Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis.

NCT04866745 | Completed DMC

• 1 other identifier: magneto-gifto
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Pain

Keywords

Knee osteoarthritis; Pain; Function; Phychosocial

Outcome Measures

Primary Outcomes (7)

• Change in knee pain

  The knee pain perceived in motion and at rest will be measured with the standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. Being the value 0 "no pain" and the value 10 "worst pain".

  Change from baseline at 4 weeks, 1 month and 4 months after intervention.

• Change in function

  Physical function, pain, and stiffness will be measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC-24). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  Change from baseline at 4 weeks, 1 month and 4 months after intervention.

• Daily knee pain

  The daily level of knee pain will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.

  Before each treatment session. 3 sessions per week (total 4 weeks)

• Daily level of functionality

  The level of functionality will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.

  Before each treatment session (during 4 weeks)

• Daily quality of sleep

  The quality of sleep will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst.

  Before each treatment session (during 4 weeks)

• Daily intake of oral non-opioid analgesic medication

  Daily intake of oral non-opioid analgesic medication (number of pills per day) during the 24 hours interval before each treatment session being the value 0 the best and 10 the worst.

  Before each treatment session (during 4 weeks)

• Change in balance and fall risk

  Test timed up and go (TUG) will be expressed in seconds. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down. The test will be performed 3 times. The mean of the three tests will be used. Less time performing this test indicates better mobility.

  Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.

Secondary Outcomes (7)

• Change in patient quality of life

  Index change from baseline at 4 weeks, 1 month and 4 months after intervention.

• Change in lower limb strength

  Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.

• Blinding assesment

  Post treatment at 4 weeks

• Number of participants with adverse effects

  Post each treatment session (during 4 weeks)

• Change in knee range of motion

  Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.

Study Arms (3)

Magnetotherapy plus exercise

EXPERIMENTAL

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.

Device: Magnetotherapy plus exercise

Sham Magnetotherapy plus exercise

PLACEBO COMPARATOR

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.

Device: Sham Magnetotherapy plus exercise

Microwave plus exercise

ACTIVE COMPARATOR

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.

Device: Microwave plus exercise

Interventions

Magnetotherapy plus exercise 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.

Also known as: Magnetotherapy, VARIMAG-4E.

Magnetotherapy plus exercise

Microwave plus exercise 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.

Also known as: Deep heating therapy, VARITRON 250-EP.

Microwave plus exercise

Sham Magnetotherapy plus exercise 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.

Also known as: Sham Magnetotherapy, VARIMAG-4E.

Sham Magnetotherapy plus exercise

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Centro de Salud Talavera Centro y Centro de Salud La Algodonera.: collaborator
• Clínica Radiodiagnóstico Marazuela: collaborator
• Empresa Helios Electromedicina S.L.: collaborator

Study Sites (1)

Juan Avendaño Coy

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Magnetic Field Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, sham-controlled, randomized clinical trial.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 30, 2021
• Study Start: June 10, 2021
• Primary Completion: January 26, 2023
• Study Completion: July 25, 2023
• Last Updated: April 4, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 01/01/2023. The data will be published in a scientific journal

Locations

ES (1)