Pulsed Electromagentic Field in Haemophilia

Hemophilia A Clinical Trial

Official title:

Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04590456
• Other study ID #: PEMF
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 19, 2020

Study information

• Verified date: December 2020
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 19, 2020
• Est. primary completion date: December 19, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

• type A hemophilia (moderate)

• free from any musculoskeletal deformities.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• PEMF
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

Locations

Country	Name	City	State
Egypt	Delta University for Science and Technology	Gamasa	Dakahelia

Sponsors (1)

Lead Sponsor	Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	swelling	The swelling degree was detected by tape	basline and after 3 months of intervention.
Secondary	range of motion	Active knee range of flexion and extension were measured by electronic goniometer.	basline and after 3 months of intervention.
Secondary	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.	basline and after 3 months of intervention.