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Pulsed Electromagentic Field in Haemophilia

Primary Purpose

Hemophilia A

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PEMF
Sponsored by
Delta University for Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

13 Years - 16 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Delta University for Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo group

PEMF group

Arm Description

Outcomes

Primary Outcome Measures

swelling
The swelling degree was detected by tape

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2020
Last Updated
December 19, 2020
Sponsor
Delta University for Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04590456
Brief Title
Pulsed Electromagentic Field in Haemophilia
Official Title
Efficacy of Pulsed Electromagnetic Field on Hemarthrotic Knee in Haemophilic Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 19, 2020 (Anticipated)
Study Completion Date
December 19, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Experimental
Arm Title
PEMF group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PEMF
Intervention Description
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
Primary Outcome Measure Information:
Title
swelling
Description
The swelling degree was detected by tape
Time Frame
basline and after 3 months of intervention.
Secondary Outcome Measure Information:
Title
range of motion
Description
Active knee range of flexion and extension were measured by electronic goniometer.
Time Frame
basline and after 3 months of intervention.
Title
muscle strength
Description
The peak concentric knee extensor (KE) and the peak concentric knee flexor (KF) was measured at 60/s angular speed by an isokinetic dynamometer.
Time Frame
basline and after 3 months of intervention.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala I. Kassem, Professor
Organizational Affiliation
Professor of physical therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Delta University for Science and Technology
City
Gamasa
State/Province
Dakahelia
ZIP/Postal Code
4030
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24472015
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.
Results Reference
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Pulsed Electromagentic Field in Haemophilia

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