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Clinical Trials/NCT04590456
NCT04590456UnknownNot Applicable

Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence

Delta University for Science and Technology1 site in 1 country30 target enrollmentStarted: September 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
swelling

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
13 Years to 16 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

PEMF group

Experimental

Intervention: PEMF (Other)

Placebo group

Experimental

Intervention: PEMF (Other)

Outcomes

Primary Outcomes

swelling

Time Frame: basline and after 3 months of intervention.

The swelling degree was detected by tape

Secondary Outcomes

  • range of motion(basline and after 3 months of intervention.)
  • muscle strength(basline and after 3 months of intervention.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

walaa eldesoukey heneidy

lecturer of physical therapy

Delta University for Science and Technology

Study Sites (1)

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