, but the differences did not
reach statistical significance. However, there
was a statistically significant improvement in
the Constant and Murley score (a measure of functional
status) for the active ESWT group. |
| |
|
| • |
In the third randomized, double-blinded study,
Peters and colleagues randomized 90 patients to
sham, low-dose, or high-dose ESWT. (26) There were
large differences in reported outcomes favoring
the high-dose ESWT group. For example, 82% of patients
in the high-dose group were pain-free after one
treatment, compared with 0% in the placebo and
low-dose groups. All patients in the high-dose
ESWT group had resolution of their calcific deposits
and none had recurrence of pain at 6 months, whereas
in the other two groups, no patients had complete
resolution of calcific deposits, and nearly all
reported recurrence of pain at 6 months. It should
be noted that statistical analysis was poorly reported
in this study, omitting some comparisons between
the treatment and placebo groups. Also, this study
used unusual outcome measures, including the average
number of treatments required to become pain-free
and the percent of patients with recurrence of
pain after 6 months. |
| |
|
| • |
Hsu and colleagues concluded from their single-center
study that ESWT showed promise for treatment of
calcifying tendonitis of the shoulder. (48) In
this study, patients were randomized to receive
two courses of ESWT (n=33) or sham treatment (n=13) Outcome
measures included radiographic outcomes, Constant
score and pain scale. ESWT results were good to
excellent in 87.9% of shoulders and fair in 12.1%.
In the controls, 69.2% had fair and 30.1% poor
results. Calcium deposits were completely eliminated
in seven and partially eliminated in 11 of ESWT
patients and partially eliminated in two control
patients. |
| |
|
| Several other published studies were
identified in the literature search; however, they
were deemed to be of lower quality due to lack
of double-blinding. (27,28) |
| |
|
| In summary, there is insufficient
evidence to permit conclusions concerning whether
ESWT improves outcomes for patients with tendinitis
of the shoulder without calcification. Results
of the two small trials enrolling patients with
this indication do not suggest a benefit from ESWT.
In contrast, data from trials enrolling patients
with calcific tendinitis are promising; however,
a confirmatory trial mirroring the good quality
of the Gerdesmeyer trial with longer follow-up
is needed. Evidence from the currently available
trials is suggestive of a treatment benefit but
is not sufficient to permit conclusions concerning
health outcomes. |
| |
|
| Lateral Epicondylitis |
| |
|
| Six randomized, double-blinded, placebo-controlled
trials enrolling 808 patients with lateral epicondylitis
met the inclusion criteria for the 2004 TEC Assessment.
(4) Two studies were rated as fair in quality due
to 1) small sample size and group differences at
baseline in duration of symptoms and prior treatment,
yielding a possibility of selection bias (29);
and 2) lack of accounting for dropouts and intent-to-treat
analysis (30). Four trials were rated “good” quality
and are summarized below: |
| |
|
| • |
In the SONOCUR trial, 114 patients were randomized
to low-energy ESWT or sham ESWT for 3 treatment
sessions administered in 1-week intervals. (31)
The main outcome measures were percent response
on self-reported pain scale (at least 50% improvement
on 0–100 VAS) and change in the Upper Extremity
Function Scale (UEFS). Results of the 2 main outcome
measures at 3 months showed greater improvement
in the ESWT group. Response rate was 60% in the
active treatment group and 29% in the placebo group
(p<0.001). There was a 51% improvement in the
UEFS score for the active treatment group, compared
with a 30% improvement in the placebo group (p<0.05). |
| |
|
| • |
The Ossatron trial randomized 183 patients to
a single session of high-energy or sham ESWT. (32)
Treatment success was defined as a 50% improvement
in investigator and self-assessment of pain on
a 0–10 VAS and no or rare use of pain medication.
At the 8-week follow-up, the ESWT group had a greater
rate of treatment success than the placebo group
(35% vs. 22%, p <0.05). Mainly responsible for
group differences in treatment success was the
investigator assessment of pain (48% vs. 29%, p <0.01);
the improvements in self-assessment of pain (81%
vs. 70%, p =0.06) and non-use of pain medication
(81% vs. 70%, p =0.09) were not statistically significant. |
| |
|
| • |
Haake and colleagues reported on a trial that
randomized 272 patients to 3 sessions of low-energy
or sham ESWT. (33) Treatment success was defined
as achieving a Roles and Maudsley score of 1 or
2 with no additional treatments. At 12 weeks, the
ESWT success rate was 25.8%, and the placebo success
rate was 25.4%. The percentage of Roles and Maudsley
scores below 3 did not differ between groups at
either 12 weeks (31.7% ESWT vs. 33.1% placebo)
or at 1 year (65.7% ESWT vs. 65.3% placebo) of
follow-up. Furthermore, the groups did not differ
on any of 5 pain assessment measures or on grip
strength. |
| |
|
| • |
Rompe and colleagues randomized 78 tennis players
to 3 treatments at weekly intervals of low-energy
or sham ESWT. (34) Outcomes included pain ratings
during wrist extension and the Thomsen Provocation
Test, the Roles and Maudsley score, the Upper Extremity
Function score, grip strength, and satisfaction
with return to activities. At 3 months follow-up,
the ESWT group, compared to placebo, significantly
improved on all outcomes except grip strength.
Treatment success (at least a 50% decrease in pain)
was 65% for the ESWT group and 28% for the placebo
group (p<0.01) and 65% of the ESWT group compared
to 35% of the placebo group were satisfied with
their return to activities (p=0.01). |
Overall, the TEC Assessment concluded that the available
data did not provide strong and consistent evidence
that ESWT improved outcomes of chronic lateral epicondylitis.
Since publication of the 2004 TEC Assessment, four
additional randomized trials were published. In
the first, sixty subjects were randomly allocated to
receive one session per week for three weeks of either
sham or active ESWT. (35) All subjects were provided
with a forearm-stretching program. After eight weeks
of therapy, subjects were classified as either treatment
successes or treatment failures according to fulfillment
of all three criteria: 1) at least a 50% reduction
in the overall pain visual analog scale score; 2) a
maximum allowable overall pain visual analog scale
score of 4.0 cm; and 3) no use of pain medication for
elbow pain for two weeks before the eight week follow-up. Success
rates in the sham and active therapy groups were not
significantly different (31% and 39%, respectively,
p=0.533).
In the second study, Pettrone and McCall reported
results from a randomized double-blind trial conducted
in three large orthopedic practices. (37) This
study enrolled 114 patients who received either placebo
or ESWT weekly for three weeks in a "focused" manner
(2,000 impulses at 0.06 mJ/mm-2 without local anesthesia). Randomization
was maintained through 12 weeks, and benefit was demonstrated
with respect to a number of outcomes, namely pain,
functional scale, and activity score. Pain assessed
on the VAS (scaled here to 10 points) declined at 12
weeks in the treated group from 7.4 to 3.8 (mean 3.6,
95% CI: 2.8 to 4.5) and among placebo patients, from
7.6 to 5.1 (mean 2.4, 95% CI: 1.6 to 3.3). A reduction
in Thomsen test pain of at least 50% was demonstrated
in 60.7% of those treated compared to 29.3% in the
placebo group (ARR 31.4%, 95% CI: 13.2 to 46.9). Mean
improvement on a 10-point upper extremity functional
activity score was 2.4 for ESWT-treated patients compared
to 1.4 in the placebo group — a difference at
12 weeks of 0.9 (95% CI .18 to 1.6). This study
found benefit of ESWT for lateral epicondylitis over
12 weeks. However, the placebo group also improved
significantly. Whether the natural history of
disease was altered is unclear.
Staples and colleagues conducted a double-blind controlled
trial of ultrasound-guided ESWT for epicondylitis.
(45) Sixty-eight patients were randomized to receive
three ESWT treatments or three treatments at a subtherapeutic
dose at weekly intervals. There were significant improvements
in most of the seven outcome measures for both groups
over six months of follow-up and no between-group differences.
The authors found little evidence to support use of
ESWT for this indication. Radwan and colleagues randomly
assigned 56 patients with persistent tennis elbow to
ESWT without anesthesia (29 patients) or percutaneous
tenotomy (27 patients). (46) Both groups improved at
all time points through 12-months follow-up. At three
months, the success rates, defined as Roles and Maudsley
score: excellent and good, were 74.1% of patients in
the tenotomy group and 65.5% of ESWT patients.
In summary, the available data are inconsistent, therefore
it is not possible to reach conclusions concerning
the overall effect of ESWT on health outcomes for chronic
lateral epicondylitis. It is not known whether
the different results are due to methodological bias
or to differences in the study populations and interventions. In
the context of mixed results from previous studies,
only exceedingly convincing differential outcomes provide
sufficient evidence to alter the conclusions of the
2004 TEC Assessment. Further, a Cochrane review,
which included nine placebo-controlled trials with
1,006 participants, concluded “there is ‘Platinum’ level
evidence [the strongest level of evidence] that shock
wave therapy provides little or no benefit in terms
of pain and function in lateral elbow pain.” (38,39) The
authors noted that when available data from the randomized
trials was pooled, most benefits observed in the positive
trials were no longer statistically significant.
Chronic Achilles Tendon Pain
Costa and colleagues conducted a randomized, double-blind,
placebo-controlled trial of ESWT for chronic Achilles
tendon pain treated monthly for three months. (40) The
study randomized 49 participants and was powered to
detect a 50% reduction in VAS pain scores. No
difference in pain relief at rest or during sport participation
was found at 1 year. Two older ESWT-treated participants
experienced tendon ruptures.
Rasmussen and colleagues reported a single-center
double-blind controlled trial with 48 patients, half
of them randomized after four weeks of conservative
treatment to four sessions of active radial ESWT and
half to sham ESWT. (44) Primary endpoints were American
Orthopaedic Foot and Ankle Society (AOFAS) score measuring
function, pain, and alignment and pain on visual analog
scale. AOFAS score after treatment increased from 70
(SD 6.8) to 88 (SD 10) in the ESWT group and from 74
(SD 12) to 81 (SD 16) in the control (p=0.05). Pain
was reduced in both groups with no statistically significant
difference between groups. The authors noted that the
AOFAS score may not be appropriate for the evaluation
of treatment of Achilles tendinopathy. They concluded
that ESWT appears to be a clinically relevant supplement
to conservative treatment of tendinopathy, however
there is no convincing evidence for recommendation
of the treatment.
No additional randomized trials investigating ESWT
for this indication were identified in a search of
the MEDLINE database. Van Leeuwen and colleagues
conducted a meta-analysis to evaluate the effectiveness
of ESWT for patellar tendinopathy and to draft a treatment
protocol. (49) Seven articles met inclusion criteria.
The authors found that most studies had methodological
deficiencies, small numbers and/or short follow-up
periods and that treatment parameters varied among
studies. They concluded that ESWT appears to be safe
and promising treatment, but that a treatment protocol
cannot be recommended and further basic and clinical
research is required.
Other
Other possible uses of ESWL noted in the literature
but not supported by evidence from randomized controlled
clinical trials include: stress fracture, delayed union
and non-union of bone fractures, avascular necrosis
of the femoral head, osteochondritis dissecans, patellar
tendinitis, and other forms of chronic tendinitis. A
search of the MEDLINE database through October, 2008
failed to identify controlled clinical trials for any
of these indications.
Summary
In summary, studies continue to provide weak or contradictory
evidence of efficacy of ESWT for all musculoskeletal
conditions and investigators continue to arrive at
contradictory conclusions regarding the efficacy of
ESWT for musculoskeletal conditions. Differences in
treatment parameters among studies including energy
dosage, method of generating and directing shock waves,
and use or absence of anesthesia preclude making generalizations
from results of multiple studies. The precise mechanism
of action of ESWT and the impact of anesthesia on outcomes
continue to be matters of discussion. Given these findings,
high-quality randomized trails with large numbers of
patients would have to demonstrate a clear and substantial
benefit for ESWT in these musculoskeletal conditions
to warrant a change in the policy statement. None of
the studies identified had such results.
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| Codes |
Number |
Description |
| CPT |
0019T
|
Extracorporeal shock wave; involving musculoskeletal
system, not otherwise specified; low energy |
| |
0101T |
Extracorporeal shock wave involving musculoskeletal
system, not otherwise specified, high energy |
| |
0102T |
Extracorporeal shock wave, high energy, performed
by a physician, requiring anesthesia other than
local, involving lateral humeral epicondyle |
| |
28890 |
Extracorporeal shock wave, high energy, performed
by a physician, requiring anesthesia other than
local, including ultrasound guidance, involving
the plantar fascia |
| HCPCS |
None |
|
Medicine Section Table of Contents 
|
