Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle SprainPED_HUIL0124NCT06222229
Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
A study testing Functional bandage in people with Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain
- What is being tested?
- Functional bandage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2024to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of grade I ankle sprain.
- Patients aged between 5 and 16 years.
- Less than 72 hours of evolution.
- Informed consent signed by guardians
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
SARA SUAREZ-CABEZAS, MD, 0034 661053106, ssuarez@salud.madrid.org
MARIA CABRERIZO-ORTIZ, MD, 0034 664174801, mariacabrerizoortiz@gmail.com
About this study
Official title: Multicentre, Randomized, Clinical Trial in Children With Mild Ankle Sprain: Bandaging vs. no Immobilization
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.
Read the detailed description
Study Design: A randomized, parallel, open-label, multi-center clinical trial will be conducted at 3 intermediate-complexity hospitals. The study received approval from the center's ethics committee.
Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. The collaborating researchers of the different hospitals 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. 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 a physical study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. The researcher in charge of each center will enter demographic data and variables obtained in the emergency department into a database hosted in the REDcap software. The data of the recruited patients should be entered in the REDcap database at least twice per week. The principal investigator or collaborators will review this REDcap database daily to check the recruited patients and prepare the SMS with the online survey to be sent. 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. The SMS will be sent using the SMS sending system of the coordinating hospital of the study.
At 7, 14, and 30 days, the guardians of the patients will receive a SMS with a link that will direct them to the REDcap online survey. In case of no response to the initial attempt, another attempt will be made the following day, and, if no response is received in 48 hours, a telephone call will be made to the patients' guardians. Non-response at 72 hours will be 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: 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 15, due to a previous study. 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), and assuming a dropout of 30%, the calculated sample size will be 112 patients (56 in each group) for superiority analysis or 90 patients (45 in each group) for non-inferiority analysis.
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. Anyway, a worst-case scenario strategy will be used in the statistical analysis to assess the losses.
- Conditions
- Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain
- Being tested
- Control, Functional bandage
- Keywords
- Ankle, Sprain
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
Functional bandageProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| No-bandaging group | Experimental | Only general measures will be recommended without the use of external support devices. Receives: Other: Control |
| Bandaging group | Active comparator | functional bandage for 5 days and general measure. Receives: Other: Control; Procedure: Functional bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at the emergency department and at 5, 14 and 30 days.
recurrence of ankle sprain
dichotomous variable reflecting the presence of new ankle sprains.
Measured: at 5, 14 and 30 days.
Secondary outcomes (10)
patient satisfaction with emergency department care
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
Measured: after 5 days
Patient satisfaction with the treatment received.
assessed subjectively on an ordinal scale, being 0 being the worst punctuation and 10 being the best.
Measured: 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.
Measured: after 30 days
Presence of functional bandaging complications
dichotomous variable (yes/no).
Measured: after 5 days
Tolerance of the functional bandage
ordinal scale (very bad, bad, average, good and very good).
Measured: after 5 days
Use of crutches
dichotomous variable (yes/ no)
Measured: after 5 days
Days on crutches
quantitative variable (days)
Measured: after 5 days
Days of use of anti-inflammatory drugs
quantitative variable (days)
Measured: after 5 days
Days with pain
quantitative variable (days)
Measured: at 5, 14 and 30 days.
Use of ankle brace
dichotomous variable (yes/ no)
Measured: at 5, 14 and 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startJan 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÁNGEL PUEYO, MD, MSc, Hospital Universitario Infanta Leonor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222229
- Sponsor's protocol ID
- PED_HUIL0124
- Acronym
- PED_HUIL0124
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33352395Waterman 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.
PubMed 20926721Wiersma 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.
PubMed 30175385Czajka 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.
PubMed 24559877Altomare 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.
PubMed 35363336Delahunt 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.
PubMed 29886432Gaddi 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.
PubMed 35872766Lacerda 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.
PubMed 36184447Maughan K.L., Jackson J. Ankle sprain in adults: Evaluation and diagnosis. En: UpToDate. 2023.
Maughan K.L., Jackson J. Ankle sprain in adults: Management. En 2023.
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.
PubMed 31470826Jones 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.
PubMed 32797734Derry 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.
PubMed 26068955Tran 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/
PubMed 33112532Gogate 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.
PubMed 33401232
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Clinical Trial in Children With Mild Ankle Sprain: Bandaging vs. no Immobilization
- ClinicalTrials.gov ID
- NCT06222229
- Acronym / sponsor ID
- PED_HUIL0124 / PED_HUIL0124
- Conditions
- Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain
- Keywords
- Ankle, Sprain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: A randomized, parallel, open-label, multi-center clinical trial will be conducted at 3 intermediate-complexity hospitals. The study received approval from the center's ethics committee.
Procedure: Every patient presenting with ankle trauma will undergo assessment by the attending physician in the emergency department. The collaborating researchers of the different hospitals 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. 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 a physical study-specific record and will store the signed informed consent in a designated folder within the pediatric emergency department. The researcher in charge of each center will enter demographic data and variables obtained in the emergency department into a database hosted in the REDcap software. The data of the recruited patients should be entered in the REDcap database at least twice per week. The principal investigator or collaborators will review this REDcap database daily to check the recruited patients and prepare the SMS with the online survey to be sent. 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. The SMS will be sent using the SMS sending system of the coordinating hospital of the study.
At 7, 14, and 30 days, the guardians of the patients will receive a SMS with a link that will direct them to the REDcap online survey. In case of no response to the initial attempt, another attempt will be made the following day, and, if no response is received in 48 hours, a telephone call will be made to the patients' guardians. Non-response at 72 hours will be 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: 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 15, due to a previous study. 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), and assuming a dropout of 30%, the calculated sample size will be 112 patients (56 in each group) for superiority analysis or 90 patients (45 in each group) for non-inferiority analysis.
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. Anyway, a worst-case scenario strategy will be used in the statistical analysis to assess the losses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization sequence was created using the Epidat 4.2 software, ensuring allocation concealment, with a single, constant 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| No-bandaging group | Experimental | Other: ControlOnly general measures will be recommended without the use of external support devices. |
| Bandaging group | Active comparator | Other: Control, Procedure: Functional bandagefunctional bandage for 5 days and general measure. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of grade I ankle sprain.
- Patients aged between 5 and 16 years.
- Less than 72 hours of evolution.
- Informed consent signed by guardians
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAll 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. | Other | Bandaging group, No-bandaging group |
| Functional bandageThe 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 | Procedure or surgery | Bandaging group |
Primary outcome
Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C)
Time frame: at 5, 14 and 30 days.
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.
Intensity of pain
Time frame: at the emergency department and at 5, 14 and 30 days.
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.
recurrence of ankle sprain
Time frame: at 5, 14 and 30 days.
dichotomous variable reflecting the presence of new ankle sprains.
10 secondary outcomes
patient satisfaction with emergency department care
Time frame: after 5 days
Patient satisfaction with the treatment received.
Time frame: after 5 days
Patient satisfaction with functional evolution.
Time frame: after 30 days
Presence of functional bandaging complications
Time frame: after 5 days
Tolerance of the functional bandage
Time frame: after 5 days
Use of crutches
Time frame: after 5 days
Days on crutches
Time frame: after 5 days
Days of use of anti-inflammatory drugs
Time frame: after 5 days
Days with pain
Time frame: at 5, 14 and 30 days.
Use of ankle brace
Time frame: at 5, 14 and 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Results publication: PubMed 33352395Saki 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.
- Results publication: PubMed 20926721Waterman 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.
- Results publication: PubMed 30175385Wiersma 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.
- Results publication: PubMed 24559877Czajka 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.
- Results publication: PubMed 35363336Altomare 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.
- Results publication: PubMed 29886432Delahunt 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.
- Results publication: PubMed 35872766Gaddi 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.
- Results publication: PubMed 36184447Lacerda 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.
- Results publicationMaughan K.L., Jackson J. Ankle sprain in adults: Evaluation and diagnosis. En: UpToDate. 2023.
- Results publicationMaughan K.L., Jackson J. Ankle sprain in adults: Management. En 2023.
- Results publication: PubMed 31470826Green 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.
- Results publication: PubMed 32797734Jones 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional bandage in people with Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain, run by Hospital Universitario Infanta Leonor at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara SUAREZ-CABEZAS, MD (0034 661053106, ssuarez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C) (time frame: at 5, 14 and 30 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06222229, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.