RESEARCH ARTICLE

Ultrasound and Laser as Stand-Alone Therapies for

Myofascial Trigger Points: A Randomized, Double-Blind,
Placebo-Controlled Study
A. Manca1,*, E. Limonta2, G. Pilurzi1,3, F. Ginatempo1, E. R. De Natale1, B. Mercante1,
E. Tolu1 & F. Deriu1
1
Department of Biomedical Sciences, University of Sassari, Sassari, Italy
2
Department of Biomedical Sciences for Health, University of Milan, Milan, Italy
3
Department of Clinical and Experimental Medicine, University of Sassari, Italy

Abstract
Background and Purpose. Ultrasound (US) and low-level laser therapy (LLLT) are commonly employed for
myofascial trigger points (MTP) despite lack of evidence for usage as stand-alone treatments. The aim of the study
was to determine, on MTP of the upper trapezius muscle (uTM), the effects of US and LLLT per se, as delivered in
accordance with the procedures reported by surveys about their usage among physiotherapists. Methods. Design
was set as a double-blind, randomized, placebo-controlled study. Sixty participants with at least one active MTP
in uTM (28 women and 32 men; mean age 24.5 ± 1.44 years) were recruited and randomly assigned to one out
of five groups: active US (n = 12), placebo US (n = 12), active LLLT (n = 11), placebo LLLT (n = 11) and no therapy
(control, n = 14). The participants and outcome assessor were blinded to the group assignment and therapy
delivered. Three outcome measures were assessed at baseline, after a 2-week treatment and 12 weeks after the
end of the intervention (follow-up): pressure pain threshold, subjective pain on a numerical rating scale and muscle
extensibility performing a cervical lateral flexion. All subjects assigned to the intervention groups were treated five
times weekly for overall 10 treatments given. Two-way ANOVA was used to compare differences before and after
intervention and among groups at each time-point. Results. After the 2-week intervention, all groups showed
pressure pain threshold, numerical rating scale and cervical lateral flexion significant improvements (p < 0.05),
which were confirmed at the follow-up. When performing multiple comparisons, controls scored significantly less
than both the active therapies and placebos, whereas no differences were detected between active therapies and
placebos. Conclusions. Ultrasound and LLLT provided significant improvements in pain and muscle extensibility,
which were superior to no therapy but not to placebos, thus raising concerns about the suitability, both economi-
cally and ethically, of administering such common physical modalities as stand-alone treatments in active MTP of
the uTM. Copyright © 2014 John Wiley & Sons, Ltd.

Received 31 July 2013; Revised 9 November 2013; Accepted 27 November 2013

Keywords
Evidence based practice; Management and Professional issues; Musculoskeletal; Physiotherapy; RCT

*Correspondence
Department of Biomedical Sciences, University of Sassari, Viale San Pietro 43/b, 07100 Sassari, Italy.
E-mail: andmanca@uniss.it

Published online in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/pri.1580

Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
Stand-alone Therapies in Myofascial Trigger Points
Introduction
Myofascial trigger points (MTP) in the neck are a com-
mon and costly condition, with a point prevalence of
10–18% and a lifetime prevalence of 30%–50% (Gur
et al., 2004). Several treatments such as manual therapy,
exercise, acupuncture, massage, ice, heat, transcutaneous
electrical nerve stimulation, anaesthetics injections, dia-
thermy, ultrasound (US) and low-level laser therapy
(LLLT) are currently provided for MTP (Robertson et
al., 2001; Alvarez and Rockwell, 2002). Particularly, US
and LLLT have achieved popularity and recognition
among physicians and physiotherapists as common,
non-invasive options of treatment (Beckerman et al.,
1992; Draper et al., 2010). Regarding the use of US for
MTP in the upper trapezius muscle (uTM), it was
reported to induce a significant reduction in pain inten-
sity (Majlesi and Ünalan, 2004), but other studies failed
in showing significant effects on pain (Gam et al., 1998)
or superiority to placebos (Lee et al., 1997); conflicting
evidence for US was also stated by a systematic review
(Vernon and Schneider, 2009). Regarding LLLT, reports
are generally positive, showing superiority to placebos
and effectiveness on pain and functional outcomes in
MTP (Vernon and Schneider, 2009). However, when
employed in a combined regimen of treatment with
exercise and stretching, results are conflicting (Altan
et al., 2005). Notably, in the United States, several
medical coverage policies do not cover LLLT for any
indication because it is considered an experimental/
investigational/unproven intervention (Blue Cross TEC,
2010). A strong disagreement between researchers and
clinical practitioners emerges when comparing clinical
guidelines (Chartered Society of Physiotherapy, 2006;
Australian Physiotherapy Association, 2001; Canadian
Physiotherapy Association, 2010) to survey about US
and LLLT protocols (Lindsay et al., 1990; Robertson
and Spurritt, 1998; Wong et al., 2007). The latter reveals
a tendency to their massive utilization as stand-alone
therapies in spite of no consensus about their effective-
ness (Gam et al., 1993; Robertson and Baker, 2001). Such
modus operandi is questionable and generally not
recommended by clinical guidelines (see in the previous
text) because these therapies are considered complemen-
tary to other more established interventions, such as
manual therapy and exercise. However, the employment
of combined regimens of treatment leads to conflict
attributions of effects (Gam et al., 1998; Altan et al.,
2005), making it difficult to evaluate the role of each
A. Manca et al.
single therapy. The aim of the present study was to assess
the effectiveness of US and LLLT delivery procedures
according to protocols commonly used by physiothera-
pists (Wong et al., 2007; Chow et al., 2009). Firstly, it
was evaluated whether a stand-alone therapy with either
US or LLLT was effective on MTP in the uTM. Secondly,
such protocols were compared with each other, with pla-
cebos or no therapy. Finally, all strategies were reassessed
after a 12-week follow-up.
Methods
Subjects and design
Trial design was set as a randomized, double-blind,
placebo-controlled, parallel-group study approved by
the local Ethical Committee (Bioethics Board of ASL
n.1-Sassari, prot. U-553, October 18, 2011; trial data fully
available at the Department of Biomedical Sciences). All
participants signed a written consent and an information
notice regarding experimental procedures before enrol-
ment. Sixty volunteers (28 women and 32 men; mean
age 24.5 ± 1.44 years; range 20–30 years) with a sponta-
neously painful area and a palpable taut band in at least
one uTM, disturbing normal daily activity, participated
in the study. Subjects were recruited among university
students, who are highly exposed to work-related mus-
culoskeletal symptoms (Hupert et al., 2004). Exclusion
criteria were the following: to meet general contraindica-
tions to electrophysical agents according to established
guidelines (Robertson et al., 2001; Chartered Society of
Physiotherapy, 2006; Houghton et al., 2010); to be a
physiotherapy student or to have already experienced
US and LLLT; a numerical rating score for pain lower
than 3 out of 10; no impact of the condition under study
on normal daily life; concomitant general diseases; dif-
fuse generalized musculoskeletal and joint pain, head,
neck or upper back pain due to osteoarticular patholo-
gies; ongoing physiotherapy treatment for the condition
under study at the time of enrolling or current use of
medications affecting pain and skin sensibility and shoul-
der and neck surgery within the previous year. The
recruited population underwent a clinical examination
performed by an orthopaedic physician experienced in
musculoskeletal disorders, and MTP were diagnosed as
active or latent (Simons, 1995). Selected subjects with
at least one active MTP within the uTM underwent
functional assessment performed by a physiotherapist
experienced in musculoskeletal conditions. The assess-
ment procedure was performed at three different times:
Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
A. Manca et al. Stand-alone Therapies in Myofascial Trigger Points

before intervention (baseline), after 2 weeks (post) and
after 12 weeks (follow-up) from the initial evaluation.
Demographic data and participants’ clinical characteris-
tics including age, sex, symptoms duration and referred
pain patterns and involved side were recorded.
examination, the active MTP (or the most painful
one, if more than one was detected) within the uTM
was marked with a dermographic pencil to allow a
reliable localization.
Active ultrasound

Randomization and blinding Eme-Medical Ultrasonic 1300, 1–3 MHz US machine

was used. Because a dose–response relationship for US
Participants were randomly assigned to one out of five
has not been identified yet by well-designed randomized
parallel groups in 1:1:1:1:1 allocation ratio, to receive
controlled trials (Robertson, 2002), delivery parameters
respectively active US (UsA-group I: n = 12), placebo
were set according to Wong et al. (2007) and Draper
US (UsP-group II: n = 12), active LLLT (LtA-group
et al. (1995): frequency 3 MHz, continuous mode, inten-
III: n = 11), placebo LLLT (LtP-group IV: n = 11) and
sity 1.5 W cm2, duration 12 minutes. US probe (head
with the fifth group acting as the control (no therapy:
size: 5 cm2) was applied steady with no pressure over
n = 14). No blocking was set for randomization. To
the trigger point. A coupling agent was used to optimize
generate the allocation sequence, Research Randomizer
delivery at the probe-skin interface. Because the painful
3.0 software was employed (Urbaniak and Plous,
area was limited to a trigger point, there was no need to
2011). Sixty opaque envelopes were prepared and
move the US probe with rotating movements as the ratio
numbered consecutively by AM, whereas participant
between effective radiating area and the size of US head
allocation to envelopes was performed by one of the
was approximately 1:1. No adverse effects such as
three physiotherapists employed to deliver treatments.
overheating occurred during the trial.
According to the envelope selection, patients were
allocated to one of the five groups listed in the previous
Placebo ultrasound
text. Both outcome assessor and participants were
blinded to interventions, whereas the three treating In group II, sham-US was applied following the
physiotherapists employed could not be blinded when same modalities of the active therapy, but the US head
delivering as they had to open each envelope and read cable was disconnected from the working device.
the assigned number and group of allocation. No Patients could not know whether the cable was
communication occurred between treating physiother- connected or not to the machine as the display was also
apists and the outcome assessor regarding trial course on with the time counting.
and participants.
Active low-level laser therapy

Interventions A J&S Medical-Cyberlight (J&S, Rome, Italy), Mod.

Ls1-Ga/As LLLT machine was used. According to the
All interventions and data collection took place at the
acknowledged guidelines (WALT, 2004), delivery pa-
Physiotherapy Clinic of the University Hospital of
rameters were: wave-length 904 nM; pulse duration
Sassari, Italy. Prior to the trials beginning, therapists
200 ns; pulse frequency 1953 Hz; peak power 90 mW;
were instructed on how to deliver both active treatment
average output 30 mW; power density 22.5 mW cm2;
and placebo, patient’s position and procedures and,
treatment time 600 seconds; energy dose 18 J per session;
also, to maintain an emotional detachment from the
spot size 4 cm2 and treatment frequency five times/week.
participant, avoiding any extra-intervention interaction
Laser probe (head size: 4 cm2) was applied steady in skin
with him/her. Sessions were performed at the same
contact with no pressure over the MTP.
time of the day and in the same location. The partici-
pants were recommended not to use any drugs for
Placebo low-level laser therapy
the condition under study throughout the 2-week
physical therapy or no therapy periods. Groups I–IV In group IV, sham-laser was applied following the
were treated five times weekly for overall 10 treatments same modalities of the active therapy, but the laser
given in 2 weeks. Patient’s position was set as re- probe cable was disconnected from the working
laxed high sitting with backrest. During orthopaedic device. As for the placebo US, patients could not

Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
Stand-alone Therapies in Myofascial Trigger Points
know whether the cable was connected or not to the
working machine.
No therapy (Control)
Subjects randomly assigned to group V (n = 14) only
underwent baseline, post and follow-up evaluations
without being given any treatment (active or sham)
in between.
Outcome measures
All groups underwent a baseline, a post-intervention
assessment and a follow-up session 12 weeks after the
end of the intervention phase. In each session, three
outcome measures were set: pressure pain threshold
(PPT); pressure-related pain assessed with a numerical
rating scale (NRS); upper trapezius extensibility
assessed, through cervical goniometry, during an active
lateral cervical flexion (cLat-Flex) to the side opposite
to the affected muscle.
Pressure pain threshold was determined using a
hand-held pressure algometer. A dual force gauge
mod. FDK-20 (Wagner Instruments, Greenwich-CT)
was used (calibration in kg cm2; capacity 10 kg × 100 g;
20 lb × 0.25 lb). The force recorded corresponded to the
quantity of pressure required to change subject’s sensa-
tion from pressure to pain. According to Fischer
(1987), pressure amount was increased at a rate of 1 kg
cm2 second, three measurements were taken with a rest
time of 20 seconds, and the mean was recorded for
data analysis.
Immediately after recording PPT, subjects were asked
to score on a NRS their pain at the changing point from
sensation of pressure to pain, and the mean was retained
for data analysis.
Lateral cervical flexion was assessed using a gravity-
reference Myrin goniometer (prod. Patterson Medical,
Illinois). Goniometer was fixed to the front of the head
with a Velcro® fastening strap. The subject’s position
was sitting with backrest and shoulders stabilized by the
examiner. As for PPT and NRS, three measurements
were taken, and the mean calculated for data analysis.
Statistical analysis
Data analysis was performed by using SigmaPlot-12
(Systat Software Inc., San Jose, California) by a blinded
statistician (EL). A priori power analysis to determine
the sample size was performed using G*Power 3
A. Manca et al.
(Faul et al., 2007). By using a power (1-β err. prob.)
of 0.80, α = 0.05 and an estimated effect size of 0.5
(Cohen, 1992), the required sample size to detect a
20% difference between treatment groups for the
primary outcomes was 11 subjects per group. Shapiro–
Wilk test was used to test the normality of distribution
for continuous variables, whereas the homogeneity of
variances was evaluated by Levene’s test. Two-way (five
conditions × three times) ANOVA was used to compare
changes in variables before and after intervention (post
and follow-up) and among groups, as well as main effects
and interactions. When significant differences were
detected, a post-hoc Holm–Sidak method multiple
comparison procedure was utilized. Significance level
was set for a p-value < 0.05. Unless otherwise stated, data
are expressed as mean ± standard deviation.
Results
Seventy-nine subjects met eligibility criteria for recruit-
ment but 16 of them refused consent, three were
excluded due to a NRS score < 3, so that 60 of 79
subjects were enrolled. Recruitment and participant
flow are presented in Figure 1. No harm or unintended
effects occurred during this trial. At baseline, all groups
were statistically homogeneous for age, PPT, NRS,
cLat-Flex, symptom duration and gender as shown in
Table 1, which reports demographic and clinical char-
acteristics of the sample. Results are shown BY GROUP
(Post vs. Pre; Follow-up vs. Pre and Follow-up vs. Post)
and detailed with scores and Cohen’s d effect sizes
(Cohen, 1992) in Table 2. After the 2-week interven-
tion for groups I–IV and no therapy for group V
(Control), each group showed statistically significant
changes (p < 0.05) of all outcome variables. In particu-
lar, PPT and cLat-Flex increased while NRS decreased.
Compared with the baseline, improvements remained
statistically significant at follow-up in all groups.
Compared with the post, further significant changes
of outcome scores were observed in several groups at
the follow-up (Table 2). Significances ensued from
multiple comparisons among groups at post and follow-
up, performed with a two-way ANOVA, are presented
in Figure 2, whereas the main effects (Condition and
Time) and interactions (Condition × Time) are reported
in Table 3.
Regarding PPT within Post, when performing all
possible comparisons, no statistically significant
differences were detected between active therapies
Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
A. Manca et al. Stand-alone Therapies in Myofascial Trigger Points

Figure 1. Organization chart

Table 1. Demographic and clinical characteristics of the sample at the baseline assessment

Group

Variable UsA (n = 12) UsP (n = 12) LtA (n = 11) LtP (n = 11) Control (n = 14)

Age (years) 24.5 ± 1.7 26 ± 0.8 24 ± 2.1 25.4 ± 0.7 23 ± 1.91

Gender (number and %) F: 7 (58.4%) F: 6 (50%) F: 7 (58.4%) F: 7 (58.4%) F: 7 (50%)
M: 5 (41.6%) M: 6 (50%) M: 5 (41.6%) M: 5 (41.6%) M: 7 (50%)
2
PPT (kg cm ) 2.13 ± 0.24 2.13 ± 0.20 2.02 ± 0.34 2.09 ± 0.27 2.12 ± 0.20
95% CI 1.99–2.27 2.02–2.24 1.82–2.22 1.93–2.25 2.02–2.22
NRS (0–10) 4.96 ± 1.20 4.68 ± 1.31 4.49 ± 0.97 5.15 ± 1.03 4.60 ± 1.05
95% CI 4.28–5.64 3.96–5.42 3.92–5.06 4.54–5.76 4.05–5.15
cLat-Flex (°) 31.17 ± 4.39) 30.75 ± 4.8 30.64 ± 4.20 31.64 ± 5.05 30.93 ± 5.15
95% CI 28.69–33.65 28.01–33.49 28.16–33.12 28.66–34.62 28.23–33.63
Symptom duration weeks 3.5 ± 1.8 3.0 ± 1.5 4.0 ± 1.0 3.0 ± 0.9 3.5 ± 0.8

UsA = active ultrasound; UsP = placebo ultrasound; LtA = active laser therapy; LtP = placebo laser therapy; Cont = no therapy; PPT = Pressure Pain
Threshold; NRS = Numerical Rating Scale; cLat-Flex = Cervical Lateral Flexion; CI = confidence interval evaluated by Levene’s test.
Values are expressed as mean ± SD.

(UsA; LtA) versus their placebos (UsP; LtP),
whereas control group scored significantly less than
both active and placebo groups (p < 0.05; d > 0.8).
No differences were found among intervention
groups (I–IV) at 12-week follow-up, while controls
kept on scoring less than any group (p < 0.05;
d > 0.5).
Regarding NRS within Post, notably LtA scored sig-
nificantly better than UsA (p = 0.04), UsP (p = 0.03)
and Control (p = 0.002) but not than LtP (p = 0.21).
Both active (UsA; LtA) and placebo therapies (UsP; LtP)
scored better than no therapy (p < 0.05; d > 0.8). Within
follow-up, no significant differences were detected
among groups with exception of UsA that scored better
than Control (p = 0.03) but not than any other inter-
vention group. When comparing LtA versus LtP versus
Control for the dependent variable NRS (Table 3), a
significant interaction (Condition × Time) was found
(F = 2.499; p = 0.048). The effect of different levels of
Time depends on the Condition, so that both factors

Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
Stand-alone Therapies in Myofascial Trigger Points A. Manca et al.

Table 2. Baseline to Post and Follow-up scores by group

Group

Outcomes UsA (n = 12) UsP (n = 12) LtA (n = 11) LtP (n = 11) Control (ref) (n = 14)
2
PPT (kg cm )
Pre 2.13 ± 0.24 2.13 ± 0.2 2.02 ± 0.34 2.09 ± 0.27 2.12 ± 0.2
Post 2.76 ± 0.24* 2.62 ± 0.25* 2.74 ± 0.41* 2.69 ± 0.37* 2.35 ± 0.28*
E.S (95% C.I) 1.56 (0.64–2.39) 1.01 (0.16–1.8) 1.14 (0.25–1.95) 1.06 (0.18–1.86)
, ,
Follow-up 2.8 ± 0.25§ 2.8 ± 0.29§ 2.8 ± 0.39§ # 2.8 ± 0.35§ 2.6 ± 0.43§ #
E.S (95% C.I) 0.56 ( 0.25–1.32) 0.54 ( 0.26–1.30) 0.49 ( 0.31–1.25) 0.51 ( 0.29–1.27)
NRS (0–10)
Pre 4.96 ± 1.2 4.68 ± 1.31 4.49 ± 0.97 5.15 ± 1.03 4.60 ± 1.05
Post 2.95 ± 0.86* 3.13 ± 1.29* 2.24 ± 1.01* 2.57 ± 0.87* 3.98 ± 1.11*
E.S (95% C.I) 1.03 (0.18–1.81) 0.71 (0.11–1.48) 1.63 (0.67–2.48) 1.39 (0.47–2.22)
, , , ,
Follow-up 1.38 ± 0.42§ # 2.0 ± 1.39§ # 1.3 ± 1.01§ # 2.1 ± 1.64§ 2.2 ± 1.54§ #
E.S (95% C.I) 0.7 (0.11–1.47) <0.3 ( 0.9–0.64) 0.67 (0.16–1.46) <0.3 ( 0.85–0.73)
cLat-Flex (°)
Pre 31.17 ± 4.39 30.75 ± 4.85 30.64 ± 4.2 31.65 ± 5.05 30.93 ± 5.15
Post 37.50 ± 3.06* 36.17 ± 2.66* 37.64 ± 3.17* 36.64 ± 3.88* 33.79 ± 5.13*
E.S (95% C.I) 0.86 (0.03–1.64) 0.57 ( 0.23–1.34) 0.88 (0.02–1.67) 0.62 ( 0.21–1.40)
Follow-up 38.17 ± 3.04§ 37.2 ± 2.12§ 37.5 ± 4.48§ 37.5 ± 4.23§ 34.9 ± 4.83§
E.S (95% C.I) 0.8 ( 0.03–1.57) 0.6 ( 0.21–1.37) 0.56 ( 0.27–1.34) 0.57 ( 0.26–1.35)

UsA = active ultrasound; UsP = placebo ultrasound; LtA = active laser therapy; LtP = placebo laser therapy; Cont = no therapy; PPT = Pressure Pain
Threshold; NRS = Numerical Rating Scale; cLat-Flex = Cervical Lateral Flexion; (ref)= reference group for Cohen’s d effect size computations.
*p < 0.05 comparing Post versus Pre.
p < 0.05 comparing Follow up versus Post.
#

§
p < 0.05 comparing Follow up versus Pre. Values are expressed as mean ± SD.

affect the outcome. Regarding cLat-Flex within Post, no Discussion

significant differences were found when comparing ac-
tive with placebo therapies. Controls scored significantly
less than active therapies (UsA, p = 0.02; d = 0.8; LtA,
p = 0.02; d = 0.8) but not than placebos (UsP, p = 0.08;
d = 0.5; LtP, p = 0.07; d = 0.6). At 12-weeks follow-
up, groups were not statistically different with excep-
tion of UsA that scored significantly better than Con-
trol (p = 0.02; d = 0.8). As presented in Figure 2, an
overall positive trend was observed across all groups
so that both active and placebo therapies achieved
statistically significant gains in the outcome measures
here considered. Control group, which was adminis-
tered with no therapy, also showed an overall
increase of clinical and functional outcomes in the
pre/post comparison, but scores were significantly
lower than other groups, suggesting a possibly higher
effectiveness for both active and placebo interven-
tions. Comparing active therapies and their placebos,
no significant differences were identified for
any outcome.
The present study, conducted in a sample representa-
tive of a cohort highly exposed to work-related muscu-
loskeletal symptoms (Hupert et al., 2004), showed that
delivering US or LLLT or their placebos or no therapy
at all was still effective in improving clinical and func-
tional scores of: (i) PPT; (ii) subjective pain on a NRS
and (iii) muscular extensibility of the affected uTM
during a cLat-Flex to the opposite side.
Pressure pain algometry is basically subjective as it for-
mally relies on patient’s feedback and sensibility that may
either be potential sources of bias. For the same reason,
the use of a numerical rating scale for pain may raise some
concerns. However, PPT has been shown to be reliable for
quantification of deep muscle tenderness (Nussbaum and
Downes, 1998; Gemmell & Hilland, 2011) and, similarly,
using a NRS for measuring musculoskeletal pain sensitiv-
ity is considered a valid tool (Williamson and Hoggart,
2005), so we are confident that appropriate procedures
in MTP assessment were here used. The same applies to

Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
A. Manca et al. Stand-alone Therapies in Myofascial Trigger Points

Figure 2. Effects of interventions on outcome variables by group (A) and significances and among groups (B). (A) Histograms show the
effects of interventions by group on each outcome (PPT, NRS; cLat-Flex) at Pre (black columns), Post (grey columns) and
Follow-up (white columns). Compared with Pre, significant improvements (p < 0.05) were observed for all outcomes in all
groups. * p < 0.05 comparing Post versus Pre; # p < 0.05 comparing Follow-up versus Post; § p < 0.05 comparing Follow-up
versus Pre. (B) Grid charts show a synopsis of significances found in all possible multiple comparisons among groups for each
outcome measure within Post and Follow-up. * p < 0.05 comparing groups within Post; # p < 0.05 comparing groups within
Follow-up. UsA = active ultrasound; UsP = placebo ultrasound; LtA = active laser therapy; LtP = placebo laser therapy; Cont = no
therapy; PPT = pressure pain threshold; NRS = numerical rating scale; cLat-Flex = cervical lateral flexion

goniometry employed in the evaluation of cLat-Flex, accepted instrument, in good agreement with more
which was performed using a well-recognized and sophisticated ones (Malmström et al., 2003).

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Stand-alone Therapies in Myofascial Trigger Points A. Manca et al.

Table 3. Main effects and interactions

Outcomes

PPT NRS cLat-Flex PPT NRS cLat-Flex

UsA versus UsA versus UsA versus LtA versus LtA versus LtA versus
UsP versus UsP versus UsP versus LtP versus LtP versus LtP versus
Cont (at Pre, Cont (at Pre, Cont (at Pre, Cont (at Pre, Cont (at Pre, Cont (at Pre,
Effects Post, Follow-up) Post, Follow-up) Post, Follow-up) Post, Follow-up) Post, Follow-up) Post, Follow-up)

Main effect F = 5.452 F = 1.860 F = 3.434 F = 2.765 F = 5.470 F = 2.645

CONDITION p = 0.006** p = 0.161 p = 0.036* p = 0.068 p = <0.001** p = 0.076
Main effect F = 48.170 F = 56.690 F = 21.388 F = 36.704 F = 50.884 F = 15.915
TIME p = <0.001** p = <0.001** p = <0.001** p = <0.001** p = 0.006** p = <0.001**
Interaction F = 1.754 F = 1.488 F = 0.767 F = 1.801 F = 2.499 F = 0.694
(CONDITION × TIME) p = 0.144 p = 0.211 p = 0.549 p = 0.135 p = 0.048* p = 0.598

UsA = active ultrasound; UsP = placebo ultrasound; LtA = active laser therapy; LtP = placebo laser therapy; Cont = no therapy; PPT = Pressure Pain
Threshold; NRS = Numerical Rating Scale; cLat-Flex = Cervical Lateral Flexion.
*Significant for p < 0.05.
**Significant for p < 0.01.

In active MTP, specifically affecting the uTM, it is
notable that the administration of a placebo or no
treatment achieved significant and consistent im-
provements similar to active interventions. When
performing comparisons among groups, data showed
that both active and placebo groups exhibited similar
outcome scores at the immediate post-intervention
assessment as well as at the follow-up, suggesting that
no superiority of one intervention over the others can
be stated. These data call into question the real efficacy
of worldwide acknowledged physical modalities, such
as US and LLLT, at least as stand-alone treatments in
the management of upper trapezius active MTP. This
point is also meaningful because no differences were
found between active and placebo interventions, even
in an experimental condition in which the operator
maintained an emotional detachment from the partici-
pant, avoiding any extra-intervention interaction. Be-
cause active therapies did not show any superiority
over sham treatments, a possible placebo effect is
therefore likely to have occurred so that psychological
factors should be considered and taken into account
by health professionals when prescribing or delivering
them to patients. The placebo effect of physical thera-
pies we experienced in this trial is consistent with a
number of studies (Ceccherelli et al., 1989; Altan
et al., 2005; Dundar et al., 2007). At the same time,
findings about the LLLT placebo effect here occurred
are inconsistent with two high-quality studies showing
superiority to placebo (Soriano and Rios, 1998; Basford
et al., 1999) and with studies in which LLLT was
successful as a mono-therapy (Simunovic, 1996;
Gur et al., 2004). Although all interventions proved
to be effective in improving subjective and objective
outcomes, controls scored significantly less than
active and placebo groups, thus suggesting that both
active and placebo therapies are more effective than
no therapy, with a medium-to-large effect size,
proving that the observed changes are clinically
important (Fritz et al., 2012). However, it seems
likely that therapies we employed in accordance to
procedures derived by the current clinical practice
had a role in speeding up the healing process more
than being essential to such process, as if US and
LLLT were useful rather than essential tools when
treating MTP of the uTM. Findings of this trial are
somehow difficult to compare to published literature
because of the high variability of a large number of
trials reporting different delivery parameters, as
described in surveys about physiotherapists’ use of
US (Ter Haar et al., 1988; Wong et al., 2007) and
LLLT (Chow et al., 2009). Such a comparison is diffi-
cult to set up also because, as far as we know, there are
no studies that prioritized the evaluation of how
physical therapies are delivered rather than what is
delivered, which was the main objective of this study.
Study limitations
In the present study, LLLT and US were delivered as
mono-therapies like commonly performed by physio-
therapists (particularly in mainland Europe and in the

Physiother. Res. Int. (2014) © 2014 John Wiley & Sons, Ltd.
A. Manca et al.
framework of health-insurance scenarios) rather than
associating them to other treatments (i.e. massage
and/or exercise) recommended by clinical guidelines.
This was carried out to assess the efficacy of US and LLLT
per se, weighing the effect of each single therapy, thus
avoiding conflicting attributions of effects, which is
commonly observed when employing combined regi-
mens of treatment (Gam et al., 1998; Altan et al., 2005).
Conclusions and implications for
physiotherapy practice
This study showed that US and LLLT, delivered as
stand-alone treatments in the management of active
MTP of the uTM, although being superior to no ther-
apy, do not provide any additional benefit beyond that
of their placebos. Such results, although consistent with
the literature, raise concerns and questions about: (i) the
appropriateness of commonly employed physical thera-
pies whose effectiveness is still debated; (ii) the efficacy
of the established modus operandi of health providers
and (iii) ethical issues concerning the standard manage-
ment of MTP.
The present findings may prove relevant for health
providers such as physicians and physiotherapists in
order to guide the decision-making process and pro-
mote informed and effective management for MTP.
This would provide potential benefit for patients,
fine-tuning third-party payer dynamics and, in the
whole, lowering social costs.
Acknowledgements
The authors gratefully thank Dr Tonino Zirattu for
performing orthopedic examinations and Drs Marco Testa
and Daniele Dragone for critically revising the manuscript.
Author contributions
Conception and design of the experiments: A.M. and F.D.
Project management: F.D. Collection, analysis and inter-
pretation of data: A.M., E.L., F.G., B.M., E.T and F.D.
Statistical analysis: E.L. Drafting the article or revising it
critically for important intellectual content: A.M., E.L.,
G.P., ER.DN. and F.D. All authors approved the final
version for publication.
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