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Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee, Ultrasound Therapy; Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed Ultrasound
Pulsed Electromagnetic field
Traditional exercise program
Sham Pulsed US & Electromagnetic field
Sponsored by
Horus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects diagnosed with moderate unilateral knee OA according to the American College of Rheumatology criteria

    • Morning stiffness
    • Crepitus on knee motion
    • Bony tenderness
    • No palpable warmth.
  2. a population of individuals (45-55 years old).
  3. patients are not obese their body mass index (BMI) will be> 30kg/ m2.
  4. with a diagnosis grade 2 radiographic severity according to the Kellgren/Lawrence scale. grading scale The severity of the disease was radiologically evaluated by an orthopedic knee specialist.

Exclusion Criteria:

Patients with the following criteria will be excluded from participating in this study:

  1. if they had received an intra-articular injection of hyaluronic acid or corticoids during the six months prior to the study.
  2. if they had a clinical history of orthopedic knee surgery, a skin disorder.
  3. cardiovascular diseases, such as acute myocardial infarction, during the previous month, or uncontrolled arterial hypertension, acute-phase respiratory conditions.
  4. or if they had been receiving another kind of physiotherapeutic treatment.

Sites / Locations

  • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Pulsed US + Exercise Group

Pulsed Electromagnetic + Exercise Group

Pulsed US + Pulsed Electromagnetic + Exercise Group

Sham + Exercise group

Arm Description

Twenty subjects will receive PUT, plus an exercise program.

Twenty subjects will receive PEMF, plus an exercise program.

Twenty subjects will receive PUT, PEMF, plus an exercise program.

Twenty subjects will receive sham PEMF and sham PUT plus exercises program.

Outcomes

Primary Outcome Measures

Pain intensity
Assessing the change in pain intensity using visual analogue scale which consists of a 10-cm line anchored at each end. Score of 10 means (Worest possible pain) while score of 0 means (No pain).
Dynamic balance
Assessing the change in Dynamic balance using timed up and go test. It will be used to asses patients functional mobility. The patient will be asked to rise from a standard armchair, walk at a safe and comfortable pace to a mark 3 m away, then return to a sitting position in the chair, using gait aids and chair armrests to assist with sit to stand as needed.
Range of motion of knee
Assessing the change in knee rane of motion using electrogoniometer.

Secondary Outcome Measures

Pain, Stiffness and function
Assessing the change in Pain, Stiffness and function using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It consists of three subscales regarding pain, stiffness, and physical function with five, two, and 17 questions, respectively. Answers for these 24 questions are scored on five-point Likert scales (none = 0, slight = 1, moderate = 2, severe = 3, extreme = 4) with total scores ranging from 0 to 96. Higher scores indicate greater disease severity.
Walking ability
Assessing the change in Walking ability using the 10-meter walk test.which is reliable and valid test in patients with OA , measuring the required time for walking on a standard flat surface of 10 m.

Full Information

First Posted
November 28, 2021
Last Updated
September 22, 2023
Sponsor
Horus University
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1. Study Identification

Unique Protocol Identification Number
NCT05151432
Brief Title
Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis
Official Title
Combined Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound Therapy in Treating Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horus University

4. Oversight

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

5. Study Description

Brief Summary
This study will be carried out to combine the effect of PEMF and PUT on pain, function, and ROM in patients with knee OA.
Detailed Description
Osteoarthritis (OA) is one of the most frequent illnesses in the world, affecting the knee joint in particular. Osteoarthritis of the knee is the most common cause of physical limitations and a decline in quality of life. OA of the knee affects 250 million individuals worldwide (3.6 percent of the population). According to the World Health Organization's study on the global burden of illness, knee OA is expected to become the eighth-most Ultrasound is one of the most often utilized and misunderstood treatment techniques. Ultrasound can help in the treatment or rehabilitation of musculoskeletal problems when utilized appropriately. When it is administered wrongly, however, the therapy provides little benefit at best, and at worst, the desired physiological effects are restricted or hindered. Electrotherapy is frequently used for the treatment of different musculoskeletal disorders, The most common types of electrotherapy are ultrasound (US), iontophoresis, laser therapy, electromagnetic therapy, and transcutaneous electrical nerve stimulation (TENS). To our knowledge, no previous clinical trials have combined the effectiveness of PEMF and PUST in the treatment of knee OA. Therefore, this study will be conducted to combine the efficacy of PEMF and PUST in the treatment of knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Ultrasound Therapy; Complications

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pulsed US + Exercise Group
Arm Type
Experimental
Arm Description
Twenty subjects will receive PUT, plus an exercise program.
Arm Title
Pulsed Electromagnetic + Exercise Group
Arm Type
Experimental
Arm Description
Twenty subjects will receive PEMF, plus an exercise program.
Arm Title
Pulsed US + Pulsed Electromagnetic + Exercise Group
Arm Type
Experimental
Arm Description
Twenty subjects will receive PUT, PEMF, plus an exercise program.
Arm Title
Sham + Exercise group
Arm Type
Experimental
Arm Description
Twenty subjects will receive sham PEMF and sham PUT plus exercises program.
Intervention Type
Device
Intervention Name(s)
Pulsed Ultrasound
Intervention Description
Active US therapy will be administered using a device 4cm², 1- MHz US with a sound-head area of effective 4cm, radiating area of 3.5 to a beam non-uniformity ratio of cm². 5:1, and a therapeutic dose of approximately 112.5J/ That is, the pulsed US will be delivered for 9.5 minutes with a peak intensity of 1W/cm² at a 20% duty cycle, to achieve a spatial-temporal average intensity of 0.2W
Intervention Type
Device
Intervention Name(s)
Pulsed Electromagnetic field
Intervention Description
The patient's knee will be placed between 2 plates coil applicator generating a magnetic field intensity of 1.5 mT and a frequency of 75Hz.
Intervention Type
Other
Intervention Name(s)
Traditional exercise program
Intervention Description
Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening
Intervention Type
Device
Intervention Name(s)
Sham Pulsed US & Electromagnetic field
Intervention Description
The patients will receive Sham Pulsed US & Electromagnetic field.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Assessing the change in pain intensity using visual analogue scale which consists of a 10-cm line anchored at each end. Score of 10 means (Worest possible pain) while score of 0 means (No pain).
Time Frame
at baseline and after 4 weeks of intervention
Title
Dynamic balance
Description
Assessing the change in Dynamic balance using timed up and go test. It will be used to asses patients functional mobility. The patient will be asked to rise from a standard armchair, walk at a safe and comfortable pace to a mark 3 m away, then return to a sitting position in the chair, using gait aids and chair armrests to assist with sit to stand as needed.
Time Frame
at baseline and after 4 weeks of intervention
Title
Range of motion of knee
Description
Assessing the change in knee rane of motion using electrogoniometer.
Time Frame
at baseline and after 4 weeks of intervention
Secondary Outcome Measure Information:
Title
Pain, Stiffness and function
Description
Assessing the change in Pain, Stiffness and function using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It consists of three subscales regarding pain, stiffness, and physical function with five, two, and 17 questions, respectively. Answers for these 24 questions are scored on five-point Likert scales (none = 0, slight = 1, moderate = 2, severe = 3, extreme = 4) with total scores ranging from 0 to 96. Higher scores indicate greater disease severity.
Time Frame
at baseline and after 4 weeks of intervention
Title
Walking ability
Description
Assessing the change in Walking ability using the 10-meter walk test.which is reliable and valid test in patients with OA , measuring the required time for walking on a standard flat surface of 10 m.
Time Frame
at baseline and after 4 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects diagnosed with moderate unilateral knee OA according to the American College of Rheumatology criteria Morning stiffness Crepitus on knee motion Bony tenderness No palpable warmth. a population of individuals (45-55 years old). patients are not obese their body mass index (BMI) will be> 30kg/ m2. with a diagnosis grade 2 radiographic severity according to the Kellgren/Lawrence scale. grading scale The severity of the disease was radiologically evaluated by an orthopedic knee specialist. Exclusion Criteria: Patients with the following criteria will be excluded from participating in this study: if they had received an intra-articular injection of hyaluronic acid or corticoids during the six months prior to the study. if they had a clinical history of orthopedic knee surgery, a skin disorder. cardiovascular diseases, such as acute myocardial infarction, during the previous month, or uncontrolled arterial hypertension, acute-phase respiratory conditions. or if they had been receiving another kind of physiotherapeutic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Fayez, Demonstrator
Organizational Affiliation
Horus University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
City
Damietta
ZIP/Postal Code
34518
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis

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