Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis. (MT-MW-EX)

University of Castilla-La Mancha

Status: Completed

Conditions: Pain; Knee Osteoarthritis

Treatments: Device: Microwave plus exercise; Device: Magnetotherapy plus exercise; Device: Sham Magnetotherapy plus exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04866745

magneto-gifto

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Magnetotherapy plus exercise

Experimental group

Description:

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.

Treatment:

Device: Magnetotherapy plus exercise

Sham Magnetotherapy plus exercise

Placebo Comparator group

Description:

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.

Treatment:

Device: Sham Magnetotherapy plus exercise

Microwave plus exercise

Active Comparator group

Description:

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.

Treatment:

Device: Microwave plus exercise