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

NCT05151432 | Completed DMC

• 1 other identifier: Horus_MSc_2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Ultrasound Therapy; Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pain, Stiffness and function

  at baseline and after 4 weeks of intervention

• Walking ability

  at baseline and after 4 weeks of intervention

Study Arms (4)

Pulsed US + Exercise Group

EXPERIMENTAL

Twenty subjects will receive PUT, plus an exercise program.

Device: Pulsed Ultrasound; Other: Traditional exercise program

Pulsed Electromagnetic + Exercise Group

EXPERIMENTAL

Twenty subjects will receive PEMF, plus an exercise program.

Device: Pulsed Electromagnetic field; Other: Traditional exercise program

Pulsed US + Pulsed Electromagnetic + Exercise Group

EXPERIMENTAL

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

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

Sham + Exercise group

EXPERIMENTAL

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

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

Interventions

Pulsed Ultrasound 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 US + Exercise Group; Pulsed US + Pulsed Electromagnetic + Exercise Group

Pulsed Electromagnetic field 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.

Pulsed Electromagnetic + Exercise Group; Pulsed US + Pulsed Electromagnetic + Exercise Group

Traditional exercise program 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; Pulsed US + Exercise Group; Pulsed US + Pulsed Electromagnetic + Exercise Group; Sham + Exercise group

Sham Pulsed US & Electromagnetic field DEVICE

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

Sham + Exercise group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

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

Damietta, 34518, Egypt

Location

Study Officials

• Ahmed Fayez, Demonstrator

  Horus University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 9, 2021
• Study Start: November 7, 2021
• Primary Completion: April 28, 2022
• Study Completion: July 6, 2022
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

EG (1)