sports

Article
Cryo plus Ultrasound Therapy, a Novel Rehabilitative
Approach for Football Players with Acute Lateral Ankle Injury
Sprain: A Pilot Randomized Controlled Trial
Antonio Ammendolia 1,2 , Alessandro de Sire 1,2, * , Lorenzo Lippi 3,4 , Valerio Ammendolia 1 ,
Riccardo Spanò 1 , Andrea Reggiani 5 , Marco Invernizzi 3,4 and Nicola Marotta 2,6

1 Physical and Rehabilitative Medicine Unit, Department of Medical and Surgical Sciences, University of Catanzaro
“Magna Graecia”, 88100 Catanzaro, Italy; [email protected] (A.A.); [email protected] (V.A.);
[email protected] (R.S.)
2 Research Center on Musculoskeletal Health, MusculoSkeletalHealth@UMG, University of Catanzaro “Magna
Graecia”, 88100 Catanzaro, Italy; [email protected]
3 Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont
“A. Avogadro”, 28100 Novara, Italy; [email protected] (L.L.); [email protected] (M.I.)
4 Integrated Activities Research and Innovation Department (DAIRI), Translational Medicine, Hospital SS.
Antonio Biagio e Cesare Arrigo, 15121 Alessandria, Italy
5 Physical and Rehabilitative Medicine, Casa di Cura La Madonnina, 20122 Milan, Italy; [email protected]
6 Physical and Rehabilitative Medicine, Department of Experimental and Clinical Medicine, University of
Catanzaro “Magna Graecia”, 88100 Catanzaro, Italy
* Correspondence: [email protected]; Tel.: +39-0961-712819

Abstract: Background: Acute lateral ankle sprains are common injuries among athletes, but the
optimal treatment strategies in elite athletes are still debated. This proof-of-concept study aimed
to assess the impact of cryo-ultrasound therapy on the short-term recovery of football players with
acute lateral ankle sprains. Methods: Semi-professional football players with grade I or II lateral
ankle sprains were randomly assigned to the experimental group (receiving cryo-ultrasound therapy
Citation: Ammendolia, A.; de Sire, combined with conventional physical therapy) or control group (sham cryo-ultrasound therapy
A.; Lippi, L.; Ammendolia, V.; Spanò, combined with conventional physical therapy). Pain intensity and physical functioning were assessed
R.; Reggiani, A.; Invernizzi, M.; by the Numeric Rating Scale (NRS) and Foot and Ankle Disability Index (FADI) at baseline (T0) at
Marotta, N. Cryo plus Ultrasound the end of treatment (T1), after one month (T2), and two months after treatment (T3). Results: After
Therapy, a Novel Rehabilitative the study intervention, significant between groups differences were reported in terms of pain relief
Approach for Football Players with
(NRS: 4.08 ± 1.29 vs. 5.87 ± 1.19; p = 0.003) and physical function (FADI: 50.9 ± 10.3 vs. 38.3 ± 11.5;
Acute Lateral Ankle Injury Sprain: A
p = 0.021). However, no significant between group differences were reported at T2 and T3. No
Pilot Randomized Controlled Trial.
adverse effects were reported. Conclusions: Cryo-ultrasound therapy combined with conventional
Sports 2023, 11, 180. https://doi.org/
10.3390/sports11090180
physical therapy can accelerate recovery and early return to sport in elite football players with acute
lateral ankle sprains. While this study contributes valuable insights into the potential benefits of
Academic Editor: Jesper Augustsson
cryo-ultrasound therapy, further investigations with a longer follow-up are needed to validate and
Received: 30 July 2023 optimize the application of physical agent modalities in the management of ankle injuries.
Revised: 5 September 2023
Accepted: 8 September 2023 Keywords: cryo-ultrasound; cryotherapy; ultrasound; ankle; sports; football; rehabilitation
Published: 9 September 2023

1. Introduction
Copyright: © 2023 by the authors.
Ankle injuries are highly prevalent among professional and amateur sports, with
Licensee MDPI, Basel, Switzerland.
the most typical mechanism of injury involving the combination of plantar flexion with
This article is an open access article
distributed under the terms and
foot inversion [1]. This injury usually shows lateral ligaments of the ankle impairments,
conditions of the Creative Commons
with an incomplete tear of one or more ligaments, which could be treated conservatively;
Attribution (CC BY) license (https://
indeed, after acute ankle sprains, initial immobilization using a soft splint resulted in faster
creativecommons.org/licenses/by/ recovery than simple tubular bandage compression [2].
4.0/).

Sports 2023, 11, 180. https://doi.org/10.3390/sports11090180 https://www.mdpi.com/journal/sports

Sports 2023, 11, 180 2 of 10

In this scenario, a short-term immobilization with functional physiotherapy is prefer-

able to 2/3 weeks conventional therapy with plaster [3]. Albeit, there is substantial evi-
dence on the management of ankle injuries [4–9], but there is a disagreement regarding the
best therapy management for acute ligament injuries in elite athletes, particularly during
COVID-19 era [10–13].
However, nonsurgical therapies can be prescribed for most acute grade I–III lateral
ligament sprains with good to excellent outcomes; in detail, physical therapy and several
pharmacological treatments and physical agent modalities can be utilized to enhance pain
relief and tissue healing, including: diathermy, laser therapy, ultrasound therapy, and other
forms of electrical therapies [14–16].
In 2012, van den Bekerom et al. [17] suggested that the possible effects of ultrasound
therapy seem to be mostly mild and there is the possibly of partial clinical implication,
particularly in the short term of the rehabilitation program after these injuries; however, the
evidence was insufficient to define an adequate dosage of ultrasound therapy that would be
beneficial. On the other hand, ultrasound therapy has been described as a helpful treatment
in relieving pain in sports injuries, acting as an edema regulator, presumably by increasing
pain thresholds, collagen flexibility, reducing edema and, consequently, inflammation and
joint stiffness [18].
Considering the current evidence, cryotherapy appears to be effective in reducing pain,
although compared to other rehabilitative approaches, the effectiveness of cryotherapy
is still considered as controversial [19,20]. The real effect of cryotherapy on the most
frequently treated acute injuries, such as joint sprains or soft tissue injuries, has not been
completely explicated [21]. Furthermore, the poor methodology of the current evidence
is of concern, so further research is needed to produce proper guidelines of cryotherapy
approach and usage, focusing on the development of modalities, durations, and frequencies
of ice treatment for dealing with the injury [22–24]. In fact, Kwiecien et al. stated that
cryotherapy-induced metabolism decreases in inflammation and tissue damage have been
proved in an in vivo muscle injury model; nonetheless, analogous evidence in humans is
absent. This lack of evidence is prospective due to the insufficient length of application of
conventional cryotherapy approach. The conventional application of cryotherapy must be
repeated to address this concern [22].
Newly, literature engagement has been raised on the role of cryo plus ultrasound ther-
apy, a physical agent modality that combines cryotherapy (cold therapy) with therapeutic
ultrasound [25]. This treatment has been used for soft tissue injuries and inflammatory con-
ditions, mainly in sports medicine and rehabilitation [26]. In this context, the combination
of cold and ultrasound, using a single device, might create a synergistic effect, providing
both anti-inflammatory and tissue-repairing benefits [26]. Despite these considerations,
there is nevertheless a considerable gap of knowledge on the therapeutic effects of cryo plus
ultrasound therapy in patients with acute ankle sprain. Furthermore, to date, no previous
trial characterized the role of a specific cryo plus ultrasound therapy by a single device in
the conventional rehabilitation of elite athletes with acute ankle sprain.
Therefore, the purpose of this pilot randomized controlled trial was to assess the
impact of cryo plus ultrasound therapy in the short-term recovery of football players
affected by acute lateral ankle sprain.

2. Materials and Methods

2.1. Participants
This trial was evaluated and registered by the local ethics committee (Comitato Etico
Territoriale Regione Calabria) providing the following code: 115/2022, in respect of the
Declaration of Helsinki and following the ethical guidelines of the responsible legislative
institute. Athletes were educated about the aim of the pilot trial and provided informed
consent to collect clinical information for scientific assessments and purposes. All rights
of the enrolled subjects in the present study were protected. All authors and research
participants were educated in caring about the privacy of the subjects involved.
Sports 2023, 11, 180 3 of 10

Inclusion criteria were: (a) adult male; (b) semi-professional football players; (c) I–II
grade lateral ankle sprain injury; (d) no persistent instability phenomena or chronic sprains;
(e) acute injury (within 2 weeks from trauma); (f) no evidence of bone edema or skin
disorder, once the area of intense pain in motion was delimited, the lack of neurological
disturbances was investigated and assessed.
Exclusion criteria were: (a) history of recurrent dislocation of the ankle or hyperlaxity
of any joint; (b) severe rheumatic diseases and/or collagen diseases; (c) athletes who
have received any form of local physical therapy and NSAIDs within the last 2 months
prior to injury; (d) athletes who admit to using steroids; (e) any contraindication and/or
limitation to the use of a physical agent modality (implantable electrophysiological devices,
active neoplasms).
Then, all the athletes included in this pilot trial were randomly allocated with a 1:1
ratio in an experimental group and control group. Randomization was performed by an
author not involved in this step of the process of the study using random blocks.

2.2. Intervention
Both groups followed the same rehabilitation program in the first week, while the
patients were treated with the experimental or sham intervention during the following
2 weeks. During the first week, the approach consisted of a synthetic splinting system
for joint immobilization, Canadian crutches for weight-bearing ease, draining massage
performed by a physiotherapist with progressive proprioceptive exercises.
After the first week, participants of the experimental group underwent a combination
of cryotherapy and ultrasound therapy treatment. The treatment was performed by an
expert physiotherapist with a single Cryosound 1.16 device (ELCAP—Giarre CT, Italy) for
both treatment groups [6].This device simultaneously delivers cryotherapy and therapeutic
ultrasound with the same applicator, not allowing the patient (the blind component of the
study) to recognize which type of therapy he was undergoing. The experimental group
was subjected to continuous application of cryo-ultrasound, with a temperature of −4 2of◦ C
Sports 2023, 11, x FOR PEER REVIEW 11
2
and a power of 1.8 watt/cm , as illustrated in Figure 1.

Figure1.1.Cryo-ultrasound
Figure Cryo-ultrasoundtherapy
therapydevice.
device.

In the control group, a sham treatment was provided without the administration of
ultrasound therapy and with the use of only the perceptible sensation of cold, but not at
the therapeutic level of cryotherapy. All patients cannot recognize the dummy therapy
because the device looks the same as the active one. A 40 min session was performed for
Sports 2023, 11, 180 4 of 10

In the control group, a sham treatment was provided without the administration of
ultrasound therapy and with the use of only the perceptible sensation of cold, but not at
the therapeutic level of cryotherapy. All patients cannot recognize the dummy therapy
because the device looks the same as the active one. A 40 min session was performed for
both groups, the first 20 min dedicated to rehabilitation recovery of articular function and
proprioceptive exercises and the remaining 20 min for the execution of cryo-ultrasound
therapy for the active or sham group.
For conventional physical therapy, stretching exercises were conducted in the early
phase with closed-chain ankle motions and unloaded dorsiflexion stretching approaches
progressing to standing calf stretch and global joint stretching in open-chain [11]. In parallel,
progressive strengthening exercises were performed after pre-injury ROM recovery, starting
with isometric exercises in both the frontal and sagittal planes. Next, the player moved
to isotonic resistance exercises using weights, bands, or therapist manual resistance for
all planes pain-tolerated motions [27]. Finally, in the initial stages, PNF exercises started
with intrinsic movement of the foot (extension of the toes with plantar flexion of the
ankle/flexion of the fingers with dorsiflexion of the ankle) and trainings implemented on a
surface of different consistencies, a plank wedge, or a Bosu [28]. Firstly, the subject should
start with a wedge plank in an anteroposterior direction; lastly, with greater pain control, a
seated Biomechanical Ankle Platform System (BAPS) was utilized for all planned exercises.

2.3. Outcome Measures

Pain intensity was considered as the primary outcome measure with a pain numeric
rating scale (NRS); considered by any functional activity or movement of the injured
ankle. The NRS is an 11-point numerical score from 0 demonstrating “no discomfort” to
10 expressing the “worst pain ever felt”.
Secondary outcome measures were the Foot and Ankle Disability index (FADI), uti-
lized as a degree of functional limitation related with foot and ankle disorders; involving a
26-item sub-score of daily living and pain; each element has a score from 0 (unable to do)
to 4 (no difficulty at all). The total possible score is 104 points and a lower score indicates a
higher value of functional limitation. Finally, we evaluated quality of life through EuroQol-
5D (EQ-5D) index. All patients underwent clinical follow-up at the end of treatment (T1),
after 1 month (T2), and 2 months after the end of treatment (T3)

2.4. Statistical Analysis

Statistical analysis was performed using JASP Statistical Package (1.16 Amsterdam,
The Netherlands). Data were verified for normal distribution according to Shapiro–Wilk
test. Homogeneity of variance analysis was assessed via Leven’s test. Categorical or di-
chotomous variables were summarized with frequencies. Continuous data were presented
with means and standard deviations. Effect sizes were presented through Cohen d (95%
Confidence interval), all outcome data were calculated for within group and between group
differences from different time points. Effect sizes were interpreted as minor <0.5; adequate
between 0.5 and 0.8; and large, >0.8. For each test, statistical analyses were 2-tailed and a
p-value cut-off set at <0.05 was considered significant. The G-Power statistics module from
JASP software was used to ensure the assessment of the appropriate sample size. Assuming
an alpha level of 0.05 and 80% power, through an effect size of 0.40, with a repeated measure
analysis of variance between group interactions, an appropriate sample size was set at
23. This was enlarged to 26 (13 participants per arm) regarding a potential 10% dropping
out assumption, and an equal group distribution of subjects included. This study was
evaluated and approved by the local ethics committee (Comitato Etico Territoriale Regione
Calabria) providing the following code: 115/2022.

3. Results
In total, 25 players who met the trial eligibility and who observed the follow-up were
evaluated, as depicted in Table 1. Twelve patients were enrolled in the control group,
Sports 2023, 11, 180 5 of 10

whereas thirteen participants were included in the experimental group. The mean age of
the players enrolled in the pilot trial was 22.8 ± 12.62 years. At T0, the groups did not
report any demographic and morphometric differences.

Table 1. Demographic and morphometric characteristics with baseline evaluations of self-reported scales.

Characteristic Group Exp (n = 13) Group Cnt (n = 12) p-Value

Age (y), mean ± SD (range) 22.5 ± 12.4 (18 to 41) 23.1 ± 11.5 (21 to 38) 0.114
Weight (kg) 75.1 ± 13 (47 to 88) 77 ± 14 (50 to 92) 0.085
Body mass index, mean ± SD 23.2 ± 4 (19 to 29) 22.9 ± 5 (18 to 30) 0.102
NRS (0–10), mean ± SD 7.69 ± 2.19 7.79 ± 1.19 0.214
EQ-5D-3L Index, mean ± SD 0.5 ± 0.3 0.6 ± 0.2 0.112
FADI (0–104), mean ± SD 32.9 ± 10.5 28.3 ± 10.6 0.079
Abbreviations: Cnt, Control Group; EQ-5D-3L, European Quality of Life 5 Dimensions 3 Level Version; Exp, Ex-
perimental group; FADI, Foot and Ankle Disability Index; NRS, Numerical Rating Scale; SD, standard deviation.

A baseline subject assessment reported that both groups had noticeable intensities of
pain, with no significant differences between the groups. Nonetheless, starting from T1 and
during the treatment plant, the athletes who were enrolled in the experimental group had a
significantly larger pain decrease than the control group; however, at T3, similar results
were reported in both groups. In parallel, the FADI results showed comparable levels of
progress over time for both study groups. Despite these results, patients who received
the active cryo plus ultrasound device management displayed significant enhancement in
control subjects at T1, but similar results at T3 (Table 2).
Table 2. Within group differences in the outcome measures for active cryo-ultrasound therapy and
control groups.

∆T0-T1 ∆T1-T2 ∆T2-T3

T0 T1 T2 T3
p ES p ES p ES
active 7.69 ± 2.19 4.08 ± 1.29 0.006 −0.9 3.29 ± 1.05 0.041 −0.3 2.78 ± 0.91 0.083 −0.5
NRS (0–10)
sham 7.79 ± 1.19 5.87 ± 1.19 0.009 −0.6 4.06 ± 1.37 0.052 −0.4 2.86 ± 1.37 0.042 −0.5
FADI active 32.9 ± 10.5 50.9 ± 10.3 0.031 0.7 79.9 ± 8.5 0.005 0.7 96.6 ± 7.6 0.012 0.6
(0–104) sham 28.3 ± 10.6 38.3 ± 11.5 0.027 0.5 76.6 ± 11.2 0.009 0.5 94.5 ± 7.1 0.039 0.6
active 0.5 ± 0.3 0.6 ± 0.2 0.106 0.1 0.7 ± 0.3 0.093 0.0 0.7 ± 0.3 0.0 −0.7
EQ-5D-3L
sham 0.6 ± 0.2 0.7 ± 0.3 0.124 0.1 0.7 ± 0.2 0.082 0.0 0.7 ± 0.2 0.0 −0.7
All data are expressed as means ± standard deviations. Abbreviations: ES, Effect size; EQ-5D-3L, European
Quality of Life 5 Dimensions 3 Level Version; FADI, Foot and Ankle Disability Index; NRS, Numerical Rating
Scale; SD, standard deviation.

In the light of these paired results, we evaluated the differences between the groups at
each time point, as shown in the Table 3.
Table 3. Between group differences in the outcome measures for active cryo-ultrasound therapy and
control groups.

T0 T1 T2 T3 ANOVA-RM
p-Value ES p-Value ES p-Value ES p-Value ES p-Value
active
NRS 0.744 −0.06 0.003 −0.69 0.212 −0.65 0.534 −0.06 0.002
sham
active
FADI 0.2 0.20 0.021 0.57 0.345 0.23 0.386 0.21 0.039
sham
EQ-5D-3L active
0.106 0.11 0.127 0.21 0.242 0.13 0.342 0.09 0.128
Index sham
Abbreviations: ES, Effect size; EQ-5D-3L, European Quality of Life 5 Dimensions 3 Level Version; FADI, Foot and
Ankle Disability Index; NRS, Numerical Rating Scale; SD, standard deviation.
 active
FADI 0.2 0.20 0.021 0.57 0.345 0.23 0.386 0.21 0.039
sham
active
EQ-5D-3L Index 0.106 0.11 0.127 0.21 0.242 0.13 0.342 0.09 0.128
sham
Sports 2023, 11, 180 Abbreviations: ES, Effect size; EQ-5D-3L, European Quality of Life 5 Dimensions 3 Level 6Version;
of 10
FADI, Foot and Ankle Disability Index; NRS, Numerical Rating Scale; SD, standard deviation.

Moreover,
Moreover, wewe reported
reported thethe repeated
repeated measures
measures analysis
analysis as aascumulative
a cumulative evaluation
evaluation
also at the follow-up (for further details, see Figure
also at the follow-up (for further details, see Figure 2). 2).

Figure 2. Marginal means plot for NRS and FADI assessment.

Figure 2. Marginal means plot for NRS and FADI assessment.
4. Discussion
4. This
Discussion
pilot randomized controlled trial aimed to evaluate the short- and long-term
This
effects of cryopilot
plusrandomized controlled
ultrasound therapy, triala aimed
using to evaluate
single device, withthe short- andphysical
conventional long-term
therapy
effectsversus
of cryoconventional physical
plus ultrasound therapy
therapy, usingalone in football
a single players
device, with with acutephysical
conventional and
subacute I–II grade ankle sprain.
At the end of the treatment (T1), active cryo plus ultrasound therapy, in addition to
the group treated with conventional physical therapy, allowed the players to obtain high
pain relief (NRS, active group: 4.08 ± 1.29 compared to the sham group: 5.87 ± 1.19) and
an increase in FADI scale score (active group: 50.9 ± 10.3 vs. sham group: 38.3 ± 11.5);
however, similar results were observed at two weeks (T2) and four weeks (T3) of follow-up
in both groups, without any side effects.
Conversely, these results legitimize the effectiveness of conventional physiotherapy in
the medium term; nonetheless, in the short term, they demonstrated an accelerated recovery
and consequent early RTS for the group treated with the synergistic use of cryotherapy and
ultrasound therapy.
Unfortunately, there are common mythoi and fallacies in ankle sprain management;
these embrace numerous and unnecessary imaging, inapt non-weight bearing, unwarranted
immobilization, delayed functional recovery, and inadequate rehabilitative approaches.
The application of an evidence-based tailored program that embraces the individual char-
acteristics of the sportsperson could be useful and should be recommended [11].
Logan et al. [29] reported that ultrasound therapy could provide therapeutic effects in
the control of pain symptoms especially in sports-related disorders, in edema management,
as well as in the reduction in stiffness and functional improvement of joint ROM, plausibly
raising the pain threshold, the microstructural flexibility provided by collagen fibers, resolv-
ing the edematous framework, as well as the cytokine pattern underlying the inflammation,
up to muscle and joint spasms [29]. In 2011, a systematic review on acute ankle sprains
concluded that UST was no more effective than a placebo in treating pain and edema,
without providing details on the techniques used for measuring UST parameters [30,31].
Doherty et al. [32] suggested that there is a lack of evidence to examine the efficacy of UST
in treating acute ankle sprains; the need for rigorous RCTs to demonstrate efficacy has been
emphasized. In this scenario, Daniel et al. [33] concluded that the association of UST with
taping and PNF training plus tape applications was most advantageous in the treatment
and rehabilitation of high ankle sprain injury; indeed, the author suggested that combined
effect functional training with UST could be explored by future research.
In fact, Kinkade’s data reported that ice applications and heat packs had match-
ing results [34]; while Costello et al. [35] established that a whole-body cryotherapy
Sports 2023, 11, 180 7 of 10

(−110 degrees C) administration provided prompt pain relief and, after 15 min, also re-
duced muscle tone. Lastly, ice could ensure an analgesic result, which might also facilitate
therapeutic exercise in early rehabilitative phase [10]. In this scenario, it can be stated that
cryotherapy, applied by a specific device, has an immediate and profound analgesic effect
on severe nociceptive pain and accelerates the tissue healing process by reflex vasodilatation
followed by vasoconstriction [36,37].
Dehghan et al. [38,39] recommended further studies that could measure the combined
effects of different rehabilitative approaches including cryo and thermo-therapy, PNF,
acupuncture, etc., on the control of pain. Indeed, there is no sufficient evidence that
applying ice alone might decrease pain and swelling, as well as enhancing functioning
in people with a I–II grade acute ankle sprain [40,41]. Nevertheless, cryotherapy for 3 to
7 days is habitually utilized to decrease pain, diminish swelling and bleeding, reduce the
effects of vasoconstriction; furthermore, the administration of spray or ice packs with a
20 min protocol every two hours is commonly considered to be useful [42]. Additionally,
it is often suggested that intermittent immersion cold therapy could be supportive for
early pain decrease [11]. The innovative element of this pilot randomized controlled trial is
instead the usage of a single device for the delivery of the physical agent, without providing
an empirical application but guaranteeing the use of an instrumental combination with the
same applicator for cryo and UTS [11].
In an injured sportsperson, appropriate timing and safe RTS or competition is the
estimated outcome of the rehabilitative approach [43,44]. In this scenario, the sports
doctor would finally have to decide on the athlete’s readiness to RTS, following a complex
procedure with controversial indication from various bases [45–48]. On the other hand,
getting feedback from rehabilitation team members is imperative, as many of the crucial
outcomes might not be assessed or supervised in appropriate settings [49]. The proper
RTS timing is often based on the severity of the injury, considering that a common mild
ankle sprain might take a 4 week recovery plan and a more deep syndesmotic damage
takes 8 weeks for an adequate RTS [50,51]. Since several professional players (particularly
in contact sports such as basketball, football and soccer) might often have suffered multiple
ankle injuries, with a common joint instability, a safe and rapid approach can be of great
help to sports medical personnel [14,52]. Clearly the athlete’s tissue healing response may
depend on key factors such as age, genetic patterns, player experience with pre-injury
condition, and their following of the rehabilitation protocol [9,53–55].

4.1. Future Perspectives

Cryotherapy seemed to play an antalgic role in the immediate post-trauma period and
also to accelerate recovery; this could suggest that the cryoultrasound approach partially
contributes to pain reduction, but larger follow-ups will be needed, even if it will be
difficult to objectify them by the acute nature of the disorder [26]. On the other hand,
cryotherapy would seem to generate a cooling cone in the tissue through which the high-
power ultrasound waves would pass, producing a deep thermal result, which is well
tolerated and efficient in reducing painful symptomatology, developing a trophic effect [54],
but larger samples with more stringent inclusion criteria will be needed.

4.2. Study Limitations

However, this proof-of-concept study is not without its limitations. First, one latent
limitation is that the ending follow-up is quite undersized. Nonetheless, because ankle
sprains are an acute and often self-limiting disorder, longer follow-up might make it difficult
to attribute recovery to intervention alone, compromising both findings and conclusions.
Secondly, in this context, it is difficult to be aware of the actual return to play, sport,
or tangible pre-injury performance. However, in the athlete’s competitive context, the
incompetence to run or jump, and therefore to train, is the most key feature to study, which
is why we consider the FADI to be a truly reliable index for this purpose. Third, there is no
assessment of a long-term follow-up. Lastly, both cryotherapy and ultrasound therapy, to
Sports 2023, 11, 180 8 of 10

the best of our knowledge, do not have an appropriate and recommended dosage for these
patients, on the other hand this is the first study aiming to analyze the combined approach
and to provide, as much as possible, the two physical agent modes using a single device.

5. Conclusions
In conclusion, this a pilot randomized controlled trial aimed at evaluating the impact
of cryo plus ultrasound therapy, using a single device, on the short-term recovery of
football players with acute lateral ankle sprains. Taking together our findings suggested
that cryo plus ultrasound therapy can accelerate recovery and an early return to sport in
elite athletes. Overall, this study contributes to the understanding of the potential benefits
of cryo plus ultrasound therapy in the management of acute lateral ankle sprains of elite
athletes. Further studies with longer follow-ups are needed to confirm these positive data
and to explore and refine the use of physical agent modalities to optimize the recovery and
return to sport of athletes with ankle injuries.
Author Contributions: Conceptualization, A.A., A.d.S. and N.M.; methodology, A.A., A.d.S. and
N.M.; software, N.M.; validation, A.A., A.d.S., L.L., A.R., M.I. and N.M.; formal analysis, N.M.;
investigation, V.A., R.S. and N.M.; resources, A.A.; data curation, A.A., A.d.S., M.I. and N.M.;
writing—original draft preparation, A.A. and N.M.; writing—review and editing, A.d.S., L.L. and
M.I.; visualization, V.A., R.S. and A.R.; supervision, A.A. and A.d.S. All authors have read and agreed
to the published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: The study was conducted in accordance with the Declaration
of Helsinki and approved by the Ethics Committee of the Calabria Region, providing the following
code: 115/2022.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: Data are not available due to ethical restrictions.
Acknowledgments: We would like to Chiara Covelli, Stefano Fasano, Maria Teresa Inzitari, Federica
Pisani, and Lorenzo Scozzafava for their contribution.
Conflicts of Interest: The authors declare no conflict of interest.

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