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Physical Therapy in Sport 6 (2005) 116121

www.elsevier.com/locate/yptsp

Original research

Ultrasound therapy in the management of acute lateral


ligament sprains of the ankle joint
Elaine Zammita, Lee Herringtonb,*
a
Physiotherapy Department, St Lukes Hospital, Malta
School of Healthcare Professionals, University of Salford, Allerton Annexe, Frederick Road, Salford, Greater Manchester M6 6PU, UK

Received 3 December 2004; revised 18 April 2005; accepted 2 May 2005

Abstract
Objectives: To determine the efficacy of ultrasound treatment in the management of acute lateral ligament sprains of the ankle joint.
Design: Single-blind randomized controlled trial.
Setting: Physiotherapy Department of St Lukes Hospital, Malta.
Participants: Thirty-four patients with acute lateral ligament sprains of the ankle joint presenting to the Accident and Emergency Department
of St Lukes Hospital, Malta were randomly assigned to one of three treatment groups: active ultrasound treatment group (nZ12); placebo
ultrasound treatment group (nZ10); no ultrasound treatment group (nZ12).
Main outcome measures: Pain (visual analogue scale), swelling (tape measure), range of motion during dorsiflexion and plantarflexion
(universal 3608 goniometer), and postural stability (balance error scoring system) were measured on days 1 (baseline), 8, 15 and 22.
Results: No statistically significant differences (aZ0.05) between treatment groups were detected in any outcome measure. Within treatment
groups, statistically significant differences (aZ0.05) were detected in pain, swelling, range of motion during dorsiflexion and plantarflexion,
and postural stability.
Conclusions: At the dose and duration used, ultrasound treatment does not increase the effectiveness of management of acute lateral ligament
sprains of the ankle joint, with respect to the following outcomes: pain, swelling, range of motion during dorsiflexion and plantarflexion, and
postural stability.
q 2005 Elsevier Ltd. All rights reserved.
Keywords: Ultrasound therapy; Ankle injuries; Lateral ligament sprains; Inversion injuries

1. Introduction
Ankle injuries are one of the commonest causes of
referral to the Accident and Emergency Department
(Packer, Goring, Gayner, & Craxford, 1991), with lateral
sprains accounting for up to 95% of all ankle injuries
(Gooch, Geiringer, & Akau, 1993) and 12% of all injuries
(Garrick & Requa, 1988). Despite their importance, there is
still debate regarding the management of acute ankle sprains
(Van der Windt et al., 2003). Standard treatment usually
comprises of rest, ice, compression and leg elevation, but
* Corresponding author. Tel.: C44 1 61 295 2326; fax: C44 1 61 295
2395.
E-mail address: l.c.herrington@salford.ac.uk (L. Herrington).

1466-853X/$ - see front matter q 2005 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ptsp.2005.05.002

additional treatment is often considered to be necessary


(Oakland, 1993; Williamson, George, Simpson, Hannah, &
Bradbury, 1986).
Ultrasound is used frequently in the treatment of
musculoskeletal disorders (Roebroeck, Dekker, & Oostendrop, 1998). Dyson (1987) reported that ultrasound therapy
improved both the rate and quality of healing by possibly
increasing the activity of polymorphonuclear leucocytes,
macrophages, fibroblasts and endothelial cells, all of which,
are involved in the early stages of repair for soft tissues. The
same author also demonstrated that following ultrasound
therapy, there was an increase in intracellular calcium,
which, suggested that mechanisms to reduce inflammation
had been activated. Laboratory research has demonstrated
that the application of ultrasound results in the promotion of
cellular metabolic rate and increased visco-elastic properties of collagen (Maxwell, 1992).

E. Zammit, L. Herrington / Physical Therapy in Sport 6 (2005) 116121

In addition to the direct cellular effects induced by


absorption of ultrasonic energy, the method of treatment can
sometimes have a therapeutic psychological effect (ElHag,
Coghlan, Christmas, Harvey, & Harris, 1985). It has been
demonstrated that the exposure of oral surgery patients to
placebo treatments can result in a lowered perception of
pain, and that this is associated with changes in plasma betaendorphin levels (Hargreaves & Wardle, 1983).
Based on these and other findings, ultrasound has been
widely used in physiotherapy to relieve pain, reduce
swelling and improve joint mobility in a wide variety of
musculoskeletal disorders, including ankle sprains. Despite
the theoretical benefits and widespread use, conclusive
evidence on the effectiveness of ultrasound therapy in
patient care is not yet available (Van der Windt et al., 2003).
Van der Windt et al. (2003) carried out a systematic
review of controlled trials to determine whether ultrasound
therapy was more effective than placebo intervention, no
treatment, or other types of interventions in patients with
acute ankle sprains, with respect to the following outcomes:
general recovery, improvement of pain relief, swelling,
functional disability and range of motion. The reviewers
concluded that: (i) ultrasound therapy does not seem to help
to reduce pain and swelling, or to improve the ability to
stand on the affected foot; (ii) the extent and quality of the
available evidence for the effects of ultrasound therapy for
acute ankle sprains is limited; (iii) the results of four
placebo-controlled trials do not support the use of
ultrasound in the treatment of ankle sprains; (iv) the
magnitude of most reported treatment effects appeared to
be small, and probably of limited clinical importance;
(v) the number of trials evaluating the effectiveness of
ultrasound therapy for acute ankle sprains is small; (vi) due
to the limited amount of information on treatment
parameters, no conclusions can be made regarding an
optimal and adequate dosage schedule for ultrasound
therapy, and whether such a schedule would improve on
the reported effectiveness of ultrasound for ankle sprains.
The purpose of this investigation was to determine the
efficacy of ultrasound therapy in the management of acute
lateral ligament sprains of the ankle joint, with respect to the
following outcomes: pain, swelling, range of motion during
dorsiflexion (DF) and plantarflexion (PF), and postural
stability.

2. Methods
2.1. Participants
Thirty-four patients with acute lateral ligament sprains of
the ankle joint presenting to the Accident and Emergency
Department of St Lukes Hospital, Malta met the criteria
(Tables 1 and 2) and were selected to participate in the
study. Informed written consent was obtained from all
participants. Ethical approval for the study was granted

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Table 1
Inclusion criteria
Grade 1 & 2 inversion injuries of the ankle joint
Duration since, injury: O24 and !96 h
Ranging in age from 20 to 50 years
First distortion ever

from the ethics committee of St Lukes Hospital, Malta and


that of the Department of Exercise and Sport Science,
Manchester Metropolitan University. Participants were
randomly assigned to one of three treatment groups. Patients
assigned to group 1 were treated with active ultrasound, ice
packs, Tubigrip and exercises (nZ12). Patients assigned to
group 2 were treated with placebo ultrasound, ice packs,
Tubigrip and exercises (nZ10). Patients assigned to group 3
were treated with ice packs, Tubigrip and exercises (nZ12).
Twenty-nine participants completed the study (10 in group
1, 10 in group 2 and nine in group 3). Three participants
(one in group 1 and two in group 3) failed to attend for the
second assessment (day 8). Two participants (one in group 1
and one in group 3) failed to attend for the third assessment
(day 15). The demographic details of the participants who
completed the study are presented in Table 3.
2.2. Design
The study was a single-blind, randomized controlled
trial. The independent variables were time (four levels: days
1, 8, 15 and 22; design: repeated measures) and treatment
group (three levels: active ultrasound treatment group,
placebo ultrasound treatment group and no ultrasound
treatment group; design: independent groups). The dependent variables were pain, swelling, range of motion during
dorsiflexion and plantarflexion, and postural stability. The
control variables were ice packs, Tubigrip and exercises.
The confounding variables were weather, type of work,
Table 2
Exclusion criteria
Fractures
Complete ruptures (grade 3)
Previous similar injury
Multiple injuries
Participants in other trials
Low back pain with sciatic symptoms
Signs of degeneration in lumbar spine, hips and knees
Neurological impairment
Diabetes
Tumours or tissue in precancerous states
Infected areas
Uncontrollable haemophilia
Severely ischaemic tissues
Recent venous thrombosis
Areas of atherosclerosis
Areas that have received radiotherapy in the last 6 months
Metal bone-fixing pins subcutaneously placed
Plastics used in replacement surgery
Anaesthetic areas

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E. Zammit, L. Herrington / Physical Therapy in Sport 6 (2005) 116121

Table 3
Demographic database

Males
Females
Age in years
Grade 1 injury
Grade 2 injury
Duration since,
injury (hours)
a

Active
ultrasound

Placebo
ultrasound

No ultrasound

4
6
29G11a
6
4
60G26a

5
5
33G12a
6
4
60G26a

5
4
30G11a
5
4
61G27a

MeanGstandard deviation.

amount of rest, severity of injury and patients pre-mobility


status.
2.3. Protocols
Treatment was standardized for all patients with the
exception of ultrasound in the active and placebo groups.
Treatment sessions were carried out on alternate days for 2
weeks (six sessions); thereafter a follow-up session was
carried out after 1 week (day 22). A Medi-Link Control
Module Model 70 (Electro-Medical Supplies 1996,
Greenham, UK) was used for ultrasound treatment. The
ultrasound machine used in this study was calibrated
immediately beforehand using the manufacturers protocol.
The output of the ultrasound machine used was tested prior
to each treatment. A treatment intensity of 0.25 W cmK2 at
a mark space ratio of 1:4 at 3 MHz was used for treatments
1, 2 and 3 with duration of 10 min. A treatment intensity of
0.50 W cmK2 at a mark space ratio of 1:2 at 3 MHz was
used for treatments 4, 5 and 6 with duration of 6 min.
Treatment time was set to allow each area to be insonated
for 2 min (Watson, 2000). Placebo ultrasound treatment was
applied in an identical manner to active ultrasound
treatment but without the emitter switched on. Participants
were not aware of whether the ultrasound machine was in its
active or sham phases.
All patients were advised to apply crushed ice in a plastic
bag over a thin layer of cloth for 15 min, three times a day,
for 2 weeks. All patients were given a suitably sized
Tubigrip to wear throughout the day, for 2 weeks. The
exercises given to all patients are presented in Table 4.
The exercises were progressed depending on the outcome of
Table 4
Exercises
Active dorsiflexion, plantarflexion, inversion and eversion in supine lying.
Dorsiflexion, plantarflexion, inversion and eversion in sitting.
Dorsiflexion, plantarflexion, inversion and eversion in standing.
Heel and toe walking.
Balance board for sagittal movements and frontal plane actions in sitting.
Balance board for sagittal movements and frontal plane actions in standing.
Standing on injured leg for 20 s.
Balance exercises performed with injured leg on balance board.
Stretching of Achilles tendon (hold 15 s).

the treatment and the overall response of the participant. All


patients were instructed to repeat each exercise 20 times,
three times a day. Exercises involving the balance board
were only performed at the Physiotherapy Department.
Pain (10 cm visual analogue scale), swelling (figure-ofeight method using a tape measure), range of motion during
dorsiflexion and plantarflexion (universal 3608 goniometer),
and postural stability (balance error scoring system
(Riemann, Guskiewicz, & Shields, 1999)) were measured
by the same physical therapist at the Physiotherapy
Department of St Lukes Hospital, Malta on days 1, 8, 15
and 22.
Before recording visual analogue scale (VAS) scores,
patients were asked to (i) walk a fixed 10 m distance,
(ii) climb up and (iii) down six steps, (iv) walk up and
(v) down the slope found just outside the Physiotherapy
Department, actively (vi) dosiflex, (vii) plantarflex,
(viii) invert and (ix) evert the injured foot in supine
lying, passively (x) dosiflex, (xi) plantarflex, (xii) invert
and (xiii) evert the injured foot in supine lying, and
(xiv) dorsiflex, (xv) plantarflex, (xvi) invert and (xvii) evert
the injured foot in standing. Pain was computed as the
mean of the VAS scores recorded for the stated activities.
Prior to the commencement of the study, pilot work was
carried out to test the intratester reliability of the figure-ofeight method using a tape measure and the universal 3608
goniometer.
2.4. Data analysis
The statistical analysis was carried out using a SupaStat
Statistical Suite package (Version 3.55). The level of
significance was set at aZ0.05.
2.4.1. Demographics
Age and duration since injury were compared between
the three treatment groups using independent groups 1-way
analysis of variance. Sex and severity of injury were
analysed using a Chi-squared test.
2.4.2. Pilot work
Descriptive calculations performed included mean and
standard deviation. The significance of any differences was
analysed by repeated measures 1-way analysis of variance.
2.4.3. Main study
Descriptive calculations performed on pain, swelling and
range of motion during dorsiflexion and plantarflexion
included mean. The significance of any differences in pain,
swelling and range of motion during dorsiflexion and
plantarflexion was analysed by mixed 2-way analysis of
variance. Descriptive calculations performed on postural
stability included median. The significance of any differences in postural stability was analysed by a number of
Friedmans and KruskallWallis tests.

E. Zammit, L. Herrington / Physical Therapy in Sport 6 (2005) 116121

119

Table 5
Results of pilot work

Swelling (cm)
Dorsiflexion (8)
Plantarflexion (8)

Assessment 1

Assessment 2

Assessment 3

Assessment 4

52G4.0
5.8G6.1
50G11

52G4.0
6.2G6.5
50G11

52G3.9
6.0G7.0
50G10

51G4.0
5.4G6.3
50G12

Values are meanGstandard deviation.

3. Results

Fig. 2. Swelling (values are mean).

There were no statistically significant differences


(aZ0.05) between the treatment groups with respect to
age, duration since, injury, sex and severity of injury.
Pilot work demonstrated no statistically significant differences (aZ0.05) between assessments for any of the
measurements (Table 5).
No statistically significant differences (aZ0.05) were
detected between treatment groups in pain, swelling, range
of motion during dorsiflexion and plantarflexion, and
postural stability. Statistically significant differences
(aZ0.05) were detected within treatment groups in pain
(F3,81Z89), swelling (F3,81Z14), range of motion during
dorsiflexion (F3,81Z19) and plantarflexion (F3,81Z16), and
postural stability (group 1: c2Z15 with 3 degrees of
freedom; group 2: c2Z21 with 3 degrees of freedom; group
3: c2Z9.2 with 3 degrees of freedom). Descriptive
calculations performed on pain, swelling, range of motion
during dorsiflexion and plantarflexion, and postural stability
are presented in Figs. 15, respectively.
At follow-up (day 22) mean changes in pain were
reductions of 3.9, 4.0 and 4.2 cm, mean changes in swelling
were reductions of 1.0, 1.3 and 1.2 cm, mean changes in
dorsiflexion were an increase of 10, 5.2 and 5.58, mean
changes in plantarflexion were an increase of 4.7, 4.6 and
8.88, and median changes in postural stability were
reductions of four errors, 7.5 errors and two errors, for the
active ultrasound, placebo ultrasound and no ultrasound
treatment groups, respectively.

4. Discussion

Fig. 3. Dorsiflexion (values are mean).

in all three treatment groups. Between treatment groups, no


statistically significant differences were measured in any
outcome measure. As the treatment groups were comparable
in every respect, the results permit the conclusions that at
the dose and duration used in this study of active ultrasound
treatment offers no benefits over placebo ultrasound
treatment, as well as, placebo ultrasound treatment offers
no benefits over no ultrasound treatment in the management
of acute lateral ligament sprains of the ankle joint, with
respect to the following outcomes: pain, swelling, range
of motion during dorsiflexion and plantarflexion, and
postural stability.
The results are in agreement with the results obtained by
Nyanzi, Langridge, Heyworth, and Mani (1999), Oakland
(1993) and Williamson et al. (1986) who reported no
statistically significant differences between true (active) and
sham (placebo) ultrasound therapy for any outcome

Pain, swelling, range of motion during dorsiflexion and


plantarflexion, and postural stability significantly improved

Fig. 1. Pain (values are mean).

Fig. 4. Plantarflexion (values are mean).

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E. Zammit, L. Herrington / Physical Therapy in Sport 6 (2005) 116121

Fig. 5. Postural stability (values are median).

measure at 714 days of follow-up. The results are not in


agreement with the results obtained by Makuloluwe and
Mouzas (1977) who reported large and significant
differences in favour of ultrasound therapy, when compared
with immobilization by elastoplast. However, Van der
Windt et al. (2003) in their systematic review considered
this study to be of relatively poor validity.
The reliability of the VAS has been extensively tested
and is reported to be high when repeatedly used with the
same individual (Revill, Robinson, Rosen, & Hogg, 1976).
However, this is obtained at some cost to content validity, as
the VAS is a unidimensional scale. Mawdsley, Hoy, and
Erwin (2000) demonstrated that the figure-of-eight method
was a reliable and valid indirect method of measuring ankle
oedema in individuals with oedema secondary to sprains.
The average of two measurements of active range of motion
of both ankle dorsiflexion and ankle plantarflexion made
with the universal goniometer generally demonstrated good
reliability when the same physical therapist made repeated
measurements (Youdas, Bogard, & Suman, 1993). The
Balance Error Scoring System (BESS) is a reliable method
of assessing postural stability in the absence of computerized balance systems (Riemann et al., 1999).
The study investigated a small number of participants,
possibly not having enough statistical power to identify an
effect of ultrasound. Group comparison studies need
sufficient power. This is obtained either by investigating a
large number of subjects or a problem in which, the
differences in outcome are of a sufficient size to identify a
difference due to an intervention. Thus, another possibility
for non-significant findings between treatment groups is that
ultrasound used for therapy does not generally have a
sufficiently large or predictable effect to be reliably
identified. The moderating effects of the homeostatic
mechanisms of the body may help explain why fewer
clinical studies identify an effect of ultrasound when in vitro
and laboratory studies clearly indicate a biological effect
under some conditions.
The study included patients with different severities of
injury in the interest of increasing subject number. Possibly,
this compounds the problem of identifying an effect. The
study was a single-blind trial. Participants were not aware of
whether the ultrasound machine was in its active or sham
phases, however, the physical therapist and outcome

assessor was aware of whether the ultrasound machine


was in its active or sham phases. This weakens the design as
it also increases the testers potential influence on the
participants results. An identical probe that is disabled, i.e.
one from which, no energy is emitted when it is switched on
consequently permitting neither patients nor operator to
discriminate between the two different treatment heads
should be used in a further study of the topic.
Another possibility to account for non-significant
findings is that perhaps therapeutic ultrasound was not
used at the optimal time (stage) or dosage for the particular
problem studied. Treatment parameter selection for this
study abides by the basic principles reported by Watson
(2000). Due to the limited amount of information on
treatment parameters, no conclusions can be made regarding
an optimal and adequate dosage schedule for ultrasound
therapy, and whether such a schedule would improve on the
reported effectiveness of ultrasound for ankle sprains (Van
der Windt et al., 2003). Until now no doseresponse
relationship for ultrasound therapy has been identified. Too
few details are still provided in most studies to identify a
relationship between dosage and treatment responses
(Robertson, 2002). Without a known doseresponse
relationship, users of therapeutic ultrasound can only
guess what dosage might be effective for a patient. There
is still little agreement in the physical therapy literature as to
the dosage required to obtain a desired outcome for specific
clinical conditions.
The study did not include a follow-up period longer than
1 month. Ultrasound therapy is assumed to be most effective
in the first phase of treatment Roebroeck et al. 1998, and
long-term effects may not be expected. Fibroblasts exposed
to therapeutic levels of ultrasound in vivo can be stimulated
to synthesize more collagen, the fibrous protein which gives
soft connective tissue most of its tensile strength (Harvey,
Dyson, Pond, & Grahame, 1975). Commencing treatment in
the inflammatory stage can result in stronger and more
elastic scar tissue (Dyson, 1987). The main outcome
measures chosen to ascertain the effects of treatment were
not sufficient to determine the quality of healing. Moreover,
a much longer follow-up period would have been required
to investigate this effect.
A physiotherapy regime of ice packs, Tubigrip and early
exercise appears to hasten recovery at the same rate as that
of patients treated with the above regime together with
ultrasound treatment. This has important clinical implications, with special reference to issues of cost effectiveness, evidence-based practice and inconvenience of therapy
when using therapeutic ultrasound for patients with acute
lateral ligament sprains of the ankle joint. Physiotherapists
should be encouraged to maximize efficiency and effectiveness of treatment by enhancing their clinical reasoning
skills, reverting to analysis prior to decision making.
The role of ultrasound in clinical practice continues to
be questioned. Further well-designed randomized controlled trials (RCTs) of the clinical effects of ultrasound are

E. Zammit, L. Herrington / Physical Therapy in Sport 6 (2005) 116121

required if its efficacy is to be established. Nevertheless,


the performance of additional RCTs of ultrasound effects
may not necessarily fully answer the question of ultrasound
efficacy. RCTs have limitations and, as such, their findings
are often not fully incorporated into clinical practice
(Freeman & Sweeney 2001). Well-designed RCTs are
characterized by the presence of strict inclusion and
exclusion criteria resulting in the investigation of a
relatively homogeneous population. Although this is a
strength of the study, it renders the results of RCTs of
ultrasound effects site-, tissue- and pathology-specific. It is
not possible to generalize the results to alternate clinical
scenarios. To provide support for the wide range of
ultrasound applications in clinical practice, an unfeasible
number of RCTs would be required. The performance of
additional RCTs of ultrasound effects may also not
necessarily provide sufficient evidence to reject the use
of ultrasound in clinical practice. In addition to being site-,
tissue- and pathology-specific, the results of RCTs of
ultrasound effects are also dosage specific. Ultrasound is
bestowed with a large number of parameters that combine
to construct the final dosage. Manipulation of these
parameters produces a near endless range of dosages.
RCTs that establish that one particular dose is not
beneficial cannot be used to generalize the potential effects
of alternative ultrasound dosages.

5. Conclusions
At the dose and duration used in this study, ultrasound
therapy is not effective in the management of acute lateral
ligament sprains of the ankle joint, with respect to the
following outcomes: pain, swelling, range of motion during
dorsiflexion and plantarflexion, and postural stability.

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