Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189625
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-12-19
Brief Title:
Mild Ankle Sprain Treatment Functional Bandaging vs no Immobilization
Sponsor:
Hospital Universitario Infanta Leonor
Organization:
Hospital Universitario Infanta Leonor
Study Overview
Official Title:
Mild Ankle Sprain Treatment Functional Bandaging vs no Immobilization Clinical Trial Randomized in Pediatric Population
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PED_HUIL1223
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 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
Detailed Description:
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 centers 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 studys 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 centers 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 sizeGroup 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 andor Shapiro-Wilks or as medians and interquartile ranges otherwise Bivariable analysis of categorical variables will be performed using the Chi-square test or Fishers exact test and that of continuous variables will be done using the Students 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 DataFor 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
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 studys 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 centers 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 sizeGroup 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 andor Shapiro-Wilks or as medians and interquartile ranges otherwise Bivariable analysis of categorical variables will be performed using the Chi-square test or Fishers exact test and that of continuous variables will be done using the Students 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 DataFor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None