Hemophilia ANCT04590456
Pulsed Electromagentic Field in Haemophilia
A study testing PEMF in people with Hemophilia A, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects. Read more about this study
- Who is it for?
- Ages 13 to 16 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- PEMF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 19 Dec 2020
- 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 13 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- type A hemophilia (moderate)
- free from any musculoskeletal deformities.
Who cannot join
- patients who performed surgical procedures 6 weeks before conducting the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence
To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.
Read the detailed description
Haemophilia is an X-linked hereditary sex recessive disorder that impairs the body's ability to make blood clots. It includes two types: A (FVIII deficit factor) and B (IX deficit factor), depending on FVIII/FIX percentage in blood. The severity of haemophilia is classified into (severe: <1%, moderate: 1-5%, and mild: >5%). The prevalence of haemophilia A is 1: 5000 live births and haemophilia B is 1: 30000 live births.
This disease is characterized by hemarthrosis which is a hemorrhage in the locomotor system, mainly muscles and joints. Joint bleeding mainly occurs in knees, ankles and elbows. Haemorrhage in the muscle or joints accounts for 80% to 90% of all bleeding episodes in people with haemophilia. The most commonly affected joints in non-prophylaxis patients are the knees (45%) which is thought to be due to the large size of the synovial membrane and large rotational forces present. It is followed by the elbows (30%), ankles (15%), shoulders (3%), and wrists (2%). Bleeds are best detected by the patients themselves as bruising and swelling or described as a feeling of warmth or tingling within the joint preceding the clinical signs.
Pulsed electromagnetic field (PEMF) has been reported to be effective in reducing pain, healing of ulcers and promote bone healing, and treating osteoarthritis and inflammatory diseases of the musculoskeletal system. Also, it was reported that PEMF exposure significantly increases the anti-inflammatory effect, suggesting its potential therapeutic use in the treatment of inflammatory bone and joint disorders.
- Conditions
- Hemophilia A
- Being tested
- PEMF
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMFOther
group A received 60 minutes of traditional program physical therapy which consisted of passive range of motion, stretching,proprioception, isotonic and isometric and 20 minutes of placebo treatment using PEMF, while group B received the same traditional physical therapy program given to the control group in addition of 20 minutes of PEMF therapy
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Experimental | Not described Receives: Other: PEMF |
| PEMF group | Experimental | Not described Receives: Other: PEMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
swelling
The swelling degree was detected by tape
Measured: basline and after 3 months of intervention.
Secondary outcomes (2)
range of motion
Active knee range of flexion and extension were measured by electronic goniometer.
Measured: basline and after 3 months of intervention.
muscle strength
The peak concentric knee extensor (KE) and the peak concentric knee flexor (KF) was measured at 60/s angular speed by an isokinetic dynamometer.
Measured: basline and after 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completion19 Dec 2020 (estimated)
- Study completion19 Dec 2020 (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 Hemophilia AStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa eldesoukey heneidy, Delta University for Science and Technology
- Investigators
- Hala I. Kassem, Professor, Study chair, Professor of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590456
- Sponsor's protocol ID
- PEMF
- Status last verified
- Dec 2020
- First submitted
- 22 Sep 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gringeri A, Ewenstein B, Reininger A. The burden of bleeding in haemophilia: is one bleed too many? Haemophilia. 2014 Jul;20(4):459-63. doi: 10.1111/hae.12375. Epub 2014 Jan 29.
PubMed 24472015
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence
- ClinicalTrials.gov ID
- NCT04590456
- Acronym / sponsor ID
- PEMF
- Conditions
- Hemophilia A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 19 Dec 2020 (estimated)
- Study completion
- 19 Dec 2020 (estimated)
- First posted
- 19 Oct 2020 (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.
To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.
Detailed description
Haemophilia is an X-linked hereditary sex recessive disorder that impairs the body's ability to make blood clots. It includes two types: A (FVIII deficit factor) and B (IX deficit factor), depending on FVIII/FIX percentage in blood. The severity of haemophilia is classified into (severe: <1%, moderate: 1-5%, and mild: >5%). The prevalence of haemophilia A is 1: 5000 live births and haemophilia B is 1: 30000 live births.
This disease is characterized by hemarthrosis which is a hemorrhage in the locomotor system, mainly muscles and joints. Joint bleeding mainly occurs in knees, ankles and elbows. Haemorrhage in the muscle or joints accounts for 80% to 90% of all bleeding episodes in people with haemophilia. The most commonly affected joints in non-prophylaxis patients are the knees (45%) which is thought to be due to the large size of the synovial membrane and large rotational forces present. It is followed by the elbows (30%), ankles (15%), shoulders (3%), and wrists (2%). Bleeds are best detected by the patients themselves as bruising and swelling or described as a feeling of warmth or tingling within the joint preceding the clinical signs.
Pulsed electromagnetic field (PEMF) has been reported to be effective in reducing pain, healing of ulcers and promote bone healing, and treating osteoarthritis and inflammatory diseases of the musculoskeletal system. Also, it was reported that PEMF exposure significantly increases the anti-inflammatory effect, suggesting its potential therapeutic use in the treatment of inflammatory bone and joint disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Experimental | Other: PEMF |
| PEMF group | Experimental | Other: PEMF |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- type A hemophilia (moderate)
- free from any musculoskeletal deformities.
Key exclusion criteria (1 listed)
- patients who performed surgical procedures 6 weeks before conducting the study
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 |
|---|---|---|
| PEMFgroup A received 60 minutes of traditional program physical therapy which consisted of passive range of motion, stretching,proprioception, isotonic and isometric and 20 minutes of placebo treatment using PEMF, while group B received the same traditional physical therapy program given to the control group in addition of 20 minutes of PEMF therapy | Other | PEMF group, Placebo group |
Primary outcome
swelling
Time frame: basline and after 3 months of intervention.
The swelling degree was detected by tape
2 secondary outcomes
range of motion
Time frame: basline and after 3 months of intervention.
muscle strength
Time frame: basline and after 3 months of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 24472015Gringeri A, Ewenstein B, Reininger A. The burden of bleeding in haemophilia: is one bleed too many? Haemophilia. 2014 Jul;20(4):459-63. doi: 10.1111/hae.12375. Epub 2014 Jan 29.
- Individual participant dataSharing planned: No
Related trials for Hemophilia A
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A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
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A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
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An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
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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.
Hala I. Kassem, Professor study chair
Professor of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF in people with Hemophilia A, run by Delta University for Science and Technology 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 2 inclusion and 1 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 22 Dec 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
swelling (time frame: basline and after 3 months of intervention.). 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 NCT04590456, 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 22 Dec 2020.