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Ankle sprains represent a prevalent pathology among the pediatric population that can result in residual effects when treated incorrectly. However, there is a lack of scientific studies defining the most appropriate therapeutic approach. Our hypothesis is that patients treated solely with general measures, without external device support, experience a faster recovery compared to those treated with ankle immobilization. A clinical trial will be carried out by randomly assigning patients to either the functional bandaging group or the control group (general measures only). Prospective follow-up will be carried out by telephone, checking the functionality of the injured ankle using 'the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)', in addition to pain control and patient satisfaction with the treatment.
Study Design: A randomized, parallel, open-label, single-center clinical trial will be conducted at an intermediate-complexity hospital. The study received approval from our center's ethics committee.
Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. All physicians in the pediatric department will participate in patient enrollment. In cases of grade I or mild sprains, patients and their guardians will be invited to participate in the study after a thorough explanation of the study's purpose and procedures. The severity of the sprain will be assessed using The West Point Ankle Grading System, with the final grading left to the discretion of the clinician. Adequate analgesia will be ensured during the emergency department consultation.
Upon agreeing to participate in the study and signing the informed consent, randomization and assignment to either the control group or intervention group (receiving a bandage applied by nursing) will take place before the final discharge from the emergency department. The discharge report will specify the standardized treatment based on the assigned group. The attending physician will complete an electronic study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. This folder will be reviewed daily by the principal investigator or their collaborators. Demographic data and variables obtained in the emergency department will be entered into a database hosted in the REDcap software. Additionally, a coded patient number and the date of emergency care will be included in a database hosted in the center's electronic repository to determine the timing of follow-up.
At 7, 14, and 30 days, the guardians of the patients will be contacted by phone, and a survey will be administered to the patient to collect data on the patients' progress. This survey will be directly completed using forms in the REDcap software. In case of no response to the initial attempt, a follow-up call will be made on the same day. If the result remains the same, another attempt will be made the following day, with non-response recorded as a loss.
The data from the REDcap electronic database will be periodically reviewed by the principal investigator to monitore data entry and look for possible adverse effect.
Statistical Analysis: No previous studies have assessed non-immobilization in patients with ankle sprains, nor have any studies evaluated the OXAFQ-C outcomes in the evolution of ankle sprain patients. Therefore, the sample size will be calculated assuming a difference of more than 10 points in the OXAFQ-C percentage scale value, estimating a standard deviation of 25. Comparing two independent means with a bilateral test and a balanced random allocation (Group 1 size/Group 2 size ratio = 1), with a type I error of 5% (alpha risk) and a power of 80% (1-beta risk), the calculated sample size will be 212 patients (106 in each group). Assuming a dropout rate of 10%, the final established sample size will be 233 (116 in each group). Given the absence of previous data, a preliminary review with the first 50 patients will be conducted to recalculate the sample size.
Categorical variables will be described using percentages, and continuous variables will be presented as mean and standard deviation (SD) if normally distributed (Kolmogorov-Smirnov and/or Shapiro-Wilks) or as medians and interquartile ranges otherwise. Bivariable analysis of categorical variables will be performed using the Chi-square test or Fisher's exact test, and that of continuous variables will be done using the Student's T-test or its non-parametric equivalents.
Both intention-to-treat and per-protocol analyses will be conducted, assuming that some patients in the control group will use ankle support against recommendations. Finally, a non-inferiority analysis will be performed between both groups for both the primary variable and the degree of pain according to the visual analog scale (VAS) at different follow-ups.
All statistical tests will be considered with a significance level of 5%. The analysis will be conducted using the R software.
Missing Data:For all patients who do not complete at least two follow-ups, the electronic medical records of all public centers in the province where the study is conducted will be reviewed through the electronic Horus program to verify the absence of relevant adverse effects or diagnostic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No-bandaging group | Experimental | Only general measures will be recommended without the use of external support devices. |
|
| Bandaging group | Active Comparator | functional bandage for 5 days and general measure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | All patients included in the study, both in the non-bandaging group and in the bandaging group, will receive a series of general measures as a recommendation, consisting of the following:
The control group will not receive any special intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C) | It is a questionnaire validated in pediatric population to determine the functionality of the ankle and/or foot in patients with pathology at this level. It consists of a survey in which 14 items belonging to three different spheres are collected: physical, social/daily activities and emotional. Each item is scored on a frequency scale: never (4), rarely (3), sometimes (2), frequently (1), always (0). The higher the score, the better the functionality. This scale can also be transformed into a percentage scale, being 100% the maximum score. | at 5, 14 and 30 days. |
| Intensity of pain | intensity of pain felt by the patient, assessed subjectively on an ordinal scale, with 0 being no pain at all and 10 the maximum pain possible. | at the emergency department and at 5, 14 and 30 days. |
| recurrence of ankle sprain | dichotomous variable reflecting the presence of new ankle sprains | at 5, 14 and 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction with emergency department care | assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best. | after 5 days |
| Patient satisfaction with the treatment received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SARA SUAREZ-CABEZAS, MD | Hospital Universitario Infanta Leonor | Principal Investigator |
| MARIA CABRERIZO-ORTIZ, MD | Hospital Universitario Infanta Leonor | Principal Investigator |
| CARMEN GOMEZ GEREZ, MD | Hospital Universitario Infanta Leonor | Principal Investigator |
| MONICA HORTIGUELA APARICIO, MD | Hospital Universitario Infanta Leonor | Principal Investigator |
| BEGOÑA PEREZ-MONEO AGAPITO, MD | Hospital Universitario Infanta Leonor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Infanta Leonor | Madrid | Madrid | 28031 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33352395 | Background | Saki F, Yalfani A, Fousekis K, Sodejani SH, Ramezani F. Anatomical risk factors of lateral ankle sprain in adolescent athletes: A prospective cohort study. Phys Ther Sport. 2021 Mar;48:26-34. doi: 10.1016/j.ptsp.2020.12.009. Epub 2020 Dec 16. | |
| 20926721 | Background | Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537. |
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Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio
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Due to the nature of the intervention, it will not be feasible to mask the received treatment at the time of care. Additionally, masking of the treatment group during clinical reviews will not be attainable, as some collected variables will be inherently related to the intervention itself. The data analyst specialist will also be unblinded to the group assignments.
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| Functional bandage | Procedure | The functional bandage will consist of a standardized wrapping in several phases. First, with 6 mm silk tape, open anchors were placed in the distal region of the metatarsals of the foot and in the middle third of the affected leg. Next, a strip of tape was applied in stirrup fashion, starting from the proximal anchor and exerting pressure cranially on the side of the affected ligament. This support was interspersed three times with another strip of tape, starting from the foot anchor and wrapping behind the ankle. Once complete, it was covered with a 7.5 cm Tensoplast spiral bandage, taking care to apply gentle pressure. The emergency nurses underwent dual training, consisting of an instructional video and a half-hour practical session. Reminder posters were also displayed in the technique box where such procedures are typically performed. As the control group, general measures will be recommended. |
|
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
| after 5 days |
| Patient satisfaction with functional evolution. | assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best. | after 30 days |
| Presence of functional bandaging complications | dichotomous variable (yes/no). | after 5 days |
| Tolerance of the functional bandage | ordinal scale (very bad, bad, average, good and very good). | after 5 days |
| Use of crutches | dichotomous variable (yes/no). | after 5 days |
| Days on crutches | quantitative variable (days) | after 5 days |
| Days of use of anti-inflammatory drugs | quantitative variable (days) | after 5 days |
| Days with pain | quantitative variable (days) | at 5, 14 and 30 days. |
| Use of ankle brace | dichotomous variable (yes/ no) | at 5, 14 and 30 days. |
| 30175385 | Background | Wiersma AJ, Brou L, Fields SK, Comstock RD, Kerr ZY. Epidemiologic comparison of ankle injuries presenting to US emergency departments versus high school and collegiate athletic training settings. Inj Epidemiol. 2018 Sep 3;5(1):33. doi: 10.1186/s40621-018-0163-x. |
| 24559877 | Background | Czajka CM, Tran E, Cai AN, DiPreta JA. Ankle sprains and instability. Med Clin North Am. 2014 Mar;98(2):313-29. doi: 10.1016/j.mcna.2013.11.003. Epub 2014 Jan 10. |
| 35363336 | Background | Altomare D, Fusco G, Bertolino E, Ranieri R, Sconza C, Lipina M, Kon E, Marcacci M, Bianchini L, Di Matteo B. Evidence-based treatment choices for acute lateral ankle sprain: a comprehensive systematic review. Eur Rev Med Pharmacol Sci. 2022 Mar;26(6):1876-1884. doi: 10.26355/eurrev_202203_28333. |
| 29886432 | Background | Delahunt E, Bleakley CM, Bossard DS, Caulfield BM, Docherty CL, Doherty C, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Remus A, Verhagen E, Vicenzino BT, Wikstrom EA, Gribble PA. Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium. Br J Sports Med. 2018 Oct;52(20):1304-1310. doi: 10.1136/bjsports-2017-098885. Epub 2018 Jun 9. |
| 35872766 | Background | Gaddi D, Mosca A, Piatti M, Munegato D, Catalano M, Di Lorenzo G, Turati M, Zanchi N, Piscitelli D, Chui K, Zatti G, Bigoni M. Acute Ankle Sprain Management: An Umbrella Review of Systematic Reviews. Front Med (Lausanne). 2022 Jul 7;9:868474. doi: 10.3389/fmed.2022.868474. eCollection 2022. |
| 36184447 | Background | Lacerda D, Pacheco D, Rocha AT, Diniz P, Pedro I, Pinto FG. Current Concept Review: State of Acute Lateral Ankle Injury Classification Systems. J Foot Ankle Surg. 2023 Jan-Feb;62(1):197-203. doi: 10.1053/j.jfas.2022.08.005. Epub 2022 Aug 18. |
| Background | Maughan K.L., Jackson J. Ankle sprain in adults: Evaluation and diagnosis. En: UpToDate. 2023. |
| Background | Maughan K.L., Jackson J. Ankle sprain in adults: Management. En 2023. |
| 31470826 | Background | Green T, Willson G, Martin D, Fallon K. What is the quality of clinical practice guidelines for the treatment of acute lateral ankle ligament sprains in adults? A systematic review. BMC Musculoskelet Disord. 2019 Aug 31;20(1):394. doi: 10.1186/s12891-019-2750-6. |
| 32797734 | Background | Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3. |
| 26068955 | Background | Derry S, Moore RA, Gaskell H, McIntyre M, Wiffen PJ. Topical NSAIDs for acute musculoskeletal pain in adults. Cochrane Database Syst Rev. 2015 Jun 11;2015(6):CD007402. doi: 10.1002/14651858.CD007402.pub3. |
| 33112532 | Background | Tran K, Argaez C. External Supports for the Treatment of Ankle Sprain: A Review of Clinical Effectiveness [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 May 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK563450/ |
| 33401232 | Background | Gogate N, Satpute K, Hall T. The effectiveness of mobilization with movement on pain, balance and function following acute and sub acute inversion ankle sprain - A randomized, placebo controlled trial. Phys Ther Sport. 2021 Mar;48:91-100. doi: 10.1016/j.ptsp.2020.12.016. Epub 2020 Dec 23. |
| 20457737 | Background | Bleakley CM, O'Connor SR, Tully MA, Rocke LG, Macauley DC, Bradbury I, Keegan S, McDonough SM. Effect of accelerated rehabilitation on function after ankle sprain: randomised controlled trial. BMJ. 2010 May 10;340:c1964. doi: 10.1136/bmj.c1964. |
| 29484236 | Background | Iammarino K, Marrie J, Selhorst M, Lowes LP. EFFICACY OF THE STRETCH BAND ANKLE TRACTION TECHNIQUE IN THE TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE ANKLE SPRAINS: A RANDOMIZED CONTROL TRIAL. Int J Sports Phys Ther. 2018 Feb;13(1):1-11. |