Supracondylar Humeral Fracture in PediatricNCT06220812
Different Modalities Interventions Post Supracondylar Humeral Fracture in Pediatrics
A study testing low level laser ,pulsed electromagnetic field . in people with Supracondylar Humeral Fracture in Pediatric, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Supracondylar Humeral Fracture in Pediatric
- What is being tested?
- low level laser ,pulsed electromagnetic field .
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 6 to 10 years of both genders.
- All subjects have unilateral extension type II and III supracondylar humeral fracture requiring closed reduction and percutaneous pinning (CRPP).
- The study will be start immediately after removal the splint.
- Children clinically and medically stable.
- Children able to follow verbal commands.
- Children sample will represent those children who enrolled in schools and other not yet.
- -
Who cannot join
- The patients will be excluded if they have one of the following criteria;
- Previous soft tissue injury at the same affected side of fracture.
- Presence of associated fractures on the ipsilateral or contralateral upper limb.
- Active infection near the fracture site.
- Children with congenital or acquired skeletal deformities in the upper limbs.
- Children with neurological deficits such as convulsions, involuntary movements, receiving muscle relaxants.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
General Beni-Seuif Hospital
Banī Suwayf
Manal Bakery, 01002326350
Fatma Ahmed, 01212185579
About this study
Official title: 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.
Read the 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.
- Being tested
- low level laser ,pulsed electromagnetic field .
- Keywords
- SCHF- low level laser- pulsed electromagnetic field.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser ,pulsed electromagnetic field .Device
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.
| Study group | Role | What they receive |
|---|---|---|
| study group A | Experimental | 20 children will receive designed physical therapy program in addition to low level laser Receives: Device: low level laser ,pulsed electromagnetic field . |
| study group B | Experimental | 20 children will receive designed physical therapy program in addition to pulsed electromagnetic field . Receives: Device: low level laser ,pulsed electromagnetic field . |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain measurement
Numerical pain rating scale will be used to assess elbow pain intensity pre and post treatment in both groups.
Measured: six weeks post intervention.
Range of motion measurement
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
Measured: six weeks post intervention
Secondary outcomes (1)
Hand function
Jebsen-Taylor Hand Function Test (JHFT) will be used to assess hand function pre and post treatment in both groups.
Measured: six weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start10 May 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Humeral Fracture in PediatricStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- low level laser and pulsed electromagnetic field will be applied separated to different study groups of children with supracondylar humeral fracture.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ezzat Abd El Mageid, Cairo University
- Investigators
- General hospital Beni-Seuif Beni-seuif, Study chair, generalhosbns@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220812
- Sponsor's protocol ID
- SCHF-LLL-PEMF
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22553105Vaquero-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.
PubMed 30662761
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes of Low Level Laser Versus Pulsed Electromagnetic Therapy in Children With Supracondylar Humeral Fracture
- ClinicalTrials.gov ID
- NCT06220812
- Acronym / sponsor ID
- SCHF-LLL-PEMF
- Keywords
- SCHF- low level laser- pulsed electromagnetic field.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- low level laser and pulsed electromagnetic field will be applied separated to different study groups of children with supracondylar humeral fracture.
| Arm | Type | Receives |
|---|---|---|
| study group A | Experimental | Device: low level laser ,pulsed electromagnetic field .20 children will receive designed physical therapy program in addition to low level laser |
| study group B | Experimental | Device: low level laser ,pulsed electromagnetic field .20 children will receive designed physical therapy program in addition to pulsed electromagnetic field . |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age ranges from 6 to 10 years of both genders.
- All subjects have unilateral extension type II and III supracondylar humeral fracture requiring closed reduction and percutaneous pinning (CRPP).
- The study will be start immediately after removal the splint.
- Children clinically and medically stable.
- Children able to follow verbal commands.
Key exclusion criteria (7 listed)
- The patients will be excluded if they have one of the following criteria;
- Previous soft tissue injury at the same affected side of fracture.
- Presence of associated fractures on the ipsilateral or contralateral upper limb.
- Active infection near the fracture site.
- Children with congenital or acquired skeletal deformities in the upper limbs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | study group A, study group B |
Primary outcome
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.
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
1 secondary outcome
Hand function
Time frame: six weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 22553105Mulpuri 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.
- Background: PubMed 30662761Vaquero-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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General hospital Beni-Seuif Beni-seuif study chair
generalhosbns@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser ,pulsed electromagnetic field . in people with Supracondylar Humeral Fracture in Pediatric, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Ezzat, master degree (01111730705, amiraezzat324@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain measurement (time frame: six weeks post intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06220812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.