Clinical trial NCT06220812: Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics
Official title: Functional Outcomes of Low Level Laser Versus Pulsed Electromagnetic Therapy in Children With Supracondylar Humeral Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supracondylar Humeral Fracture in Pediatric
Keywords: SCHF- low level laser- pulsed electromagnetic field.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: low level laser and pulsed electromagnetic field will be applied separated to different study groups of children with supracondylar humeral fracture.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: pain measurement
timeFrame: six weeks post intervention.
measure: Range of motion measurement
timeFrame: six weeks post intervention
Secondary outcomes:
measure: Hand function
timeFrame: six weeks post intervention
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: General Beni-Seuif Hospital
Study officials:
affiliation: generalhosbns@gmail.com
name: General hospital Beni-Seuif Beni-seuif
role: STUDY_CHAIR
References:
citation: Mulpuri K, Hosalkar H, Howard A. AAOS clinical practice guideline: the treatment of pediatric supracondylar humerus fractures. J Am Acad Orthop Surg. 2012 May;20(5):328-30. doi: 10.5435/JAAOS-20-05-328. No abstract available.
citation: Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.