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Archives of Physical Medicine and Rehabilitation 2013;94:961-76

REVIEW ARTICLE (META-ANALYSIS)

Subacromial Impingement Syndrome: Effectiveness

of Pharmaceutical InterventionseNonsteroidal
Anti-Inflammatory Drugs, Corticosteroid, or Other
Injections: A Systematic Review
Renske van der Sande, MD,a Willem D. Rinkel, MSc,b Lukas Gebremariam, MD,a
Elaine M. Hay, FRCP, MD,c Bart W. Koes, PhD,a Bionka M. Huisstede, PhDa,b
From the Departments of aGeneral Practice and bRehabilitation Medicine, Erasmus MC e University Medical Center, Rotterdam, The
Netherlands; and cthe Arthritis Research Campaign National Primary Care Centre, Keele University, Keele, United Kingdom.

Abstract
Objective: To present an evidence-based overview of the effectiveness of pharmaceutical interventions, including nonsteroidal anti-inflammatory
drugs, corticosteroid injections, and other injections, used to treat the subacromial impingement syndrome (SIS). An overview can help physicians
select the most appropriate pharmaceutical intervention, and it can identify gaps in scientific knowledge.
Data Sources: The Cochrane Library, PubMed, Embase, PEDro, and CINAHL databases.
Study Selection: Two reviewers independently selected relevant reviews and randomized clinical trials.
Data Extraction: Two reviewers independently extracted the data and assessed the methodologic quality.
Data Synthesis: A best evidence synthesis was used to summarize the results. Three reviews and 5 randomized clinical trials were included.
Although we found limited evidence for effectiveness in favor of 2 sessions with corticosteroid injections versus 1 session, for the effectiveness of
corticosteroid injections versus placebo, nonsteroidal anti-inflammatory drugs, or acupuncture, only conflicting and no evidence for effectiveness
was found. Moderate evidence was found in favor of immediate release oral ibuprofen compared with sustained-released ibuprofen in the short-
term. Also, moderate evidence for effectiveness was found in favor of glyceryltrinitrate patches versus placebo patches in the short-term and mid
term. Furthermore, injections with disodium ethylene diamine tetraacetic acid plus ultrasound with ethylene diamine tetraacetic acid gel were
more effective (moderate evidence) than was placebo treatment in the short- and long-term.
Conclusions: This article presents an overview of the effectiveness of pharmaceutical interventions for SIS. Some treatments seem to be
promising (moderate evidence) to treat SIS, but more research is needed before firm conclusions can be drawn.
Archives of Physical Medicine and Rehabilitation 2013;94:961-76
ª 2013 by the American Congress of Rehabilitation Medicine

Musculoskeletal disorders of the shoulder, including tendinitis between shoulder complaints and work-related factors, such as
and bursitis, are difficult to differentiate in clinical practice. In repetitive work, working with the hand above the shoulder, and high
the Complaints of the Arm, Neck, and/or Shoulder (CANS) model, psychosocial job demands, has been found positive by
the term subacromial impingement syndrome (SIS) is used for the several authors.3
rotator cuff syndrome, tendonosis of the Musculus infraspinatus, In general practice, SIS is the most frequently reported diag-
Musculus supraspinatus, and Musculus subscapularis, and bursitis nosis of the shoulder, with a cumulative incidence of 5 per 1000
in the shoulder area.1 More than 50% of the patients suffering from patients per year.4 Patients with SIS are characterized by pain
chronic CANS reported complaints of the shoulder.2 The relation localized in the shoulder that is exacerbated when performing
overhead activities.5 The first step in treatment for SIS by
a general practitioner often includes an analgesic.6 Also, corti-
No commercial party having a direct financial interest in the results of the research supporting
this article has or will confer a benefit on the authors or on any organization with which the authors
costeroid injections are an often-used intervention in primary
are associated. care.7 New treatment modalities such as tenoxicam injections8

0003-9993/13/$36 - see front matter ª 2013 by the American Congress of Rehabilitation Medicine
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962 R. van der Sande et al

have been studied for their effectiveness. A systematic review on population, interventions, and outcome measures. A consensus
this subject is necessary to give an evidence-based overview of procedure was used to solve any disagreement between the
(new) studies8-12 and the effectiveness of pharmaceutical inter- authors. Results were reported in short-term (3mo), midterm
ventions, that is, nonsteroidal anti-inflammatory drugs (NSAIDs), (4e6mo), and long-term (>6mo).
corticosteroid injections, and other injections, to treat SIS.
Methodologic quality assessment
Methods
Two reviewers (L.G., M.S.R.) independently assessed the meth-
Search strategy odologic quality of each RCT using Furlan’s 12 criteria (table 1).13
Each item was scored as “yes,” “no,” or “unclear.” “High-quality”
The Cochrane Library, PubMed, Embase, PEDro, and CINAHL was defined as a “yes” score of
50%. A consensus procedure
were searched up to March 2009. Keywords related to SIS and was used to solve disagreement between the reviewers.
interventions were included. The complete search strategy is In a (Cochrane) review, the use of a methodologic quality
available on request. assessment is a standard procedure. We describe the methodologic
quality scale/criteria that were used in the review, and used the
Inclusion criteria authors’ definitions of high and low quality for the included studies.

Systematic reviews and randomized clinical trials (RCTs) were

included if they fulfilled all of the following criteria: (a) acute or
Data synthesis
chronic SIS (grades IeIV), not caused by an acute trauma or any
systemic disease as described in the definition of CANS, was studied; A quantitative analysis of the studies was not possible due to
(b) an intervention for treating SIS was evaluated; (c) results on pain, heterogeneity of the outcome measures. Therefore, we summarized
function, or recovery were reported; and (d) a follow-up period of
2 the results using a best-evidence synthesis.14 The article was
weeks was reported. There were no language restrictions. included in the best-evidence synthesis only if a comparison was
After the full-text articles were included, we divided the included made between the groups and the level of significance was reported.
studies into different treatment groups for which separate reviews The results of the study were labeled “significant” if 1 of the 3
could be conducted. One of these groups is pharmaceutical inter- outcome measures on pain, function, or recovery reported significant
vention. For this review, only those studies were included in which results. The levels of evidence for effectiveness are given in table 2.
pharmaceutical therapy (oral, injected, or patched) was compared
with placebo, no treatment, or another nonsurgical treatment.
Results
Study selection
Characteristics of the included studies
Two reviewers (B.M.H., L.G.) independently applied the inclusion
criteria to select potential relevant studies from the title, abstracts, The initial search resulted in 5 reviews from the Cochrane library.
and full-text articles, respectively. A consensus method was used Via PubMed 5 reviews and 215 RCTs, via Embase 21 reviews and
to solve any disagreements concerning inclusion of studies, and 193 RCTs, via CINAHL 141 reviews/RCTs, and via PEDro
a third reviewer (B.W.K.) was consulted if disagreement persisted. 0 reviews and 13 RCTs were identified. Finally, 3 reviews and 5
RCTs reported on the effectiveness of pharmaceutical interven-
Categorization of the relevant literature tions and were included.
The review of Green et al15 that studied the effectiveness of
Relevant articles are categorized under 3 headers: Systematic reviews physiotherapy for shoulder pain included 26 trials; 11 trials
describes all (Cochrane) reviews; Recent RCTs contains all RCTs reported on SIS and were included in the present review. Another
published after the search date of the systematic review on the same review of Green et al16 studied the effectiveness of acupuncture
intervention; Additional RCTs describes all RCTs concerning an for shoulder pain and included 9 trials; 2 trials reported on SIS and
intervention that has not yet been described in a systematic review. were included in the present review.
The review of Buchbinder et al17 studied the effectiveness of
Data extraction corticosteroid injections for shoulder pain. Seven of the 26 trials
included in this review met our inclusion criteria and were
Three authors (L.G., R.S., B.M.H.) independently extracted data included in the present review. The characteristics of the included
from the included articles. Information was collected on the study studies are listed in appendices 1, 2, and 3.

List of abbreviations: Methodologic quality assessment

CANS Complaints of the Arm, Neck, and/or Shoulder
CI confidence interval The results of the methodologic quality assessment are presented
EDTA ethylene diamine tetraacetic acid in table 3.
GTN glyceryltrinitrate Four (of the 5 included) RCTs were of high quality. Most
NSAIDs nonsteroidal anti-inflammatory drugs prevalent methodologic flaws were (1) care provider not blinded
RCT randomized clinical trial
and (2) unclear whether allocation was concealed.
ROM range of motion
The 3 reviews used a methodologic scoring list of 11 items16 or
SIS subacromial impingement syndrome
5 items17: 18 of the 20 RCTs in these reviews scored
50% on the

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Pharmaceutics for subacromial impingement syndrome 963

ibuprofen (1200mg 2 times a day). At 3-week follow-up, significant

Table 1 Methodologic quality assessment: sources of risk bias
differences between the groups were found in favor of conventional
A. 1. Was the method of randomization adequate? tablets ibuprofen on complete pain relief of shoulder tendonitis (7%
B. 2. Was the treatment allocation concealed? vs 21%, PZ.02) and on patients’ global assessment on a 5-point
C. Was knowledge of the allocated interventions scale (no data given, PZ.04); no significant differences were
adequately prevented during the study? found on the patient’s assessment concerning better or complete
3. Was the patient blinded to the intervention? relief, or the physician’s assessment.
4. Was the care provider blinded to the intervention? There is moderate evidence for effectiveness in favor of
5. Was the outcome assessor blinded to the intervention? conventional ibuprofen tablets versus sustained-released ibuprofen
D. Were incomplete outcome data adequately addressed? tablets for SIS in the short-term (3wk).
6. Was the dropout rate described and acceptable?
7. Were all randomized participants analyzed in the Effectiveness of analgesics: glyceryltrinitrate transdermal
group to which they were allocated? patches versus placebo
E. 8. Are reports of the study free of suggestion A high-quality RCT12 (nZ53; 57 shoulders) compared glyceryl-
of selective outcome reporting? trinitrate (GTN) patches with placebo patches. Both groups also
F. Other sources of potential bias: received a tendon rehabilitation program. Significant differences
9. Were the groups similar at baseline regarding were found between the groups on decrease in pain at rest in favor of
the most important prognostic indicators? the GTN patches group at 12- (PZ.04) and 24-week (PZ.03)
10. Were cointerventions avoided or similar? follow-up (no further data given). From baseline to 24 weeks, the
11. Was the compliance acceptable in all groups? range of motion (ROM) increased by 24% (17%e31%) in the GTN
12. Was the timing of the outcome assessment similar group versus 8% (4%e13%) in the placebo group (no P value
in all groups? given). Increases in force (supraspinatus, subscapularis, adduction,
and external and internal rotation) were all significant in favor of the
quality assessment and were classified as high quality. The RCT GTN group at 12- and 24-week follow-up (no exact data given,
by Berry et al18 was included in all the 3 reviews. P value ranged from .001 to .02). At 24-week follow-up, there were
significant differences between the groups for the outcome
“asymptomatic shoulder” in favor of the GTN group (64% vs 24%,
Effectiveness of pharmaceutical interventions for SIS PZ.007; weighted mean difference, .26; 95% CIZ.19e.32).
There is moderate evidence for the effectiveness of GTN patches
Table 4 shows the interventions for which moderate or strong versus placebo for SIS in the short- (12wk) and midterm (24wk).
evidence for effectiveness for pharmaceutical interventions for
SIS was found. Table 5 presents a complete overview. Effectiveness of injections: coricosteroid injections versus
placebo
Effectiveness of analgesics: NSAIDs versus laser therapy Seven RCTs in the systematic review of Buchbinder et al17
In a systematic review, 1 high-quality RCT19 (nZ20) included in the compared corticosteroid injections with placebo injections. Five
review of Green et al15 compared NSAIDs (naproxen sodium 550mg of the 7 trials compared subacromial steroid injection with
2 times a day for 2wk) with laser therapy (902nm) for shoulder placebo.18,20-23 One trial compared intraarticular injection with
tendinitis. Significantly less pain (mean difference, 2; 95% confi- placebo,24 and another trial compared supraspinatus tendon
dence interval [CI]Z1e3.5) was reported for laser versus NSAIDs injection with placebo.25
at 2-week follow-up. No significant results were found on function. Two high-quality trials20,22 (nZ90) reported a significant
There is moderate evidence for the effectiveness of laser improvement between the groups in patients treated with cortico-
therapy versus NSAIDs in the short-term (2wk). steroid injections with respect to pain (standard mean difference, .83;
95% CIZ.39e1.26), ROM (abduction) (standard mean difference,
Effectiveness of analgesics: ibuprofen tablet versus sustained- .63; 95% CIZ.20e1.06), and function (standard mean difference,
release ibuprofen .82; 95% CIZ.39e1.25) at 4-week follow-up. A low-quality study21
One high-quality RCT11 (nZ147) compared conventional tablets (nZ40) reported significantly better results (no exact data given) in
ibuprofen (600mg 4 times a day) with sustained-release tablets the corticosteroid group versus placebo on pain and ROM at a mean
of 33-week and 28-week follow-up, respectively. Furthermore, no
Table 2 Levels of evidence significant differences between the groups were reported on
Strong evidence: consistent (ie, when
75% of the trials report improvement in daily activities (no exact follow-up time given).
the same findings) positive (significant) findings within A high-quality trial18 (nZ24) found no significant differences
multiple higher quality RCTs on pain, ROM (abduction), or success rate between the 2 groups at
Moderate evidence: consistent positive (significant) findings 4-week follow-up. Another high-quality study26 (nZ57) also
within multiple lower quality RCTs and/or 1 high-quality RCT found no significant differences on pain and ROM (abduction)
Limited evidence for effectiveness: positive (significant) between the 2 groups (no further data were given) at 12-week
findings within 1 low-quality RCT follow-up. Strobel (low quality)24 (nZ40) reported significantly
Conflicting evidence: provided by conflicting (significant) greater reduction in pain in the placebo group versus the treatment
findings in the RCTs (<75% of the studies reported consistent group at 90 and 360 days. Another high-quality study25 (nZ25)
findings) studied treatment with supraspinatus tendon injection versus
No evidence: RCT(s) available, but no (significant) differences placebo in patients with supraspinatus tendonitis. No significant
between the intervention and control groups were reported differences were found on pain improvement or analgesic
consumption between the 2 groups at 2- and 8-week follow-up.

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964 R. van der Sande et al

Table 3 Methodologic quality scores of the included recent and additional RCTs
Incomplete
Blinding? Outcome Incomplete
Adequate Allocation Blinding? Blinding? Outcome Data Addressed? Outcome Data?
Reference Randomization? Concealment? Patients? Caregiver? Assessors? Dropouts? ITT Analysis?
Paoloni et al12 þ þ þ  þ þ þ
Akgun et al9 þ ? þ  þ þ þ
Friis et al11 þ ? þ ? ? þ ?
Cacchio et al10 þ ? þ  þ þ þ
Itzkowitch et al8 ? ? þ ? ? þ 
Methodologic quality scores of Green et al15*
Random Concealed Blind Blind Blind Between-group Adequate
Allocation? Allocation? Subjects? Therapists? Assessors? Comparisons? Follow-up?
Ebenbichler27 þ þ þ þ þ þ þ
Nykanen28 þ  þ þ þ þ þ
Saunders29 þ ? þ þ þ þ 
Vecchio et al23 þ  þ þ þ þ þ
Berry et al18 þ    þ þ þ
Conroy30 þ    þ þ þ
Dal Conte31 þ  þ þ  þ þ
England et al19 þ  þ  þ þ þ
Bang32 þ     þ þ
Brox33 þ    þ þ 
Perron34 þ    þ þ þ
Methodologic quality scores of Green et al16y
Berry et al18 þ   n.p. þ þ þ
Methodologic quality scores of Buchbinder et al17z
Appropriate
Acceptable Statistical
Blind Blind Lost to Analysis? Allocation
Participants? Assessors? Follow-up?x (ITT Analysis?) Concealed
Adebajo et al20 þ þ þ þ þ
Petri et al22 þ þ þ þ þ
Withrington et al25 þ þ þ þ ?
Berry et al18 ? þ þ þ ?
Vecchio et al23 þ þ þ  ?
White et al35 þ þ  þ 
Blair et al21 þ þ ? ? ?
Strobel24 ? ?   ?
Abbreviations: þ, yes; , no; ?, unclear/unsure; ITT, intention-to-treat; n.p., not possible.
* Based on the PEDro scale (specifically designed and validated for the assessment of validity for trials of physiotherapy interventions)

([Link]
y
Based on the Cochrane reviewer’s handbook (Alderson P, Green S, Higgins JPT, editors. Cochrane reviewers’ handbook. Chichester, UK: John
Wiley & Sons, Ltd; December 2003).
z
Adapted from the Cochrane reviewers’ handbook (Clarke M, Oxman AD, editors. Cochrane reviewers’ handbook 4.0 [updated July 1999]. In:
The Cochrane Library [database on CDROM]. The Cochrane Collaboration. Oxford: Update Software; 2000, Issue 2, 1999).
x
Lost to follow-up: We defined this item as positive if the percentage of lost to follow-up is <20% for the short-term follow-up and <30%
for the long-term follow-up.

A recent high-quality RCT9 (nZ48) compared 3 groups the Constant score between the 3 groups at 1- and 3-month
according to 2 therapeutic injections given at a 10-day interval: follow-up.
group 1 received corticosteroid injections at the first and second We found conflicting evidence for the effectiveness of corti-
sessions, group 2 received corticosteroid injections at the first costeroid injections versus placebo for SIS in the short- (4wk) and
session and placebo injections at the second session, and group 3 long-term (12wk).
received placebo injections at both sessions. Only on pain causing
sleep disturbance, significant differences between the groups were Effectiveness of injections: coricosteroid injections versus
found in favor of group 1 a month after treatment (P<.001). acupuncture
However, at 3-month follow-up, this significant difference was not In a systematic review, 1 high-quality RCT18 (nZ24) included in
sustained. Furthermore, no significant differences were found on the review of Green et al16 compared acupuncture with

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Pharmaceutics for subacromial impingement syndrome 965

Table 3 Continued
Free of Suggestions Similarity Cointerventions Compliance Timing of
of Selective of Baseline Avoided Acceptable the Outcome Maximum Score
Outcome Reporting? Characteristics? or Similar? in all Groups? Assessment Similar? Score Study Percentage
þ þ þ þ þ 12 11 92
þ þ þ þ þ 12 10 83
þ þ þ þ þ 12 8 67
þ þ ? ? þ 12 8 67
þ ? ? ? þ 12 4 33
Methodologic quality scores of Green et al15*
Availability
of Point
Estimates and
Measures of
Variability of Specification
ITT Baseline Primary Outcome of Eligibility Score Score
Analysis? comparability? Measures? Criteria? Maximum Study Percentage
 þ þ þ 11 10 91
 þ þ þ 11 9 82
þ þ þ þ 11 9 82
 þ þ þ 11 9 82
 þ þ þ 11 7 64
 þ þ þ 11 7 64
 þ  þ 11 7 64
  þ þ 11 7 64
 þ þ þ 11 6 55
þ þ þ  11 6 55
 þ þ  11 6 55
Methodologic quality scores of Green et al16y
 þ þ þ 10 7 70
Methodologic quality scores of Buchbinder et al17z
Score Score
Maximum Study Percentage
5 4 80
5 4 80
5 4 80
5 3 60
5 3 60
5 3 60
5 2 40
5 0 0

moxibustion (a form of fire heat treatment that stimulates specific Effectiveness of injections: coricosteroid injections versus
acupuncture points of the body) with corticosteroid injections. NSAIDs
Postintervention pain, range of abduction, and success in the In a systematic review, 3 high-quality trials20,22,35 (nZ120)
short-term showed no significant differences between the included in the review of Buchbinder et al17 compared sub-
2 groups. acromial corticosteroid injections with NSAIDs. No significant
There is no evidence for the effectiveness of corticosteroid differences between the groups were found on pain and ROM at 4-
injections versus acupuncture plus moxibustion in the short- to 6-wk follow-up,20,22,35 on improvement in function at 4-week
term (4wk). follow-up,20,22 and on global assessment at 6-week follow-up.35

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966 R. van der Sande et al

results (P<.001) were found on improvement of the active

Table 4 Evidence for the effectiveness of pharmaceutical
shoulder mobility in favor of the treatment group.
interventions for SIS
There is limited evidence for the effectiveness of tenoxicam
SIS injections versus placebo for rotator cuff tendonitis in the short-term.
Conservative
Oral Ob Effectiveness of injections: disodium ethylene diamine
Injection Oc,f tetraacetic acid plus ultrasound versus placebo
Other Oa,d,e A high-quality study10 compared disodium ethylene diamine
tetraacetic acid (EDTA) injections plus ultrasound (using diso-
NOTE. O, strong or moderate evidence found; 0, RCT(s) found, but only
dium EDTA gel) with placebo in patients with calcific tendinitis
limited, conflicting, or no evidence for the effectiveness of interven-
(nZ80). Disodium EDTA could bind and remove calcium
tions was found; empty cells, no RCTs or reviews found.
Short-term: deposits on the tendon. The treatment group showed significantly
a: Moderate evidence: NSAID vs laser therapy.* (P<.01) more improvements on pain (2.871.21 vs 6.95.30) and
b: Moderate evidence: Ibuprofen* vs sustained-release ibuprofen. on the Constant and Murley score (75.623.96 vs 45.856.25) at
c: Moderate evidence: Disodium EDTA plus ultrasound* vs placebo. 1-week and 1-year follow-up (2.001.30 vs 7.01.30 and
d: Moderate evidence: GTN patches* vs placebo. 75.504.07 vs 46.428.52, respectively). The treatment group
Midterm: had a significantly (P<.01) smaller amount of calcification versus
e: Moderate evidence: GTN patches* vs placebo. the placebo group after the treatment (3.163.28 vs 16.924.03).
Long-term: We found moderate evidence for the effectiveness of disodium
f: Moderate evidence: Disodium EDTA plus ultrasound* vs placebo.
EDTA plus ultrasound versus placebo in treating patients with
* In favor of.
calcific tendonitis in the short-term (1wk) and the long-term (52wk).

There is no evidence for the effectiveness of corticosteroid

injections versus NSAIDs for SIS in the short-term (4e6wk). Discussion

Effectiveness of injections: coricosteroid injection plus NSAID In this review, we give an overview of the evidence for effec-
versus placebo tiveness of all pharmaceutical therapiesdNSAIDs, corticosteroid
In a systematic review, Berry et al18 (nZ24) compared cortico- injections, and other injectionsdstudied in a randomized
steroid injection plus NSAID versus placebo. No significant controlled setting in the treatment of SIS.
differences between the 2 groups were found on pain and success
rate at 4-week follow-up. On the range of abduction, significant Analgesics
differences were found in favor of placebo (weighted mean
difference, 27.60; 95% CIZ49.99 to 5.21). According to the results of this review, for physicians wishing to give
There is no evidence for the effectiveness of corticosteroid plus analgesics to treat SIS we would recommend the use of oral ibuprofen
NSAID versus placebo for SIS in the short-term (4wk). rather than sustained-release ibuprofen (for 3wk; moderate evidence).
However, our review has highlighted the lack of evidence regarding the
Effectiveness of injections: coricosteroid injection plus NSAID use of simple analgesics (paracetamol/acetaminophen), mild opioids
versus NSAID (eg, codeine phosphate), or other commonly used NSAIDs for SIS.
In a systematic review, Petri et al22 (nZ50) studied the effec- Although we found moderate evidence for the short-term (3mo) and
tiveness of corticosteroid plus NSAID versus NSAID alone. No mid-term (6mo) benefits of GTN patches, the body’s systemic
significant differences were reported on pain, improvement in responses on GTN or the pharmacokinetics are not entirely clear.
function, and improvement in range of abduction between the
groups at 4-wk follow-up. Injections
There is no evidence for the effectiveness of corticosteroid injec-
tion plus NSAID versus NSAID alone for SIS in the short-term (4wk).
For other specific CANS, strong and moderate evidence was found
Effectiveness of injections: coricosteroid injection (plus in favor of the effectiveness of corticosteroid injections versus
placebo NSAID) versus acupuncture placebo in the short-term but not in the long-term.36,37 In contrast
In a systematic review, 1 high-quality RCT18 (nZ24) compared to these findings, for SIS we found conflicting evidence in the
steroid injection plus placebo NSAID and steroid injection plus short- and long-term. More research is needed to allow us to draw
NSAID with acupuncture. No significant differences were found definite conclusions about the effectiveness of corticosteroid
for postintervention pain or range of abduction. injections for treating SIS. Future research should also concentrate
There is no evidence for the effectiveness of corticosteroid on the long-term benefits and disadvantages, as well as the
injection (plus placebo NSAID) versus acupuncture for SIS in the accuracy and safety, of corticosteroid injections.
short-term (4wk). A new treatment modality, an injection with disodium EDTA,
seems to be promising in both the short-term (1wk) and the long-
Effectiveness of injections: tenoxicam injections versus term. Disodium EDTA is a heavy metal and mineral chelator amino
placebo injections acid. EDTA can bind and remove calcium deposits on the rotator
One low-quality RCT8 compared periarticular tenoxicam injec- cuff tendon.38 Cacchio et al10 concluded that disodium EDTA
tions (20mg/2mL) with placebo injections once a week for up to administered through single needle mesotherpy and ionopheresis is
4 weeks in 80 patients with rotator cuff tendinitis. Significant safe and effective for treating patients with calcific tendinitis.
results (P<.001) were found in favor of tenoxicam injections on However, this conclusion is based on 1 RCT only and more research
pain at rest and on pain during active movement. Also, significant is needed to confirm the effectiveness and safety of disodium EDTA.

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Pharmaceutics for subacromial impingement syndrome 967

Table 5 CANS: Evidence for the effectiveness of pharmaceutical interventions for SIS
Injections
Oral Treatment Corticosteroid Tenoxicam
NSAID
< NSAID vs laser therapy* < Corticosteroid injection vs placebo < Tenoxicam* injection
vs placebo
Short-term þþ Short-term  Short-term þ
Ibuprofen Long-term 
< Ibuprofen* vs < Corticosteroid injection Disodium EDTA
sustained-release ibuprofen 1 session vs 2 sessions* < Disodium EDTA
plus ultrasound
(with EDTA gel) vs placebo
Short-term þþ þ Short-term þþ
Long-term þþ
< Corticosteroid injection vs
acupuncture plus moxibustion
Other conservative Short-term NE
GTN patches
< GTN patches* vs placebo < Corticosteroid injection vs
Short-term þþ NSAID
Mid-term þþ
Short-term NE
< Corticosteroid injection
plus NSAID vs placebo
Short-term NE
< Corticosteroid injection
plus NSAID vs NSAID
Short-term NE
< Corticosteroid injection
plus placebo NSAID vs acupuncture
Short-term NE
NOTE. þ, limited evidence found; þþ, moderate evidence found; þþþ, strong evidence found; , conflicting evidence for effectiveness; NE, no
evidence found for effectiveness of the treatment: RCT(s) available, but no differences between intervention and control groups were found.
* In favor of.

Study limitations GTN and injections with disodium EDTA plus ultrasound with
EDTA gel. GTN patches were more effective (moderate evidence)
The present review has some limitations. First, the methodologic than placebo patches in the short- and midterm. Injections with
quality assessment of the RCTs included in the reviews and our disodium EDTA plus ultrasound with EDTA gel were more
methodologic quality assessment of the recent and additional RCTs effective (moderate evidence) than placebo treatment in the short-
differ greatly; for example, we defined a study as “high quality” and long-term.
when the study scored
50% on the quality assessment. However,
in the Cochrane reviews, no clear definition is given as to whether Keywords
the study is considered to be of high or low quality. Buchbinder
et al17 used only 5 items, in contrast to the 12 items of Furlan et al13 Drug therapy; Pain; Rehabilitation; Shoulder impingement
that we used to assess the methodologic quality of the recent and syndrome; Treatment outcome
additional RCTs. Therefore, a risk of bias can be introduced by
categorizing some of the studies as high-quality studies. Second,
some studies with a small sample size were categorized as high- Corresponding author
quality studies. Therefore, the results must be viewed with
caution. Furthermore, the RCTs in which corticosteroids are studied Bionka M. Huisstede, PhD, Department of Rehabilitation, Eras-
must be interpreted with the notion that different types and dosages mus MC e University Medical Center Rotterdam, Room H-016,
of corticosteroids are compared with each other. PO Box 2040, 3000 CA Rotterdam, The Netherlands. E-mail
address: [Link]@[Link].

Conclusions
Acknowledgment
Moderate evidence for effectiveness was found in the short-term
in favor of oral ibuprofen versus sustained-release ibuprofen. We thank M.S. Randsdorp (M.S.R.), MD, for her participation in
Furthermore, promising results were found for the effectiveness of the quality assessment.

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 968
Appendix 1 Data extractiondsystematic reviews
Total Number
Author of Patients Treatment Placebo Control/Comparison Outcome Measures Effect Size
Buchbinder et al17 Corticosteroid injections
Corticosteroid vs placebo injection
Adebajo et al20 90 Subacromial steroid injection Placebo (nZ45) Pain improvement SMD 0.83 (95% CIZ0.39e1.26)
and Petri et al22 (1mL of 80mg/mL triamcinolone (VAS) (4wk) ifo injection
hexacetomide) (nZ45)
Rotator cuff tendonitis
Improvement in SMD 0.63 (95% CIZ0.20e1.06)
function (4wk) ifo injection
Improvement in ROM SMD 0.82 (95% CIZ0.39e1.25)
abduction (4wk) ifo injection
Blair et al21 40 Subacromial steroid injection Placebo (nZ21) No data were given At a mean of 33wk in corticosteroid
SIS (2mL of 40mg/mL triamcinolone group and 28wk in placebo group, the
acetonide) (nZ19) corticosteroid group was significantly
better with respect to pain and ROM.
No significant difference between the
groups with respect to improvement
(ADL)

Berry et al18 60 Intraarticular steroid injection Placebo (nZ12) Pain (VAS) (4wk) WMD 4.60 (95% CIZ15.99 to 25.19)
with 40mg methylprednisolone
(nZ12)
Rotator cuff lesion
Range of WMD 20.20 (95%
abduction (4wk) CIZ47.50 to 7.10)
Success rate* RR 0.67 (95% CIZ0.35e1.28)
Vecchio et al23 57 Subacromial steroid injection Placebo (nZ28) No data were given No significant differences
Rotator cuff tendonitis (40mg methylprednisolone) (nZ29) with respect to pain and ROM
between the treatment
and placebo groups

Strobel24 40 Subacromial steroid injection (20mg Placebo (nZ20) No data were given Greater reduction in pain in the
Subacromial bursitis or triamcinolone hexacetonide (nZ20) placebo group at 90 and 360d
supraspinatus tendinitis
Withrington et al25 25 Supraspinatus injection with Saline (nZ13) No data were given No difference in improvement
Supraspinatus tendonitis 80mg methylprednisolone (nZ12) in pain or analgesic consumption
between the 2 groups at 2 and 8wk
Corticosteroid vs acupuncture
Berry et al18 Intraarticular steroid injection Acupuncture (once a Pain (VAS) (4wk) WMD 7.50 (95% CIZ27.47 to 12.47)

R. van der Sande et al

[Link]

Rotator cuff lesion (40mg methylprednisolone) (nZ12) week) (nZ12)

Range of abduction (4wk) WMD 2.90 (95% CIZ32.63 to 26.83)
Success rate (4wk) RR 0.83 (95% CIZ0.35e2.00)
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Pharmaceutics for subacromial impingement syndrome

Appendix 1 (continued )
Total Number
Author of Patients Treatment Placebo Control/Comparison Outcome Measures Effect Size
Corticosteroid vs NSAID
Adebajo et al,20 200/120 Subacromial steroid injection NSAID (50mg diclofenac Pain improvement SMD 0.18 (95% CIZ 0.54 to 0.18)
Petri et al,22 (1mL of 80mg/mL triamcinolone thrice a day for 28d) (VAS) (4e6wk)
White et al35 hexacetomide) (nZ45)

Improvement in SMD 0.03 (95% CIZ0.39 to 0.44)

function (4wk)
(nZ60) (nZ60)
Rotator cuff tendonitis (nZ45) (nZ45) Improvement in range of SMD 0.17 (95% CIZ0.53 to 0.19)
abduction (4e6wk)
(nZ60) (nZ60)
(nZ15) (nZ15)
Global assessment score SMD 0.03 (95% CIZ0.75 to 0.68)
(sum of pain and motion
deficit) (0e9 points) (6wk)
Corticosteroid plus NSAID vs placebo
Berry et al18 60 Intraarticular steroid injection plus Placebo (nZ12) Pain (VAS) (4wk) WMD 7.20 (95% CIZ 14.03 to 28.43)
Rotator cuff lesion NSAID (40mg methylprednisolone
plus 50mg diclofenac thrice Range of abduction (4wk) WMD 27.60 (95% CIZ49.99
a day (nZ12) to 5.21) ifo placebo
Success rate* RR 0.56 (95% CIZ0.26e1.17)
Corticosteroid plus NSAID vs NSAID
Petri et al22 100 Subacromial steroid injection plus NSAID (500mg naproxen Pain improvement WMD 0.19 (95% CIZ0.73 to 1.11)
Rotator cuff tendonitis NSAID (1mL of 40mg/mL twice a day for 30d) (0e5 scale) (4wk)
triamcinolone plus 500mg naproxen (nZ25) Improvement in WMD 0.10 (95% CIZ0.96 to 0.76)
twice a day for 30d) (nZ25) function (4wk)
Improvement in range WMD 0.56 (95% CIZ0.15 to 1.27)
of abduction (4wk)
Corticosteroid plus NSAID vs
acupuncture
Berry et al18 60 Steroid (400mg tolmetin sodium thrice Acupuncture once a week Pain (VAS) MD 7.50 (95% CIZ12.47 to 27.47)
Rotator cuff lesion a day plus anterior injection of with moxibustion (nZ12) (postintervention)
40mg methylprednisolone) (nZ12) Range of abduction MD 2.90 (95% CIZ26.83 to 32.63)
(postintervention)
Success rate (short term) RR 0.83 (95% CIZ0.35e2.00)

Abbreviations: ADL, activities of daily living; ifo, in favor of; MD, mean difference; RR, relative risk; SMD, standardized mean difference; VAS, visual analog scale; WMD, weighted mean difference.
* Success rate Z success or failure of the treatment at the end of 4wk defined as the need for a steroid injection.

969
 970
Appendix 2 Data extractiondrecent RCTs
Outcome Measures
Author Treatment Placebo Control Comparison and FU Time ResultsdStatistical ResultsdWords
Corticosteroid injections
Corticosteroid vs placebo
Akgun et al9 Group 1: 2 injections, Group 3: only Rest pain NS (no P value Group 1: from 4.31.6
SIS 10-d interval: 10cc of 1% lignocaine (nZ16) given) at baseline to 0.50.4
lignocaine þ 40mg at 1-mo FU vs group 3:
methylprednisolone for from 3.81.2 at baseline
both injections (nZ16) to 1.00.9 at 1-mo FU
NS (no P value given) At 3-mo FU: Group 1:
0.80.6 vs group 3: 0.70.6
Activity pain NS (no P value given) Group 1: from 6.11.9
at baseline to 1.10.9
at 1-mo FU vs group 3:
from 5.52.3 at baseline
to 1.71.0 at 1-mo FU
NS (no P value given) At 3-mo FU: Group 1:
0.80.7 vs group 3: 0.70.6
Pain disturbing Significant Group 1: from 4.51.2 at
sleep (no P value given) baseline to 0.80.7 at
1-mo FU vs group 3: from
4.61.1 at baseline to 2.01.2
at 1-mo FU ifo group 1
NS (no P value given) At 3-mo FU:
Group 1: 0.940.9
vs group 3: 0.90.7
Constant score NS (no P value given) Group 1: from 63.622.2
at baseline to 87.815.4
at 1-mo FU vs group 3:
from 65.5 21.4 at baseline
to 82.116.1 at 1-mo FU
NS (no P value given) At 3-mo FU: Group 1: 91.68.3
vs group 3: 91.69.1
SIS Group 1: 2 injections, 10-d Group 2: first injection 10cc Rest pain NS (no P value given) Group 1: from 4.31.6
interval: 10cc of 1% lignocaine of 1% lignocaine þ40mg at baseline to 0.50.4 at
þ 40 mg methylprednisolone methylprednisolone, second 1-mo FU vs group 2: from

R. van der Sande et al

[Link]

for both injections (nZ16) injection only lignocaine 4.31.7 at baseline to 1.00.8
(nZ16) at 1-mo FU
NS (no P value given) At 3-mo FU:
Group 1: 0.80.6 vs
group 2: 1.30.9
Activity pain NS (no P value given) Group 1: from 6.11.9
(continued on next page)
[Link]

Pharmaceutics for subacromial impingement syndrome

Appendix 2 (continued )
Outcome Measures
Author Treatment Placebo Control Comparison and FU Time ResultsdStatistical ResultsdWords
at baseline to 1.10.9
at 1-mo FU vs group 2:
from 6.41.5 at baseline
to 1.41.1 at 1-mo FU
NS (no P value given) At 3-mo FU:
Group 1: 0.80.7 vs
group 2: 0.810.9
Pain disturbing S (no P value given) Group 1: from 4.51.2
sleep at baseline to 0.80.7
at 1-mo FU vs group 2:
from 4.01.3 at baseline
to 4.61.1 at 1-mo
FU ifo group 1
NS (no P value given) At 3-mo FU:
Group 1: 0.940.9 vs
group 2: 0.80.7
Constant score NS (no P value given) Group 1: from 63.622.2 at
baseline to 87.815.4
at 1-mo FU vs group 2:
from 65.6 23.4 at baseline
to 84.116.2 at 1-mo FU
NS (no P value given) At 3-mo FU: Group 1:
91.68.3 vs group 2: 89.89.5
Abbreviations: FU, follow-up; ifo, in favor of; NS, not significant; S, significant.

971
 972
Appendix 3 Data extractiondadditional RCTs
Outcome Measures Resultsd
Author Treatment Placebo Control/Comparison and FU Time Statistical ResultsdWords
Analgesics
Ibuprofen tablet vs
sustained-released ibuprofen
Friis et al11 Conventional tablets Sustained-release tablets Patients’ global PZ.04 SRTI vs CTI ifo CTI
Shoulder tendonitis ibuprofen (CTI) (600mg QID) ibuprofen (SRTI) (1200mg BID) assessment 5-point (no exact data given)
plus 1 local injection with plus 1 local injection with scale (3wk)
corticosteroid at day 0 (nZ74) corticosteroid at day 0 (nZ73)
Complete pain relief PZ.02 SRTI 7% (no 95% CI given) vs
(3wk) CTI 21% (no 95% CI given)
Improvement: better or .2<P<.3 SRTI 67% (95% CIZ55%e77%) vs
complete relief (3wk) CTI 77% (95% CIZ65%e86%)

Improvement: (doctor’s No P value SRTI 73% (no 95% CI given) vs

assessment) (3wk) given CTI 79% (no 95% CI given)

GTN transdermal vs placebo

Paoloni et al12 Placebo patch plus 24 tablets Decrease in pain at rest PZ.04 12wk: GTN vs placebo ifo GTN,
Chronic supraspinatus GTN patch plus 24 tablets paracetamol 500mg for use (0e4) no exact data given
tendinopathy paracetamol 500mg for use with with possible headache plus
possible headache plus tendon tendon rehabilitation program PZ.03 24wk: GTN vs placebo ifo GTN,
rehabilitation program (nZ27 [29 shoulders]) no exact data given
(nZ26 [28 shoulders])

Decrease in pain with P>.05 12wk: GTN vs placebo, no exact

activity (0e4) data given
PZ.01 24wk: GTN vs placebo ifo of GTN,
no exact data given

Decrease in pain at PZ.03 12wk: GTN vs placebo ifo of GTN,

night (0e4) no exact data given

PZ.01 24wk: GTN vs placebo ifo GTN,

no exact data given

Patient-related pain No P value GTN: from baseline to 24wk,

R. van der Sande et al

[Link]

scores (at rest, at night, given a reduction of 65% (64%e67%)

with activity) vs placebo: from baseline to 24wk,
a reduction of 30% (27%e33%)

(continued on next page)

[Link]

Pharmaceutics for subacromial impingement syndrome

Appendix 3 (continued )
Outcome Measures Resultsd
Author Treatment Placebo Control/Comparison and FU Time Statistical ResultsdWords
ROM No P value GTN: from baseline to 24wk, an
given increase of 24% (17%e31%) vs
placebo: from baseline to 24wk,
an increase of 8% (4%e13%)

Increase in supraspinatus PZ.001 12wk: GTN vs placebo ifo of GTN,

force no exact data given

PZ.001 24wk: GTN vs placebo ifo of GTN,

no exact data given

Increase in external PZ.01 12wk: GTN vs placebo ifo GTN,

rotation force no exact data given
PZ.01 24wk: GTN vs placebo ifo GTN,
no exact data given

Increase in internal PZ.01 12wk: GTN vs placebo ifo GTN,

rotation force no exact data given
PZ.01 24wk: GTN vs placebo ifo of GTN,
no exact data given

Increase in subscapularis PZ.02 12wk: GTN vs placebo ifo GTN,

force no exact data given
PZ.02 24wk: GTN vs placebo ifo GTN,
no exact data given
Increase in adduction PZ.003 12wk: GTN vs placebo ifo GTN,
force no exact data given
PZ.003 24wk: GTN vs placebo ifo GTN,
no exact data given
Increase in dynanometer- No P value GTN: from baseline to 24wk, an
measured shoulder force given increase of 29% (10%e61%) vs
placebo: from baseline to 24wk,
an increase of 12% (5%e 32%)

Impingement signs No P value GTN: from baseline to 24wk, a

given decrease of 76% (74%e78%) vs
placebo: from baseline to 24wk,
a decrease of 43% (40%e47%)

973
(continued on next page)
 974
Appendix 3 (continued )
Outcome Measures Resultsd
Author Treatment Placebo Control/Comparison and FU Time Statistical ResultsdWords
Asymptomatic at 24wk PZ.007 24wk: GTN 64% vs placebo 24%,
no range given
24wk: mean estimated effect size
GTN: 0.26 (95% CIZ0.19e0.32)

Other injections
Tenoxicam injection vs
placebo injection
Itzkowitch et al8 Tenoxicam injection Placebo injection Pain at rest (VAS) NS Baseline:
20mg/2mL once per week (nZ39) (2e4wk) Tenoxicam: 4.682.7 vs placebo:
Rotator cuff for up to 4wk (nZ38) 4.842.35
tendinitis
P<.001 Last available score:
Tenoxicam: 1.732.41
vs placebo: 3.182.73

Pain on active NS Baseline:

movement Tenoxicam: 7.381.35
(VAS) (2-4wk) vs placebo: 6.981.65

P<.001 Last available score:

Tenoxicam: 2.382.65 vs
placebo: 4.992.95

Active abduction NS Baseline:

(degrees) (2e4wk) Tenoxicam: 111.239.7 vs
placebo: 116.435.5

P<.001 Last available score:

Tenoxicam: 141.835.4 vs
placebo: 12940.1

Disodium EDTA plus Study group vs placebo

US vs placebo
Cacchio et al10 Study-group: injection with Sham injection plus sham Pain (VAS) P<.43 Baseline: 6.780.28 vs 6.630.17
Calcific tendinitis 1mL disodium EDTA, 1mL of 1% US (nZ40)
procaine and 3mL injectable P<.01 1wk: 2.871.21 vs 6.950.30
H2O (once a week for 3wk) plus

R. van der Sande et al

[Link]

15-min pulsed-mode US (1MHz) P<.01 1y: 2.001.30 vs 7.010.30

using 15% solution disodium
EDTA gel (5 times a week for 3wk)
(nZ40) Study group vs placebo
Total Constant and P<.53 Baseline: 47.685.79 vs 46.576.94
Murley score
(continued on next page)
Pharmaceutics for subacromial impingement syndrome 975

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[Link]