Research Report

Effectiveness of Standardized Physical

Therapy Exercises for Patients With
Difficulty Returning to Usual Activities
After Decompression Surgery for
Subacromial Impingement Syndrome:
Randomized Controlled Trial
D avid H 0 y ru p C hristian se n , Poul Frost, D e b o ra h Falla, Jens Peder Haahr,
Lars H e n rik Frich, Linda C h ris tie A n d re a , Susanne W u lff Svendsen

Background. Little is known about the effectiveness of exercise programs after decom
pression surgery for subacromial impingement syndrome. For patients with difficulty returning
to usual activities, special efforts may be needed to improve shoulder function.

Objective. The purpose of this study was to evaluate the effectiveness at 3 and 12 months
of a standardized physical therapy exercise intervention compared with usual care in patients
with difficulty returning to usual activities after subacromial decompression surgery.
Design. A multicenter randomized controlled trial was conducted.
Setting. The study was conducted in 6 public departments of orthopedic surgery, 2
departments of occupational medicine, and 2 physical therapy training centers in Central
Denmark Region.
Patients. One hundred twenty-six patients reporting difficulty returning to usual activities
at the postoperative clinical follow-up 8 to 12 weeks after subacromial decompression surgery
participated.

D.H.
Christiansen,
PT,
PhD,
D epartm ent
of
O ccupational
Medicine, Danish Ramazzini Cen
tre,
Regional
Hospital West
Jutland-University Research Clinic,
Cl Landevej 61, 7400 Herning,
Denmark. Address all correspon
dence to Dr Christiansen at:
David.Christiansen@ vest.rm.dk.
P. Frost, M D, PhD, D epartm ent of
O ccupational Medicine, Danish
Ramazzini Centre, Aarhus Hospi
tal, Aarhus University Hospital,
Aarhus, Denmark.
D. Falla, PT, PhD, School o f Sport,
Exercise and Rehabilitation Sci
ences, College of Life and Environ
mental Sciences, University of
Birm ingham , Birm ingham , United
Kingdom , and Pain Clinic, Center
fo r Anesthesiology, Emergency
and Intensive Care Medicine, Uni
versity Hospital G ottingen, G o ttin
gen, Germany.
J.P. Haahr, M D, MPH, Departm ent
o f O ccupational Medicine, Danish
Ramazzini
Centre,
Regional
Hospital West Jutland-University
Research Clinic.

Intervention. A standardized exercise program consisting of physical therapist-super

vised individual training sessions and home training was used.

L.H. Frich, M D, PhD, O rthopedic

Departm ent, Odense University
Hospital, Odense, Denmark.

Outcome Measures. The primary outcome measure was the Oxford Shoulder Score.
Secondary outcome measures were the Constant Score and the Fear-Avoidance Beliefs
Questionnaire.

L.C. Andrea, M D, D epartm ent of

O ccupational Medicine, Danish
Ramazzini
Centre,
Regional
Hospital West Jutland-University
Research Clinic.

Results. At 3 and 12 months, follow-up data were obtained for 92% and 83% of the patients,
respectively. Intention-to-treat analyses suggested a between-group difference on the Oxford
Shoulder Score favoring the exercise group at 3 months, with an adjusted mean difference of
2.0 (95% confidence interval = 0.5, 4.6), and at 12 months, with an adjusted mean difference
of 5.8 (95% confidence interval=2.8, 8.9). Significantly larger improvements for the exercise
group were observed for most secondary and supplementary outcome measures.
Limitations. The nature of the exercise intervention did not allow blinding of patients and

S.W.
Svendsen,
M D,
PhD,
D epartm ent
of
O ccupational
Medicine, Danish Ramazzini Cen
tre, Regional Hospital West Jut
land-U niversity Research Clinic.

Author information continues on

next page.

care providers.

Conclusion. The standardized physical therapy exercise intervention resulted in statisti

cally significant and clinically relevant improvement in shoulder pain and function at 12
months compared with usual care.

P o s t a R a p id R e s p o n s e t o
t h is a r t ic le a t:

ptjournal.apta.org
June 2 0 1 6

V o lu m e 9 6

N um ber 6

Physical T h e ra p y

787

Standardized Physical Therapy Exercises and Subacromial Impingement Syndrome

[C h ris tia n s e n D H , F ro st P, Falla D , e t al. E ffe c
tiv e n e s s

o f s ta n d a rd iz e d

p h y s ic a l

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ex e rcise s f o r p a tie n ts w it h d iff ic u lt y r e tu r n

in g to u su a l a c tiv itie s a fte r d e c o m p re s s io n
s u rg e ry f o r s u b a c ro m ia l im p in g e m e n t s y n
d ro m e :

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2 0 1 6 ;9 6 : 7 8 7 - 7 9 6 . ]

2 0 1 6 A m e ric a n Physical T h e ra p y A sso cia tio n

P u b lish e d A h e a d o f P rin t:
F e b ru a ry 2 5 , 2 0 1 6
A c c e p te d : F e b ru a ry 1 5 , 2 0 1 6
S u b m itte d : N o v e m b e r 2 7 , 2 0 1 5

788

P h ysica l T h e ra p y

V o lu m e 9 6

ubacromial impingement syn sion surgery for SIS.15 The trial had 4
drome (SIS) is the most common randomization arms: (1) physical therapy
upper extremity musculoskeletal exercises, (2) occupational medical assis
disorder in the working population.1
tance, (3) physical therapy exercises and
Initial treatment of SIS is nonsurgical and occupational medical assistance, and (4)
includes
rest,
nonsteroidal
anti usual care. Patients were randomized to
inflammatory drugs, corticosteroid injec 1 of the 4 arms if they were employed in
tions, and different modalities of physical paid work for at least 25 hours per week.
therapy. Surgical intervention, in the Patients who did not meet the 25 hours
form of arthroscopic subacromial employment criterion were randomly
decompression, is usually reserved for assigned to only 1 of the 2 arms without
patients who do not respond sufficiently occupational medical assistance (ie,
to initial nonsurgical treatment.2 Data physical therapy exercises or usual care).
suggest 2- to 8-fold increases in surgery Accordingly, we planned to use a parallel
rates since the late 1990s,3-6 with prob group design to evaluate the effective
abilities of success varying between 60% ness of the physical therapy interven
and 84%.7-9
tion, treating occupational medical assis
tance as a cointervention; all patients
Physical therapist-supervised exercises (with and without paid work) could be
and instructions in self-training are often included in these analyses. For patients
used to restore shoulder function after who were employed in paid work, the
surgery for SIS.10 There is no consensus effectiveness of the occupational inter
about the most appropriate postopera vention will be evaluated in a separate
tive exercise strategy, and little is known publication, with primary' outcomes
about the effectiveness of different exer being sickness absence percentage at 3
cise programs following subacromial months and transfer income percentage
decompression.11-14 It is unknown at 12 months.15
whether physical therapist-supervised
exercises should be offered to all Setting and Participants
patients or reserved for those with more Patients were recruited from the 6 public
persistent symptoms. Special efforts may departments of orthopedic surgery in
be needed to facilitate return to normal Central Denmark Region over a 3-year
function for patients who have failed to period until December 31, 2013. At the
return to usual activities 8 to 12 weeks postoperative clinical follow-up 8 to 12
after surgery. The aim of this study was weeks after surgery, patients aged >18
to compare the effectiveness of a stan to <63 years and living in the region
dardized physical therapy exercise inter were assessed for eligibility if they had
vention with usual care in patients with undergone arthroscopic subacromial
difficulty returning to usual activities decompression surgery' (surgical code
after subacromial decompression sur KNBH51, KNBH91, KNBG09, K.NBL39,
gery for SIS. We hypothesized that stan or KNBM79 according to the Danish ver
dardized physical therapy exercises sion of the Nordic Medico-Statistical
would yield superior results with respect Committee Classification of Surgical
to improvement in shoulder pain and Procedures16) under a main diagnosis of
function compared with usual care.
SIS or acromioclavicular osteoarthritis
(International Classification o f Dis
eases, 10th revision17: M75.1-M75.8 or
Method
Ml 9). Exclusion criteria were full
Design Overview
The study was conducted within the thickness rotator cuff tear, traumatic
framework of the Shoulder Intervention lesion, rheumatoid arthritis, frozen
Project, which included a pragmatic shoulder, severe fibromyalgia, glenohu
multicenter randomized controlled trial meral osteoarthritis, and insufficient
to evaluate the effectiveness of physical Danish language skills. Until April 2012,
therapy exercises and occupational med patients also were excluded if they had
ical assistance in reducing shoulder pain previous shoulder surgery or diabetes, if
and improving function and in reducing they were not employed in paid work for
postoperative work disability after at least 25 hours per week, and if they
arthroscopic subacromial decompres were not full-time sick-listed; these

Num ber 6

June 2 0 1 6

Standardized Physical T herapy Exercises and Subacromial Im p in g em e n t Syndrome

exclusion criteria were abandoned due

to slow recruitment.15 Eligible patients
were provided with information on the
Shoulder Intervention Project. Via a tele
phone interview, patients who con
sented to be contacted were invited to
participate if they reported at least slight
shoulder problems doing usual activities,
when assessed on a 5-level scale (no
problems, slight problems, moderate
problems,
severe
problems,
and
unable).IKWritten informed consent was
given by all patients who participated in
the trial. Within 1 week after the postop
erative clinical follow-up, a baseline
assessment was performed in 1 of the 2
departments of occupational medicine in
Central Denmark Region (east or west
center).
R andom ization and
Interventions

Randomization took place after baseline

data collection and was performed by a
research secretary, who assigned partic
ipants to interventions. Computer
generated randomization (1:1 ratio) was
used, with stratification by the surgical
department and blocking within strata
using randomly permuted block sizes of
12, 8, and 4.
Physical

th e r a p y

e x ercise

in te r

The intervention consisted

of a standardized exercise program,
which was conducted in 1 of 2 municipal
training centers. The development of the
intervention and details of the program
have been presented elsewhere.19 Addi
tionally, a detailed manual for physical
therapists and a patient pamphlet with
home training instructions and a training
diary' are available.20 The intervention
was delivered as a combination of phys
ical therapist-supervised individual train
ing sessions and home training for 8
weeks followed by home training for an
additional 4 weeks. The supervised train
ing sessions lasted up to 60 minutes
each. All training sessions started with
aerobic exercise on a stationary bicycle,
and additional manual treatment was
offered in case of restricted range of
motion or pain. The shoulder-specific
training consisted of a core set of 7 exer
cises, each with 3 performance levels:
(1) exercises focusing on activation of
the scapula and rotator cuff muscles, (2)
v e n tio n .

June 2 0 1 6

progression in terms of starting position

and range of motion, and (3) exercises in
full range of motion and with higher
demands on coordination and core sta
bility'. Patients were scheduled to receive
a minimum of 8 and a maximum of 15
training sessions (including the initial
and final clinical evaluations) during the
first 8 weeks. During the first 4 of these
weeks, the training was typically distrib
uted with supervised sessions 2 times a
week plus home training at least twice a
week. During the next 4 weeks, the fre
quency of supervised sessions could be
reduced and the frequency of home
training increased, depending on the
patients individual need for supervision
and ability to perform the exercises. This
was done to gradually make the patients
more confident in handling the training
themselves. Patients were informed that,
in general, shoulder activities are not
harmful and may lead to reduced symp
toms and improved function. Patients
also were advised to be physically active
at moderate-to-high intensity for at least
30 minutes at least 3 times a week,21 as
physical activity is generally recom
mended in the management of musculo
skeletal pain.22'23
Each patient kept a diary for home train
ing and physical activity. The physical
therapists registered any adverse events,
their assessment of deviations from the
exercise program, and the patients over
all adherence to the intervention in the
manual. The latter 2 assessments were
made using a 5-point scale ranging from
to a very great extent to to a very little
extent and from very good to very
poor, respectively. The 5 intervention
physical therapists had an average of 10
years (ran g e= 6-l4) of experience in the
management of patients with shoulder
disorders and treated an average of 12
(range=7-15) patients with shoulder
complaints per week. They had com
pleted 2 to 5 postgraduate courses on
the treatment of shoulder disorders.
Throughout the project period, a uni
form application of the intervention was
supported by center-specific team meet
ings, with the presence of an investigator
every second month.
U sual ca re .
Patients in the usual care
group received no intervention as part of

the study, but they were advised to con

tinue treatment as directed by the hospi
tal. At 3 months, questionnaire data were
collected on the number of treatments, if
any, received by physical therapists since
baseline and the type of treatment
received (shoulder-specific exercise
instructions or supervised exercise
therapy, manual therapy, or other
modalities).
C o in te rv e n tio n s .
The subgroup of
patients who were employed in paid
work for at least 25 hours per week
could be randomized to occupational
medical assistance provided by an occu
pational physician. This intervention
included a standardized assessment of
work instability (ie, imbalance between
functional capabilities and job demands
to an extent where job retention is
threatened) and construction of a
3-month action plan to promote job
retention. At 6 weeks, progress was eval
uated by telephone, and at the 3-month
follow-up, patients were seen for a final
consultation and workplace-oriented
advice. Details of the occupational med
ical assistance are provided elsewhere.15
Information on treatment received from
physicians, chiropractors, or other
health care providers was obtained by
questionnaire at the 3-month follow-up.

O utcom e Measures and

Follow-up

The patients were assessed at baseline

(8-12 weeks postsurgery) and at 3- and
12-month follow-ups. At baseline and 3
months, the patients completed a ques
tionnaire prior to a standardized shoul
der examination and physical testing. At
12 months, data were collected using a
mailed questionnaire. The primary out
come measure was the validated Oxford
Shoulder Score,24_2K which contains 12
items related to pain and activities of
daily living summarized into a total score
of 0 to 48, with 48 being the best out
come. Secondary outcome measures
were the Constant Score (evaluated only
at baseline and at 3 months) and the
Fear-Avoidance Beliefs Questionnaire
physical activity scale. The Constant
Score is a 100-point system for functional
assessment of the shoulder, which com
bines subjective parameters (pain and
activities of daily living) and objective

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S ta n d a r d iz e d P h ysical T h e r a p y Exercises a n d S u b a c ro m ia l Im p in g e m e n t S y n d r o m e

parameters (range of motion and

strength), with a score of 100 points
being the best outcome.29-30 The assess
ment of Constant Score was performed
according to a standardized test proto
col,31 which has demonstrated accept
able intrarater and interrater reliability.32
Shoulder strength was measured with an
IsoForceControl dynamometer (Medical
Device Solutions AG, Oberburg, Switzer
land). The Fear-Avoidance Beliefs Ques
tionnaire physical activity scale was used
in a version modified to the shoulder,
yielding a 0- to 24-point score, with
higher scores reflecting a higher ten
dency for fear-avoidance beliefs.33-34
According to the fear-avoidance model,
pain-related fear may cause patients to
avoid physical activities in order to
reduce pain, and if exaggerated, this
reaction pattern may increase pain and
lead to disability.35 Reduction of fear
avoidance might be part of the interven
tions mechanism of action on shoulder
pain and function.36-37
We included 5 supplementary outcome
measures. Health-related quality of life
was measured at 3 and 12 months with
the EQ-5D-3L questionnaire,38 and the
measurements combined with utility val
ues derived from a general population
sample to calculate an index score rang
ing from 0.6 to 1.0, with higher scores
representing a better health state.39 At 3
months, the following clinical outcome
measures were evaluated: maximum
oxygen uptake, positive pain provoca
tion signs, and scapula dyskinesis. Maxi
mum oxygen uptake (mL 0 2/min/kg)
was evaluated using the Astrand and
Rhyming Cycle Ergometer Test (Monark
928E Pro Vo2 bike, Monark Exercise AB,
Vansbro, Sweden).40-41 This outcome
measure was included, in part, as an
incentive for the patients to follow the
advice on general physical activity and
because increased fitness might be part
of the interventions mechanism of
action on shoulder pain. Positive pain
provocation signs were evaluated and
defined as > 2 positive tests out of the
following: Hawkins test, modified Hawk
ins test, painful arc test, and Jobe test.42
Scapular dyskinesis was evaluated and
defined in terms of a positive Scapula
Dyskinesis Test with obvious signs of
altered scapular movement judged by

790

Physical T h e ra p y

V o lu m e 9 6

visual inspection combined with a posi

tive Scapula Assistance Test or a positive
Scapula Retraction Test showing an
effect of manual correction on dysfunc
tion and symptoms.42-43 This outcome
measure was included because it was
thought that scapular dyskinesis might
be associated with postoperative pain
and disability and that reduction of
altered mobility patterns might be part of
the interventions mechanism of action.
Finally, at both 3 and 12 months, the
Patients Global Impression of Change
scale scores were evaluated to assess the
patients global impression of change in
their shoulder condition. This score was
assessed on a 7-point scale ranging from
much better to much worse. Clinical
examinations were performed by a
blinded assessor, but blinding of the
patients and those who provided the
interventions was not possible. At 3
months, the allocation of each patient
was estimated by the assessor so that the
success of blinding of the assessor could
be evaluated.
D a ta A n a ly s is

With a power of 0.8, a significance level

of .05, and a total of 65 patients who
received the physical therapy interven
tion and 65 patients who did not receive
it, a minimal mean difference of 2.4
points in the Oxford Shoulder Score
could be detected at 12 months when
assuming a standard deviation of 9.0
points,25 a correlation between baseline
and follow-up scores of 0.5, and a 10%
dropout rate.
Main analyses were performed in accor
dance with the intention-to-treat princi
ple. Supplementary per-protocol analy
ses (ie, analyses restricted to patients
who received the intervention as
intended) also were performed. The
effectiveness of the physical therapy
intervention was estimated as mean dif
ferences between groups using linear
regression models for continuous out
comes and as odds ratios using nominal
logistic regression for binary outcomes
and ordered logistic regression for the
categorical outcome measure Patients
Global Impression of Change scale,
where the 7 original response categories
were collapsed to 4. Models included the
occupational
intervention
(yes/no/

Num ber 6

irrelevant), center (east/west), and

respective baseline values where appli
cable. The robustness of the results was
investigated by sensitivity analyses (ie,
assigning higher and lower scores in
patients without follow-up data). For
comparison with previous literature on
exercise management, standardized
effect size was calculated for the primary
outcome (ie, the unadjusted mean differ
ence between the groups divided by the
pooled standard deviation at baseline).
The minimal clinically important change
(MCIC) for the Oxford Shoulder Score
has been estimated to be 6 points44-45;
the number of patients who clinically
improved and the number needed to
treat were calculated based on this pre
viously reported threshold. Stata version
13 (StataCorp LP, College Station, Texas)
was used.
R o le o f t h e F u n d in g S o u rc e

The study was a researcher-initiated

study, primarily funded by The Danish
Agency for Science, Technology and
Innovation (grant number 09-066985),
with co-funding from the Danish
Ramazzini Centre.

Results
P a rtic ip a n ts

The Figure shows the flow of partici

pants from assessment of eligibility at the
postoperative clinical follow-up 8 to 12
weeks after surgery and throughout the
trial. Patients who declined to participate
in the study did not differ from those
who participated with respect to age,
sex, and employment status. A total of
126 patients were randomized. Patients
in the 2 comparison groups were bal
anced with respect to baseline character
istics, allocation to occupational medical
assistance (Tab. 1), and baseline out
come scores (Tab. 2), except for the
EQ-5D-3L index, maximum oxygen
uptake, and the prevalence of patients
with positive pain provocation signs.
M is s in g a n d In c o m p le te D a ta

At baseline, 1 patient left 2 questions

unanswered on the Oxford Shoulder
Score, and 2 patients left 1 and 2 ques
tions unanswered, respectively, on the
Fear-Avoidance Beliefs Questionnaire
physical activity scale. This was reme
died by replacing the missing question

June 2 0 1 6

Standardized Physical Therapy Exercises and Subacromial Impingement Syndrome

Table 1.
Baseline Characteristics of Participants According to Random Allocation to Usual Care or
Physical Therapy Exercise Groups '3

C h a ra c te ris tic
Fem ale

U sual C are

P hysical T h e ra p y

C ro u p ( n = 6 6 )

Exercise C ro u p ( n = 6 0 )

4 2 (6 3 .6 )

4 0 (6 6 .7 )

A g e (y), X (SD )

4 9 .0 (7 .1 )

48.1 (7 .9 )

B o d y mass in d e x ( k g / m 2), X (SD )

2 9 .8 (7 .5 )

2 8 .2 (5 .0 )

B ila te ra l s h o u ld e r p a in b

30 (4 6 .2 )

2 2 (3 6 .7 )

D o m in a n t s h o u ld e r a ffe c te d

4 5 (6 8 .2 )

37 (6 1 .7 )

3 7 (5 6 .1 )

34 (5 6 .3 )

3 (4 .6 )

3 (5 .0 )

1 6 (2 4 .2 )

15 (2 5 .0 )

8 (1 2 .1 )

7 (1 1 .7 )

E m p lo y m e n t status
E m p lo y e d in p a id w o r k 3 :2 5 h /w k
S e lf-e m p lo y e d
U n e m p lo y e d
Early re tire m e n t/fle x ib le jo b /d is a b ility p e n s io n
S tu d e n t/o n leave

2 (3 .0 )

1 (1 -7 )

4 2 (6 3 .6 )

38 (6 3 .3 )

P a ra c e ta m o l/N S A ID s

5 2 (7 8 .8 )

4 3 (7 1 .7 )

O p io id s

1 9 (2 8 .8 )

9 ( 1 5 .0 )

N o in s tr u c tio n o r h a n d o u ts

1 0 (1 5 .2 )

1 0 (1 6 .7 )

In s tru c tio n b y ph ysica l th e ra p is t in s e lf-tra in in g

2 6 (3 9 .4 )

1 8 (3 0 .0 )

Physical th e ra p is t-s u p e rv is e d exercises

30 (4 5 .5 )

32 (5 3 .3 )

1 (1 -9 )

3 (1 -7 )

51 (7 7 .3 )

4 6 (7 6 .7 )

6 (9 .1 )

4 (6 .7 )

S pinal m a n ip u la tio n /m o b iliz a tio n

5 (7 .6 )

8 (1 3 .3 )

M a s s a g e /a c u p u n c tu re

4 ( 6 .1 )

2 (3 .3 )

2 0 (3 0 .3 )

2 2 (3 6 .7 )

Sick leave be cause o f s h o u ld e r s y m p to m s '

Treatment Effect

Use o f analgesics w it h in last 4 w k

P o s to p e ra tiv e exercises in firs t 8 - 1 2 w k

N u m b e r o f sessions w it h a ph y s ic a l th e ra p is t,
m e d ia n (IQ R )
A d d itio n a l tre a tm e n t
None
S te ro id in je c tio n

A llo c a tio n t o o c c u p a tio n a l m e d ic a l assistanced

O c c u p a tio n a l m e d ic a l assistance
U sual care

1 7 (2 5 .8 )

12 (2 0 .0 )

Irre le v a n t

2 9 (4 3 .9 )

2 6 (4 3 .3 )

V alues are n u m b e rs (p e rc e n ta g e s ) unless o th e rw is e s ta te d . IQ R = in te rq u a rtile ra n g e ,

N S A ID s = n o n s te ro id a l a n ti-in fla m m a to ry d ru g s .
b D a ta m is s in g fo r o n e p a tie n t.
c P a tie n ts sic k -lis te d fr o m p a id w o rk , s e lf-e m p lo y m e n t, o r u n e m p lo y m e n t.
d P atien ts e m p lo y e d in p a id w o r k f o r a t least 2 5 h /w k w e re r a n d o m ly a llo c a te d to o c c u p a tio n a l
m e d ic a l assistance ( w ith o r w it h o u t ph y s ic a l th e ra p y exercises) o r usual care ( w ith o r w it h o u t ph ysica l
th e ra p y exercises); th is w as irre le v a n t f o r re m a in in g p a tie n ts .

by the mean value of their other

responses on the scale (single mean
imputation). Two patients, one who left
all items on the Fear-Avoidance Beliefs
Questionnaire physical activity scale
unanswered at baseline and one who
failed to answer the EQ-5D-3L question
naire at 3 months, were left out of the

June 2016

patients at baseline (Tab. 2) and in 2

patients at 3 months (one in each group),
as they were not able to perform active
abduction or flexion >90 degrees
because of pain. Missing clinical test val
ues were not replaced. At 12 months,
scores were calculated by the use of sin
gle mean imputation in one patient who
left one question unanswered on the
Oxford Shoulder Score and in one
patient who left one question unan
swered in the Fear-Avoidance Beliefs
Questionnaire physical activity scale.

analysis of these outcomes. For 9

patients (6 at baseline and 3 at 3-month
follow-up), the maximum oxygen uptake
could not be estimated due to medica
tion use, inability to perform the cycle
ergometer test with enough resistance,
or other health problems. Scapular dyskinesis could not be assessed in 11

At 3 and 12 months, 92% and 83% of the

patients, respectively, were followed up.
At 3 months, intention-to-treat analysis
showed a nonsignificant difference in
favor of the physical therapy exercise
intervention with regard to the Oxford
Shoulder Score (Tab. 2). Analyses of sec
ondary and supplementary outcome
measures significantly favored the exer
cise group with respect to the Constant
Score, scapular dyskinesis, maximum
oxygen uptake, and Patients Global
Impression of Change scale score. At 12
months, significantly larger improve
ments were found in the physical ther
apy exercise group with respect to the
Oxford Shoulder Score, the FearAvoidance Beliefs Questionnaire physi
cal activity scale, the EQ-5D-3L index,
and the Patients Global Impression of
Change scale (Tab. 2). The standardized
effect size for the Oxford Shoulder Score
was 0.74 (95% confidence interval
[Cl] =0.30, 1.17). More patients in the
exercise group (69%) than in the usual
care group (51%) improved > 6 points in
their Oxford Shoulder Score; the
adjusted odds ratio was 2.4 (95% CI= 1.0,
5.6), with a number needed to treat of
5.0 (95% CI=2.6, 48.6). When perprotocol analyses were performed, the
differences in favor of the physical ther
apy exercise intervention at 3 months
also reached statistical significance for
the Oxford Shoulder Score, with an
adjusted mean difference of 2.8 (95%
CI=0.2, 5.4), and for the Fear-Avoidance
Beliefs Questionnaire physical activity
scale, with an adjusted mean difference
of -2 .4 (95% C I= -4 .5 , -0.4).

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Standardized Physical Therapy Exercises and Subacromial Impingement Syndrome

Table 2.
Effectiveness of Physical Therapy Exercises Compared With Usual Care With Respect to Primary, Secondary, and Supplementary Outcome
Measures0
U sual C are

Physical T h e ra p y

In t e n t io n - to - T r e a t

G ro u p

Exercise G ro u p

T r e a t m e n t E ffe c t6

V a ria b le s
C o n tin u o u s o u tc o m e s , n, X, (SD )

M e a n d iffe r e n c e ( 9 5 % C l)

Oxford Shoulder Scorec

Baseline

66

29.1 (8.0)

60

31.0 (6.4)

3 mo

61

35.0 (9.5)

55

37.7 (7.9)

2.0 (-0 .5 , 4.6)

12 mo

S3

34.2 (11.3)

51

41.2 (7.1)

5.8 (2.8, 8.9)

Constant Scored
Baseline

66

52.7(13.5)

60

54.1 (15.0)

3 mo

59

63.9 (19.1)

54

70.4(17.5)

11.3(6.4)

6.7 (1.2, 12.2)

Fear-Avoidance Beliefs Questionnaire physical activity scale score'

Baseline

65

12.6 (6.0)

60

3 mo

61

10.1 (7.0)

55

7.8 (6.5)

- 1 .8 (- 3 .8 , 0.3)

12 mo

53

10.2 (7.4)

51

6.0 (5.9)

- 3 .3 (- 5 .6 , -0 .9 )

Baseline

66

0.67 (0.16)

60

0.72 (0.11)

3 mo

60

0.72 (0.21)

55

0.77 (0.14)

0.04 (-0 .0 2 , 0.10)

12 mo

53

0.71 (0.24)

51

0.83 (0.14)

0.09 (0.02, 0.17)

EQ-5D-3L index score'

Maximum oxygen uptake (mL Q2/m in/kg)

Baseline

61

26.3 (8.3)

59

29.3 (8.3)

3 mo

55

27.1 (7.6)

51

32.3 (9.6)

B in a ry o u tco m e s , n, X, ( % )

2.1 (0.1, 4.1)

OR ( 9 5 % Cl)

Positive pain provocation signs9

Baseline

66

53 (80.3)

60

38 (63.3)

3 mo

55

36 (61.0)

54

23 (42.6)

Baseline

59

18 (30.5)

56

16 (28.6)

3 mo

52

13 (25.0)

50

4 (8.0)

0.6 (0.3, 1.3)

Scapular dyskinesish

0.2 (0.1, 0.8)'

C a te g o ric a l o u tc o m e , n ( % )

Patients' Global Impression of Change scale score

3 mo
Worse

7(11.5)

3 (5.5)

No change

21 (34.4)

Better

20 (32.8)

9 (16.4)

Much better

13(21.3)

24 (43.6)

19(34.6)

2.1 (1.0, 4.1 y

12 mo
Worse

10(19.9)

3 (5.9)

No change

17(32.1)

15 (29.4)

Better

12(22.6)

10 (19.6)

Much better

14 (26.4)

23(45.1)

2.2 (1.1, 4.6)7

CI=confidence interval, OR=odds ratio.

b Results of linear and logistic regression analyses adjusted for occupational medical assistance, center, and the respective baseline values.
c Oxford Shoulder Score: 0 -4 8 .
d Constant Score: 0-100.
' Fear-Avoidance Beliefs Questionnaire physical activity score: 0 -24.
' EQ-5D-3L index score: - 0 .6 to 1.0.
9 Positive pain provocation signs defined as > 2 positive of Hawkins test, modified Hawkins test, painful arc test, and jobe test.
h Scapular dyskinesis defined as a positive Scapula Dyskinesis Test (obvious signs) and a positive Scapula Assistance Test or Scapula Retraction Test.
' Adjustment for occupational medical assistance and center not applicable because of few cases.
Results of ordered logistic regression analyses adjusted for occupational medical assistance and center.
a

792

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Volume 96

Number 6

June 2016

Standardized Physical Therapy Exercises and Subacromial Im p in g em e n t Syndrome

In terven tio n and Adherence

In the east center, the number of patients

treated in each municipal center and by
each physical therapist was as follows:
first physical therapist (n=6), second
physical therapist (n = l4 ), and third
physical therapist (n=10). In the west
center, one physical therapist treated all
patients (n=22) (the second physical
therapist substituted in only 1 or 2 ses
sions). Patients allocated to physical ther
apy exercises received a median of 12
(interquartile range=9-13) supervised
training sessions. Ten patients did not
receive physical therapy exercises as
intended (Figure). The main reasons
given by these patients were long travel
ing distance, lack of time, or a new job.
Seven and 6 of the 10 patients who did
not adhere provided data at 3 and 12
months, respectively.

Excluded (n=276)
Inclusion criteria not met (n=92)*
Frozen shoulder (n=38)
Planned reoperation (n=14)
Declined to participate (n=132)

Assessment for eligibility at postoperative

control (n=613)

Excluded (n=202)
Could not be contacted/late referral
(n=41)
Inclusion criteria not met (n=72)
Reported no problems (n=62)
Other inclusion criteria not met (n=10)
Declined to participate (n=89)
Distance\work\personal reasons (n=49)
Satisfied w ith current treatm ent (n=19)
Planned surgery on other shoulder (n=2)
Other reason/reason not stated (n=19)

Structured telephone interview

(n = 3 3 7 )'

Baseline assessment (n=135)

Excluded (n=9)
Frozen shoulder (n=6)
New trauma (n=1)
Inability to participate due to other health
problems (n=2)

Randomized (n=126)
Department of occupational medicine:
east center (n=76), west center (n=50)

a
>

Allocated to usual care (n=66)

Received allocated intervention (n=66)
Did not receive allocated intervention (n=0)

Allocated to physical therapy exercises (n=60)

Received allocated intervention (n=50)
Did not receive allocated intervention (n=10):
2 w ithdrew before first session, 6 at first session,
and 2 after 3 and 4 sessions (1 due to new job,
1 stated no reason)

At the final training session, 37 out of 50

patients (74%) performed at least 5 of the
7 exercises at the highest level (level C),
and, on average, resistance in loaded
exercises had increased by 74% (95%
CI=53%, 95%). The physical therapists
rated the overall patient adherence to
the physical therapy exercise interven
tion as very high or high in 44 (88%) of
the 50 patients who received the inter
vention. The exercise manual could only
be followed to some extent for 8 patients
and to a very limited extent for 1 patient.
Of the 60 patients allocated to physical
therapy exercises, 44 (73%) adhered.
Additional manual treatment as part of
the intervention was received by 34
(68%) of 50 patients who received the
intervention, and the median number of
sessions that included manual treatment
was 2 (interquartile range= 0-7). A total
of 46 patients filled in their home train
ing diary; they completed their home
training program an average of 2.1
(SD=0.8) times a week and performed
physical activity at moderate-to-high
intensity for at least 30 minutes an aver
age of 3-1 (SD= 1.7) days a week over the
12-week period.
At 3 months, 48 (79%) of the 61 patients
in the usual care group reported that
they had received shoulder-specific exer
cise instructions or exercise therapy dur
ing the intervention period. Twentyseven patients (44%) had received

June 2 0 1 6

<

Lost to follow -up at 3 m onths (n=5)

Reoperation (n=1), withdrawal (n=2), no show
(n=2). Two additional patients declined clinical
re-examination

Lost to fo llo w -u p at 3 m onths (n=5)

Reoperation (n=1), withdrawal (n=1), no show
(n=3). One additional person declined clinical
re-examination

Analyzed at 3 m onths (n=61)

Excluded from analysis (n=0)

Analyzed at 3 m onths (n=55)

Excluded from analysis (n=0)

'
Lost to follo w -u p at 12 m onths (n=8)
Did not respond to questionnaire (n=8)

Lost to follo w -u p a t 12 m onths (n=4)

Did not respond to questionnaire (n=4)

Analyzed at 12 m onths (n=53)

Excluded from analysis (n=0)

Analyzed at 12 m onths (n=51)

Excluded from analysis (n=0)

F ig u re.

Flowchart of participants in the study, fin April 2012, when 9 patients were included in the
trial, the following exclusion criteria were abandoned due to slow recruitment: previous
shoulder surgery or diabetes, not employed in paid work for at least 25 hours per week, and
not full-time sick-listed.

massage/manual treatment, 7 (11%) had

received acupuncture, 22 (36%) had
received electrotherapy or thermother
apy, and 34 (56%) had seen a physical
therapist for their shoulder problem,
with a median of 8 (interquartile
ran g e= 4 -l6 ) treatments received.
Cointerventions

The number of patients who had con

sulted a physician for their shoulder
problem during the intervention period

was significantly lower in the physical

therapy exercise group than in the usual
care group (5 [9%] versus 18 [30%],
P<.()01). No significant differences were
observed between groups for the num
ber of patients who received one or
more subacromial injections (6 [11%] in
the physical therapy exercise group ver
sus 11 [18%] in the usual care group).
Chiropractor treatment was received by
1 patient (2%) in the exercise group and
6 patients (10%) in the usual care group,

V o lu m e 96

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S ta n d a r d iz e d P h ysical T h e r a p y Exercises a n d S u b a c ro m ia l Im p in g e m e n t S y n d r o m e

and alternative treatment was received

by 3 patients (6%) versus 7 patients
(12%), with no significant differences
between groups.
A d v e rs e E ven ts

Except for muscle tenderness after train

ing and 2 cases of temporary headache in
relation to training, no adverse events
were noted. Two patients were reoper
ated on (one in each group) within the
first 3 months (Figure).
S e n s itiv ity A n a ly s is a n d Success
o f B lin d in g

Sensitivity analysis demonstrated that for

the results to no longer significantly
favor the intervention at 12 months, a
14-point higher mean Oxford Shoulder
Score would be needed in patients who
were lost to follow-up in the usual care
group than in those who were lost to
follow-up in the physical therapy exer
cise group. In total, 96 (85%) of 113
patients were examined by the same
assessor at baseline and follow-up. The
assessors correctly classified 32 patients
(54%) in the usual care group and 23
patients (43%) in the physical therapy
exercise group.
D is c u s s io n

A standardized physical therapy exercise

intervention was compared with usual
care for patients with difficulty returning
to usual activities after subacromial
decompression surgery for SIS. At 3
months,
intention-to-treat
analyses
showed a statistically nonsignificant dif
ference in favor of the intervention with
respect to the primary outcome mea
sure, the Oxford Shoulder Score, and in
per-protocol analyses, this difference
was significant. At 12 months, intentionto-treat analyses demonstrated signifi
cantly larger improvement in the physi
cal therapy exercise group with respect
to the Oxford Shoulder Score, fearavoidance beliefs, health-related quality
of life, and the patients perception of
overall improvement.
The study benefited from a randomized
design, high treatment adherence, vali
dated primary and secondary outcome
measures, limited loss to follow-up,
blinding of clinical assessors, and evalu
ation of treatment application and co

794

Physical T h e ra p y

V o lu m e 9 6

interventions. The study had some limi

tations. The total number of 613 patients
assessed for eligibility over a 3-year
period was lower than expected. This
lower number most likely reflected gen
eral difficulty of recruiting patients from
clinical practice, rather than systematic
selection, and, therefore, should not
affect the generalizability of the results to
patients with orthopedic conditions eval
uated for SIS. Patients could be included
only if they reported at least slight prob
lems doing usual activities, and it may be
questioned whether this could be
defined as difficulty returning to usual
activities. However, we find it unlikely
that patients would agree to participate
in the trial if they did not experience
significant shoulder problems. The blind
ing of the outcome assessors at 3 months
was successful, but the nature of exer
cise interventions did not allow blinding
of patients and care providers. Informa
tion on physical therapy received by
patients in the usual care group was col
lected at the 3-month follow-up. This
approach might imply underestimation
of the use of physical therapy, as visits to
a physical therapist might have been for
gotten, but such underestimation would
not explain the results in favor of the
intervention. Within the first year of the
trial, we widened the inclusion criteria to
increase recruitment. Before that, only 9
patients had been included; therefore,
the change probably only affected our
results in terms of larger generalizability
because the population was more repre
sentative of postoperative SIS patients of
working age.
The number of missing responses to
items in the questionnaires was limited,
which supports the internal validity of
the study findings. For the evaluation of
scapular dyskinesis at 3 months, missing
information was more common because
the assessment could not always be per
formed due to pain provocation. Conse
quently, these results may not apply to
patients with higher pain intensities and
more severe limitations in shoulder func
tion. Furthermore, the validity and reli
ability of combining visual inspection
and manual correction to identify scapu
lar dyskinesis have not been established.
We chose to omit patients without out
come data at 3 and 12 months from the

Num ber 6

analyses (complete case analysis).4647

More advanced statistical approaches to
handle loss to follow-up are available (ie,
multiple imputation),48 but sensitivity
analyses suggested that our findings
were robust.
To our knowledge, this is the largest
study that has evaluated physical therapy
exercises after decompression surgery
for SIS. Previous studies that have com
pared exercises and home training have
reached
contradictory
results.11-14
Holmgren et al13 and Park et al14 found
superior short-term effectiveness of exer
cises aiming to strengthen rotator cuff
and scapular muscles compared with
instructions in mobility-focused home
exercises or passive modalities only (ie,
electrotherapy and thermotherapy). In
contrast, no short-term or long-term
effects of physical therapist-supervised
exercises were found compared with
home training with rotator cuff strength
ening exercises11 or when more progres
sive exercise programs were compared
with traditional exercise programs.12
Compared with the exercise interven
tion in previous studies, our program
was initiated later because we wanted to
focus our intervention efforts on patients
who did not respond sufficiently to sur
gery and initial postoperative care.
We included fear-avoidance beliefs, max
imum oxygen uptake, and scapular dys
kinesis as secondary and supplementary
outcome measures because they might
be part of the interventions mechanism
of action. This possibility was not contra
dicted by the reported results. Maximum
oxygen uptake could further be inter
preted as a marker of adherence. Patients
in the physical therapy exercise group
continued to improve after the interven
tion period, whereas no further improve
ment was observed in the usual care
group. Supported by a detailed patient
pamphlet with home training instruc
tions, patients in the physical therapy
exercise group were gradually encour
aged to handle training themselves and
taught how to progress home training,
maintain or improve general physical
activity, and handle flare-ups, which may
have contributed to this result. The
observed treatment effect size for the
Oxford Shoulder Score was moderate to

June 2 0 1 6

S ta n d a r d iz e d Physical T h e r a p y Exercises a n d S u b a c ro m ia l Im p in g e m e n t S y n d r o m e

large, with patients in the exercise group

having 2.4 times higher odds of clinically
important improvement (ie, a 6 points)
at 12 months, and this was found for a
health condition where exercise
interventions typically show small-tomoderate effects.49 At 3 months, more
than half of the patients in the usual care
group had received physical therapy for
their shoulder problem. Nevertheless,
we observed significantly greater
improvement in the physical therapy
exercise group across outcome measures
at both 3- and 12-month follow-ups. In
our opinion, this finding suggests that
the standardized physical therapy exer
cise intervention could be of substantial
benefit for patients with SIS who have
difficulty returning to usual activities
after decompression surgery.

T he au th o rs th a n k ja n n e N ielsen, PT, M e tte

Balle Olsen, PT, Bjarne Leif Sorensen, PT,
A nja Ellegaard Kjeldsen, PT, and Jesper Eliasen, PT, w h o de live re d th e tria l in te rv e n tio n ;
A nd ers D a m g a a rd

M o lle r,

PT, an d

Klaus

D a h le ru p D jernes, PT, fo r assistance w ith

clin ic a l o u tc o m e assessment; an d research
secretaries Inge-Lis Laursen an d A nn C hristie
Poulsen.
T he s tu d y w as a p p ro v e d b y th e C e ntral D e n
m ark

R egion

Research

C o m m itte e s

Ethics

M -2 0 1 0 0 1 3 1 )
P ro te c tio n

on

(id e n tific a tio n

an d

A g e n cy

by

th e

B iom edical
n u m b e r:

D anish

(jo u rn a l

Data

n u m b e r:

2 0 1 0 -4 1 -4 3 1 6 ).
This w as a rese a rch e r-in itia te d study, p rim a r
ily fu n d e d b y th e Danish A g e n cy f o r Science,
T e c h n o lo g y and In n o v a tio n (g ra n t n u m b e r
0 9 -0 6 6 9 8 5 ) w ith c o -fu n d in g fro m th e D a n
ish Ram azzini C entre.
T rial re g is tra tio n : C u rre n t C o n tro lle d Trials

We conducted a pragmatic trial, with the

intervention delivered by general physi
cal therapists in the existing framework
of public rehabilitation, and the interven
tion was compared with usual care,
which often included physical therapy
and shoulder-specific exercises. Conse
quently, we would expect that compara
ble results could be achieved in other
physical therapy outpatient settings.
In conclusion, the results supported the
effectiveness of a standardized physical
therapy exercise intervention compared
with usual care in patients with difficulty
returning to usual activities 8 to 12
weeks after subacromial decompression
surgery for SIS. Thus, the present study
suggests a potential for optimizing the
quality of care for patients with SIS who
are surgically treated. A detailed exercise
manual and a patient pamphlet allow
researchers to replicate the trial and cli
nicians to apply the exercise program.
D r Frost and D r Svendsen con ceived th e
p ro je c t. A ll a u th o rs w e re in v o lv e d in th e
desig n o f th e s tud y. Assisted b y D r Frost and
D r Svendsen, D r C hristiansen d e v e lo p e d th e
physical th e ra p y in te rv e n tio n , p e rfo rm e d th e
statistical analyses, an d d ra fte d th e m a n u
scrip t. All a u th o rs c o n trib u te d to in te rp re ta
tio n o f data and c ritic a l revision o f th e m a n
u scrip t. A ll a u th o rs read a n d a p p ro v e d th e
fin a l m a n u s c rip t a nd stand b y th e in te g rity o f
th e e n tire w o rk .

(ISRCTN55 7 6 8 7 4 9 ).
D O I: 1 0 .2 5 2 2 /p tj.2 0 1 5 0 6 5 2

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