Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics

January 14, 2024 updated by: Amira Ezzat Abd El Mageid, Cairo University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • General Beni-Seuif Hospital
        • Contact:
          • Manal Bakery
          • Phone Number: 01002326350
        • Contact:
          • Fatma Ahmed
          • Phone Number: 01212185579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group A
20 children will receive designed physical therapy program in addition to low level laser
Device: low 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.
Experimental: study group B
20 children will receive designed physical therapy program in addition to pulsed electromagnetic field .
Device: low 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain measurement
Time Frame: six weeks post intervention.
Numerical pain rating scale will be used to assess elbow pain intensity pre and post treatment in both groups.
six weeks post intervention.
Range of motion measurement
Time Frame: six weeks post intervention
The 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
six weeks post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand function
Time Frame: six weeks post intervention
Jebsen-Taylor Hand Function Test (JHFT) will be used to assess hand function pre and post treatment in both groups.
six weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: General hospital Beni-Seuif Beni-seuif, generalhosbns@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHF-LLL-PEMF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Supracondylar Humeral Fracture in Pediatric

Clinical Trials on low level laser ,pulsed electromagnetic field .

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe