Pulsed Electromagentic Field in Haemophilia

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.

Study Overview

• Status: Unknown
• Conditions: Hemophilia A
• Intervention / Treatment: Other: PEMF

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahelia
    • Gamasa, Dakahelia, Egypt, 4030
      • Delta University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Placebo group	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
EXPERIMENTAL: PEMF group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
swelling	The swelling degree was detected by tape	basline and after 3 months of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	Active knee range of flexion and extension were measured by electronic goniometer.	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.	basline and after 3 months of intervention.

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology
• Investigators: Study Chair: Hala I. Kassem, Professor, Professor of physical therapy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): December 19, 2020
• Study Completion (ANTICIPATED): December 19, 2020

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: PEMF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No