Comparison of Supination/Flexion Maneuver to Hyperpronation Maneuver

Emergencies Clinical Trial

Official title:

Comparison of Supination/Flexion Maneuver to Hyperpronation Maneuver in the Reduction of Radial Head Subluxations: A Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05828641
• Other study ID #: 211913807
• Status: Terminated
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: March 26, 2024

Study information

• Verified date: March 2024
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed as a randomized controlled study. The investigators aim to compare the success of supination-flexion and hyperpronation maneuvers in the treatment of preschool children presenting to the emergency department with radial head subluxation. All children aged 0-6 years, who are diagnosed with radial head subluxation secondary to traction of the forearm, had no evidence of direct trauma to the arm or fracture in the arm (no deformity, swelling, ecchymosis), had no history of musculoskeletal disease, and are approved to participate in the study by their legal guardians, will be included in the study. Patients who are considered to have radial head subluxation initially but had an X-ray performed by the physician and had a fracture in the arm will be excluded from the study. In the study, patients will be randomized and assigned to two treatment groups: the supination-flexion group and the hyperpronation group. In the supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint. In the hyperpronation group, the forearm will be pronated with the child's palm facing down. In both groups, maneuvers will be performed by 3 emergency medicine specialists with at least 2 years of experience. First-attempt failure is determined as the primary outcome of the study. Failure in the second attempt, ultimate failure, recurrence, patient satisfaction during the procedure, pain intensity (assessed by the Face, Legs, Activity, Cry, Consolability - FLACC pain scale), and treatment-related adverse events are determined as secondary outcomes of the study. The investigators calculated the sample size and decided to include 117 patients in each group.

Description:

INTRODUCTION Radial head subluxation also called nursemaid's elbow and pulled elbow, usually results from a sudden pull on the outstretched arm and is the most common cause of upper extremity injuries in preschool children. The diagnosis is made clinically and there is no need for routine imaging. The child complains of pain and refuses to use the affected arm. Radial head subluxation is treated with manual reduction of the subluxated radial head. Among the various reduction maneuvers available, the commonly used methods are supination-flexion and hyperpronation maneuvers. The issue of which maneuver is more successful is still controversial. Supination-flexion is generally accepted as the standard maneuver and is the most preferred method. However, the hyperpronation technique was reported to be superior in a 2017 Cochrane review with 8 articles. But in a more recent randomized controlled trial on 152 patients it was reported that the supination-flexion maneuver was more successful. Controversial is not just the contradiction of previous study results. In addition, the quality of evidence is also controversial, as previous studies carry a high risk of bias. There is a serious risk of selection bias in most of the studies due to the lack or insufficiency of randomization or allocation concealment. Again, since there is no assessor blinding in the majority of the studies, the risk of detection bias is inevitable. Furthermore, in most of the previous randomized controlled trials, the sample size was not calculated. As a result, as highlighted in the Cochrane review, most previous randomized controlled trials, have a high risk of bias. The investigators think that well-planned, low-bias randomized controlled trials, are needed to answer this clinical question, both due to the high risk of bias in previous studies and conflicting results regarding which maneuver is superior in published reports. In this randomized controlled study, the investigators aimed to compare the success of supination-flexion and hyperpronation maneuvers in the treatment of preschool children presenting to the emergency department with radial head subluxation. METHODS This study will be conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement. Design This parallel group open-label randomized controlled trial will be conducted between May 2023 and May 2024 in a tertiary education and research hospital. Ethics committee approval was obtained from the local ethics committee of Umraniye Training and Research Hospital (Ethics Committee approval date: 21 March 2023, approval number: 211913807). Population All children aged 0-6 years, who will be diagnosed with radial head subluxation secondary to traction of the forearm, had no evidence of direct trauma to the arm or fracture in the arm (no deformity, swelling, ecchymosis), had no history of musculoskeletal disease, and will be approved to participate in the study by their legal guardians, will be included in the study. Patients who are considered to have radial head subluxation initially but had an X-ray performed by the physician and had a fracture in the arm will be excluded from the study. Diagnosis The patients will be diagnosed with radial head subluxation clinically, and if the child shows symptoms of pain after traction on the arm and refuses to use the arm on that side, the diagnosis of radial head subluxation will be made. In cases where routine imaging will not be requested, but the history and physical examination are not clear, imaging will be requested at the discretion of the physician managing the patient. Interventions In the study, patients will be randomized and assigned to two treatment groups: the supination-flexion group and the hyperpronation group. In the supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint. In the hyperpronation group, the forearm will be pronated with the child's palm facing down. In both groups, maneuvers will be performed by 3 emergency medicine specialists with at least 2 years of experience. Outcome measurements First-attempt failure is determined as the primary outcome of the study. 10 minutes after the procedure, the patient will be re-examined and the success of the treatment will be evaluated. If additional treatment is needed or if the child still avoids using his/her arm after the procedure, it will be considered a treatment failure. If the participant's pain decreases and the participant can use the effected arm easily, the maneuver will be considered successful. Failure in the second attempt, ultimate failure (failure after the third reduction attempt), recurrence (re-admission with radial head subluxation in the same arm within 72 hours), and pain intensity of the patient (will be assessed by the Face, Legs, Activity, Cry, Consolability pain scale (FLACC)), treatment-related adverse events (fracture of the forearm, hyperemia, vascular injury, nerve injury after the first attempt) are determined as secondary outcomes of the study. Randomization Randomization will be done via www.randomizer.org and in 6 blocks. Treatment allocation will be concealed and performed by means of a computerized balanced allocation method. Blinding The study is not suitable for blindness since two different maneuvers will be applied as intervention and therefore it was designed as open-label. However, the accessors will be blinded to the study. Sample Size Calculation G*Power 3.1.9.6 software was used for sample size calculation. In studies comparing two reduction methods in the literature, the failure rate at the first attempt was reported as 16.2-34.2% in the supination-flexion group and 4.4-20.9% in the hyperpronation group. In addition, in the Cochrane review, which compared both reduction methods and was published in 2017, the failure rate in the supination-flexion group was reported as 26.4%. The supination-flexion group was considered the control group, and a 15% reduction in failure was considered clinically significant. To detect such a difference, it was calculated that 106 patients should be included in each group using a two-sided alpha value of 5% and a power of 80%. Finally, considering the potential data loss of 10%, it is decided to include 117 patients in each group. Statistical analysis SPSS 26 (IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp.) will be used for statistical analysis. The normal distribution of continuous data will be determined by the Shapiro-Wilk test and histograms. Normally distributed data will be expressed as mean and standard deviation and non-normally distributed data will be expressed as median and quartiles. The Student-T test will be used for the comparison between groups for continuous data with normal distribution, and the Mann-Whitney U test for those without normal distribution. Categorical data, such as primary outcome treatment failure rates, will be expressed as frequency and percentage, and the Chi-square test will be used for group comparison for categorical variables (Fisher's exact test where necessary). A statistically significant level of p<0.05 was accepted.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 6 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of radial head subluxation
• No evidence of direct trauma to the arm
• No fracture in the arm
• No history of musculoskeletal disease Exclusion Criteria: -Refusing to participate in the study

Related Conditions & MeSH terms

• Emergencies
• Orthopedics
• Radial Head Subluxation

Intervention

Procedure:
• Supination-flexion maneuver
In the Supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint (Supination-flexion maneuver).
• Hyperpronation maneuver
In the hyperpronation group, the forearm will be pronated with the child's palm facing down (hyperpronation maneuver).

Locations

Country	Name	City	State
Turkey	Umraniye Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Choung W, Heinrich SD. Acute annular ligament interposition into the radiocapitellar joint in children (nursemaid's elbow). J Pediatr Orthop. 1995 Jul-Aug;15(4):454-6. doi: 10.1097/01241398-199507000-00008. — View Citation

Green DA, Linares MY, Garcia Pena BM, Greenberg B, Baker RL. Randomized comparison of pain perception during radial head subluxation reduction using supination-flexion or forced pronation. Pediatr Emerg Care. 2006 Apr;22(4):235-8. doi: 10.1097/01.pec.0000210172.17892.a1. — View Citation

Gunaydin YK, Katirci Y, Duymaz H, Vural K, Halhalli HC, Akcil M, Coskun F. Comparison of success and pain levels of supination-flexion and hyperpronation maneuvers in childhood nursemaid's elbow cases. Am J Emerg Med. 2013 Jul;31(7):1078-81. doi: 10.1016/j.ajem.2013.04.006. Epub 2013 May 20. — View Citation

Guzel M, Salt O, Demir MT, Akdemir HU, Durukan P, Yalcin A. Comparison of hyperpronation and supination-flexion techniques in children presented to emergency department with painful pronation. Niger J Clin Pract. 2014 Mar-Apr;17(2):201-4. doi: 10.4103/1119-3077.127557. — View Citation

Hanes L, McLaughlin R, Ornstein AE. Suspected Radial Head Subluxation in Infants: The Need for Radiologic Evaluation. Pediatr Emerg Care. 2021 Jan 1;37(1):e58-e59. doi: 10.1097/PEC.0000000000001848. — View Citation

Krul M, van der Wouden JC, Kruithof EJ, van Suijlekom-Smit LW, Koes BW. Manipulative interventions for reducing pulled elbow in young children. Cochrane Database Syst Rev. 2017 Jul 28;7(7):CD007759. doi: 10.1002/14651858.CD007759.pub4. — View Citation

McDonald J, Whitelaw C, Goldsmith LJ. Radial head subluxation: comparing two methods of reduction. Acad Emerg Med. 1999 Jul;6(7):715-8. doi: 10.1111/j.1553-2712.1999.tb00440.x. — View Citation

Porozan S, Forouzan A, Hassanzadeh R. Hyperpronation versus Supination-Flexion in Radial Head Subluxation Reduction: A Randomized Controlled Trial. J Pediatr Intensive Care. 2020 Dec;9(4):256-260. doi: 10.1055/s-0040-1709703. Epub 2020 Apr 29. — View Citation

Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of first attempt failure	After the first attempt (the maneuver according to group), the patient will re-examined and the success of the treatment will be evaluated. If additional treatment was needed or if the child still avoided using his/her arm after the procedure, it was considered as treatment failure	10 minutes after the first-attempt, the outcome will be evaluated.
Secondary	Rate of second attempt failure	After the second attempt (same maneuver as the first maneuver), the patient will re-examined and the success of the treatment will be evaluated. If additional treatment was needed or if the child still avoided using his/her arm after the procedure, it was considered as treatment failure	10 minutes after the second-attempt, the outcome will be evaluated.
Secondary	Rate of third attempt failure (ultimate failure)	In the presence of treatment failure despite performing the same maneuver 3 times, this will be considered as ultimate failure.	10 minutes after the third-attempt, the outcome will be evaluated.
Secondary	Number of patients presenting with recurrence of radial head subluxation	Re-admission with radial head subluxation in the same arm within 72 hours.	72 hours after of first admission with same diagnosis.
Secondary	Pain intensity of the patients during the first attempt of the maneuver	The pain intensity of the patient will be assessed by the Face, Legs, Activity, Cry, Consolability pain scale (FLACC). Higher scores mean worse outcome.; Assessment of the score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain	Just before (1 minute) and during the first attempt of the maneuver.
Secondary	Adverse events detected during the first attempt of the maneuver	Fracture of the forearm, hyperemia, vascular injury, nerve injury after the first attempt.	Side effect assessment will begin immediately after the reduction maneuver is performed. The patient will be followed up for side effects for a week and any side effects seen during this period will be recorded.