Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2023-07-25

Brief Summary

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The high prevalence of knee osteoarthritis and the absence of well-defined protocols for the application of Magnetotherapy (MT), makes it necessary to investigate the effect of this therapy on patients with knee osteoarthritis. Furthermore, no studies are comparing the effectiveness of the two interventions proposed in this project (MT) and microwaves (MW), which are routinely applied in clinical practice, without solid scientific evidence to justify their use.

The purpose of the present clinical trial is to compare MT with MW both combined with a therapeutic exercise program in patients with painful knee osteoarthritis and its influence on pain and function.

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Detailed Description

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This study is a double-blinded, sham-controlled, randomized clinical trial whose main objective is to investigate the effect on pain and function in people with moderate knee osteoarthritis of the intervention with Magnetotherapy (MT) combined with an exercise program compared to microwave (MW) application combined with an exercise program and to MT placebo combined with an exercise program. The study will take place at several centers of primary healthcare centers in Spain. After receiving the approval of the Ethics and Clinical Research Committee of Talavera de la Reina Hospital (Toledo). It is proposed to perform the study between May 2021 to May 2022.

The secondary objectives are:

* To investigate the effect of intervention with MT and MW plus exercise on quality of life and psychosocial factors of pain in people with osteoarthritis of the knee.
* To evaluate the effect of both interventions on knee joint kinematics and range of motion and lower limb strength.
* To evaluate the success of the blinding method of participants and professionals.
* To measure the possible adverse effects of the application of MT and MW in patients with moderate osteoarthritis of the knee.

The participants will be randomly assigned in three groups:

* Group A: Magnetotherapy combined plus exercise program.
* Group B: Sham magnetotherapy plus exercise program.
* Group C: Microwaves combined plus exercise program.

A minimum of 60 adults, older than 45 years old, diagnosed with osteoarthritis of the knee who meet the inclusion criteria will be recruited by voluntary admission.

Conditions

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Knee Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, sham-controlled, randomized clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The assignment to the MT and MT placebo group will be only known by the technician from the external device manufacturer who programs the coded MT equipment. The coded MT equipment will be programmed in such a way that the physical therapist that applies the intervention will enter the code for each participant without knowing the group to which the patient is assigned. Therefore, the therapists that apply the intervention will only know the assignment to the MW group. For the blinding of the subjects, the same protocol will be followed in the placebo treatment as in the experimental group (number of sessions, application area, and device). The researchers who perform the recruitment, the participants, the researcher who will perform the assessments and the analysis of the data, and the therapists who will apply the exercise program will be blinded.

Study Groups

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Magnetotherapy plus exercise

The patients will receive a total of 12 sessions, 3 sessions per week of magnetotherapy. The duration of treatment will be 20 minutes with a magnetic field frequency of 50Hz and a power of 100 Gauss.

After the magnetotherapy treatment, the patient will have to perform 12 sessions, 3 sessions per week of a program of therapeutic exercise with a duration of 25 minutes. This exercise program will be the same in the microwave and sham groups.

Group Type EXPERIMENTAL

Magnetotherapy plus exercise

Intervention Type DEVICE

The VARIMAG-4E magnetotherapy device will be used. It is a pulsed radiofrequency energy device. The device has a voltage of 220V, 4 amps of intensity, 50 Hz of frequency and a maximum power of 100 Gauss. For the active treatment application, the patient will be in supine position and will introduce both knees in the 50 cm coil in case of bilateral knee osteoarthritis. In the case of unilateral knee osteoarthritis, the affected knee will be introduced in the 30cm coil. The duration of the treatment will be 20 minutes, the frequency administered will be 50 Hz and a power of 100 Gauss.

Sham Magnetotherapy plus exercise

The patients will receive a total of 12 sessions, 3 sessions per week of sham magnetotherapy. For the simulated/sham magnetotherapy group, it will be applied in the same way as the real MT group, but the equipment will be programmed to apply 0 Gauss. The physiotherapist performing the application will not have access to the magnetotherapy parameters on the display of the device, but will only have to enter the code. After the application of sham magnetotherapy, the patient will have to perform a program of therapeutic exercise.

Group Type PLACEBO_COMPARATOR

Sham Magnetotherapy plus exercise

Intervention Type DEVICE

The protocol and device will be the same in the active/placebo treatment. The sham device does not emit an electromagnetic field. The energy from the active device is not felt by the user, and the active device cannot be distinguished in any way from the placebo device.

Microwave plus exercise

The patients will receive a total of 12 sessions, 3 sessions per week of microwave therapy. The duration of the session will be 20 minutes, 10 minutes on the anterior side and 10 minutes on the posterior side of the joint in case of unilateral knee osteoarthritis. In the case of bilateral knee osteoarthritis, the MW will be applied 20 minutes over the anterosuperior side of both knees. After the microwave session, the patient will have to perform a program of therapeutic exercise.

Group Type ACTIVE_COMPARATOR

Microwave plus exercise

Intervention Type DEVICE

The application of deep heating therapy will be with the patient in a sitting position. The VARITRON 250-EP microwave device will be used with a frequency of 2450 MHz and a maximum output power of 250W. In the case of unilateral knee osteoarthritis, the circular applicator with a diameter of 170mm will be placed approximately 15 cm from the knee. The duration of the session will be 20 minutes, 10 minutes over the internal face and 10 minutes over the external face of the knee. In the case of bilateral knee osteoarthritis, the large lumbar applicator will be placed approximately 15 cm from the anterosuperior face of both knees for 20 minutes. The patient will have to perceive a moderate heat sensation.

Interventions

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Magnetotherapy plus exercise

The VARIMAG-4E magnetotherapy device will be used. It is a pulsed radiofrequency energy device. The device has a voltage of 220V, 4 amps of intensity, 50 Hz of frequency and a maximum power of 100 Gauss. For the active treatment application, the patient will be in supine position and will introduce both knees in the 50 cm coil in case of bilateral knee osteoarthritis. In the case of unilateral knee osteoarthritis, the affected knee will be introduced in the 30cm coil. The duration of the treatment will be 20 minutes, the frequency administered will be 50 Hz and a power of 100 Gauss.

Intervention Type DEVICE

Microwave plus exercise

The application of deep heating therapy will be with the patient in a sitting position. The VARITRON 250-EP microwave device will be used with a frequency of 2450 MHz and a maximum output power of 250W. In the case of unilateral knee osteoarthritis, the circular applicator with a diameter of 170mm will be placed approximately 15 cm from the knee. The duration of the session will be 20 minutes, 10 minutes over the internal face and 10 minutes over the external face of the knee. In the case of bilateral knee osteoarthritis, the large lumbar applicator will be placed approximately 15 cm from the anterosuperior face of both knees for 20 minutes. The patient will have to perceive a moderate heat sensation.

Intervention Type DEVICE

Sham Magnetotherapy plus exercise

The protocol and device will be the same in the active/placebo treatment. The sham device does not emit an electromagnetic field. The energy from the active device is not felt by the user, and the active device cannot be distinguished in any way from the placebo device.

Intervention Type DEVICE

Other Intervention Names

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Magnetotherapy, VARIMAG-4E. Deep heating therapy, VARITRON 250-EP. Sham Magnetotherapy, VARIMAG-4E.

Eligibility Criteria

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Inclusion Criteria

* Patients older than 45 years old
* Unilateral or bilateral knee osteoarthritis.
* Kellgren and Lawrence (K-L) grade II or III.
* Visual analog scale (VAS) greater than 40mm.
* Affectation of more than one year of evolution.
* Sign and understand the informed consent form.

Exclusion Criteria

* Secondary cause osteoarthritis
* History of uncontrolled metabolic diseases.
* Decompensated or uncontrolled pathologies
* Tumor processes.
* Collagenopathies and neurological diseases.
* Changes in medication or invasive treatments at least 1 month prior to treatment.
* Receiving physiotherapy treatment or having received it one month prior to the start of the osteoarthritis study.
* Patients with alterations in thermal sensitivity.
* Pacemaker
* Skin alterations (recent wounds or burns).
* Knee prosthesis
* Thrombophlebitis

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No