Pulsed Electromagentic Field in Haemophilia

Sponsor
Delta University for Science and Technology (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04590456
Collaborator
(none)
30
1
2
3.6
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PEMF
N/A

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
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 19, 2020
Anticipated Study Completion Date :
Dec 19, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. swelling [basline and after 3 months of intervention.]

    The swelling degree was detected by tape

Secondary Outcome Measures

  1. range of motion [basline and after 3 months of intervention.]

    Active knee range of flexion and extension were measured by electronic goniometer.

  2. muscle strength [basline and after 3 months of intervention.]

    The peak concentric knee extensor (KE) and the peak concentric knee flexor (KF) was measured at 60/s angular speed by an isokinetic dynamometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 16 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Delta University for Science and Technology Gamasa Dakahelia Egypt 4030

Sponsors and Collaborators

  • Delta University for Science and Technology

Investigators

  • Study Chair: Hala I. Kassem, Professor, Professor of physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
walaa eldesoukey heneidy, lecturer of physical therapy, Delta University for Science and Technology
ClinicalTrials.gov Identifier:
NCT04590456
Other Study ID Numbers:
  • PEMF
First Posted:
Oct 19, 2020
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2020