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

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

This study will be carried out to combine the effect of PEMF and PUT on pain, function, and ROM in patients with knee OA.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee; Ultrasound Therapy; Complications
• Intervention / Treatment: Device: Pulsed Ultrasound; Other: Traditional exercise program; Device: Pulsed Electromagnetic field; Device: Sham Pulsed US & Electromagnetic field

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt, 34518
    • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed US + Exercise Group; Twenty subjects will receive PUT, plus an exercise program.	Device: Pulsed Ultrasound; 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; Other: Traditional exercise program; Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening
Experimental: Pulsed Electromagnetic + Exercise Group; Twenty subjects will receive PEMF, plus an exercise program.	Other: Traditional exercise program; Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening; Device: Pulsed Electromagnetic field; 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.
Experimental: Pulsed US + Pulsed Electromagnetic + Exercise Group; Twenty subjects will receive PUT, PEMF, plus an exercise program.	Device: Pulsed Ultrasound; 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; Other: Traditional exercise program; Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening; Device: Pulsed Electromagnetic field; 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.
Experimental: Sham + Exercise group; Twenty subjects will receive sham PEMF and sham PUT plus exercises program.	Other: Traditional exercise program; Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening; Device: Sham Pulsed US & Electromagnetic field; The patients will receive Sham Pulsed US & Electromagnetic field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at baseline and after 4 weeks of intervention
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.	at baseline and after 4 weeks of intervention
Range of motion of knee	Assessing the change in knee rane of motion using electrogoniometer.	at baseline and after 4 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline and after 4 weeks of intervention
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.	at baseline and after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Horus University
• Investigators: Principal Investigator: Ahmed Fayez, Demonstrator, Horus University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: November 28, 2021
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Horus_MSc_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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