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No evidence of long-term benefits of arthroscopic acromioplasty in the treatment of shoulder impingement syndrome FIVE-YEAR RESULTS OF A RANDOMISED CONTROLLED TRIAL

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To report the five-year results of a randomised controlled trial examining the effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two groups: 1) supervised exercise programme (n = 70, exercise group); and 2) arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain as measured on a visual analogue scale. At the five-year assessment a total of 109 patients were examined (52 in the exercise group and 57 in the combined treatment group). There was a significant decrease in mean self-reported pain on the VAS between baseline and the five-year follow-up in both the exercise group (from 6.5 (1 to 10) to 2.2 (0 to 8); p < 0.001) and the combined treatment group (from 6.4 (2 to 10) to 1.9 (0 to 8); p < 0.001). The same trend was seen in the secondary outcome measures (disability, working ability, pain at night, Shoulder Disability Questionnaire and reported painful days). An intention-to-treat analysis showed statistically significant improvements in both groups at five years compared with baseline. Further, improvement continued between the two- and five-year timepoints. No statistically significant differences were found in the patient-centred primary and secondary parameters between the two treatment groups. Differences in the patient-centred primary and secondary parameters between the two treatment groups were not statistically significant, suggesting that acromioplasty is not cost-effective. Structured exercise treatment seems to be the treatment of choice for shoulder impingement syndrome.
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VOL. 2, No. 7, JULY 2013 132
UPPER LIMB
No evidence of long-term benefits of
arthroscopic acromioplasty in the treatment
of shoulder impingement syndrome
FIVE-YEAR RESULTS OF A RANDOMISED CONTROLLED TRIAL
S. Ketola,
J. Lehtinen,
T. Rousi,
M. Nissinen,
H. Huhtala,
Y. T. Konttinen,
I. Arnala
From Kanta-Häme
Central Hospital,
Hämeenlinna,
Finland
S. Ketola, MD, Orthopaedic
Surgeon
Coxa Hospital for Joint
Replacement, Biokatu 6b, P.O.
Box 652, FI-33101 Tampere,
Finland.
J. Lehtinen, MD, PhD,
Orthopaedic Surgeon
Hatanpää Hospital, PL 437, FI-
33101 Tampere, Finland.
T. Rousi, MD, Physiatrist
Suomen Terveystalo, Ahjonkatu
1, FI-05800 Hyvinkää, Finland.
M. Nissinen, MD, PhD,
Physiatrist, Assistant Professor
Helsinki University Central
Hospital, Rehabilitation Unit, PO
Box 100, FI-00029 HUS, Finland.
H. Huhtala, MSci,
Biostatistician
University of Tampere, School of
Health Sciences, FI-33014
Tampere, Finland.
Y. T. Konttinen, MD, PhD,
Professor of Medicine
University of Helsinki and Helsinki
University Central Hospital,
Department of Medicine,
Biomedicum, PO Box 700, FI-
00029 HUS, Finland.
I. Arnala, MD, PhD, Adjunct
Professor, Orthopaedic Surgeon
Kanta-Häme Central Hospital,
Ahvenistontie 20, Hämeenlinna
FI-13530, Finland.
Correspondence should be sent
to Dr I. Arnala; e-mail:
ilkka.arnala@khshp.fi
10.1302/2046-3758.27.2000163
$2.00
Bone Joint Res 2013;2:132–9.
Received 12 February 2013;
Accepted after revision 14 June
2013
Objectives
To report the five-year results of a randomised controlled trial examining the effectiveness of
arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome.
Methods
A total of 140 patients were randomly divided into two groups: 1) supervised exercise
programme (n = 70, exercise group); and 2) arthroscopic acromioplasty followed by a
similar exercise programme (n = 70, combined treatment group).
Results
The main outcome measure was self-reported pain as measured on a visual analogue scale.
At the five-year assessment a total of 109 patients were examined (52 in the exercise group
and 57 in the combined treatment group). There was a significant decrease in mean self-
reported pain on the VAS between baseline and the five-year follow-up in both the exercise
group (from 6.5 (1 to 10) to 2.2 (0 to 8); p < 0.001) and the combined treatment group
(from 6.4 (2 to 10) to 1.9 (0 to 8); p < 0.001). The same trend was seen in the secondary
outcome measures (disability, working ability, pain at night, Shoulder Disability
Questionnaire and reported painful days). An intention-to-treat analysis showed statistically
significant improvements in both groups at five years compared with baseline. Further,
improvement continued between the two- and five-year timepoints. No statistically
significant differences were found in the patient-centred primary and secondary parameters
between the two treatment groups.
Conclusions
Differences in the patient-centred primary and secondary parameters between the two
treatment groups were not statistically significant, suggesting that acromioplasty is not
cost-effective. Structured exercise treatment seems to be the treatment of choice for
shoulder impingement syndrome.
Article focus
The effectiveness of acromioplasty in
shoulder impingement syndrome
Key messages
Structured exercise treatment is the treat-
ment of choice for shoulder impingement
syndrome
Strengths and limitations of this
study
A randomised controlled trial
Results may in part reflect the natural
course of shoulder impingement syndrome
Introduction
Shoulder pain is a common complaint,
sometimes described as the second most
common musculoskeletal disorder after
low back pain.1-4 Impingement is often
cited as the leading cause of pain in the
shoulder,5 which was initially thought to
arise from the mechanical friction of the
tendon under the acromion.6 However, fur-
ther studies and treatment trials have not
been able to demonstrate a pure mechani-
cal aetiology for this syndrome,7,8 and
therefore current treatment options remain
controversial.9-16
Freely available online
Keywords : Shoulder impingement, Syndrome, Operation, Physiotherapy, Arthroscopic, Acromioplasty
133 S. KETOLA, J. LEHTINEN, T. ROUSI, M. NISSINEN, H. HUHTALA, Y. T. KONTTINEN, I. ARNALA
BONE & JOINT RESEARCH
Impingement of the shoulder has a severe and long-
lasting effect on the patient, with costs of treatment and
absence from work causing economic consequences.
The syndrome is traditionally divided into three stages:
Stage I, oedema and haemorrhage; Stage II, fibrosis and
tendinitis; and Stage III, tears of the rotator cuff, biceps
ruptures and bone changes.17 The condition usually
begins gradually and then over time becomes continu-
ous.18 Its diagnosis is based on clinical examination,
which makes its nature somewhat imprecise. The first
mode of treatment is non-operative, involving rest, sub-
acromial corticosteroid injections,19 oral non-steroidal
anti-inflammatory drugs20 and physiotherapy.9,20-23
Although surgical treatment has not been conclusively
shown to be superior to conservative treatment,13- 16 , 24
arthroscopic acromioplasty is still a popular procedure
with a rising incidence over the last decade.25,26
Clear indications for different modes of treatment
based on randomised clinical trials have not yet been
defined. It seems that the expectations of both the sur-
geons and the patients and the availability of the
arthroscopic technology affect the demand.
We designed a randomised clinical trial to investigate
the eventual additional effect of arthroscopic decompres-
sion with acromioplasty on a supervised exercise pro-
gram.24 We now report the five-year results.
Patients and Methods
The study design was a prospective, controlled and ran-
domised trial. Patients were recruited from the area of
Kanta-Häme Health Care District (population 165 000)
between June 2001 and July 2004. The full exclusion and
inclusion criteria are provided in Table I. The eligibility of
the patients was examined at baseline by a physician (a
specialist in rehabilitation or orthopaedics). Impingement
was tested with Neer’s method17 by assessing whether
lidocain injected into the subacromial space relieved the
pain. All patients had a plain radiograph and MRI of the
symptomatic shoulder.27 The risks and benefits of both
treatments were discussed and the patients were also
given written information. Included patients were asked
to sign a written consent in which they voluntarily agreed
to comply with the randomised treatment protocol and
follow-up visits, with the right to withdraw at any time
without giving reason for it.
A total of 140 patients (52 men and 88 women) with a
mean age of 47.1 years (23 to 60) were recruited to the
study, which was approved by the Ethics Committee of
the Hospital District. Patients were randomly assigned to
the treatment groups using computer-generated num-
bers sealed in envelopes prepared by an independent
statistician not otherwise involved with the study.
Demographic data and disability-values and a struc-
tured Shoulder Disability Questionnaire (SDQ)28,29 were
collected at baseline. The SDQ contains common situa-
tions referring to the preceding 24 hours (yes/no/not
applicable (i.e. not occurred)). The score is calculated by
dividing the number of positive scores to the total num-
ber of applicable items subsequently multiplied by 100
(0 no disability, 100 all applicable items positive). All
patients had received various types of physiotherapy
including massage, heat, transcutaneous nerve stimula-
tion and exercises, but had not been treated by a special-
ised physician before entering the study.
The control visit assessment, including SDQ-score and
the clinical measurements, were performed by an inde-
pendent, blinded investigator (physiotherapist), not oth-
erwise involved in the study or rehabilitation, at three and
six months and at one, two and five years. The health-
related quality of life was measured at the five-year visit
using the 15D quality of life tool.30
Supervised exercise. Physiotherapeutic training was
based on home exercises, for which the patients
received individual guidance and general information
during an average of seven visits to an independent
physiotherapist.
The aim of the supervised exercise treatment was to
restore painless, normal mobility of the shoulder complex
and to increase the dynamic stability of the glenohumeral
joint and the scapula.31 Series of long painless movement
with repetition were undertaken with the aim of strength-
ening the tendons. Patients were instructed to do nine
different exercises at least four times a week, with three
courses of 30 to 40 repetitions. As the self-assessed ability
and strength improved, resistance was increased and rep-
etitions diminished. The progress was evaluated at con-
trol visits (mean of seven) and continued until the patient
and the therapist considered that the trainee was inde-
pendently able to maintain the practise level.
Combined treatment: surgery. One independent expe-
rienced orthopaedic surgeon performed all the
Tab l e I. Inclusion and exclusion criteria (NSAIDs, non-steroidal anti-
inflammatory drugs)
Criteria
Inclusion criteria
Clinical symptoms of shoulder impingement syndrome
A positive Neer’s test
Symptom duration of at least three months
Attempts to treat with: rest, NSAIDs, subacromial corticosteroid injections
and regular physiotherapy
Age between 18 and 60 years
No previous operations on shoulder region
Willingness and capacity to comply with the treatment protocol and follow-
up visits
Exclusion criteria
Osteoarthritis
Signs of glenohumeral instability
A penetrating rupture of the rotator cuff
Cervical radicular syndrome
Adhesive capsulitis
Neuropathy of the shoulder region
NO EVIDENCE OF LONG-TERM BENEFITS OF ARTHROSCOPIC ACROMIOPLASTY IN THE TREATMENT OF SHOULDER IMPINGEMENT SYNDROME 134
VOL. 2, No. 7, JULY 2013
arthroscopic decompressions under regional anaesthesia
at Kanta-Häme Central Hospital, Hämeenlinna, Finland.
Debridement and decompression were performed with a
shaver and/or a vaporisator. Acromioplasty was under-
taken with a burr drill (Arthroscope Karl Storz GmbH, Tut-
tlingen, Germany). A standard posterior portal was used
to analyse the structures of the glenohumeral joint and to
reach the subacromial space. An anterolateral portal was
used to perform debridement and decompression. The
range of movement was tested under arthroscopic visual-
isation to check for any local impingement.
The use of a collar cuff sling was recommended for one
week, after which mobilisation was allowed with free
active movements, starting with pendular motion. In the
rehabilitation period patients in the combined treatment
group received similar training instructions from a phys-
iotherapist as were provided for the exercise group with
the same kind of follow-up schedule. The training pro-
gramme was individually planned and progressive. It
started progressing once the post-operative pain had
started to diminish. Like in the supervised exercise treat-
ment group, the progress was evaluated at the visits to
the physiotherapist (mean of six visits).
Follow-up. At five years one trained independent phys-
iotherapist, who had not been involved with the
patients before evaluation and who was blinded to the
mode of treatment, performed all standardised assess-
ments. Patients were instructed not to indicate their
treatment group and they wore a T-shirt to cover even-
tual operation scars.
Outcome measures. Self-reported shoulder pain, as the
primary outcome measure, was assessed on a visual ana-
logue scale (VAS) ranging from 0 (no pain) to 10 (extreme
pain). Secondary outcome measures included disability
(measured on a VAS from 0 (no disability) to 10 (total dis-
ability)), working ability (VAS from 0 (totally unable to
work) to 10 (no restriction on work)), pain at night (VAS
from 0 (no pain) to 10 (extreme pain)), SDQ score, num-
ber of painful days during the previous three months and
the proportion of pain-free patients (defined as a VAS for
pain ≤ 3). The health related quality of life was measured
at the five-year visit using the 15-D tool and compared
with the age-adjusted population values.30
Statistical analysis. Power calculations were performed
based on the use of self-reported pain (VAS) as the pri-
mary outcome measure. Using 1.5 (SD 2.5) as a clinically
important change,32 the sample size was estimated to
45 patients per group, if 5% type I (α) and 20% type II (β)
errors were allowed. As the standard deviation of the out-
come measure was only a rough estimate, a total of
70 patients were included in both groups.
Statistical analyses were performed using IBM SPSS
Statistics for Windows v19.0 (IBM Corp., Armonk, New
York). Descriptive statistics are presented as percent-
ages, frequencies, and means. The independent sam-
ples t-test was used for group comparisons, paired
samples t-test for comparisons within groups over time
and the chi-squared test for equal proportions of pain-
free patients between groups. A p-value < 0.05 was con-
sidered to represent statistical significance.
Results
The study groups did not differ at baseline in any pre-
operative measure (Table II). During the follow-up
between two and five years, a total of four patients in the
exercise group had undergone acromioplasty and one
patient had undergone operation of a rotator cuff rup-
ture. The mean time after randomisation until these five
operations were performed was 2.9 years (2.6 to 3.3).
Additionally, a total of 12 patients originally allocated to
the combined treatment group refused operation; one of
whom went on to undergo surgery at a follow-up of
2.6 years. The total number of operated patients in the
exercise group was 18. All these patients were invited to
and attended the five-year control visit. The follow-up
results were analysed using an intention-to-treat
approach, but the outcome is also described based on the
actual treatment using a per protocol approach.
The five-year follow-up was attended by 109 (77.9%) of
the original 140 patients recruited; 52 patients (74.3%) in
the exercise group and 57 (81.4%) in the combined
group. A statistically significant decrease in the mean self-
reported pain was observed from baseline to the five-year
follow-up in both groups: from 6.5 (1 to 10) to 2.2 (0 to 8)
in the exercise group and from 6.4 (2 to 10) to 1.9 (0 to 8)
in the combined treatment group (both p < 0.001, t-test).
There was no difference in self-reported pain between the
groups at the five-year follow-up (p = 0.44, independent-
samples t-test).
At five years, there was no statistically significant differ-
ence between the two groups in terms of self-reported
disability (p = 0.57), working ability (p = 0.41), night pain
(p = 0.95) or SDQ (p = 0.33, independent-samples t-tests)
(Table II). The proportion of pain-free patients at two
years was similar in the two groups, with 64% (42 of 66)
of the exercise group and 65% (44 of 68) of the combined
treatment group pain-free (p = 0.89, chi-squared test).
These proportions increased to 77% (40 of 52) of the
exercise group and 73% (43 of 57) of the combined treat-
ment group at five years (p = 0.86, chi-squared test)
(Table II). Of the 109 patients who attended the five-year
follow-up, 39 (36%) reported that they had had similar
symptoms or complaints in the contralateral shoulder:
18 (35%) in the exercise group (35%) and 21 (37%) in the
combined treatment group.
The 15D quality of life index was analysed in an inten-
tion-to-treat setting. Figure 1 displays the mean scores for
each parameter for the two groups and also the age-
adjusted general population.30 The groups had similar
15D values for total score (p = 0.82) and also by each
domain (mobility, p = 0.13; vision, p = 0.91; hearing,
p = 0.95; breathing, p = 0.67; sleeping, p = 0.81; eating,
135 S. KETOLA, J. LEHTINEN, T. ROUSI, M. NISSINEN, H. HUHTALA, Y. T. KONTTINEN, I. ARNALA
BONE & JOINT RESEARCH
p = 0.30; speech, p = 0.95; elimination, p = 0.01; usual
activities, p = 0.49; mental function, p = 0.45; discomfort
and symptoms, p = 0.81; depression, p = 0.99; distress,
p = 0.57; vitality, p = 0.45; and sexual activity, p = 0.61; all
independent samples Mann–Whitney U test). In compar-
ison with the age-adjusted general population the
Table II. Results in the intention-to treat analysis (CI, confidence inter val)
Mean outcome (range)*Exercise Combined treatment Mean difference (99% CI) p-value
Number of patients
At baseline (n = 140) 70 70
At two years (n = 134) 66 68
At five years (n = 109) 52 57
Self-reported pain VAS
Baseline 6.5 (1 to 10) 6.4 (2 to 10) -0.1 (-1.01 to 0.77) 0.73
Two years 2.9 (0 to 9) 2.5 (0 to 10) -0.4 (-1.60 to 0.78) 0.37
Five years 2.2 (0 to 8) 1.9 (0 to 8) -0.3 (-1.54 to 0.84) 0.44
Mean change from baseline
At two years -3.7 -3.9 -0.2 (-1.61 to 1.14) 0.65
At five years -4.1 -4.7 -0.6 (-2.13 to 1.01) 0.35
p-value (baseline vs five-year) < 0.001< 0.001
Disability VAS
Baseline 6.5 (2 to 10) 6.2 (1 to 10) -0.3 (-1.13 to 0.75) 0.23
Two years 2.6 (0 to 9) 2.0 (0 to 10) -0.6 (-1.81 to 0.62) 0.21
Five years 1.8 (0 to 9) 1.5 (0 to 8) -0.3 (-1.45 to 0.93) 0.57
Mean change from baseline
At two years -3.8 -4.2 -0.4 (-1.76 to 1.00) 0.47
At five years -4.4 -4.8 -0.4 (-2.07 to 1.16) 0.46
Working ability VAS
Baseline 5.9 (0 to 9) 5.7 (0 to 9) -0.2 (-1.42 to 0.85) 0.78
Two years 8.0 (1 to 10) 8.0 (0 to 10) 0.0 (-0.82 to 0.85) 0.96
Five years 7.5 (2 to 10) 7.8 (1 to 10) +0.3 (-0.66 to 1.27) 0.41
Mean change from baseline
At two years +2.0 +2.3 +0.3 (-0.93 to 1.52) 0.47
At five years +1.6 +2.2 +0.6 (-0.81 to 2.18) 0.23
Night pain VAS
Baseline 6.4 (0 to 10) 6.2 (0 to 10) -0.2 (-1.46 to 0.93) 0.60
Two years 2.6 (0 to 9) 2.0 (0 to 8) -0.6 (-1.95 to 0.65) 0.19
Five years 1.7 (0 to 8) 1.7 (0 to 9) 0.0 (-1.19 to 1.25) 0.95
Mean change from baseline
At two years -3.8 -4.2 -0.4 (-2.00 to 1.17) 0.51
At five years -4.8 -4.8 0.0 (-1.75 to 1.73) 0.99
SDQ score
Baseline 82.5 (0 to 100) 78.1 (0 to 100) -4.4 (-14.4 to 4.47) 0.21
Two years 32.8 (0 to 100) 24.2 (0 to 100) -8.6 (-23.34 to 6.10) 0.13
Five years 22.2 (0 to 100) 16.9 (0 to 100) -5.3 (-19.54 to 8.90) 0.33
Mean change from baseline
At two years -50.0 -53.2 -3.2 (-19.11 to 12.75) 0.6
At five years -61.7 -60.4 +1.3 (-15.74 to 18.34) 0.84
Reported painful days in
preceding three months (n)
Baseline 73.8 (5 to 90) 70.1 (0 to 90) -3.7 (-16.28 to 8.86) 0.44
Two years 19.7 (0 to 90) 13.9 (0 to 90) -5.8 (-18.16 to 6.52) 0.22
Five years 11.8 (0 to 90) 12.2 (0 to 90) +0.4 (-12.52 to 13.32) 0.94
Mean change from baseline
At two years -53.3 -55.0 -1.7 (-19.68 to 16.22) 0.80
At five years -59.4 -60.8 -1.4 (-20.57 to 17.83) 0.85
Patients pain-free (%)
Baseline 4% (3 of 70) 11% (8 of 70) +7% (-0.197 to 0.055) 0.21§
Two years 64% (42 of 66) 65% (44 of 68) +1% (-0.224 to 0.203) 0.89§
Five years 77% (40 of 52) 75% (43 of 57) -2% (-0.219 to 0.195) 0.86§
* VAS, visual analogue scale: pain/night pain (0 = no pain, 10 = extreme pain), disability (0 = no disability, 10 = total disability), working ability
(0 = tot ally unable to work , 10 = no restriction on wor k); SD Q, Sho ulder Disability Quest ionnaire (from 0 to 100, wit h 0 denoting no functional
impairment)
† independent samples t-test, unless otherwise stated
‡ paired samples t-test, unless otherwise stated
§ chi-squared test
NO EVIDENCE OF LONG-TERM BENEFITS OF ARTHROSCOPIC ACROMIOPLASTY IN THE TREATMENT OF SHOULDER IMPINGEMENT SYNDROME 136
VOL. 2, No. 7, JULY 2013
exercise treatment group had lower values in the ‘usual
activities’ and ‘discomfort’ dimensions (p = 0.040 and
p = 0.037, respectively), and the combined treatment
group had lower values in the ‘mobility’, ‘sleeping’ and
‘discomfort’ parameters (p < 0.001, p = 0.049 and
p = 0.028, respectively; all independent samples Mann–
Whitney U test). All these differences exceeded the mini-
mally clinically important difference (MCID) of between
0.02 and 0.0333 (Fig. 1).
Of the whole group, 16 patients were retired at five
years (one already at enrolment). In the combined treat-
ment group five were retired, one due to old age and four
on a disability/unemployment pension unrelated to
shoulder symptoms. In the exercise group 11 patients
were retired, three due to old age and eight were on a dis-
ability/unemployment pension, two of which were due
to shoulder-related reasons. Two additional patients were
part-time retired, one due to shoulder-related reasons
(exercise group).
Seven patients in each group reported that changes
had been made in their working arrangements due to
shoulder-related reasons.
Discussion
The current study suggests that treatment with
arthroscopic decompression combined with structured
exercise treatment did not provide better results at five
years compared with structured exercise alone, when
assessed by self-reported pain. The same pattern was
seen in the secondary outcome measures of disability,
pain at night, SDQ score, number of painful days and the
proportion of pain-free patients.
The improvements seen in both groups at the two-year
follow-up continued to the five-year follow-up, resulting
in highly significant improvements compared with the
baseline values. However, there were no statistically
significant differences between the groups. These five-
year results indicate that arthroscopic decompression
does not have any additional effect on conservative struc-
tured exercise. Furthermore, based on the current results,
arthroscopic decompression does not have any
prophylactic effect from a five-year perspective because
the non-decompressed conservatively treated patients
did as well as those who underwent operative release of
the impingement.
Some parameters of the 15D quality of life index were
slightly worse in patients treated for shoulder impinge-
ment than in the age-adjusted general population, but
there were no differences between the treatment groups
in these health-related quality of life parameters.
There have been randomised controlled trials compar-
ing conservative and operative treatment of shoulder
impingement syndrome13, 14 and others have investigated
the effect of the treatment on disability and working
capacity.15,16 In these earlier studies, failure to respond to
regular physiotherapy and other conservative treatment
was used as an inclusion criterion. In contrast, the present
study aimed to examine whether operative treatment
0.4
0.5
0.6
0.7
0.8
0.9
1
Mobility
Vision
Hearing
15D index
Breathing
Sleeping
Eating
Speech
Excretion
Visual
activities
Mental
function
Discomfort &
symptoms
Depression
Distress
Vitality
Sexual
activity
TOTAL
Population
Combined treatment
Exercise treatment
Fig. 1
Graph showing the 15D Quality of Life index in the combined and exercise treatment groups and in comparison with age-adjusted standard pop-
ulation at five years.
137 S. KETOLA, J. LEHTINEN, T. ROUSI, M. NISSINEN, H. HUHTALA, Y. T. KONTTINEN, I. ARNALA
PUBLISHE D BY BONE & JOINT
provided any additional value to a conservative struc-
tured exercise treatment. At all follow-up visits the
patients were evaluated by a blinded, independent asses-
sor, thus minimising any bias. Selection and drop-out
biases were minor as all eligible consecutive 140 patients
volunteered to the study and the drop-out rate even at
five years was relatively small (six of 140 at two years and
31 of 140 at five years).
As the study was conducted in an ordinary provincial
hospital setting, not in a highly specialised shoulder cen-
tre, the external validity is relatively good. All operations
were performed by one experienced orthopaedic sur-
geon and without any significant surgical complications.
Although it concerns patients’ health and their decision,
in reality patients do not always follow the given
guidance. The similarity of the groups at baseline con-
firms a successful randomisation. Therefore, the adher-
ence to the treatment was probably rather similar in both
study groups.
The diagnosis of the impingement syndrome requires a
thorough patient history and a careful clinical examina-
tion to exclude other conditions that may mimic impinge-
ment. All patients were examined also with MRI at
baseline, in order to exclude conditions such as penetrat-
ing ruptures of the rotator cuff.
The age limits for inclusion were set at 18 and 60 years
in conformity with previous studies.13 -1 6 In patients aged
< 18 years, glenohumeral instability is the leading cause
of shoulder problems.34 However, our study included
only four patients aged < 30 years. The frequency of rota-
tor cuff tears is higher in patients aged > 60 years,35-37
hence their exclusion from our study.
Luyckx et al38 described 166 patients who underwent
arthroscopic subacromial decompression, and reported a
mean time between operation and full activity of
11.1 weeks (with a minimum of one week). In the present
study, patients in the combined treatment group reported
a mean of 28.1 days leave of absence due to shoulder-
related reasons at the month follow-up visit and additional
4.6 days between the three- and six-month follow-up visits
due to surgical procedure (Table III). The use of sick leave
was minimal between the two- and five-year follow-up
visits. Values were slightly higher in the exercise group,
probably due to shifts in the group and operations per-
formed between the two- and five-year visits. The differ-
ence in the total number of sick leave days was not
statistically significant between the study groups
(p = 0.11), but still almost double in the combined treat-
ment group, which raises the overall health care costs.
Use of descriptive data in an ad hoc per protocol ana-
lysis (43 patients in the exercise group and 43 patients in
the combined treatment group) produced only slightly
better results (Table IV) than the intention-to-treat ana-
lysis (Table II). There were no statistically significant dif-
ferences between the groups in the per protocol
analysis.
The reasons for the rising incidence of arthroscopic
acromioplasty are complex. This trend may be driven by
patient, surgeon, technology, society and/or employer
related reasons. At present, expenses and best evidence
must also be taken into consideration. Based on our
Table III. Leave of absence from work due to shoulder-related symptoms during the
three months preceding the control visit, except at five years when the year preceding
the visit was used
Mean absence from work (days) (range)
Control point Exercise Combined treatment p-value*
3 months 5.3 (0 to 60) 28.1 (0 to 90) < 0.001
6 months 2.4 (0 to 65) 4.6 (0 to 90) 0.45
12 months 4.2 (0 to 58) 4.4 (0 to 90) 0.94
2 years 3.8 (0 to 65) 0.1 (0 to 4) 0.03
5 years 3.2 (0 to 110) 0.4 (0 to 10) 0.22
Tot a l 16.5 31. 2 0.11
* t-test
Tab l e IV. Results in the per protocol analysis at five years (SDQ,
Shoulder Disability Questionnaire)
Mean outcome
Full exercise
treatment group
(n = 43)
Full combined
treatment group
(n = 43)
Self-reported pain
2 years 2.5 2.4
5 years 1.8 1.6
Disability
2 years 2.1 2.0
5 years 1.3 1.2
Working ability
2 years 8.5 8.0
5 years 8.0 7.8
Night pain
2 years 2.1 2.1
5 years 1.2 1.3
SDQ score
2 years 26.9 22.1
5 years 16.7 12.0
Painful days
2 years 13.6 13.9
5 years 8.3 7.8
NO EVIDENCE OF LONG-TERM BENEFITS OF ARTHROSCOPIC ACROMIOPLASTY IN THE TREATMENT OF SHOULDER IMPINGEMENT SYNDROME 138
VOL. 2, No. 7, JULY 2013
two-year results we concluded that acromioplasty is not
cost-effective.24 Structured exercise treatment should be
the treatment of choice for shoulder impingement syn-
drome. Operative treatment should be offered with dis-
cernment. In 2010 the Finnish National Institute for
Health and Welfare reported that the combined inci-
dence of open and arthroscopic acromioplasties was
91.6/100 000 in Finland.39 In the New York area the inci-
dence was 101.9/100 000 in 2006 and has risen vastly in
the previous decade.25 The indications for arthroscopic
acromioplasty should also be thoroughly discussed. We
believe that the natural course of the disease should be
better defined to improve the judgement of different
treatment options.
The indications for arthroscopic acromioplasty in the
treatment of shoulder impingement syndrome should be
reconsidered. Based on our results, it seems that the mere
presence of an uncomplicated shoulder impingement
syndrome is not an indication for arthroscopic acromio-
plasty per se, as conservative treatment with a structured
exercise program provides as good results at five years at
a lower cost.
Conclusions. The additional effect of acromioplasty on
top of structured exercise is not significant in the treat-
ment of shoulder impingement syndrome when evalu-
ated at two and five years. Approximately 75% of patients
recover well and the rest continue to have discomfort
despite the treatment. The effects of the arthroscopic
acromioplasty may have been overestimated due to
regression to the mean and the natural long-term course
of the shoulder impingement syndrome.
The authors would like to thank A-M. Lampela, Physiotherapist, for assistance in examining
the patients and Professor H. Sintonen for providing the 15D age-adjusted general popula-
tion data for comparison.
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139 S. KETOLA, J. LEHTINEN, T. ROUSI, M. NISSINEN, H. HUHTALA, Y. T. KONTTINEN, I. ARNALA
BONE & JOINT RESEARCH
Funding statement:
None declared
Author contributions:
S. Ketola: Planning of the study (overall planning), Substantive intellectual contribu-
tion, Seeking permits from the ethical committee, Seeking permits from the hospitals,
Recruitment of the patients, Organisation of the study, Collection and organisation of
the data, Statistical analysis, Literature review, Writing the draft, Critical commenting
and improvement of the manuscript
J. Lehtinen: Recruitment of the patients, Organisation of the study, Thesis supervision,
Clinical analysis of the data, Literature review, Writing the draft, Critical commenting
and improvement of the manuscript
T. Rousi: Planning of the study (overall and especially physiotherapeutic aspects), Seek-
ing permits from the ethical committee, Seeking permits from the hospitals, Clinical
analysis of the data, Critical commenting and improvement of the manuscript
M. Nissinen: Planning of the study, Recruitment of the patients, Seeking permits from
the hospitals, Critical commenting and improvement of the manuscript
H. Huhtala: Statistical analysis, Critical commenting and impro vement of the manuscript
Y. T. Konttinen: Substantive intellectual contribution, Clinical analysis of the data, Criti-
cal commenting and improvement of the manuscript
I. Arnala: Planning of the study (overall and especially operative aspects), Seeking per-
mits from the hospitals, Organisation of the study, Thesis supervision, Clinical analysis
of the data, Critical commenting an d improvement of the manuscript
ICMJE Conflict of Interest:
None declared
©2013 The British Editorial Society of Bone & Joint Surgery. This is an open-access arti-
cle distributed under the terms of the Creative Commons Attributions licence, which per-
mits unrestricted use, distribution, and reproduction in any medium, but not for
commercial gain, provided the original author and source are credited.
... The underlying mechanism for rotator cuff abnormalities has been thought to include intrinsic and extrinsic factors. Whereas SAI has long been accepted as the major extrinsic factor for rotator cuff tendinopathy [20], some studies have demonstrated that surgical decompression has no beneficial effects in patients with SAI in the short-term period compared with exercise therapy or placebo surgery for patients with SAI [38][39][40][41][42][43][44][45][46]. Regarding long-term outcome, Ketola et al. reported no long-term beneficial effect of subacromial decompression on pain compared with placebo and exercise in the treatment of patients with rotator cuff tendinopathy at least 10 years after the treatment [47]. ...
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Impingement on the tendinous portion of the rotator cuff by the coracoacromial ligament and the anterior third of the acromion is responsible for a characteristic syndrome of disability of the shoulder. A characteristic proliferative spur and ridge has been noted on the anterior lip and undersurface of the anterior process of the acromion and this area may also show erosion and eburnation. The treatment of the impingement is to remove the anterior edge and undersurface of the anterior part of the acromion with the attached coracoacromial ligament. The impingement may also involve the tendon of the long head of the biceps and if it does, it is best to decompress the tendon and remove any osteophytes which may be in its groove, but to avoid transplanting the biceps tendon if possible. Hypertrophic lipping at the acromio-clavicular joint may impinge on the supraspinatus tendon when the arm is in abduction and, if the lip is prominent, this joint should be resected. These are the principles of anterior acromioplasty.
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The measurement of outcome in the treatment of acid-related diseases can be assessed against the background of various types of economic evaluation. Apart from endoscopic confirmation of healing (or nonhealing), the measurement of outcome has been based on recording separately the occurrence of various symptoms and possible adverse effects, as experienced and reported by the patients. Findings have been reported as the proportions of total patients who are free from some or all symptoms. These proportions may be noted in terms of prevalence or incidence. However, unless one treatment dominates the others (is superior or at least is not worse) on all outcome measures, it is impossible to say conclusively which treatment is the best overall, provided of course that there is no difference between the treatments in the severity of symptoms and adverse effects. Decision trees have been built to combine some outcomes. However, in the future, measurements that give a more complete picture of the combined severity of various symptoms and adverse effects need to be adopted. These should help to assess how quickly and to what degree the severity of disease is affected by treatment. The emerging guidelines for economic evaluations encourage the measurement of outcome prospectively in terms of quality of life and/or survival, since for most drugs the ultimate outcome of therapy is to improve them, and expressing them as quality-adjusted life-years (QALYs) gained. Quality-of-life measures potentially appropriate for QALY calculations in acid-related diseases (EuroQol Group 1988; Kaplan & Anderson 1988; Rosser & Kind 1978; Sintonen & Pekurinen 1993) are briefly reviewed. Further, the use of decision analysis is encouraged to ensure that all relevant outcomes and their possibly changing probabilities over time are considered and quantified. Expressing results as proportions and numbers achieving specified targets (success) is recommended, because they are relatively easy to incorporate into economic evaluation. The use of cost-benefit analysis based on the human capital approach is discouraged, since there may not be an economic loss or benefit to society through a patient’s lack of, or return to, productive capacity.
Article
Purpose of the studyClassically, the shoulder joint is thought to age more by its tendons than by its cartilages, the incidence of rotator cuff tears being considered to increase with age. The purpose of this work was to assess the natural history of the shoulder joint based on a clinical and radiological study of 200 patients aged 70 to 101 years.
Article
The aim of this paper is to describe a physiotherapy method for treatment of patients with rotator cuff disease (impingement syndrome stages II and III). A comprehensive treatment programme based on biomechanics and the physiology of collagen tissue was designed in 1981. This method, which we call ‘supervised exercises’, is discussed in relation to recent biomechanical knowledge and clinical studies. ‘Supervised exercises’ emphasises reduction of mechanical subacromial stress, relearning of normal patterns of movement, specific endurance training to increase nutrition of the collagen tissue and simple advice to prevent relapse. In the presence of a positive impingement sign and test, a functional diagnosis is mandatory to pinpoint the cause of impingement as a guideline for an individual treatment programme. Reactivating the supraspinatus muscle to improve the initial movement pattern in abduction, together with promotion of agility of movement, are central elements of ‘supervised exercises’. Two large clinical studies have evaluated the treatment effect. A randomised, controlled study suggests that the supervised exercise regimen has a causative effect. The mechanisms are not clear and should be addressed in future studies.
Article
The purposes of this study was to better understand the utilization of anterior acromioplasty over time, in the absence of rotator cuff repair; to examine the relation to patient characteristics (age, sex) and types of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement); and to assess the utilization of arthroscopy in this procedure. Using the resources of the Rochester Epidemiology Project, cataloging medical records of residents in Olmsted County, Minnesota, we identified 246 patients who underwent anterior acromioplasty between 1980 and 2005. It has previously been shown that rarely does a resident of Olmsted County undergo an orthopaedic procedure at a facility outside the county. The incidence of anterior acromioplasty increased over time (P < .001), with crude rates of 3.3 per 100,000 persons in 1980 to 1985 and 19.0 per 100,000 persons in 2000 to 2005. Sex, age, and types of rotator cuff pathology did not significantly change over the 26-year period. There was a dramatic shift from use of the open approach to the arthroscopic approach over this time period (P < .001) and a decrease in the concomitant performance of distal clavicle resection (P < .001). The frequency of anterior acromioplasty has dramatically increased over time. Increasing knowledge about this syndrome, including better imaging, has facilitated patient treatment for a stable spectrum of rotator cuff pathology (inflammation or fibrosis, partial-thickness tearing, full-thickness tearing undergoing debridement), as has the application of endoscopic surgery. Level III, epidemiologic study.
Article
Acromioplasty is considered a technically simple procedure but has become controversial with regard to its indications and therapeutic value. Two complementary databases were used to ascertain the frequency of acromioplasty over a recent span of time. In Part A, the New York Statewide Planning and Research Cooperative System (SPARCS) ambulatory surgery database was searched from 1996 to 2006 to identify all ambulatory surgery acromioplasties as well as all orthopaedic ambulatory surgery procedures. In Part B, the American Board of Orthopaedic Surgery (ABOS) database was searched from 1999 to 2008 to identify all arthroscopic acromioplasties as well as all orthopaedic procedures. Part A revealed that in 1996 there were 5571 acromioplasties in New York State, representing a population incidence of 30.0 per 100,000. In 2006 there were 19,743 acromioplasties, representing a population incidence of 101.9 per 100,000. Over these eleven years, the volume of acromioplasties increased by 254.4%, compared with only a 78.3% increase in the volume of all orthopaedic ambulatory surgery procedures. In 2006, as compared with 1996, patients were 2.4 times more likely to have an acromioplasty compared with all other orthopaedic ambulatory procedures (p < 0.0001). Part B revealed that, in 1999, a mean of 2.6 arthroscopic acromioplasties were reported per candidate for Board certification. In 2008 a mean of 6.3 arthroscopic acromioplasties per candidate were reported. Over these ten years, the mean number of arthroscopic acromioplasties reported increased by 142.3%, compared with only a 13.0% increase in the mean number of all orthopaedic surgery procedures. In 2008, as compared with 1999, candidates were 2.2 times more likely to report an arthroscopic acromioplasty compared with all other orthopaedic procedures (p < 0.0001). There has been a substantial increase in the overall volume and the population-based incidence of acromioplasties in recent years on both the state and national levels in the United States. The reasons for this increase have yet to be determined and are likely multifactorial, with patient-based, surgeon-based, and systems-based factors all playing a role.
Article
We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven.
Article
In a prospective randomised study we compared the results of arthroscopic subacromial bursectomy alone with debridement of the subacromial bursa followed by acromioplasty. A total of 57 patients with a mean age of 47 years (31 to 60) suffering from primary subacromial impingement without a rupture of the rotator cuff who had failed previous conservative treatment were entered into the trial. The type of acromion was classified according to Bigliani. Patients were assessed at follow-up using the Constant score, the simple shoulder test and visual analogue scores for pain and functional impairment. One patient was lost to follow-up. At a mean follow-up of 2.5 years (1 to 5) both bursectomy and acromioplasty gave good clinical results. No statistically significant differences were found between the two treatments. The type of acromion and severity of symptoms had a greater influence on the clinical outcome than the type of treatment. As a result, we believe that primary subacromial impingement syndrome is largely an intrinsic degenerative condition rather than an extrinsic mechanical disorder.