Article, Orthopedics

Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial

a b s t r a c t

Introduction: Coolant spray application in musculoskeletal injuries is an effective and harmless method to treat pain and reduce functional limitation. This study assessed the clinical value of coolant spray application on pa- tient comfort before and during the radiographic imaging process along with its early analgesic and anti- edema effects.

Methods: A total of 155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study. The patients were randomly assigned to either a coolant spray or a saline spray (placebo) group. To the coolant spray group patients, Cryos (R)Spray (Phyto Performance, Italy) was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrig- erated at 4 ?C was sprayed. Radiographic images of the patients were scored for appropriateness of the standard imaging characteristics.

Results: The mean scores were 8.13 +- 1.8 and 6.58 +- 2.2 for the coolant spray and normal saline spray groups, respectively; the differences were statistically significant between the two groups (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000). Patients with fractures on their radiographs and treated with coolant spray received higher scores than similar patients treated with normal saline spray (mean difference:-1.92, 95% CI:-3.28 to

-0.55; p = .009). The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025).

Conclusions: The radiographic images taken after coolant spray intervention in patients with acute ankle trauma were more successful in showing the target structures.

(C) 2020

  1. Introduction

Acute ankle trauma, one of the most common soft tissue injuries [1], results from sports as well as daily routine activities of people. Treat- ment modalities targeting pain relief at the time of admission typically increase the patient’s comfort and satisfaction. Cryotherapy, the thera- peutic application of cold to the injured area, is one of the preferred treatment options in patients with acute ankle injuries.

The application of cryotherapy in musculoskeletal injuries is effec- tive in alleviating pain and ensuring the patient’s rapid return to normal activity [2]. Potential side effects are minimal due to the non- pharmacological nature of cryotherapy, and it is now routinely used to treat soft tissue injuries in sports medicine [3]. The effectiveness of

* Corresponding author at: Department of Emergency Medicine, Faculty of Medicine, Ataturk University, 25240 Erzurum, Turkey.

E-mail address: [email protected] (S.T.A. Gur).

early cryotherapeutic intervention in reducing functional limitation was previously demonstrated [4]. Coolant spray intervention is a thera- peutic cooling method that draws heat out of the underlying soft tissue through latent heat evaporation [5]. Larger areas can be sprayed with- out repeated application, providing ease of use for Healthcare workers [6].

This study assessed the clinical value of coolant spray application on patient comfort before and during the radiographic imaging process along with its early analgesic and anti-edema effects. Multiple studies have compared the effectiveness of various cryotherapy methods for the management of swelling, pain, and disability in musculoskeletal in- juries. However, prior studies have not investigated the clinical advan- tages of early cryotherapy in patients with acute trauma based on radiographic imaging. Since this study was carried out in the emergency department (ED), coolant spray treatment was preferred for cryother- apy because of its ease of use by health care workers and its rapid effect on the injured areas.

https://doi.org/10.1016/j.ajem.2019.12.054

0735-6757/(C) 2020

  1. Methods
    1. Study design

A prospective, randomized, controlled, double-blinded clinical trial was conducted at a single university hospital between April 1, 2019, and June 31, 2019, with the approval of the hospital’s ethics committee.

Patient selection

A total of 1178 patients (aged 16 years or older) with acute ankle in- juries were admitted to the hospital’s ED for management of pain and/ or discomfort in the injured area and assessed for eligibility. Patients were assessed for inclusion in the study using the Ottawa Ankle Rules to exclude fractures of the ankle and mid-foot [7].

Exclusion criteria for this study were: (1) non-acceptance to partic- ipate, (2) admittance to the ED 24 h or later post-injury, (3) pregnancy,

Table 1

Checklist for scoring target points

Patient Number:

Anteroposterior and mortise view

Medial and lateral malleoli Yes ? No ?
  • Anterior tibial tubercle Yes ? No ?
  • Talar dome Yes ? No ?
  • Lateral talar process Yes ? No ?
  • Calcaneal insertion of the extensor digitorum brevis Yes ? No ?
  • Lateral view

    1. Posterior tibial malleolus Yes ? No ?
    2. Tubercles of the posterior talus process Yes ? No ?
    3. Dorsal to the talonavicular joint Yes ? No ?
    4. Anterior calcaneus process Yes ? No ?
    5. The base of the Fifth metatarsal bone Yes ? No ?

    Total points:

    (4) having a serious or life-threatening condition (stroke, heart attack, cardiac tamponade, intracranial hemorrhage, etc.), (5) having an open fracture, (6) having additional trauma, and (7) inability to provide in- formed consent (altered mental state, non-Turkish-speaking). Informed consent was obtained from patients meeting the eligibility criteria. The study coordinator randomized the patients into one of two treatment groups using a formal computer randomization protocol (www. random.org/integers). The randomization sequence in the two groups was generated according to the order in which patients were admitted to the ED.

    Interventions

    The patients were treated by Emergency Medicine residents who first assessed them in the ED. The residents applied the designated treatment protocol for each group. For the placebo group, normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 ?C was prepared. In the other group, coolant spray (Cryos (R)Spray, Phyto Performance, Italy) was applied as suggested by the manufac- turer (at a distance of 20 cm from the injured area for 5-10 s) [8]. Also saline solution sprayed for the same duration and at the same distance from the injured area. Ten minutes after applying the sprays, radio- graphic examinations were conducted for both groups of patients. The Imaging results were subsequently evaluated by two experts (an

    emergency medicine physician and an orthopedist) independently. The study coordinator combined all the results and generated a mean score for each patient.

    Outcomes

    Anteroposterior (AP), lateral, and internal rotation (Mortise) views of the ankle were obtained as the standard radiographic series for each patient. Ten target sites were determined to evaluate the appropri- ateness of the standard imaging characteristics [9]: AP and Mortise views were evaluated together for 5 points; medial and lateral malleoli, anterior tibial tubercle, talar dome, lateral talus process and calcaneal insertion of the extensor digitorum brevis. And lateral views were eval- uated for the remaining 5 points; posterior tibial malleolus, tubercles of the posterior talus process, area dorsal to the talonavicular joint, ante- rior process of the calcaneus and the base of the fifth metatarsal bone (Fig. 1). One point was assigned to each target that was viewed (Table 1).

    Statistical analysis

    All statistical analyses were performed using the Statistical Package for the Social Sciences for Windows 20.0 (SPSS, Chicago, IL, USA). The characteristics of the two groups were exhibited as frequency for

    Fig. 1. Approach to reviewing ankle radiographs. A to C, A standard radiographic series of the ankle has three views: an anteroposterior view (A), an internal rotation or Mortise view (B), and a lateral view (C). Ten target sites were identified to evaluate the appropriateness of the standard imaging characteristics. For A and B together; (1) the medial and lateral malleoli,

    (2) anterior tibial tubercle, (3) talar dome, (4) lateral talus process and (5) calcaneal insertion of the extensor digitorum brevis. For C; (1) posterior tibial malleolus, (2) tubercles of the posterior talus process, (3) area dorsal to the talonavicular joint, (4) anterior process of the calcaneus and (5) the base of the fifth metatarsal bone.

    categorical variables and mean (with standard deviation- SD) for con- tinuous variables. The continuous variables were analyzed for normal distribution using the Shapiro-Wilk test. Student’s t-test or the Mann-

    Table 2

    Baseline characteristics

    Placebo (n = 80) Coolant Spray (n = 75) p value

    Whitney test was used to compare continuous variables between the two groups. The chi-square test was used for categorical variables. A p-value of 0.05 was used as the level of significance. inter-observer agreement was analyzed by kappa analysis.

    1. Results

    Age, years 42.8 (12.8) 40.7 (12.8) 0.303

    Gender, n 0.171

    Female 44 33

    Male 36 42

    Cause of injury, n

    Motor vehicle accident 56 49 0.535

    Fall 20 24 0.334

    Other 4 2 0.45

    80 to the placebo group and 80 to the intervention group (Fig. 2). Five patients in the coolant spray group did not agree to imaging and were excluded. Seventy-seven patients (49.7%) were male with a mean age of 41.7 years (Standard deviation, 12.7; Range 16-63). Demographic characteristics and baseline variables of patients are shown in Table 2; no significant differences were determined between the two groups. Before admission to the ED, 46 (29.7%) patients stated that he/she could not bear weight on his/her injured ankle or walk on it. During physical examination of patients, tenderness of the lateral and medial malleoli was determined in 72 (46.5%) and 83 (53.5%) patients, respectively.

    3.1. Baseline characteristics

    Localization, n

    Right

    40

    39

    0.803

    Left

    40

    36

    0.803

    Of the 1178 patients assessed for enrollment, 160 were randomized:

    Fracture, n

    16

    12

    0.518

    3.2. Efficacy

    The mean score of radiographic imaging results was 8.13 +- 1.8 and

    6.58 +- 2.2 for patients treated with coolant and normal saline sprays,

    Values expressed as number or mean (standard deviation).

    respectively; the difference between the two groups was statistically significant (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000) (Fig. 3). A high level of agreement (k = 0.96) (p b .001) was found be- tween the two researchers who evaluated the patient radiographs.

    The difference in scores for the two patient groups havinga fracture or not in their radiographs was also investigated. Radiographs present- ing fractures received lower scores. The differences were statistically significant in both groups; (mean difference: 2.28, 95% CI:1.45 to 3.12, p = .001) and (mean difference: 1.75, 95% CI:0.44 to 3.04, p = .012) for the saline spray and coolant spray groups, respectively. However, 12 patients who presented fractures on their radiographs in the coolant spray group received higher scores than 16 patients who also presented

    Fig. 2. CONSORT (Consolidated Standards of Reporting Trials) diagram.

    Fig. 3. The radiographic scores for two patient groups. (error bars are 95% confidence intervals) (black lines are mean). SD, standard deviation.

    fractures on their radiographs in the normal saline group (mean differ- ence: -1.92, 95% CI: -3.28 -0.55; p = .009).

    In total, 68 patients, 26 in the coolant spray group and 42 in the nor- mal saline group, received Analgesic drugs before their discharge from the ED; the proportion of patients requesting analgesic drugs was statis- tically higher in the normal saline group compared to the coolant spray group (p = .025).

    3.3. Retrospective power analysis

    There were no prior studies using similar data and our research per- spective; hence, we assessed our own findings to define the radio- graphic scoring. If both patient groups included the minimum 55 patients, the power of the test was estimated at 0.90 while type 1 error was 0.01.

    1. Discussion

    This study aimed to clinically evaluate the impact of coolant spray cryotherapy on patient comfort before and during radiographic imag- ing. The rapid analgesic and anti-edema effects of coolant spray applica- tion improved patient comfort, permitting them to hold the affected extremity in the proper position during radiographic imaging. Higher scores on radiographs showing target points indicated that the treat- ment was clinically effective. The study also indicated a reduced need for analgesic drugs in patients with acute ankle trauma.

    Soft tissue trauma resulting in acute pain is one of the leading causes of overcrowding in EDs [10]. Cryotherapy is an effective treatment mo- dality for such patients. It reduces pain and edema, decreases Muscle spasms, and enables functional recovery of the injured extremity [11]. Practical solutions are needed to mitigate pain effectively and increase patient satisfaction during ongoing diagnosis and treatment. Standard cryotherapy treatment begins late and typically requires repeated ses- sions. Coolant spray is an easy-to-use, quick, and effective treatment method [6] with similar effects on reducing edema and providing pain relief as standard cryotherapy [5,12,13].

    The efficacy of cryotherapy has been investigated under various clin- ical conditions and Pain measurement methods have been used fre- quently in these studies [3,14,15]. However, pain description by the patient is subjective; it is generally assessed by self-reporting and is therefore variable. Individual experiences, intensity of past pain epi- sodes, personality differences, and genetic traits can influence pain reporting. Therefore, we assessed patient radiographs to be appropriate standard evaluation criteria, independent of how patients felt and per- ceived the pain. The main reason for examining the imaging results was to make an objective evaluation independent of the patients’ and investigators’ comments. We found that visibility of the target struc- tures on radiography was higher in the coolant spray group than in the normal saline spray group. This suggests that cryotherapy can re- duce pain, edema, and muscle spasms, and facilitate joint movements to restore functions in a short time period [1]. We demonstrated that coolant spraying at admission made it easier for standard imaging.

    Lin et al. investigated the role of cryotherapy in preventing postoper- ative complications in patients who had undergone calcaneal fracture surgery [16]. The patients were divided into three groups (preoperative cryotherapy, postoperative cryotherapy, and control) and their radio- graphs were evaluated. The radiographic examination of these patients showed no significant differences in the average Bohler’s angle and cru- cial angle of Gissane among all three groups at any point. There is no similar study in the literature examining the clinical advantages of cryo- therapy by scoring imaging results in patients with acute trauma.

    Cryotherapy is effective on both bone and Soft tissues. Ho et al. dem- onstrated its positive effect on bone blood flow and metabolism by pro- viding Damage control [17]. In this study, we demonstrated that coolant spray intervention increased the radiographic scores of patients with a bone pathology.

    randomized controlled studies evaluating the requirement for anal- gesic drugs after cryotherapy intervention have been reported in the lit- erature with varying interpretations. Watkins et al. pointed out that performing postoperative cryotherapy in patients who underwent open abdominal surgery had reduced analgesic requirements, but the results were not statistically significant [3]. Konrath et al. also reported no statistically significant differences in analgesic requirements

    between the cryotherapy and placebo patient groups [18]. However, we observed a significant reduction in analgesic requirement after coolant spray intervention. Therefore, a decrease in analgesic requirements in cases of acute trauma without life-threatening tissue and organ injury can have a positive impact on ED boarding and workload.

    1. Limitations

    Our study was conducted in patients admitted to the ED and only Short-term effects of cryotherapy were investigated. If patients were followed for longer durations and reevaluated, it may have yielded ad- ditional information about the long-term results of cryotherapy, such as the time when patients returned to daily activity. In addition, radio- graphs which did not meet the standard scoring were not followed; re- peating imaging or patient readmission to the ED and their Associated costs could not be evaluated as long-term follow-up of these patients was not performed.

    1. Conclusion

    In conclusion, we demonstrate that radiographic imaging of target structures was significantly improved after coolant spray application on patients presenting to the ED with acute ankle trauma. We also show that coolant spray treatment reduces the need for analgesic drugs in these patients. Hence, cryotherapy with coolant spray is a quick and easy treatment option that can be used effectively in daily emergency room practice.

    Declaration of competing interest

    The authors declare no competing interests to disclose

    Acknowledgements

    None.

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