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CompletedNCT05151432Updated Sep 25, 2023

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

An interventional study of Pulsed Ultrasound and Pulsed Electromagnetic field in Osteo Arthritis Knee and Ultrasound Therapy; Complications, sponsored by Horus University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.

Sponsored by Horus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteo Arthritis Knee
  • Ultrasound Therapy; Complications
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Horus University is the lead sponsor of 31 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Pulsed US + Exercise Group

    Twenty subjects will receive PUT, plus an exercise program.

    Device: Pulsed Ultrasound · Other: Traditional exercise program

  • Experimental
    Pulsed Electromagnetic + Exercise Group

    Twenty subjects will receive PEMF, plus an exercise program.

    Device: Pulsed Electromagnetic field · Other: Traditional exercise program

  • Experimental
    Pulsed US + Pulsed Electromagnetic + Exercise Group

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

    Device: Pulsed Ultrasound · Device: Pulsed Electromagnetic field · Other: Traditional exercise program

  • Experimental
    Sham + Exercise group

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

    Other: Traditional exercise program · Device: Sham Pulsed US & Electromagnetic field

Interventions

  • DevicePulsed 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

  • DevicePulsed 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.

  • OtherTraditional 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

  • DeviceSham Pulsed US & Electromagnetic field

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: at baseline and after 4 weeks of intervention

  2. 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.

    Time frame: at baseline and after 4 weeks of intervention

  3. Range of motion of knee

    Assessing the change in knee rane of motion using electrogoniometer.

    Time frame: at baseline and after 4 weeks of intervention

Secondary outcomes

  1. 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.

    Time frame: at baseline and after 4 weeks of intervention

  2. 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.

    Time frame: at baseline and after 4 weeks of intervention

07

Study locations

1 site
  • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
    Damietta, 34518, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05151432
Lead sponsor
Horus University
Responsible party
Ahmed Fayez Zehiry (Principal investigator, Horus University) — Principal investigator
First posted
Dec 9, 2021
Start date
Nov 7, 2021
Primary completion
Apr 28, 2022
Completion
Jul 6, 2022
Last update
Sep 25, 2023

Study contacts

Ahmed Fayez, Demonstrator
principal investigator · Horus University in Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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