Article

Surgery for Shoulder Osteoarthritis: A Cochrane Systematic Review

University of Alabama at Birmingham, Birmingham, AL 35294-3408, USA.
The Journal of Rheumatology (Impact Factor: 3.19). 04/2011; 38(4):598-605. DOI: 10.3899/jrheum.101008
Source: PubMed
ABSTRACT
To determine the benefits and harm of surgery for shoulder osteoarthritis (OA).
We performed a Cochrane Systematic Review of clinical trials of adults with shoulder OA, comparing surgical techniques [total shoulder arthroplasty (TSA), hemiarthroplasty, implant types, and fixation] to placebo, sham surgery, nonsurgical modalities, and no treatment. We also reviewed trials that compared various surgical techniques, reporting patient-reported outcomes (pain, function, quality of life, etc.) or revision rates. We calculated the risk ratio for categorical outcomes and mean differences for continuous outcomes with 95% CI.
There were no controlled trials of surgery versus placebo or nonsurgical interventions. Seven studies with 238 patients were included. Two studies compared TSA to hemiarthroplasty (n = 88). Significantly worse scores on the 0-100 American Shoulder and Elbow Surgeons scale (mean difference, -10.05 at 24-34 mo; 95% CI -18.97 to -1.13; p = 0.03) and a nonsignificant trend toward higher revision rate in hemiarthroplasty compared to TSA (relative risk 6.18; 95% CI 0.77 to 49.52; p = 0.09) were noted. With 1 study providing data (n = 41), no differences were noted between groups for pain scores (mean difference 7.8; 95% CI -5.33 to 20.93), quality of life on Medical Outcomes Study Short-Form 36 physical component summary (mean difference 0.80; 95% CI -6.63 to -8.23), and adverse events (relative risk 1.2; 95% CI 0.4 to 3.8).
TSA was associated with better shoulder function, with no other demonstrable clinical benefits compared to hemiarthroplasty. More studies are needed to compare clinical outcomes between them and comparing shoulder surgery to sham, placebo, and other nonsurgical treatment options.

Full-text

Available from: Jasvinder A Singh, Sep 20, 2015
1
Singh and Fitzgerald: Botulinum toxin for shoulder pain
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Review
Botulinum Toxin for Shoulder Pain: A Cochrane
Systematic Review
J
ASVINDER A. SINGH and PATRICK M. FITZGERALD
A
BSTRACT. Objective. To perform a Cochrane Systematic Review of benefits and harms of botulinum toxin for
shoulder pain.
Methods. We included clinical trials of adults with shoulder pain (population), comparing botulinum
toxin (intervention) to placebo or other therapies (comparison), and reporting benefits or harms (out-
comes). We calculated relative risk (RR) for categorical outcomes and mean differences (MD) for
continuous outcomes.
Results. Six randomized controlled trials (RCT) with 164 patients all comparing single botulinum
toxin type A injections to placebo were included. Five RCT in patients with post-stroke shoulder pain
found that an intramuscular injection of botulinum toxin type A significantly reduced pain at 3–6
months (MD –1.2 points on 0–10 scale, 95% CI –2.4 to –0.07) and improved shoulder external rota-
tion at 1 month (MD 9.8˚, 95% CI 0.2˚ to 19.4˚). Number of adverse events did not differ between
groups (RR 1.46, 95% CI 0.6 to 24.3). One RCT in arthritis-related shoulder pain showed that sin-
gle intraarticular botulinum toxin type A injection reduced pain (MD –2.0 on 0–10 scale, 95% CI
–3.7 to –0.3) and shoulder disability (MD –13.4 on 0–100 scale, 95% CI –24.9 to –1.9) and improved
shoulder abduction (MD 13.8˚, 95% CI 3.2˚ to 44.0˚) at 1 month, compared with placebo. Serious
adverse events did not differ between groups (RR 0.35, 95% CI 0.11, 1.12).
Conclusion. With evidence from few studies with small sample sizes and medium to high risk of
bias, botulinum toxin type A injections decreased pain and improved shoulder function in patients
with chronic shoulder pain due to spastic hemiplegia or arthritis. (J Rheumatol First Release Feb 1
2011; doi:10.3899/jrheum.101081)
Key Indexing Terms:
BOTULINUM TOXIN SHOULDER PAIN BENEFIT
SAFETY COCHRANE SYSTEMATIC REVIEW
From the Medicine Service, Birmingham Veterans Affairs (VA) Medical
Center and Department of Medicine, University of Alabama at
Birmingham, Birmingham, Alabama; Center for Surgical Medical Acute
Care Research and Transitions, Birmingham VA Medical Center;
Division of Epidemiology, School of Public Health, University of Alabama
at Birmingham; Department of Health Sciences Research and Department
of Orthopedic Surgery, Mayo Clinic School of Medicine, Rochester,
Minnesota; and Medicine Service, Minneapolis VA Medical Center,
Minneapolis, Minnesota, USA.
Supported by National Institutes of Health (NIH) Clinical Translational
Science Award 1 KL2 RR024151-01 (Mayo Clinic Center for Clinical and
Translational Research) and the Birmingham VA Medical Center,
Alabama, USA. Dr. Singh has received speaker honoraria from Abbott;
research and travel grants from Allergan, Takeda, Savient, Wyeth, and
Amgen; and consultant fees from Savient, URL pharmaceuticals, and
Novartis.
J.A. Singh, MBBS, MPH, Medicine Service, Center for Surgical Medical
Acute Care Research and Transitions, Birmingham VA Medical Center;
Department of Medicine, Division of Epidemiology, School of Public
Health, University of Alabama at Birmingham; Department of Health
Sciences Research and Department of Orthopedic Surgery, Mayo Clinic
School of Medicine; P.M. Fitzgerald, MPH, Medicine Service,
Minneapolis VA Medical Center.
The views expressed in this article are those of the authors and do not
necessarily reflect the position or policy of the Department of Veterans
Affairs.
This is a reformatted version of a Cochrane Review, which is available in
The Cochrane Library, Issue 9, 2010. Cochrane Reviews are regularly
updated as new evidence emerges and in response to feedback, and The
Cochrane Library should be consulted for the most recent version of the
Review.
Address correspondence to Dr. J.A. Singh, University of Alabama at
Birmingham, Faculty Office Tower, Room 805B, 510 20th Street S.,
Birmingham, AL 35294-3408, USA. E-mail: jasvinder.md@gmail.com
Shoulder pain is one of the most common musculoskeletal
disorders affecting the adult population, with an estimated
prevalence of 7% to 25% in Western general popula-
tions
1,2,3,4,5
. Persistent shoulder pain lasting longer than 1
month affects over 5% of adult Americans each year
2
.
Shoulder pain limits the ability to enjoy an optimal quality
of life and perform key functions in daily living
5,6,7
, leading
to disability
8
, and higher healthcare utilization
9
. The com-
mon causes of shoulder pain include rotator cuff tendinitis,
adhesive capsulitis, osteoarthritis (OA) of the shoulder, and
acromio-clavicular joint disease. In the elderly, shoulder
pain is a common complication after stroke
10
that is associ-
ated with reduction in quality of life
11
. Post-stroke shoulder
pain may be due to spasticity, adhesive capsulitis, shoulder
subluxation, or rotator cuff injury.
Conservative treatment options for shoulder pain include
Page 1
a
nalgesics and antiinflammatory medications, oral
steroids
12
, local steroid injections
13
, arthrographic disten-
sion
1
4
, physiotherapy
1
5,16
, acupuncture
1
7
, and, more recent-
ly, novel interventions such as topical glyceryl trinitrate
1
8
.
However, a significant proportion of patients are intolerant
o
r refractory to these therapies, and therefore new treatment
options are needed.
Botulinum toxin is one of the neurotoxins produced by
Clostridium botulinum bacteria. Botulinum neurotoxins are
zinc-dependent enzymes that reversibly block neurotrans-
mission by inhibiting release of neurotransmitters (the
chemical signals) and disrupting neuronal communica-
tion
1
9,20
. There are 7 botulinum serotypes (A to G), all of
which inhibit acetylcholine release at the neuromuscular
junction to prevent the muscle from contracting. This mech-
anism of action is thought to underlie its efficacy in treating
spasticity associated with stroke, multiple sclerosis,
Parkinson’s disease, and cerebral palsy and for the treatment
of facial wrinkles. There is also emerging evidence on the
use of botulinum toxin for pain relief in neuropathic pain
2
1
and arthritis-related pain
2
2
.
Laboratory observations suggest that botulinum neuro-
toxin A can directly inhibit peripheral nerve nociceptor acti-
vation and sensitization by local neurotransmitter release,
and may indirectly reduce central sensitization in spinal
cord neurons — mechanisms important in chronic pain. In a
rat model of induced acute inflammatory pain, prior injec-
tion of botulinum neurotoxin A just below the paw skin
reduced spinal cord activity and paw inflammation
23
.
Botulinum neurotoxin A inhibited release of substance P in
in vitro studies of embryonic rat dorsal neurons
24
; substance
P acts as a neurotransmitter and is associated with inflam-
matory processes and pain. The clinical evidence for inhibi-
tion of pain sensation by botulinum neurotoxin is mounting:
(1) improvement of neck pain has been noted before reduc-
tion in muscle spasm following botulinum toxin type A
injection for cervical dystonia
25
; (2) pain relief typically
outweighed the degree of spasm reduction in the treatment
of painful spasticity in the extremities
26
; (3) botulinum toxin
type A injections reduced severity/frequency of migraine
and tension headaches
27
; and (4) observation of pain relief
in patients with myofascial pain
28,29,30
and chronic tennis
elbow
31,32,33
. These observations suggest an antinociceptive
action for botulinum toxin that may be independent of its
well described muscle paralyzing action.
The objective of this Cochrane systematic review was to
assess the benefit and harms of botulinum toxin for shoulder
pain, as compared to placebo or other treatment options
34
.
MATERIALS AND METHODS
Selection criteria and search methodology. We considered all published
clinical trials including adults (age > 18 years) with shoulder pain treated
with botulinum toxin injections by any route (including but not limited to
intramuscular, subcutaneous, intradermal, or intraarticular) compared to
placebo/comparator, reporting benefits and/or harms. Shoulder pain could
be due to any type of arthritis in the glenohumeral or acromio-clavicular
joint [OA, rheumatoid arthritis (RA), and other inflammatory arthritides],
rotator cuff tendinitis, adhesive capsulitis, or post-stroke shoulder pain.
With the search strategy shown in Appendix 1, we searched the follow-
ing databases in September 2009: Cochrane Central Register of Controlled
Trials (CENTRAL; The Cochrane Library 2009, Issue 3) on Wiley
InterScience (www.thecochranelibrary.com); Ovid MEDLINE (1966 to
August Week 4, 2009); CINAHL (via EBSCOhost; 1982 to September
2009); Dissertation abstracts; EMBASE (1980 to Week 36, 2009); Science
Citation Index (Web of Science; 1945 to August 2009); and Current
Controlled Trials. The search was updated January 22, 2010.
We also searched the US Food and Drug Administration (FDA)
(www.fda.gov/) and European Medicines Agency (EMEA) websites
(www.ema.europa.eu/) for labels and warnings to summarize warnings
related to botulinum toxin injections.
Data collection and analysis. Two authors (JAS, PMF) independently
reviewed trials identified for potential inclusion, based on predetermined
criteria (see “Criteria for selecting studies”) and extracted data independ-
ently including source of funding, study population, number of centers,
intervention, route and dose, comparator, and outcomes. A third individual
(K. McMaken) checked data accuracy by comparing original data from
included articles to the abstracted data. When possible, we extracted num-
bers based on intention-to-treat analysis.
Primary and secondary outcomes. Primary outcomes were (1) Pain, on
visual analog scale (VAS), numeric rating scale (NRS), or semiquantitative
descriptive scales such as the short-form McGill Pain Questionnaire (range
0–45; higher score denotes worse pain)
35
or other instruments; and (2)
Harms, as assessed by total and serious adverse events, number of with-
drawals due to adverse events, and deaths.
Secondary outcomes were (1) Disability/function measured using
instruments such as the American Shoulder and Elbow Surgeons Shoulder
Score (ASES)
36
; (2) Joint range of motion in flexion and extension, and
abduction and adduction; (3) Quality of life, assessed by validated instru-
ments such as the Medical Outcomes Study Short-form 36 (SF-36); (4)
Patient or physician evaluated success of treatment; (5) Radiographic pro-
gression for patients with shoulder arthritis; (6) Stroke patient disability
instruments, including the Barthel Index
37
, motor component of the
Functional Independence Measure (M-FIM), and/or the Modified Ranking
Scale
38
.
Assessment of risk of bias in studies. For each included study, 2 authors
(JAS, PMF) independently assessed risk of bias against key criteria
39
: ran-
dom sequence generation; allocation concealment; blinding of participants,
personnel and outcome assessors; incomplete outcome data; selective out-
come reporting; and other sources of bias, in accordance with methods rec-
ommended by The Cochrane Collaboration
39
. These criteria were labeled
as: Yes (low risk of bias); No (high risk of bias); or Unclear (either lack of
information or uncertainty over the potential for bias). Different assess-
ments by the 2 authors for risk of bias were resolved by consensus.
Data analyses. We calculated mean differences for continuous outcomes
and risk ratios (RR) with corresponding 95% confidence interval (CI) for
dichotomous outcomes. Number needed to treat to benefit or harm (NNT)
was calculated using the Visual Rx NNT calculator for categorical out-
comes
40
and the Wells calculator software for continuous outcomes (avail-
able from the Cochrane Musculoskeletal Group). Based on an a priori deci-
sion, we analyzed arthritis studies separately from the post-stroke studies.
We assessed studies for clinical homogeneity. Outcomes of clinically
homogeneous studies were pooled for metaanalysis using the random-
effects model to be conservative. We used the I
2
statistic to test statistical
heterogeneity
41
, as follows: 0–40%, not important heterogeneity; 30–60%,
moderate heterogeneity; 50–90%, substantial heterogeneity; and 75–100%,
considerable heterogeneity.
We present the main results of the review in the summary of findings
(see Table 3), with a priori chosen outcomes (pain; disability/function; total
adverse events; number of withdrawals due to adverse events; serious
2
The Journal of Rheumatology 2011; 38:3; doi:10.3899/jrheum.101081
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Page 2
adverse events; revision rate), as recommended by The Cochrane
Collaboration
4
2
. The summary of findings includes an overall grading of
the evidence related to each of the main outcomes, using the GRADE
approach
43
.
RESULTS
Description of studies and risk of bias. The search strategy
is provided in Appendix 1. The original search (September
2
009) identified 160 titles and abstracts (Figure 1). Of the 21
articles that qualified for full-text review, 6 studies met the
inclusion criteria; 15 were excluded (Figure 1). An updated
search on January 22, 2010, identified another 7 potential
studies, but none qualified for full-article review. Therefore, 6
studies were included in this systematic review
4
4,45,46,47,48,49
.
Table 1 describes the key characteristics of the included
studies. All were double-blind randomized controlled trials
(RCT).
The sample size ranged from 17 patients
45
to 43
patients
4
9
. All studies used botulinum toxin type A, a
one-time injection (at single or multiple sites), and it was
compared to placebo in all studies but one
4
6
, where it was
compared to triamcinolone. Botulinum toxin was injected
intramuscularly in patients with spasticity after stroke or
hemiplegia in 5 studies
44,45,46,47,48
, and intraarticularly in
patients with refractory pain due to OA or RA in one
study
49
. The preparation was 500 units of Dysport
®
(Ipsen
Inc., Slough, UK) in 3 studies
45,47,48
and 100 units of
Botox
®
(Allergan Pharmaceuticals Inc.) in 3 studies
44,46,49
.
The results were described separately based on the under-
lying condition, that is, shoulder spasticity due to hemiple-
gia or shoulder arthritis, and by the comparator (placebo vs
t
riamcinolone).
In general, there was medium to high risk of bias across
all the included studies due to small sample size and lack of
blinding (Table 2). Four studies were partially funded by the
makers of botulinum toxin
45,46,48,49
.
Summary of findings for spasticity studies: Botulinum toxin
compared to placebo. Three of the 5 prespecified outcomes
for the summary of findings were not presented in any spas-
ticity study serious adverse events and withdrawals due
to adverse events (Table 3). For most outcomes, data were
available from only one study. No heterogeneity was noted
between study estimates for the few outcomes where 2 stud-
ies provided data.
Pain severity was reduced more significantly in the botu-
linum toxin group compared to placebo at 12–24 weeks,
with 1.2-unit greater reduction in pain severity on a 0–10
scale (p = 0.02; Table 3). No difference in number of
adverse events was noted between botulinum toxin and
placebo groups.
Shoulder spasticity due to hemiplegia: Effect of intramuscu-
lar botulinum toxin compared with intramuscular placebo
or with intraarticular triamcinolone. In addition to present-
ing pain and adverse event outcomes in the summary of
findings, we analyzed additional outcomes as follows. Four
3
Singh and Fitzgerald: Botulinum toxin for shoulder pain
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Figure 1. The process of study selection.
Page 3
studies provided data comparing botulinum toxin to place-
bo
44,45,47,48
(Table 4) and one study comparison to triamci-
nolone injection
46
. The details of each outcome at 4–6
weeks and at 6–12 weeks (as applicable) are provided.
Compared to placebo, pain reduction at 4–6 weeks was
not statistically different in the botulinum toxin group (p =
0.22). As noted above, pain reduction at 12–24 weeks was
statistically significantly greater in the botulinum toxin group
compared to placebo (p = 0.02). The I
2
statistic (measure of
heterogeneity) was 76% at 4 to 6 weeks, the timepoint when
the difference was not significant; and 0% at the 12 to 24-
week endpoint, when the difference was significant. The het-
erogeneity at 4 to 6 weeks was due to a single study
45
in
which the magnitude of change favored placebo; removal of
this study reduced the heterogeneity to 0% and the difference
between botulinum toxin was statistically significantly in
favor of botulinum toxin (mean difference 2.0, 95% CI
1.0–3.5, p = 0.0002). Sensitivity analyses assuming a fixed-
effect instead of a random-effects model had no effect on the
6 to 12 week estimate, but made the 4 to 6 week estimate sig-
nificant, with a mean difference of –0.9 favoring botulinum
toxin over placebo (95% CI –1.8 to –0.1, p = 0.03).
Compared to placebo, shoulder external rotation was sig-
nificantly better in patients who received botulinum toxin,
with a difference of 9.8 degrees (95% CI 0.20, 19.5). There
were no significant differences in shoulder flexion, abduc-
tion, spasticity, or number of adverse events [for botulinum
toxin, 9/31 (29%) vs placebo groups, 8/34 (24%)] between
groups. Sensitivity analyses using a fixed-effect model did
not change estimates or significance for any outcome except
shoulder abduction at 4 to 6 weeks, which changed from
being insignificant in the random-effects model to being sig-
nificant in the fixed-effect model (mean difference 9.6, 95%
CI 1.6 to 17.5, p = 0.02). The I
2
statistic was 36% at 4 to 6
weeks and 67% at 6 to 12 weeks for shoulder abduction.
One study (25 participants) comparing intramuscular
4
The Journal of Rheumatology 2011; 38:3; doi:10.3899/jrheum.101081
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Table 1. Characteristics of included studies.
Study Followup, mo Intervention/ Population Route Mean Age, Primary Secondary
Comparison yrs; M/F Outcome Outcomes
De Boer 2008
44
3 100 units Post-stroke IM 59; 12/9 Pain VAS, external
Botox
vs placebo shoulder spasticity rotation
Kong 2007
45
3 500 units Post-stroke IM 52; n = 17 Pain VAS Muscle tone,
Dysport
TM
vs shoulder spasticity shoulder
placebo abduction
Lim 2008
46
3 100 units Post-stroke IM 61; 15/14 Pain NRS, Spasticity,
Botox
vs shoulder spasticity physician global, adverse events,
triamcinolone shoulder ROM arm function
acetonide
Marco 2007
47
6 TENS + 500 units Post-stroke IM 66; 21/8 Pain VAS Spasticity,
Dysport
T
M
vs TENS shoulder spasticity shoulder ROM
+ placebo
Yelnik 2007
48
1 500 units Post-stroke IM 54 15/5 Pain VAS,
Dysport
T
M
vs placebo shoulder spasticity spasticity, use of
analgesics, ROM,
spasticity
Singh 2009
4
9
1 100 units OA, RA IA 71; 35/1 Pain VAS Dropout, shoulder
Botox
vs placebo disability, global
scale, quality of
life, adverse events
VAS: visual analog scale; NRS: numeric rating scale; IM: intramuscular; IA: intraarticular; OA: osteoarthritis; RA: rheumatoid arthritis. ROM: range of
motion.
Table 2. Risk of bias of studies.
Study Adequate Sequence Allocation Blinding Incomplete Outcome Free of Free of
Generation Concealment Data Addressed Selective Reporting Other Bias
De Boer 2008
44
Unclear Unclear Unclear Unclear Unclear Yes
Kong 2007
45
Yes No Unclear Yes Unclear No
Lim 2008
46
Yes Yes Yes Yes Unclear No
Marco 2007
47
Yes Yes Yes Yes Unclear Yes
Yelnik 2007
48
Yes Unclear Unclear Yes Unclear No
Singh 2009
49
Yes Yes Yes Yes Yes No
“Unclear”: enough information was not available to make a determination regarding that criterion.
Page 4
botulinum toxin to intraarticular triamcinolone found no sig-
nificant differences in pain severity, physician global rating,
shoulder range of motion, or muscle spasticity between bot-
ulinum toxin and placebo groups
46
.
Shoulder arthritis due to OA or RA: Effect of intraarticular
botulinum toxin compared to placebo. One study provided
data
49
. The efficacy data were presented by joints, and safe-
ty data by patient as the unit of analysis. At 1 month, there
were significantly greater improvements in VAS pain,
patient-reported shoulder disability, active shoulder abduc-
tion, Short-Form McGill Pain Questionnaire total, sensory,
and affective pain scores in the botulinum toxin group com-
pared with the placebo group (Table 5). There were no sig-
nificant between-group differences in shoulder flexion, seri-
ous events, number of patients with one or more adverse
events, or deaths (Table 5).
None of the planned subgroup analyses (route, dose, type
of toxin, and underlying diagnosis) could be carried out due
to lack of studies.
Summary of warnings from the FDA and other regulato-
ry websites and other outcomes are provided in the pub-
lished Cochrane review
34
.
DISCUSSION
In this study we reviewed 6 small RCT of botulinum toxin
in patients with shoulder pain due to hemiplegia (5 RCT)
and endstage arthritis (one RCT). In patients with shoulder
pain and spasticity after hemiplegia, a single intramuscular
injection of botulinum toxin A was associated with statisti-
cally significantly greater reduction in pain severity at 3 to 6
months compared to placebo. Significantly greater improve-
ments in shoulder external rotation were noted at 1 month
but not at 3 to 6 months. No significant differences were
noted in muscle spasticity, shoulder flexion, or shoulder
abduction. Adverse events were reported by only 3 studies
and were not significantly different between placebo and
botulinum toxin.
In patients with endstage arthritis, significant improve-
ments were noted in pain severity, shoulder-related disabili-
ty, and shoulder abduction in participants receiving a single
intraarticular injection of botulinum toxin compared with
placebo at 1-month followup. Quality of life improvements
were also reported to be significantly greater in the botu-
linum toxin group. Again, the outcomes were at 1-month
followup and the sample size was small.
The improvements in pain severity with botulinum toxin
A were not only statistically significant in both patient pop-
ulations (hemiplegia and arthritis) but also exceeded the
threshold for clinically important changes in pain severity of
2 points or a 33% reduction
50
. This is an important observa-
tion, since the findings of significant pain relief were repli-
cated by multiple studies, with a similar magnitude of pain
5
Singh and Fitzgerald: Botulinum toxin for shoulder pain
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Table 3. Summary of findings comparing intramuscular botulinum toxin to placebo in patients with shoulder spasticity.
Outcomes Illustrative Comparative Risks* (95% CI) Relative No. Quality of Comments
Assumed Risk Corresponding Risk Effect Participants Evidence
Control Intramuscular (95% CI) (studies) (GRADE)
Botulinum toxin
Pain (0–10 cm VAS or Mean pain (0–10 cm VAS): Mean pain (0–10 cm VAS): NA 76 (3) + + – Absolute risk difference
0–10 VRS at 12–24 wks pain at 6–12 wks in pain at 6–12 wks in 12% (95% CI 1% to 24%);
control groups was 4.8 intervention groups was Low
1
,2
relative percentage change
1.22 lower (0.07 to 2.37 lower) 25% (95% CI 1% to 49%);
NNT benefit = 4 (95% CI
2 to 102)
No. adverse events 235 per 1000 343 per 1000 RR 1.46 65 (3) + + – Absolute risk difference
(followup 4-24 wks) (150 to 790) (0.64 to 3.36) Low
1,2
9% (95% CI –22% to 39%);
relative percentage change
46% (95% CI –36% to
226%); NNT harm =
not estimable
3
Disability/function Not reported in any study Not reported in any study Not estimable NA NA
Withdrawals due to Not reported in any study Not reported in any study Not estimable NA NA
adverse events
Serious adverse events Not reported in any study Not reported in any study Not estimable NA NA
* The basis for the assumed risk (e.g., the median control group risk across studies) is provided in footnotes. The corresponding risk (95% is based on the
assumed risk in the comparison group and the relative effect of the intervention (95% CI).
1
Allocation sequence generation and allocation concealment was
not described in some studies.
2
Sample sizes were small for all studies, making estimates liable to error.
3
95% CI includes both positive and negative num-
bers, therefore NNT harm is not estimable.
GRADE Working Group grades of evidence: High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate qual-
ity: further research is likely to have an important influence on our confidence in the estimate of effect and may change the estimate. Low quality: further
research is very likely to have an important influence on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We
are very uncertain about the estimate. RR: risk ratio; NA: not applicable; VAS: visual analog scale; VRS: verbal rating scale; NNT: number needed to treat.
Page 5
reduction, and findings were consistent across 2 disease
conditions (hemiplegia and arthritis). The route of adminis-
tration differed between the 2 conditions, intramuscular for
hemiplegia and intraarticular for arthritis. The pain reduc-
tion at 1 month in the hemiplegia group did not achieve sta-
tistical significance, primarily due to one study that report-
ed an effect in the opposite direction favoring placebo
45
,
which led to high heterogeneity; effects became statistically
6
The Journal of Rheumatology 2011; 38:3; doi:10.3899/jrheum.101081
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Table 4. Additional outcomes for comparison of intramuscular botulinum toxin to placebo or to triamcinolone in patients with shoulder spasticity.
Outcome No. Studies No. Patients Mean difference or Risk Ratio*
(95% CI)
Intramuscular botulinum toxin compared to placebo: outcomes at 4–6 and 12-24 weeks
Pain (0–10 cm VAS or verbal rating scale)
At 4–6 wks 4 86 –1.12 (–2.89, 0.66)
At 12–24 wks 3 66 –1.22 (–2.37, –0.07)**
Spasticity on modified Ashworth Scale (0–5; higher = worse)
At 4–6 wks 2 45 –0.62 (–1.40, 0.17)
At 12–24 wks 2 45 –0.13 (–0.65, 0.38)
Passive shoulder flexion (0–180; higher = better function) 1
At 4–6 wks 1 29 3.00 (–15.54, 21.54)
At 12–24 wks 1 29 1.00 (–17.87, 19.87)
Passive shoulder abduction (0–180; higher = better function)
At 4–6 wks 3 65 8.49 (–2.40, 19.39)
At 12–24 wks 2 45 17.72 (–9.61, 45.04)
Shoulder external rotation (0–180; higher = better function)
At 4–6 wks 3 70 9.84 (0.20, 19.49)**
At 12–24 wks 2 50 11.86 (–0.61, 24.33)
No. adverse events 3 65 1.46 (0.64, 3.36)
At 4–6 wks 1 20 3.00 (0.37, 24.17)
At 12–24 wks 2 45 0.84 (0.10, 7.10)
Intramuscular botulinum toxin compared to triamcinolone: outcomes at 12 weeks
Change in pain on 0–10 numeric rating scale (higher = more pain) 1 29 1.70 (–0.08, 3.48)
Change in physician global rating scale (0–4; 4 = maximum improvement) 1 29 0.00 (–0.72, 0.72)
Change in passive shoulder flexion (0–180; higher = better function) 1 29 8.30 (–4.06, 20.66)
Change in passive shoulder abduction (0–180; higher = better function) 1 29 5.60 (–6.05, 17.25)
Change in passive shoulder external rotation (0–90; higher = better) 1 29 7.90 (–5.30, 21.10)
Change in passive shoulder internal rotation (0–90; higher = better) 1 29 9.30 (–0.36, 18.96)
Change in spasticity on modified Ashworth Scale (0–5; higher = worse) 1 29 –0.20 (–1.00, 0.60)
* All numbers are mean differences except number of adverse events for which risk ratio is presented. ** Significant with p < 0.03 for all. VAS: visual ana-
log scale.
Table 5. Intraarticular botulinum toxin compared to placebo in patients with arthritis: outcomes at 4 weeks.
Outcome No. Studies No. Patients Mean difference or Risk Ratio*
(95% CI)
Pain on visual analog scale (0–10 cm; higher = worse pain) 1 36 –2.00 (–3.71, –0.29)**
SPADI disability subscale score (0–100; higher = worse function) 1 36 –13.40 (–24.93, –1.87)**
SPADI pain subscale score (0–100; higher = worse pain) 1 36 –9.10 (–20.33, 2.13)
Active shoulder flexion (0–180; higher = better function) 1 36 13.80 (–9.21, 36.81)
Active shoulder abduction (0–180; higher = better function) 1 36 23.60 (3.25, 43.95)**
McGill total pain score (0–45; higher = worse pain) 1 36 –7.20 (–13.06, –1.34)
McGill sensory dimension pain (0–33; higher = worse) 1 36 –4.50 (–8.96, – 0.04)
McGill affective dimension pain (0–12; higher = worse pain) 1 36 –2.70 (–4.39, –1.01)
Serious adverse events 1 36 0.35 (0.11, 1.12)
No. patients with 1 or more serious adverse events 1 36 0.79 (0.20, 3.10)
Death 1 36 Not estimable
* All numbers are mean differences except number of adverse events for which risk ratio is presented. ** Significant with p 0.02 for all. Differences are
significant when 95% confidence interval for the mean difference does not include 0 and 95% confidence interval for the relative risk does not include 1. No
patient in either group died. SPADI: Shoulder Pain and Disability Index.
Page 6
significant when this study was excluded. The magnitude of
effect (mean difference of –1.1 points from placebo on a 0
to 10 pain scale) was similar to the –1.3-point difference
n
oted at 3 to 6 months. There was greater heterogeneity (I
2
= 68%) at 1 month compared to that noted at 3 to 6 months
in the hemiplegia group (I
2
= 0%); when the single study
leading to heterogeneity was removed, I
2
was reduced to 0%
at 4–6 weeks and the difference in pain severity became sta-
tistically significant. In conjunction with the absence of a
statistically significant improvement in spasticity in these
studies, this observation supports the notion that the
antinociceptive action of botulinum toxin type A is likely to
be independent of its muscle spasmolytic action, as dis-
cussed in detail in the introduction section of this report.
The antinociceptive action of botulinum toxin A for
shoulder pain noted in this review is very similar to the
antinociceptive action of botulinum toxin A noted for neck
pain in patients with torticollis (or “wry neck”)
51
. Other
studies of botulinum toxin have demonstrated a potential
antinociceptive action in patients with migraine and tension
headaches
27
, myofascial and back pain
28,29,52
, and chronic
tennis elbow
29,52
.
Our study has several limitations. Most studies were
small and were performed at tertiary medical centers, rais-
ing issues of generalizability. The strength of evidence syn-
thesis is limited by the quality of the included studies, some
of which were not of the highest quality. More evidence is
needed from large multicenter studies to confirm these find-
ings. Our review is limited to published data and therefore
we may have overlooked unpublished data showing absence
of effect. In studies of patients with hemiplegia, patients had
both spasticity and pain in the shoulder and the findings may
be applicable only to hemiplegic patients with both spastic-
ity and pain. Only a single injection of botulinum toxin A
was tested in these studies; it is unknown if different dosing
schedules may have had better efficacy. The duration of pain
relief following a single injection is unknown with the cur-
rent evidence. Three studies were partially supported by
pharmaceutical company funding and the authors of one
study had received grants from these companies in the past.
Our study has several strengths including a published
protocol, use of standard methodology for performing sys-
tematic review, and duplicate abstraction of data up to
January 2010.
Shoulder pain is a common medical problem in the gen-
eral population, with very few effective treatment options.
This review summarizes data from 5 RCT of shoulder pain
associated with shoulder spasticity after stroke and one RCT
of patients with endstage shoulder arthritis pain. The inter-
pretation of these findings is limited because it is based on
few studies with small sample sizes and moderate to high
risks of bias. A single intramuscular or intraarticular injec-
tion of botulinum toxin A decreased shoulder pain severity
in the short term postinjection, with no significant decrease
in spasticity. However, studies included in this systematic
review were of small sample size and of mediocre quality.
Large-scale multicenter RCT are needed to confirm these
f
indings and to assess safety. Botulinum toxin A is not
approved by the FDA for use in post-stroke or arthritis
shoulder pain. Future studies should confirm these findings
in a larger sample and test different dosages and schedules
to determine the schedule or dose that is most effective and
safe.
ACKNOWLEDGMENT
We thank Louise Falzon and Renea Johnston of the Cochrane
Musculoskeletal Group for help in performing the searches and suggestions
regarding the protocol; and Kelly McMaken for checking the extracted
data.
APPENDIX The search strategy.
Ovid MEDLINE
®
In-Process and Other Non-Indexed Citations and Ovid
MEDLINE
®
1. Shoulder Pain/
2. Shoulder Impingement Syndrome/
3. Rotator Cuff/
4. exp Bursitis/
5. Shoulder/
6. Shoulder Joint/
7. exp Pain/
8. (5 or 6) and 7
9. ((should$ or rotator cuff) adj5 (bursitis or frozen or impinge$ or
tend?nitis or pain$)).tw.
10. or/1-4,8-9
11. exp Botulinum Toxins/
12. botulin$.tw.
13. botox.tw.
14. OnabotulinumtoxinA.tw.
15. RimabotulinumtoxinB.tw.
16. AbobotulinumtoxinA.tw.
17. BTXA.tw.
18. dyslor.tw.
19. dysport.tw.
20. lanzox.tw.
21. myobloc.tw.
22. neurobloc.tw.
23. oculinum.tw.
24. prosigne.tw.
25. vistabel.tw.
26. vistabex.tw.
27. xeomin.tw.
28. or/11-27
29. 10 and 28
EMBASE
1. Shoulder Pain/
2. Shoulder Impingement Syndrome/
3. rotator cuff/
4. Bursitis/
5. shoulder/
6. exp Pain/
7. 5 and 6
8. ((should$ or rotator cuff) adj5 (bursitis or frozen or impinge$ or
tend?nitis or pain$)).tw.
9. or/1-4,7-8
7
Singh and Fitzgerald: Botulinum toxin for shoulder pain
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Page 7
10. exp botulinum toxin/
11. botulinum toxin E/ or botulinum toxin B/ or botulinum toxin A/ or
botulinum toxin F/
12. botulin$.tw.
13. botox.tw.
14. OnabotulinumtoxinA.tw.
15. RimabotulinumtoxinB.tw.
16. AbobotulinumtoxinA.tw.
17. BTXA.tw.
18. dyslor.tw.
19. dysport.tw.
20. lanzox.tw.
21. myobloc.tw.
22. neurobloc.tw.
23. oculinum.tw.
24. prosigne.tw.
25. vistabel.tw.
26. vistabex.tw.
27. xeomin.tw.
28. or/10-27
29. 9 and 28
The Cochrane Library
#1 MeSH descriptor Shoulder Pain explode all trees
#2 MeSH descriptor Shoulder Impingement Syndrome explode all trees
#3 MeSH descriptor Rotator Cuff explode all trees
#4 MeSH descriptor Bursitis explode all trees
#5 MeSH descriptor Shoulder explode all trees
#6 MeSH descriptor Shoulder Joint explode all trees
#7 MeSH descriptor Pain explode all trees
#8 (( #5 OR #6 ) AND #7)
#9 ((should* or rotator cuff) Near/5 (bursitis or frozen or impinge* or ten-
dinitis or pain*)):ti,ab
#10 (#1 OR #2 OR #3 OR #4 OR #8 OR #9)
#11 MeSH descriptor Botulinum Toxins explode all trees
#12 botulin*:ti,ab
#13 botox:ti,ab
#14 OnabotulinumtoxinA:ti,ab
#15 RimabotulinumtoxinB:ti,ab
#16 AbobotulinumtoxinA:ti,ab
#17 BTXA:ti,ab
#18 dyslor:ti,ab
#19 dysport:ti,ab
#20 lanzox:ti,ab
#21 myobloc:ti,ab
#22 neurobloc:ti,ab
#23 oculinum:ti,ab
#24 prosigne:ti,ab
#25 vistabel:ti,ab
#26 vistabex:ti,ab
#27 xeomin:ti,ab
#28 (#11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR
#19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27)
#29 (#10 AND #28)
CINAHL
S28 S12 and S27
S27 S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21 or S22
or S23 or S24 or S25 or S26
S26 ti vistabex or ab vistabex
S25 ti vistabel or ab vistabel
S24 ti prosigne or ab prosigne
S23 ti oculinum or ab oculinum
S22 ti neurobloc or ab neurobloc
S21 ti lanzox or ab lanzox
S20 ti myobloc or ab myobloc
S19 ti dyslor or ab dyslor
S18 ti dysport or ab dysport
S17 ti OnabotulinumtoxinA or ab OnabotulinumtoxinA or ti
RimabotulinumtoxinB or ab RimabotulinumtoxinB or ti
AbobotulinumtoxinA or ab AbobotulinumtoxinA
S16 ti BTXA or ab BTXA
S15 ti botox or ab botox
S14 ti botulin* or ab botulin*
S13 (MH “Botulinum Toxins”) Search
S12 S1 or S2 or S3 or S4 or S9 or S10 or S11
S11 TI rotator cuff N5 bursitis or AB rotator cuff N5 bursitis or TI rotator
cuff N5 frozen or AB rotator cuff N5 frozen or TI rotator cuff N5 impinge*
or AB rotator cuff N5 impinge* or TI rotator cuff N5 tendonitis or AB rota-
tor cuff N5 tendonitis or TI rotator cuff N5 tendinitis or AB rotator cuff N5
tendinitis or TI rotator cuff N5 pain* or AB rotator cuff N5 pain* Search
modes
S10 TI should* N5 bursitis or AB should* N5 bursitis or TI should* N5
frozen or AB should* N5 frozen or TI should* N5 impinge* or AB should*
N5 impinge* or TI should* N5 tendonitis or AB should* N5 tendonitis or
TI should* N5 tendinitis or AB should* N5 tendinitis or TI should* N5
pain* or AB should* N5 pain*
S9 S7 and S8
S8 S5 or S6
S7 (MH “Pain+”)
S6 (MH “Shoulder Joint+”)
S5 (MH “Shoulder”)
S4 (MH “Bursitis+”)
S3 (MH “Rotator Cuff+”)
S2 (MH “Shoulder Impingement Syndrome”)
S1 (MH “Shoulder Pain”)
Web of Science
#3 #2 AND #1
#2 Topic=(botulin* or botox or OnabotulinumtoxinA or Rimabotulinum -
toxinB or AbobotulinumtoxinA or BTXA or dyslor or dysport or lanzox or
myobloc or neurobloc or oculinum or prosigne or vistabel or vistabex or
xeomin)
#1 Topic=(shoulder* AND (pain* or frozen or impinge* or tendonitis or
tendinitis or bursitis)) OR Topic=(rotator cuff)
Dissertation Abstracts
Shoulder* or rotator cuff in citation and abstract
AND (botulin* or botox or OnabotulinumtoxinA or RimabotulinumtoxinB
or AbobotulinumtoxinA or BTXA or dyslor or dysport or lanzox or
myobloc or neurobloc or oculinum or prosigne or vistabel or vistabex or
xeomin) in in citation and abstract
Current Controlled Trials
Search 1 botox and shoulder*
Search 2 botox and rotator cuff
Search 3 botulin* and shoulder*
Search 3 BTXA
Search 4 dyslor
Search 5 dysport
Search 6 lanzox
Search 7 neurobloc
Search 8 oculinum
Search 9 prosigne
Search 10 vistabel
Search 11 vistabex
8
The Journal of Rheumatology 2011; 38:3; doi:10.3899/jrheum.101081
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Page 8
REFERENCES
1. Bergenudd H, Lindgarde F, Nilsson B, Petersson CJ. Shoulder pain
in middle age. A study of prevalence and relation to occupational
work load and psychosocial factors. Clin Orthop 1988;231:234-8.
2. Bjelle A. Epidemiology of shoulder problems. Baillieres Clin
Rheumatol 1989;3:437-51.
3. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey
of chronic pain in Europe: prevalence, impact on daily life, and
treatment. Eur J Pain 2006;10:287-333.
4. Chakravarty KK, Webley M. Disorders of the shoulder: an often
unrecognised cause of disability in elderly people. BMJ
1990;300:848-9.
5. Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB.
Shoulder disorders in the elderly: a community survey. Arthritis
Rheum 1991;34:766-9.
6. Croft P, Pope D, Silman A. The clinical course of shoulder pain:
prospective cohort study in primary care. BMJ 1996;313:601-2.
7. Pope DP, Croft PR, Pritchard CM, Silman AJ, Macfarlane GJ.
Occupational factors related to shoulder pain and disability. Occup
Environ Med 1997;54:316-21.
8. Nygren A, Berglund A, von Koch M. Neck and shoulder pain, an
increasing problem. Strategies for using insurance material to
follow trends. Scand J Rehabil Med Suppl 1995;32:107-12.
9. Wofford JL, Mansfield RJ, Watkins RS. Patient characteristics and
clinical management of patients with shoulder pain in U.S. primary
care settings: secondary data analysis of the National Ambulatory
Medical Care Survey. BMC Musculoskelet Disord 2005;6:4.
10. Turner-Stokes L, Jackson D. Shoulder pain after stroke: a review of
the evidence base to inform the development of an integrated care
pathway. Clin Rehabil 2002;16:276-98.
11. Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan
SR, et al. Poststroke shoulder pain: its relationship to motor
impairment, activity limitation, and quality of life. Arch Phys Med
Rehabil 2007;88:298-301.
12. Buchbinder R, Green S, Youd JM, Johnston RV. Oral steroids for
adhesive capsulitis. Cochrane Database Syst Rev 2006;CD006189.
13. Buchbinder R, Green S, Youd JM. Corticosteroid injections for
shoulder pain. Cochrane Database Syst Rev 2003;CD004016.
14. Buchbinder R, Green S, Youd JM, Johnston RV, Cumpston M.
Arthrographic distension for adhesive capsulitis (frozen shoulder).
Cochrane Database Syst Rev 2008;CD007005.
15. Green S, Buchbinder R, Glazier R, Forbes A. Interventions for
shoulder pain. Cochrane Database Syst Rev 2003;CD001156.
16. van der Windt DA, Bouter LM. Physiotherapy or corticosteroid
injection for shoulder pain? Ann Rheum Dis 2003;62:385-7.
17. Green S, Buchbinder R, Hetrick S. Acupuncture for shoulder pain.
Cochrane Database Syst Rev 2005;CD005319.
18. Cumpston M, Johnston RV, Wengier L, Buchbinder R. Topical
glyceryl trinitrate for rotator cuff disease. Cochrane Database Syst
Rev 2009;CD006355.
19. Simpson KH. Individual choice of opioids and formulations:
strategies to achieve the optimum for the patient. Clin Rheumatol
2002;21 Suppl 1:S5-8.
20. Setler PE. Therapeutic use of botulinum toxins: background and
history. Clin J Pain 2002;18 Suppl:S119-24.
21. Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type
A induces direct analgesic effects in chronic neuropathic pain. Ann
Neurol 2008;64:274-83.
22. Mahowald M, Singh J, Dykstra D. Long term effects of
intra-articular botulinum toxin type A on refractory joint pain.
Neurotox Res 2006;9:179-88.
23. Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous
administration of botulinum toxin A reduces formalin-induced pain.
Pain 2004;107:125-33.
24. Purkiss J, Welch M, Doward S, Foster K. Capsaicin-stimulated
release of substance P from cultured dorsal root ganglion neurons:
involvement of two distinct mechanisms. Biochem Pharmacol
2000;59:1403-6.
25. Jankovic J, Schwartz K. Botulinum toxin injections for cervical
dystonia. Neurology 1990;40:277-80.
26. Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H,
et al. Management of spasticity associated pain with botulinum
toxin A. J Pain Symptom Manage 2000;20:44-9.
27. Gobel H, Heinze A, Heinze-Kuhn K, Jost W. Evidence based
medicine: Botulinum toxin A in migraine and tension type
headache. J Neurol 2001;248 Suppl:34-8.
28. Cherkin D, Wheeler K, Barlow W, Deyo R. Medication use for low
back pain in primary care. Spine 1998;23:607-14.
29. Porta M. A comparative trial of botulinum toxin type A and
methylprednisolone for the treatment of myofascial pain syndrome
and pain from chronic muscle spasm. Pain 2000;85:101-5.
30. Smith HS, Audette J, Royal MA. Botulinum toxin in pain
management of soft tissue syndromes. Clin J Pain 2002;18
Suppl:S147-54.
31. Hayton MJ, Santini AJ, Hughes PJ, Frostick SP, Trail IA, Stanley
JK. Botulinum toxin injection in the treatment of tennis elbow. A
double-blind, randomized, controlled, pilot study. J Bone Joint Surg
Am 2005;87:503-7.
32. Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK.
Treatment of lateral epicondylitis with botulinum toxin: a
randomized, double-blind, placebo-controlled trial. Ann Intern Med
2005;143:793-7.
33. Keizer SB, Rutten HP, Pilot P, Morre HH, van Os JJ, Verburg AD.
Botulinum toxin injection versus surgical treatment for tennis
elbow: a randomized pilot study. Clin Orthop Relat Res
2002;401:125-31.
34. Singh JA, Fitzgerald PM. Botulinum toxin for shoulder pain.
Cochrane Database Syst Rev 2010;CD008271.
35. Melzack R. The short-form McGill Pain Questionnaire. Pain
1987;30:191-7.
36. Richards R, An KN, Bigliani LU, Friedman RJ, Gartsman GM,
Gristina AG, et al. A standardized method for the assessment of
shoulder function. J Shoulder Elbow Surg 1994;3:347-52.
37. Sulter G, Steen C, De Keyser J. Use of the Barthel index and
modified Rankin scale in acute stroke trials. Stroke 1999;
30:1538-41.
38. Kwon S, Hartzema AG, Duncan PW, Min-Lai S. Disability
measures in stroke: relationship among the Barthel Index, the
Functional Independence Measure, and the Modified Rankin Scale.
Stroke 2004;35:918-23.
39. Higgins JP, Altman DG. Assessing risk of bias in included studies.
In: Higgins JP, Green S, editors. Cochrane handbook for systematic
reviews of interventions version 500 [updated February 2008]: The
Cochrane Collaboration. [Internet. Accessed Nov 15, 2010.]
Available from: www.cochrane-handbook.org
40. Cates C. Dr Chris Cates’ EBM Web Site. Visual Rx Version 3.
[Internet. Accessed Nov 15, 2010.] Available from:
http://www.nntonline.net/visualrx/
41. Deeks J, Higgins J, Altman D. Analysing data and undertaking
meta-analyses. Cochrane handbook for systematic reviews of
interventions version 5.0.0 (updated February 2008): The Cochrane
Collaboration. [Internet. Accessed Nov 15, 2010.] Available from:
www.cochrane-handbook.org
42. Schünemann HJ, Oxman AD, Higgins JP, Vist GE, Glasziou P,
Guyatt GH. Presenting results and ‘Summary of findings tables’.
In: Higgins JP, Green S, editors. Cochrane handbook for systematic
reviews of interventions version 500 [updated February 2008]: The
Cochrane Collaboration. [Internet. Accessed Nov 15, 2010.]
Available from: www.cochrane-handbook.org
43. Schünemann HJ, Oxman AD, Higgins JP, Vist GE, Glasziou P,
9
Singh and Fitzgerald: Botulinum toxin for shoulder pain
Personal non-commercial use only. The Journal of Rheumatology Copyright © 2011. All rights reserved.
Page 9
Guyatt GH. Interpreting results and drawing conclusions. In:
Higgins JP, Green S, editors. Cochrane handbook for systematic
reviews of interventions version 500 [updated February 2008]: The
Cochrane Collaboration. [Internet. Accessed Nov 15, 2010.]
Available from: www.cochrane-handbook.org
44. de Boer KS, Arwert HJ, de Groot JH, Meskers CG, Mishre AD,
Arendzen JH, et al. Shoulder pain and external rotation in spastic
hemiplegia do not improve by injection of botulinum toxin A into
the subscapular muscle. J Neurol Neurosurg Psychiatry
2008;79:581-3.
45. Kong KH, Neo JJ, Chua KS. A randomized controlled study of
botulinum toxin A in the treatment of hemiplegic shoulder pain
associated with spasticity. Clin Rehabil 2007;21:28-35.
46. Lim JY, Koh JH, Paik NJ. Intramuscular botulinum toxin-A reduces
hemiplegic shoulder pain: a randomized, double-blind, comparative
study versus intraarticular triamcinolone acetonide. Stroke
2008;39:126-31.
47. Marco E, Duarte E, Vila J, Tejero M, Guillen A, Boza R, et al. Is
botulinum toxin type A effective in the treatment of spastic
shoulder pain in patients after stroke? A double-blind randomized
clinical trial. J Rehabil Med 2007;39:440-7.
48. Yelnik AP, Colle FM, Bonan IV, Vicaut E. Treatment of shoulder
pain in spastic hemiplegia by reducing spasticity of the subscapular
muscle: a randomised, double blind, placebo controlled study of
botulinum toxin A. J Neurol Neurosurg Psychiatry 2007;78:845-8.
49. Singh JA, Mahowald ML, Noorbaloochi S. Intra-articular
botulinum toxin A for refractory shoulder pain: a randomized,
double-blinded, placebo-controlled trial. Transl Res 2009;
153:205-16.
50. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining
the clinically important difference in pain outcome measures. Pain
2000;88:287-94.
51. Herskowitz A, Herskowitz B. Treatment of neck and shoulder pain
with botulinum neurotoxins. Pain Pract 2004;4 Suppl 1:S27-37.
52. Smith H, Audette J, Royal M. Botulinum toxin in pain management
of soft tissue syndromes. Clin J Pain 2002;18 Suppl:S147-S54.
10
The Journal of Rheumatology 2011; 38:3; doi:10.3899/jrheum.101081
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Page 10
  • Source
    • "Degenerative joint disease of the shoulder is common worldwide. The definitive treatment option is joint replacement.[1] However, outcomes of anatomic arthroplasty with an osteoarthritic rotator­cuff­deficient shoulder have been limited.[2,3,4] "
    [Show abstract] [Hide abstract] ABSTRACT: Many factors influence the outcomes of reverse shoulder arthroplasty (RSA). The purpose of this study was to compare the clinical and functional outcomes of RSA depending on the surgical approach, type of prosthesis, and indication for surgery through a comprehensive, systematic review. A literature search was conducted (1985 to June 2012) using PubMed, CINAHL, EBSCO-SPORTDiscus, and Cochrane Central Register of Controlled Trials. Levels I-IV evidence, in-vivo human studies (written in English with minimum of 2 years of follow-up and sample size of 10 patients) reporting clinical and/or functional outcomes after RSA were included. The outcomes were analyzed depending on the surgical approach, type of prosthesis (with medialized or lateralized center of rotation), or indication for surgery. A total of 35 studies were included involving 2049 patients (mean [SD] percentage of females, age, and follow-up of 71.6% [13.4], 71.5 years [3.7], and 43.1 months [18.8], respectively). Studies using deltopectoral approach with lateralized prostheses demonstrated greater improvement in external rotation compared with medialized prostheses with the same approach (mean 22.9° and 5°, respectively). In general, RSA for cuff tear arthropathy demonstrated higher improvements in Constant and American Shoulder and Elbow Society scores, and range of motion compared with revision of anatomic prosthesis, failed rotator cuff repair, and fracture sequelae. Lateralized prostheses provided more improvement in external rotation compared to medialized prostheses. Indications of RSA for cuff tear arthropathy demonstrated higher improvements in the outcomes compared with other indications. RSA demonstrated high patient's satisfaction regardless of the type of prosthesis or indication for surgery. Level IV.
    Full-text · Article · Feb 2015 · International Journal of Shoulder Surgery
  • Source
    • "He reported excellent or satisfactory outcome in 41 of 47 patients diagnosed with primary or secondary osteoarthritis treated with stemmed hemiarthroplasty with a mean follow-up of six years. Subsequent advances in surgical technique and arthroplasty design have led to an increased use of shoulder arthroplasties in order to obtain pain relief and increased mobility2345678. The Copeland Mark 3 resurfacing arthroplasty (Biomet Merck, Swindon, UK) was introduced in 1993 as the first modern hydroxyapatite-coated resurfacing arthroplasty. "
    [Show abstract] [Hide abstract] ABSTRACT: Purpose: The aim of this study was to conduct a randomised, clinical trial comparing stemmed hemiarthroplasty and resurfacing hemiarthroplasty in the treatment of glenohumeral osteoarthritis. Methods: A total of 40 shoulders (35 patients) were randomised to stemmed hemiarthroplasty or resurfacing hemiarthroplasty and evaluated three and 12 months postoperatively using the Constant-Murley score (CMS) and Western Ontario Osteoarthritis of the Shoulder (WOOS) index. Results: There were no statistically significant differences in age, gender or pre-operative scores except for WOOS at baseline. Two patients were lost to follow-up. Significant improvements in CMS and WOOS were observed at one year after both arthroplasty designs. At one year, the mean CMS was 48.9 (range 6-80) after resurfacing hemiarthroplasty and 59.1 (range 0-88) after stemmed hemiarthroplasty {mean difference 10.2 [95 % confidence interval (CI) -3.3 to 23.6], P = 0.14}. The mean WOOS was 59.2 (range 5.2-100.0) and 79.4 (range 12.8-98.6), respectively [mean difference 20.2 (95 % CI 3.4-36.9), P = 0.02]. No major complications occurred and there were no revisions. Conclusions: The effects of resurfacing hemiarthroplasty tended to be inferior to those of stemmed hemiarthroplasty. It is unclear whether this reflects a real difference in effect or baseline differences due to the limited number of randomised patients. We suggest there is a need for a larger, more definitive trial.
    Full-text · Article · Aug 2014 · International Orthopaedics
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    • "Nonetheless, some patients fail to benefit from the operation, which may be due to glenoid wear (Parsons et al. 2004). Total shoulder arthroplasty (TSA) may be the preferred treatment due to a superior functional outcome, but the risk of glenoid loosening has been worrying (Bishop and Flatow 2005, Bryant et al. 2005, Radnay et al. 2007, Singh et al. 2011). The first resurfacing hemiarthroplasty (RHA) to be used in a greater numbers was the SCAN (Scandinavian) Cup, which was introduced in 1981 for the treatment of rheumatoid arthritis (Jonsson et al. 1986). "
    [Show abstract] [Hide abstract] ABSTRACT: Purpose We used patient-reported outcome and risk of revision to compare hemiarthroplasty (HA) with total shoulder arthroplasty (TSA) and stemmed hemiarthroplasty (SHA) with resurfacing hemiarthroplasty (RHA) in patients with glenohumeral osteoarthritis. Patients and methods We included all patients reported to the Danish Shoulder Arthroplasty Registry (DSR) between January 2006 and December 2010. 1,209 arthroplasties in 1,109 patients were eligible. Western Ontario Osteoarthritis of the Shoulder index (WOOS) was used to evaluate patient-reported outcome 1 year postoperatively. For simplicity of presentation, the raw scores were converted to a percentage of the maximum score. Revision rates were calculated by checking reported revisions to the DSR until December 2011. WOOS and risk of revision were adjusted for age, sex, previous surgery, and type of osteoarthritis. Results There were 113 TSAs and 1096 HAs (837 RHAs and 259 SHAs). Patients treated with TSA generally had a better WOOS, exceeding the predefined minimal clinically important difference, at 1 year (mean difference 10, p < 0.001). RHA had a better WOOS than SHA (mean difference 5, p = 0.02), but the difference did not exceed the minimal clinically important difference. There were no statistically significant differences in revision rate or in adjusted risk of revision between any of the groups. Interpretation Our results are in accordance with the results from other national shoulder registries and the results published in systematic reviews favoring TSA in the treatment of glenohumeral osteoarthritis. Nonetheless, this registry study had certain limitations and the results should be interpreted carefully.
    Full-text · Article · Apr 2014 · Acta Orthopaedica
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