Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization

NCT06222229 | Unknown

• 1 other identifier: PED_HUIL0124
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. The 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 a online survey send by SMS, 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.

Conditions

Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain

Keywords

Ankle; Sprain

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (10)

• patient satisfaction with emergency department care

  after 5 days

• Patient satisfaction with the treatment received.

  after 5 days

• Patient satisfaction with functional evolution.

  after 30 days

• Presence of functional bandaging complications

  after 5 days

• Tolerance of the functional bandage

  after 5 days

Study Arms (2)

No-bandaging group

EXPERIMENTAL

Only general measures will be recommended without the use of external support devices.

Other: Control

Bandaging group

ACTIVE COMPARATOR

functional bandage for 5 days and general measure.

Other: Control; Procedure: Functional bandage

Interventions

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: * Administration of anti-inflammatory drugs as ibuprofen at 7.5 mg/kg/8 hours for 2-3 days. If pain continues, recommendation of paracetamol 15 mg/kg 4 hours after ibuprofen. * Application of local ice for a maximum of 10 minutes as required. * Elevation of the affected limb when resting. * Early mobilization and load according to tolerance, using crutches if required. * Sports rest at least for one week or until the patient is able to walk without pain, with gradual incorporation according to tolerance. During the following year, use of elastic ankle brace for sports activities. The control group will not receive any special intervention.

Bandaging group; No-bandaging group

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

Bandaging group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of grade I ankle sprain.
• Patients aged between 5 and 16 years.
• Less than 72 hours of evolution.
• Informed consent signed by guardians

You may not qualify if:

• Penetrating trauma.
• Associated fracture.
• Consultation more than 72 hours after the trauma.
• Developmental disorders (cerebral palsy, previous gait disorders, autism, etc.).
• Previous or concurrent disease that involves an increased risk of fractures (osteoporosis, bone diseases, etc).
• Previous ankle pathology.
• Impossibility of telephone contact

Sponsors & Collaborators

• Hospital Universitario Infanta Leonor: lead

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

RECRUITING

Related Publications (17)

• 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.

  PMID: 33352395 RESULT

• 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.

  PMID: 20926721 RESULT

• 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.

  PMID: 30175385 RESULT

• 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.

  PMID: 24559877 RESULT

• 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.

  PMID: 35363336 RESULT

• 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.

  PMID: 29886432 RESULT

• 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.

  PMID: 35872766 RESULT

• 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.

  PMID: 36184447 RESULT

• Maughan K.L., Jackson J. Ankle sprain in adults: Evaluation and diagnosis. En: UpToDate. 2023.

  RESULT

• Maughan K.L., Jackson J. Ankle sprain in adults: Management. En 2023.

  RESULT

• 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.

  PMID: 31470826 RESULT

• 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.

  PMID: 32797734 RESULT

• 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.

  PMID: 26068955 RESULT

• 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/

  PMID: 33112532 RESULT

• 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.

  PMID: 33401232 RESULT

• 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.

  PMID: 20457737 RESULT

• 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.

  PMID: 29484236 RESULT

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Sara SUAREZ-CABEZAS, MD

CONTACT

0034 661053106; ssuarez@salud.madrid.org

Maria CABRERIZO-ORTIZ, MD

CONTACT

0034 664174801; mariacabrerizoortiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Specialist Physician

Model Details: Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 24, 2024
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

ES (1)