824691

research-article2019
CRE0010.1177/0269215518824691Clinical RehabilitationAceituno-Gómez et al.

CLINICAL
Original Article REHABILITATION

Clinical Rehabilitation

Efficacy of high-intensity 1­–10

© The Author(s) 2019
Article reuse guidelines:
laser therapy in subacromial sagepub.com/journals-permissions
DOI: 10.1177/0269215518824691
https://doi.org/10.1177/0269215518824691

impingement syndrome: journals.sagepub.com/home/cre

a three-month follow-up
controlled clinical trial

Javier Aceituno-Gómez1, Juan Avendaño-Coy2 ,

Julio Gómez-Soriano2,
Venancio Miguel García-Madero1,
Gerardo Ávila-Martín3, Diego Serrano-Muñoz3,
Jaime González-González4,5
and Juan José Criado-Álvarez4,5

Abstract
Objectives: To evaluate the effectiveness of high-intensity laser therapy on shoulder pain and function in
subacromial impingement syndrome.
Design: Clinical controlled trial with alternate allocation.
Setting: Hospital Department of Rehabilitation.
Subjects: A total of 46 participants with subacromial impingement syndrome.
Intervention: Participants were sequence allocated to an intervention group (high-intensity laser
therapy + exercise therapy) and control group (sham-laser + exercise therapy) and received 15 sessions
(five days a week during three weeks).
Main measures: Patiens were evaluated at baseline, after 15 sessions, and at one month and at
three months after completing the intervention. The main outcome variables were pain and functionality as
measured by visual analogue scale; pressure pain threshold; Shoulder Pain and Disability Index; Constant-
Murley Score; and QuickDASH. Secondary outcomes were number of sessions at discharge and drug use.
Results: A total of 21 patients in high-intensity laser therapy group (56.7 ± 8.9 years) and 22 patients in
sham-laser group (61.3 ± 8.9 years) concluded the study. Visual analogue scale (cm) at baseline, one-month,

1University General Hospital Nuestra Señora del Prado, 5Medicine

Gerencia de Atención Integrada de Talavera de la Reina
(SESCAM), Toledo, Spain
2Toledo Physiotherapy Research Group (GIFTO), E.U.
Enfermería y Fisioterapia de Toledo, Universidad de Castilla-
La Mancha, Toledo, Spain
3Sensorimotor Function Group, Hospital Nacional de
Parapléjicos, Toledo, Spain
4Gerencia de Atención Integrada de Talavera de la Reina
(SESCAM), Toledo, Spain
Department, Facultad de Terapia Ocupacional,
Logopedia y Enfermería, Universidad de Castilla-La Mancha,
Ciudad Real, Spain
Corresponding author:
Juan Avendaño-Coy, Toledo Physiotherapy Research
Group (GIFTO), E.U. Enfermería y Fisioterapia de Toledo,
Universidad de Castilla-La Mancha, Avd Carlos III s/n, 45071
Toledo, Spain.
Email: Juan.Avendano@uclm.es
2 Clinical Rehabilitation 00(0)

and three-months were 6.2 ± 0.5, 3 ± 2.6, and 2.6 ± 2.4 for the control group and 5.4 ± 1.5, 3.6 ± 1.3,
and 1.8 ± 1.7 for experimental group, respectively. Shoulder Pain and Disability Index (points) at baseline,
one-month, and three-monts were 51.8 ± 16.1, 16.3 ± 16.1, and 13.6 ± 17.1 in the control group and
41.8 ± 20.6, 20.5 ± 19.7, 11 ± 14.5 in experimental group, respectively. No differences were found
between groups (P > 0.05).
Conclusion: The effect of high-intensity laser therapy plus exercise is not higher than exercise alone to
reduce pain and improve functionality in patients with subacromial syndrome.

Keywords
High-intensity laser therapy, shoulder impingement syndrome, shoulder pain

Date received: 30 July 2018; accepted: 22 December 2018

Introduction group,14,15 using short follow-up periods.

Subacromial impingement syndrome is defined as
a symptomatic irritation of the rotator cuff and the
subacromial bursa in the limited subacromial
space;1 the term encompasses a wide range of dis-
orders, causing an alteration in the relationship
between soft tissue (inflammation) and structure
(stiffness), which is especially critical when the
arm is abducted in an arc between 60° and 120°.2
Subacromial impingment syndrome prevalence
data indicate values of over 35%.3,4 These data
highlight the importance of the approach taken to
this disorder, especially in view of its tendency to
chronification.5
Low-level laser therapy has been used as a treat-
ment for shoulder disorders, but its effectivenesss
is controversial.6–8 High-intensity laser therapy
using neodymium-doped yttrium aluminum garnet
(Nd:YAG) laser is an alternative technique which
could serve to boost the analgesic, anti-inflamma-
tory, and biostimulant effects of laser emission.9 It
has some advantages over low-level, particularly
its greater tissue-penetration capacity owing to its
high power and the lower absorption of 1064 nm
wavelength by subcutaneous chromophores,10
which make for a reduction in the high-intensity
versus the low-level exposure time required to
achieve treatment goals,11 as well as recovery times
when a power of more than 1 W is used.12
In subacromial syndrome, studies with high-
intensity laser therapy have been limited to a series
of cases,13 or studies without a placebo-controlled
Accordingly, the main objective of this study was
to evaluate the efficacy of 15 sessions of high-
intensity laser therapy versus sham laser after the
end of the intervention and at one- and three-
month follow-up on pain and functionality levels
among subjects diagnosed with subacromial syn-
drome. The secondary objective was to ascertain
the influence of high-intensity laser therapy on the
total number of sessions at discharge and the pre-
scribed use of medications.
Material and methods
We conducted a sham-controlled, double-blind
(patients and outcome assessor) clinical trial. It
was approved by the Clinical Research Ethics
Committee of the Talavera de la Reina Integrated
Health Area (Spain) (CEIC21/2016) and registered
in the ClinicalTrials.gov ww (NCT02971215). The
study, intervention and follow-up took place
between November 2016 and June 2017, was
undertaken by the University of Castilla La Mancha
in collaboration with the Castilla La Mancha
Health Service.
Study participants
The study included patients who were attended at
a Hospital Rehabilitation Department, were diag-
nosed with subacromial impingement syndrome
by an independent rehabilitation specialist, and
fulfilled the following inclusion criteria: (1) age
Aceituno-Gómez et al. 3
18–75 years; (2) visual analogue scale (VAS)
score of 7 or less; and, (3) able to perform anterior
shoulder flexion to at least 100°. Inclusion criteria
(2) and (3) were chosen because patients with a
higher level of pain and/or shoulder disability
may require additional therapeutic interventions.
The exclusion criteria were as follows: (1) sub-
jects treated with physiotherapy for this disorder
at least one month before entering the trial; (2)
subjects diagnosed with calcifying tendinitis, full-
thickness rotator-cuff tear, adhesive capsulitis,
and/or fibromyalgia; (3) subjects with altered
thermal sensitivity; or (4) subjects presenting
with one or more absolute and/or relative con-
traindications to laser therapy. The withdrawal
criterion was defined as receiving another medi-
cal technique (injection) or physiotherapy tech-
nique (electrotherapy) during the course of the
study.
This study had consecutive, alternate allocation
to one of two groups, that is, sham-controlled
(sham laser) or intervention (high-intensity laser
therapy) group. Participants were allocated to the
two groups according to their order of admission,
with the first participant being allocated to the
experimental group, the second to the control
group, and so on. The choice of which group was to
begin the study was made prior to beginning the
study by the toss of a coin.
All participants received verbal and written
information about the study and gave their informed
consent in writing prior to taking part.
Intervention
The intervention lasted three weeks and comprised
a total of 15 sessions (five sessions/week). During
each session, participants received high-intensity
laser therapy (experimental group) or sham-laser
intervention (sham-controlled group); thereafter,
all subjects received the same purpose-designed
exercise therapy protocol for subacromial syn-
drome, consisting of stretching and strengthening
exercises (Supplemental Figure S1). The exercise
therapy protocol was applied by three physiothera-
pists blinded to the treatment group and suitably
instructed as regards the procedure to be followed.
However, all laser sessions (real and sham) were
performed by the same physiotherapist, who had
experience in the technique and was not blinded to
the treatment group allocation.
Laser treatment was applied using the iLux
Laser device (Mectronic Medicale, Italy), which
emits a wavelength of 1064 nm (Nd:YAG laser)
with 15 W maximum power output. Each session
of high-intensity intervention consisted of two
phases: phase one, applying a power of 12 W at a
frequency of 50 Hz and a 20% work cycle, during
which 50 J/cm2 were administered; and phase two,
applying a power of 15 W in burst mode (10 pulses
for 900 ms per train), during which 250 J/cm2 were
administered.
The sham-laser group was given the same time
of treatment in the same phases, with the device’s
guide light switched on, but with the power set at
0 W.
In all cases, protective goggles were used as a
safety measure, and the laser head was separated
from the skin by a 2.5 cm diameter applicator
attached to the head of the device, which placed it
at light source–to-skin distance of 1 cm. Before
commencing treatment, the area to be treated was
mapped on the skin with a dermographic pen, and
the requisite area was obtained to calculate the
dose. The mode of application to this area was
dynamic, so as to prevent any risk posed by the
thermal effect.
Measures
All subjects were evaluated by a single assesor
blinded to the treatment group allocation.
Demographic and clinical data on gender, age,
time of evolution of the pathology, and health-
related quality of life as rated by the European
Quality of Live Five Dimensions scale were taken
at baseline. Outcome variables based on pain and
functionality were taken at four time points
(Figure 1) as follows:
The VAS was scored by means of a 10-cm long
horizontal line ranging from (0 cm = no pain) at one
end to (10 cm = maximum imaginable pain) at the
other, on which participants marked a point accord-
ing to their subjective perception of pain.
4 Clinical Rehabilitation 00(0)

Assessed for eligibility (n=48)

Enrollment

Excluded (n=2)
♦ Not meeting inclusion criteria (n=1)
♦ Declined to participate (n=1)

Alternate Allocation (n=46)

Allocation

Allocated to intervention group (15 Allocated to Placebo group (15 sessions)

sessions) HILT + Physical Therapy Protocol Sham laser + Physical Therapy Protocol
(n=23) (n=23)
♦ Received allocated intervention (n=23) ♦ Received allocated intervention (n= 23)

Follow-Up
Lost to follow-up at 3 treatment weeks (n=0) Lost to follow-up at 3 treatment weeks (n=0)

Lost to follow-up at 1 month after the end of

the treatment (n=1)* Lost to follow-up at 1 month after the end of
the treatment (n=0)

Lost to follow-up at 3 months after the end of Lost to follow-up at 3 months after the end of
the treatment (n=1)* the treatment (n=1)*

Analysis

Analysed (n= 21) Analysed (n=22)

Figure 1.  CONSORT Flow diagram for participant recruitment, allocation, follow-up and analysis.
*Corticosteroid injection.
HILT: high-intensity laser therapy.

The validated Spanish version of the Shoulder
Pain and Disability Index was used.16 It composed
10 questions: 4 relating to pain and 6 to disability,
scored from 0 to 10, with the highest scores denot-
ing greatest pain and disability.
The Constant–Murley Score is made up of four
subscales that assess the following: pain (15/100);
activities of daily living (20/100); range of motion
(40/100); and strength (25/100). We excluded the
last measure (strength) as proposed by Patel et al.,17
so that the final score was based on a maximum of
75 points, and the highest score shows better shoul-
der status.
To measure functionality (in terms of subjects’
ability to perform activities), the QuickDASH
scale was used. This shortened version of the
Aceituno-Gómez et al. 5
Disabilities of the Arm, Shoulder and Hand
(DASH) index has shown good correlation in
shoulder pathology.18 It composed 11 items, and in
all cases, refers to the subject’s condition in the
week preceding the test. The highest scores on this
scale correspond to reduced functionality.
Pressure Pain Threshold was determined with
an analogue algometer (WAGNER FPN100) at the
most painful point of the subacromial area. This
point was determined by a previous examination
based on the point that the patient determined as
‘his or her point of maximum pain’. The unit of
measurement was kg/cm2, and three measurements
were taken every 30 seconds. The average of the
three consecutive measurements was taken as the
final value.
As secondary variables, we recorded pharma-
cologic treatment (noting whether, at the date of
assessment, the patient was taking the analgesic/
anti-inflammatory medication prescribed by his
or her physician), and the total number of recom-
mended exercise-protocol sessions received.
When a participant did not progress enough to be
discharged after the experimental period, he or
she continued with the exercise protocol until
reaching the goals for discharge. A record was
kept of the number of sessions received after
the experimental period. For ethical reasons, an
external evaluation performed by a clinician not
involved in the study was used to decide whether
(1) the patient had concluded the treatment and
would be discharged, (2) the patient would con-
tinue with the purpose-designed exercise therapy
protocol; or 3) the patient would, alternatively, be
recommended to use another therapeutic tech-
nique (in which case, the patient was considered
lost to follow-up).
Statistical analysis
Sample size was calculated using the Epidat
programme version 4.1. The proportion of effec-
tiveness was estimated to be 90% using high-
intensity laser in the intervention group, and
50% in the control group, with a ratio of 1
between the sample sizes of the two groups.
Using a 95% confidence level (P < 0.05) and a
power of 80%, we obtained a minimum sample
size of 20 patients in each group (a total of 40
patients). Since losses were estimated to be
15%, the sample was increased by three partici-
pants per group.
All statistical analyses were performed using
the SPSS software package (Statistical Package
Social Sciences, version 15.0). Comparison of
the demographic data of the groups was per-
formed using a Student’s t-test and a chi-square
test. A one-way analysis of variance (one-way
ANOVA) test and a Student’s t-test were used
for inter- and intra-group comparisons of the
outcome variables at each time point. In addi-
tion, we used a repeated-measures analysis of
variance (RM ANOVA) to analyse differences
in outcome values between the two groups
according to time points. Statistical significance
was defined as a P value of less than 0.05. The
researcher who performed the statistical analy-
sis was blinded at the treatment group.
Results
A total of 46 patients were initially included and
were evaluated before group allocation, 23 being
assigned to the high-intensity group and 23 to the
control group. Across the study, there were three
losses to follow-up (two in the intervention group
and one in the control group) and finally, a total of
43 subjects concluded the trial (21 intervention and
22 control; Figure 1). The entire patient withdraw-
als were due to receiving another treatment (corti-
costeroid injection).
Table 1 shows demographic characteristics
and clinical variables at baseline by treatment
group allocation. There were significant differ-
ences in the European Quality of Live Five
Dimensions scale (worse self-perceived quality
of life in the “high-intensity laser therapy”
group). In the outcome variables, the baseline
score displayed significant differences (higher
VAS score and lower Constant–Murley score in
the control group).
Table 2 shows the results obtained by both
groups on the scales used to measure pain and
functionality, as well as the comparison between
6 Clinical Rehabilitation 00(0)
Table 1.  Demographics and background clinical characteristics of both groups.
Outcomes Control
Age, (years) 61.3 SD 8.95
Evolution (months) 12.1 SD 15,88
EQ-5D 8.7 SD 1.14
Sex M/F (%) 11 (47.8)/12 (52.2)
VAS (cm) 6.2 SD 0.97
PPT (kg/cm2) 2.9 SD 0.61
SPADI 51.8 SD 16.12
CMS 41.7 SD 9.78
QuickDASH 46.2 SD 16.07
HILT, high-intensity laser therapy; EQ-5D, European Quality of life Five Dimensions; SD, standard deviation; M/F, male/female;
VAS, visual analogue scale; PPT, Pain Pressure Threshold in subacromial area; SPADI, Shoulder Pain and Disability Index; CMS,
Constant–Murley Score.
*P < 0.05; #chi-square test.
the different time points. Significant improvements
were observed in both groups in all variables vis-à-
vis to baseline. Comparisons showed improve-
ments at three months with respect to immediately
posttreatment and improvements at three months
with respect to one month posttreatment on several
scales in the experimental group alone, without
values reaching significance in the sham-controlled
group (Table 2).
Comparisons of the effect between interven-
tions only showed a greater effect on the pain
scale between one month and three months after
intervention in the experimental group versus the
control group (1.4 cm 95% confidence interval:
0.17–2.62) and a greater effect on the Shoulder
Pain and Disability Index between baseline and
one month after intervention in the control group
versus the experimental group (Shoulder Pain
Index: 14.2; 95% confidence interval: 0.66–
27.73). Others between-group comparisons were
not significant at any time point (Supplemental
Table S1).
In terms of the secondary variables, prescribed
use of medication for analgesic and anti-inflammatory
purposes and number of sessions for discharge,
the high-intensity laser group obtained better
results than did the control group but without sta-
tistically significant differences (Supplemental
Table S2). No adverse effects were observed
across the trial.
HILT Differences
56.7 SD 8.90 −4.6 (−9.90 to 0.70)
11 SD 8.80 −1.1 (−8.72 to 6.52)
7.9 SD 1.06 0.8* (−1.45 to −0.14)
7 (30.4)/16 (69.6) P > 0.05#
5.4 SD 1.47 −0.8* (−1.56 to −0.03)
2.5 SD 0.89 −0.4 (0.06 to −0.86)
41.8 SD 20.61 −10 (−21.36 to 1.36)
49.9 SD 10.39 8.2* (1.98 to 14.41)
39.2 SD 16.04 −7 (−16.89 to 2.89)
Discussion
This study compared the results obtained after a
consecutive three-week period (15 sessions) of
hign-intensity laser therapy versus sham laser in
patients diagnosed with subacromial syndrome.
Both groups evidenced a clinical and statistically
significant improvement over baseline in terms of
pain and function immediately postintervention
and at three months follow-up without evidence of
differences between groups.
This is the first study on the use of high-inten-
sity laser therapy in subacromial impingement
syndrome to conduct a three-month follow-up.
Previous studies consisted of one case series
with follow-up at eight weeks postintervention13
and two clinical trials without any subsequent
follow-up.14,15 Moreover, while our intervention
protocol provided for 15 laser sessions (five ses-
sions/week for three weeks), the protocol used by
Karaca13 and Pekyavas and Baltaci14 stipulated
nine sessions on alternate days (three weeks) and
Santamato et al.15 used 10 sessions (five sessions/
week for two weeks).
Karaca13 analysed a series of 42 cases, the effect
seen by Karaca lengthens one month more in this
study, but this effect was not better than placebo.
Santamato et al.15 reported finding better results in
the high-intensity group than in the ultrasound
group. Pekyavas and Baltaci14 applied a design
Table 2.  Outcomes measures results and within-group effects (mean difference and 95% CI).
Outcomes T0 T1 T2 T3 T1-T0 T2-T0 T3-T0 T2-T1 T3-T1 T3-T2

VAS (cm)  
 Control 6.2 4.1 3.0 2.6 −2.1 −3.2 −3.5 −1.1 −1.4 0.4
Aceituno-Gómez et al.

(n = 22) (0.97) (1.80) (2.60) (2.43) (−3.22 to −0.95) (−4.88 to −1.67) (−4.98 to −2.12) (−2.53 to 0.35) (−2.94 to 0.39) (−0.64 to 1.36)
 HILT 5.4 3.6 3.6 1.8 −1.8 −1.8 −3.6 0 −1.8 −1.8
(n = 21) (1.47) (1.88) (2.37) (1.76) (−2.94 to − 0.67) (−3.34 to − 0.27) (−4.67 to −2.56) (−1.63 to 1.63) (−3.01 to −0.60) (−3.30 to −0.31)
PPT  
(kg/cm2)
 Control 2.9 3.5 4.0 4.4 0.5 1.0 1.45 0.5 0.9 0.4
(n = 22) (0.61) (0.92) (1.06) (1.46) (−0.10 to 1.17) (0.27 to 1.73) (0.42 to 2.48) (−0.11 to 1.05) (0.08 to 1.75)
(−0.13 to 1.03)
 HILT 2.5 3.4 3.6 4.4 0.9 1.0 1.9 0.2 1.0 0.8
(n = 21) (0.89) (1.05) (1.07) (1.23) (0.53 to 1.30) (0.59 to 1.56) (1.14 to 2.64) (−0.25 to 0.59) (0.33 to 1.61)
(0.15 to 1.48)
SPADI  
 Control 51.8 23.0 16.3 13.6 −28.8 −35.5 −38.2 −6.8 −9.4 −2.7
(n = 22) (16.12) (17.15) (16.14) (17.09) (−20.08 to −37.45) (−46.76 to −24.14) (−50.77 to −25.59) (−2.39 to 15.75) (−20.56 to 1.74) (−10.25 to 4.79)
 HILT 41.8 20.2 20.5 11.0 −21.6 −21.3 −30.8 0.3 −9.2 −9.5
(n = 21) (20.61) (16.15) (19.76) (14.49) (−33.66 to −9.47) (−37.45 to −5.10) (−43.43 to −18.18) (−12.45 to 11.87) (−17.06 to −1.41) (−17.93 to −1.11)
CMS  
 Control 41.7 57.5 62.9 66.3 15.8 21.1 24.6 5.4 8.7 3.3
(n = 22) (9.78) (9.02) (9.86) (8.94) (9.66 to 21.97) (13.94 to 28.50) (18.14 to 31.03) (−11.55 to 0.73) (3.21 to 14.32) (−0.03 to 6.75)
 HILT 49.9 61.6 65.2 68.5 11.7 15.3 18.6 3.5 6.9 3.3
(n = 21) (10.39) (9.61) (8.07) (7.38) (6.36 to 17.11) (7.06 to 23.52) (12.54 to 24.78) (−3.06 to 10.21) (2.31 to 11.54) (−0.91 to 7.62)
QuickDASH  
 Control 46.2 23.1 17.5 14.8 −23.1 −28.7 −31.4 −5.5 −8.2 −2.6
(n = 22) (16.07) (16.62) (17.16) (17.06) (−2.26 to −14.02) (−38.25 to −19.18) (−41.15 to −29.65) (−14.69 to 3.54) (−17.41 to 0.88) (−7.54 to 2.17)
 HILT 39.2 19.5 17.7 9.9 −19.7 −21.5 −29.3 −1.8 −9.6 −7.8
(n = 21) (16.04) (13.22) (18.50) (10.71) (−26.68 to −12.71) (−35.28 to −7.78) (−37.18 to −21.47) (−10.44 to 14.11) (−15.82 to −3.43) (−17.48 to 1.89)

VAS, visual analogue scale; PPT, Pain Pressure Threshold; HILT, high-intensity laser therapy; SPADI, Shoulder Pain and Disability Index; CMS, Constant–Murley Score; CI,
confidence interval.
Left panel shows descriptive values (mean and (SD)) at T0 (Baseline), T1 (After the 15 sessions intervention programme), T2 (After one month of the intervention pro-
gramme), and T3 (After three months of the intervention programme). Right panel shows specific differences between time points (mean and 95% CI). Values provided with
bold typeface (P < 0.05)
7
8 Clinical Rehabilitation 00(0)
without placebo and assessed only the posttreat-
ment results, which showed that high-intensity
laser therapy combined with other physiotherapy
techniques leads to better results.
With regard to the three-month follow-up results
in the shoulder region, Kim et al.19 studied the
effects of high intensity versus placebo in frozen
shoulder, with a postintervention follow-up of
three months. A total of nine sessions were admin-
istered across three weeks (three sessions/week),
with significant improvement being obtained on
the pain scale in the immediate posttreatment
assessment and at eight weeks postintervention in
high-intensity group respect to sham-laser group.
At three months, however – as with our study –
both groups registered the same effect. Placebo-
controlled studies of high-intensity laser therapy
with a minimum three month follow-up show that
as compared to placebo, maximum results in terms
of pain and functionality are obtained in the inter-
mediate periods.19–21
In terms of dosage, our study applied a different
power and different energy depositions according
to phase. We applied the premise that for any given
wavelength, the higher the power, the greater the
ensuing penetration effects and the less the disper-
sion of energy. Even though Karaca13 used a simi-
lar protocol to this study, with two phases per
session, they used less power than we did (8 and
7 W, respectively). Other studies used a three-phase
protocol.14,15 The premise of our research is in con-
trast with the theory of the conceptual basis of laser
photobiomodulation, the so-called the Arndt-
Schulz Law, which indicates that the increase in
biostimulation intensity causes an activation of
biologic processes to a critical point above which
any further increase in intensity causes an inhibi-
tion of the biologic processes.22 Both lines of work
should guide the way towards the ideal dosage to
be used in ever more powerful devices.
The trend towards lower consumption of anal-
gesic and anti-inflammatory medication in the
intervention group obtained in our study suggests a
line of research in this direction and coincides with
recent studies which highlight this premise.23,24
This study has shown that an exercise therapy
protocol, alone or in combination with high-intensity
laser therapy, can bring about a clinically and
statistically significant improvement on function
and pain which is maintained for a period of at least
three months posttreatment. Our findings coincide
with previous evidence of the effect of exercise in
subacromial impingement syndrome.25,26
The foremost major limitation of the study is
due to the small number of patients. The absence of
significant differences between the high-intensity
and sham-laser groups could be due to the expected
difference of 40% when calculating sample size.
However, a smaller difference could also be clini-
cally significant but be masked by an underesti-
mated sample size. Another important issue that
might act as a limitation on this study is the use of
consecutive alternate allocation, which is not a spe-
cific randomization method. Only the first subject
was strictly randomized and this could signifi-
cantly bias the study. A further limitation may lie in
the fact that the therapist who applied the laser
treatment was not blinded to the group. Nonetheless,
the use of alternate allocation meant that he did not
intervene in the choice. In addition, subjects were
evaluated by a single assessor blinded to the treat-
ment group and the researcher who performed the
statistical analysis was also blinded. Yet, even
though physiotherapists were blinded to the treat-
ment group and trained to apply the same protocol
to all participants, three different physiotherapists
were included in the study, and this could increase
the risk of bias. A third major limitation was the
accidental fact that the experimental group had less
pain and better function at baseline. To minimize
this, the specific intra-group effect was analysed
for comparison between groups.
The results of this study do not provide suffi-
cient evidence to support the administration of
this therapy in subacromial impingement, though
by the same token there is no evidence to show
that it is harmful. However, comparison of effects
at one month versus three months posttreatment
showed a significant improvement on various
scales in the experimental group without any cor-
responding change in the control group, though
this may perhaps be due to the fact that the experi-
mental group had less severe problems at baseline.
Finally, to establish whether or not the possible
long-term within-group differences seen in the
experimental group are genuine, future research
Aceituno-Gómez et al. 9
with more patients and a six-month follow-up are
needed to address the long-term effects and to
optimize the dosage of high-intensity laser ther-
apy in subjects with subacromial impingement
syndrome.
Clinical Messages
•• Adding high-intensity laser therapy to
standard exercise therapy was not associ-
ated with any relevant effect or detecta-
ble harm.
•• Medication intake and numbers of ses-
sions for discharge do not decrease sig-
nificantly when adding high-intensity
laser therapy to standard exercise therapy.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest
with respect to the research, authorship, and/or publica-
tion of this article.
Ethical approval
This trial was approved by the Clinical Research Ethics
Committee, Talavera de la Reina Integrated Health Area
(Área Integrada de Salud de Talavera de la Reina),
SESCAM CEIC 21/2016.
Funding
The author(s) received no financial support for the
research, authorship, and/or publication of this article.
ORCID iDs
Juan Avendaño-Coy https://orcid.org/0000-0002
-8760-3490
Juan José Criado-Álvarez https://orcid.org/0000
-0002-7733-9788
Trail registration
This was registered at ClinicalTrials.gov (NCT02971215).
Supplemental material
Supplemental material for this article is available online.
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