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Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics

Functional Outcomes of Low Level Laser Versus Pulsed Electromagnetic Therapy in Children With Supracondylar Humeral Fracture

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06220812
Enrollment
40
Registered
2024-01-24
Start date
2023-05-10
Completion date
2024-10-15
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supracondylar Humeral Fracture in Pediatric

Keywords

SCHF- low level laser- pulsed electromagnetic field.

Brief summary

the aim of the study is comparing the effects of LLLT and PEMFT on range of motion of elbow and radioulnar joint ,pain ,muscles strength of upper limb and hand function in children with post-operative type II and III supracondylar humeral fracture.

Detailed description

intervention study describe the effects of low level laser and pulsed electromagnetic field in children with supracondylar humeral fracture . All children will be randomly classified by envelope method into two study groups of equal number. study group A and study group B. Both groups will receive designed physical therapy program, 20 minutes, 3 times per week for six weeks in addition to study group A will receive LLLT, 5 minutes and study group B will receive the same physical therapy program, in addition to PEMF, 20 minutes.

Interventions

DEVICElow level laser ,pulsed electromagnetic field .

LLL ,ASA via Alessandro Volta, 9 .36057 Arcugnano- Italy. With 905-nm wavelength, and maximum power output of 500 mW, laser spot of approximately 1 cm2 . PEMF, ASA, Easy teraza serie (ETS), Italy 2011, its code F9020087 and 230 its voltage.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

low level laser and pulsed electromagnetic field will be applied separated to different study groups of children with supracondylar humeral fracture.

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

1. Age ranges from 6 to 10 years of both genders. 2. All subjects have unilateral extension type II and III supracondylar humeral fracture requiring closed reduction and percutaneous pinning (CRPP). 3. The study will be start immediately after removal the splint. 4. Children clinically and medically stable. 5. Children able to follow verbal commands. 6. Children sample will represent those children who enrolled in schools and other not yet. \-

Exclusion criteria

The patients will be excluded if they have one of the following criteria; 1. Previous soft tissue injury at the same affected side of fracture. 2. Presence of associated fractures on the ipsilateral or contralateral upper limb. 3. Active infection near the fracture site. 4. Children with congenital or acquired skeletal deformities in the upper limbs. 5. Children with neurological deficits such as convulsions, involuntary movements, receiving muscle relaxants. \-

Design outcomes

Primary

MeasureTime frameDescription
pain measurementsix weeks post intervention.Numerical pain rating scale will be used to assess elbow pain intensity pre and post treatment in both groups.
Range of motion measurementsix weeks post interventionThe 2- in-1 Digital Angle Ruler goniometer will be used to assess elbow and radio-ulnar joint ROM (flexion-extension -supination and pronation) pre and post treatment in both groups

Secondary

MeasureTime frameDescription
Hand functionsix weeks post interventionJebsen-Taylor Hand Function Test (JHFT) will be used to assess hand function pre and post treatment in both groups.

Countries

Egypt

Contacts

Primary ContactAmira Ezzat, master degree
amiraezzat324@yahoo.com01111730705
Backup ContactHoda Eltalawy, professer
Hoda_eltalawy@hotmail.com01006605506

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026