Osteo Arthritis KneeNCT05151432
Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound in Treating Knee Osteoarthritis
A study testing Pulsed Ultrasound, Pulsed Electromagnetic field and Traditional exercise program in people with Osteo Arthritis Knee and Ultrasound Therapy; Complications, run by Horus University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Ultrasound Therapy; Complications
- What is being tested?
- Pulsed Ultrasound, Pulsed Electromagnetic field and Traditional exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2021to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
Damietta, 34518
About this study
Official title: 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.
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.
- Being tested
- Pulsed Ultrasound, Pulsed Electromagnetic field, Traditional exercise program, Sham Pulsed US & Electromagnetic field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed UltrasoundDevice
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 fieldDevice
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 programOther
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 fieldDevice
The patients will receive Sham Pulsed US \& Electromagnetic field.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed US + Exercise Group | Experimental | Twenty subjects will receive PUT, plus an exercise program. Receives: Device: Pulsed Ultrasound; Other: Traditional exercise program |
| Pulsed Electromagnetic + Exercise Group | Experimental | Twenty subjects will receive PEMF, plus an exercise program. Receives: 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. Receives: 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. Receives: Other: Traditional exercise program; Device: Sham Pulsed US & Electromagnetic field |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: at baseline and after 4 weeks of intervention
Range of motion of knee
Assessing the change in knee rane of motion using electrogoniometer.
Measured: at baseline and after 4 weeks of intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start7 Nov 2021
- Primary completion28 Apr 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fayez Zehiry, Horus University
- Investigators
- Ahmed Fayez, Demonstrator, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151432
- Sponsor's protocol ID
- Horus_MSc_2021
- Status last verified
- Sep 2023
- First submitted
- 28 Nov 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Pulsed Electromagnetic Field and Pulsed Ultrasound Therapy in Treating Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05151432
- Acronym / sponsor ID
- Horus_MSc_2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 7 Nov 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulsed US + Exercise Group | Experimental | Device: Pulsed Ultrasound, Other: Traditional exercise programTwenty subjects will receive PUT, plus an exercise program. |
| Pulsed Electromagnetic + Exercise Group | Experimental | Device: Pulsed Electromagnetic field, Other: Traditional exercise programTwenty subjects will receive PEMF, plus an exercise program. |
| Pulsed US + Pulsed Electromagnetic + Exercise Group | Experimental | Device: Pulsed Ultrasound, Device: Pulsed Electromagnetic field, Other: Traditional exercise programTwenty subjects will receive PUT, PEMF, plus an exercise program. |
| Sham + Exercise group | Experimental | Other: Traditional exercise program, Device: Sham Pulsed US & Electromagnetic fieldTwenty subjects will receive sham PEMF and sham PUT plus exercises program. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects diagnosed with moderate unilateral knee OA according to the American College of Rheumatology criteria
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed UltrasoundActive 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 | Device | Pulsed US + Exercise Group, Pulsed US + Pulsed Electromagnetic + Exercise Group |
| Pulsed Electromagnetic fieldThe 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. | Device | Pulsed Electromagnetic + Exercise Group, Pulsed US + Pulsed Electromagnetic + Exercise Group |
| Traditional exercise programStretching exercises, Isometric quadriceps exercise, Straight leg raising (SLR) exercise, Isometric hip adduction exercise, Hip abductor strengthening, Hip extensor strengthening, Hip external rotator strengthening | Other | Pulsed Electromagnetic + Exercise Group, Pulsed US + Exercise Group, Pulsed US + Pulsed Electromagnetic + Exercise Group, Sham + Exercise group |
| Sham Pulsed US & Electromagnetic fieldThe patients will receive Sham Pulsed US \& Electromagnetic field. | Device | Sham + Exercise group |
Primary outcome
Pain intensity
Time frame: 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).
Dynamic balance
Time frame: 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
Time frame: at baseline and after 4 weeks of intervention
Assessing the change in knee rane of motion using electrogoniometer.
2 secondary outcomes
Pain, Stiffness and function
Time frame: at baseline and after 4 weeks of intervention
Walking ability
Time frame: at baseline and after 4 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Fayez, Demonstrator principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Ultrasound, Pulsed Electromagnetic field and Traditional exercise program in people with Osteo Arthritis Knee and Ultrasound Therapy; Complications, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: at baseline and after 4 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.