Clinical trial NCT04590456: Pulsed Electromagentic Field in Haemophilia
Official title: Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia A
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 30
Sex: MALE
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* type A hemophilia (moderate)
* free from any musculoskeletal deformities.

Exclusion Criteria:

* patients who performed surgical procedures 6 weeks before conducting the study

Primary outcomes:
measure: swelling
timeFrame: basline and after 3 months of intervention.
Secondary outcomes:
measure: range of motion
timeFrame: basline and after 3 months of intervention.
measure: muscle strength
timeFrame: basline and after 3 months of intervention.
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta University for Science and Technology
state: Dakahelia
Study officials:
affiliation: Professor of physical therapy
name: Hala I. Kassem, Professor
role: STUDY_CHAIR
References:
citation: 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.