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

NCT ID: NCT05151432

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-07
• Study Completion Date: 2022-07-06

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.

Conditions

Osteo Arthritis Knee; Ultrasound Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pulsed US + Exercise Group

Twenty subjects will receive PUT, plus an exercise program.

Group Type: EXPERIMENTAL

Pulsed Ultrasound

Intervention Type: DEVICE

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

Traditional exercise program

Intervention Type: OTHER

Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening

Pulsed Electromagnetic + Exercise Group

Twenty subjects will receive PEMF, plus an exercise program.

Group Type: EXPERIMENTAL

Pulsed Electromagnetic field

Intervention Type: DEVICE

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.

Traditional exercise program

Intervention Type: OTHER

Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening

Pulsed US + Pulsed Electromagnetic + Exercise Group

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

Group Type: EXPERIMENTAL

Pulsed Ultrasound

Intervention Type: DEVICE

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

Pulsed Electromagnetic field

Intervention Type: DEVICE

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.

Traditional exercise program

Intervention Type: OTHER

Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening

Sham + Exercise group

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

Group Type: EXPERIMENTAL

Traditional exercise program

Intervention Type: OTHER

Stretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening

Sham Pulsed US & Electromagnetic field

Intervention Type: DEVICE

The patients will receive Sham Pulsed US \& Electromagnetic field.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Sham Pulsed US & Electromagnetic field

The patients will receive Sham Pulsed US \& Electromagnetic field.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Horus University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Fayez Zehiry

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Fayez, Demonstrator

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt

Locations

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

Damietta, , Egypt

Countries

Egypt

Other Identifiers

Horus_MSc_2021

Identifier Type: -

Identifier Source: org_study_id