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

Not Applicable

Completed

• Conditions: Ultrasound Therapy; Complications; Osteo Arthritis Knee
• Interventions: Device: Pulsed Electromagnetic field; Device: Pulsed Ultrasound; Device: Sham Pulsed US & Electromagnetic field; Other: Traditional exercise program

• Registration Number: NCT05151432
• Lead Sponsor: Horus University

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.

Study Timeline

• Study Start: 2021-11-07
• Study First Submitted: 2021-11-28
• Study First Submitted QC: 2021-11-28
• Study First Posted: 2021-12-09
• Primary Completion: 2022-04-28
• Study Completion: 2022-07-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham + Exercise group	Sham Pulsed US & Electromagnetic field	Twenty subjects will receive sham PEMF and sham PUT plus exercises program.
Pulsed Electromagnetic + Exercise Group	Pulsed Electromagnetic field	Twenty subjects will receive PEMF, plus an exercise program.
Pulsed US + Pulsed Electromagnetic + Exercise Group	Traditional exercise program	Twenty subjects will receive PUT, PEMF, plus an exercise program.
Pulsed US + Exercise Group	Pulsed Ultrasound	Twenty subjects will receive PUT, plus an exercise program.
Pulsed Electromagnetic + Exercise Group	Traditional exercise program	Twenty subjects will receive PEMF, plus an exercise program.
Sham + Exercise group	Traditional exercise program	Twenty subjects will receive sham PEMF and sham PUT plus exercises program.
Pulsed US + Exercise Group	Traditional exercise program	Twenty subjects will receive PUT, plus an exercise program.
Pulsed US + Pulsed Electromagnetic + Exercise Group	Pulsed Ultrasound	Twenty subjects will receive PUT, PEMF, plus an exercise program.
Pulsed US + Pulsed Electromagnetic + Exercise Group	Pulsed Electromagnetic field	Twenty subjects will receive PUT, PEMF, plus an exercise program.

Primary Outcome Measures

Name	Time	Method
Dynamic balance	at baseline and after 4 weeks of intervention	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	at baseline and after 4 weeks of intervention	Assessing the change in knee rane of motion using electrogoniometer.
Pain intensity	at baseline and after 4 weeks of intervention	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).

Secondary Outcome Measures

Name	Time	Method
Pain, Stiffness and function	at baseline and after 4 weeks of intervention	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	at baseline and after 4 weeks of intervention	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.

Trial Locations

Locations (1)

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt; 🇪🇬 Damietta, Egypt