Burns of ThighNCT06525103
PEMT Versus WBV on Quadriceps Strength Post Burn
A study testing electromagnitic field therapy and whole body vibration in people with Burns of Thigh, run by Cairo University.
Trial summary
The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns of Thigh
- What is being tested?
- electromagnitic field therapy and whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Both sexes.
- Their ages were ranged from 25 to 40 years.
- Had second degree burn of 10 % to 25 %.
- Their body mass index (BMI) was not exceeded 34.9 Kg/m2.
- All patients were clinically and medically stable when attending the study
Who cannot join
- • Unstable cardiovascular problems like arrhythmia and heart failure.
- Diabetes mellitus.
- Chronic chest disease.
- Patients on medications affecting muscle power as steroids.
- Auditory and visual problems.
- Pregnancy \& lactation.
Show all 11Show fewer
- Patients with history of epilepsy.
- Clinically significant peripheral vascular disease.
- Musculoskeletal or neurological limitation to physical exercise.
- Any cognitive impairment that interferes with prescribed exercise procedures.
- Amputation of lower limb.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
The purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn.
Read the detailed description
A burn is an injury to the skin or other organic tissue primarily caused by heat, radiation or radioactivity, electricity, friction, or contact with chemicals. It is the fourth most common type of trauma worldwide and a major cause of mortality and disability in developing countries. Patients with ≥ 20% total burn surface area (TBSA) injury are potentially predisposed to significant morbidity and mortality. The immobilization period after burn is accompanied by numerous detrimental effect namely sever deconditioning such as sever weakness, impaired motor control decrease cognitive status, pain, risk of graft shearing and psychological factors. Severe burns are typically followed by a hypermetabolic response that lasts for at least 9-12 months post-injury. The endocrine status is also markedly altered with an initial and then sustained increase in proinflammatory 'stress' hormones such as cortisol and other glucocorticoids, and catecholamines including epinephrine and norepinephrine by the adrenal medulla and cortex. These hormones exert catabolic effects leading to muscle wasting . Pulsed electromagnetic fields (PEMFs) are known to be a noninvasive, safe and effective therapy agent without apparent side effects. Numerous studies have shown that PEMFs possess the potential to become a stand-alone or adjunctive treatment modality for treating musculoskeletal disorders. There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulate mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing. Whole Body Vibration Training (WBVT) can be described as exercising on a platform with an oscillating motion. Whole Body Vibration (WBV) is a newly developed neuromuscular training method, in which vibrations of various frequencies are provided to mechanically stimulate the receptors in the body such as muscle spindles. Whole Body Vibration Training (WBVT) elicits a biological adaptation that is connected to the neural potentiation effect. In this effect the proprioceptive pathways are strongly stimulated by the vibration which results in reflexive muscle contractions. Although WBVT combined with resistance training is becoming increasingly popular in various training recommendations, there is still an ongoing debate in literature, whether there are additional effects of WBV on muscle fitness and muscle performance in comparison to conventional exercise.
- Conditions
- Burns of Thigh
- Being tested
- electromagnitic field therapy, whole body vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnitic field therapyDevice
EMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology.
- Frequency : 50 or 60 Hz.
- Intenisty: 0-100 .Input voltage: 230 V
whole body vibrationDevice
Crazy fit machine.
- Input voltage:220 V.
- Frequency : 30 Hz.
- Maximum power: 1500W.
- Intensity:1 to 50 levels.
| Study group | Role | What they receive |
|---|---|---|
| Group (A): Fifteen patients will receive whole body vibration | Experimental | Not described Receives: Device: whole body vibration |
| Group (B): Fifteen patients will receive pulsed electromagnetic field (PEMF) | Experimental | Not described Receives: Device: electromagnitic field therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the strengh of quadriceps
evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start18 Oct 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burns of ThighStudies 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
- Thirty patients (male and female) who suffering from second degree burn with burned body surface area 10% \_25% BSA will participate in this study, they will be recruited from Al-Ahrar Teaching Hospital at Alsharqiya Governorate, Egypt. Their ages will be ranged from 25 to 40 years
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Talaat Moustafa Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525103
- Sponsor's protocol ID
- PEMT VS WBV on Qadri
- Status last verified
- Oct 2024
- First submitted
- 2 Jul 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheing GL, Li X, Huang L, Kwan RL, Cheung KK. Pulsed electromagnetic fields (PEMF) promote early wound healing and myofibroblast proliferation in diabetic rats. Bioelectromagnetics. 2014 Apr;35(3):161-9. doi: 10.1002/bem.21832. Epub 2014 Jan 3.
PubMed 24395219
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Therapy Versus Whole Body Vibration on Quadriceps Strength Post Burn
- ClinicalTrials.gov ID
- NCT06525103
- Acronym / sponsor ID
- PEMT VS WBV on Qadri
- Conditions
- Burns of Thigh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Oct 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Jul 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 purpose of the study is to evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn.
Detailed description
A burn is an injury to the skin or other organic tissue primarily caused by heat, radiation or radioactivity, electricity, friction, or contact with chemicals. It is the fourth most common type of trauma worldwide and a major cause of mortality and disability in developing countries. Patients with ≥ 20% total burn surface area (TBSA) injury are potentially predisposed to significant morbidity and mortality. The immobilization period after burn is accompanied by numerous detrimental effect namely sever deconditioning such as sever weakness, impaired motor control decrease cognitive status, pain, risk of graft shearing and psychological factors. Severe burns are typically followed by a hypermetabolic response that lasts for at least 9-12 months post-injury. The endocrine status is also markedly altered with an initial and then sustained increase in proinflammatory 'stress' hormones such as cortisol and other glucocorticoids, and catecholamines including epinephrine and norepinephrine by the adrenal medulla and cortex. These hormones exert catabolic effects leading to muscle wasting . Pulsed electromagnetic fields (PEMFs) are known to be a noninvasive, safe and effective therapy agent without apparent side effects. Numerous studies have shown that PEMFs possess the potential to become a stand-alone or adjunctive treatment modality for treating musculoskeletal disorders. There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulate mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing. Whole Body Vibration Training (WBVT) can be described as exercising on a platform with an oscillating motion. Whole Body Vibration (WBV) is a newly developed neuromuscular training method, in which vibrations of various frequencies are provided to mechanically stimulate the receptors in the body such as muscle spindles. Whole Body Vibration Training (WBVT) elicits a biological adaptation that is connected to the neural potentiation effect. In this effect the proprioceptive pathways are strongly stimulated by the vibration which results in reflexive muscle contractions. Although WBVT combined with resistance training is becoming increasingly popular in various training recommendations, there is still an ongoing debate in literature, whether there are additional effects of WBV on muscle fitness and muscle performance in comparison to conventional exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Thirty patients (male and female) who suffering from second degree burn with burned body surface area 10% _25% BSA will participate in this study, they will be recruited from Al-Ahrar Teaching Hospital at Alsharqiya Governorate, Egypt. Their ages will be ranged from 25 to 40 years
| Arm | Type | Receives |
|---|---|---|
| Group (A): Fifteen patients will receive whole body vibration | Experimental | Device: whole body vibration |
| Group (B): Fifteen patients will receive pulsed electromagnetic field (PEMF) | Experimental | Device: electromagnitic field therapy |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Both sexes.
Key exclusion criteria (11 listed)
- • Unstable cardiovascular problems like arrhythmia and heart failure.
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 |
|---|---|---|
| electromagnitic field therapyEMSCULPT device (BTL Industries Inc., Boston, MA) based on HIFEM technology. * Frequency : 50 or 60 Hz. * Intenisty: 0-100 .Input voltage: 230 V | Device | Group (B): Fifteen patients will receive pulsed electromagnetic field (PEMF) |
| whole body vibrationCrazy fit machine. * Input voltage:220 V. * Frequency : 30 Hz. * Maximum power: 1500W. * Intensity:1 to 50 levels. | Device | Group (A): Fifteen patients will receive whole body vibration |
Primary outcome
measure the strengh of quadriceps
Time frame: basline
evaluate which is more effective pulsed electromagnetic field therapy or whole-body vibration on quadriceps strength after chronic burn
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 24395219Cheing GL, Li X, Huang L, Kwan RL, Cheung KK. Pulsed electromagnetic fields (PEMF) promote early wound healing and myofibroblast proliferation in diabetic rats. Bioelectromagnetics. 2014 Apr;35(3):161-9. doi: 10.1002/bem.21832. Epub 2014 Jan 3.
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.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnitic field therapy and whole body vibration in people with Burns of Thigh, run by Cairo University.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aya talaat moustafa (01060480024, drayatalaat7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the strengh of quadriceps (time frame: basline). 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 NCT06525103, which also lists 1 linked publication.
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 8 Oct 2024.