Comparison of Supination/Flexion Maneuver to Hyperpronation Maneuver

NCT05828641 | Terminated DMC

• 1 other identifier: 211913807
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergencies; Orthopedics; Radial Head Subluxation

Keywords

Pediatric; pulled elbow; radial head subluxation; hyperpronation; supination-flexion; nursemaid's elbow; emergency medicine; supination flexion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of second attempt failure

  10 minutes after the second-attempt, the outcome will be evaluated.

• Rate of third attempt failure (ultimate failure)

  10 minutes after the third-attempt, the outcome will be evaluated.

• Number of patients presenting with recurrence of radial head subluxation

  72 hours after of first admission with same diagnosis.

• Pain intensity of the patients during the first attempt of the maneuver

  Just before (1 minute) and during the first attempt of the maneuver.

• Adverse events detected during the first attempt of the maneuver

  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.

Study Arms (2)

Supination-flexion

ACTIVE COMPARATOR

Supination-flexion maneuver will be applied in the treatment of patients in this group.

Procedure: Supination-flexion maneuver

Hyperpronation

ACTIVE COMPARATOR

Hyperpronation maneuver will be applied in the treatment of patients in this group.

Procedure: Hyperpronation maneuver

Interventions

Supination-flexion maneuver PROCEDURE

In the Supination-flexion group, the forearm will be supinated first, followed by full flexion of the elbow joint (Supination-flexion maneuver).

Also known as: Supination flexion

Supination-flexion

Hyperpronation maneuver PROCEDURE

In the hyperpronation group, the forearm will be pronated with the child's palm facing down (hyperpronation maneuver).

Also known as: Hyper pronation

Hyperpronation

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of radial head subluxation
• No evidence of direct trauma to the arm
• No fracture in the arm
• No history of musculoskeletal disease

You may not qualify if:

• Refusing to participate in the study

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Research and Training Hospital

Istanbul, 34764, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 7560033 BACKGROUND

• 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.

  PMID: 31283721 BACKGROUND

• 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.

  PMID: 28753234 BACKGROUND

• 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.

  PMID: 33133740 BACKGROUND

• 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.

  PMID: 21350618 BACKGROUND

• 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.

  PMID: 23702058 BACKGROUND

• 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.

  PMID: 10433531 BACKGROUND

• 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.

  PMID: 16651912 BACKGROUND

• 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.

  PMID: 24553032 BACKGROUND

• Aksel G, Kuka B, Islam MM, Demirkapi F, Ozturk I, Islek OM, Ademoglu E, Eroglu SE, Satici MO, Ozdemir S. Comparison of supination/flexion maneuver to hyperpronation maneuver in the reduction of radial head subluxations: A randomized clinical trial. Am J Emerg Med. 2025 Feb;88:29-33. doi: 10.1016/j.ajem.2024.11.026. Epub 2024 Nov 18.

  PMID: 39579408 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome accessors will be blinded to the study. They will not know which group is supination-flexion group or hyperpronation group from the data set. Group names will be included in the dataset as group 1 and group 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is designed as parallel group randomized controlled trial.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 25, 2023
• Study Start: May 2, 2023
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)