An interventional study of Magnetotherapy plus exercise and Microwave plus exercise in Knee Osteoarthritis and Pain, sponsored by University of Castilla-La Mancha. Completed at 1 site in Spain. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by University of Castilla-La Mancha · Not applicable, Interventional, and Treatment
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.
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:
The participants will be randomly assigned in three groups:
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Castilla-La Mancha is the lead sponsor of 104 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
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
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
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
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.
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.
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.
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in patient quality of life
The European Quality of life 5 Dimensions (EuroQoL 5D-5L) is a questionnaire that evaluates the generic quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health state is usually represented using a 5-digit number (profile) where 11111 indicates perfect health and 55555 the worst health state.
Time frame: Index change from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in lower limb strength
Maximal isometrical knee extension and flexion strength will be measure with a hand dynamometer and will be expressed in Kgs. The researcher will perform three measurements and the final result will be the average of the three.
Time frame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Blinding assesment
The success of participant and assessor blinding will be evaluated through a questionnaire after each intervention with five questions: (1) "Strongly believe the applied intervention is new treatment"; (2) "Somewhat believe the applied intervention is new treatment"; (3) "Somewhat believe the applied intervention is a placebo", (4) "Strongly believe the applied intervention is a placebo", or (5) "Do not know".
Time frame: Post treatment at 4 weeks
Number of participants with adverse effects
The number of participants who suffered adverse effects will be reported by the researcher (for example skin erythema, rush, or itching...).
Time frame: Post each treatment session (during 4 weeks)
Change in knee range of motion
Knee active and passive range of motion will be measure with the WERIUM sensors. It will be expressed in degrees. The mean of 3 movements of flexion and extension will be calculated.
Time frame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in perceived generic health status
The European Quality of life 5 Dimensions (EuroQoL 5D-5L) questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time frame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Doses of analgesic and antidepressant medication
The doses of analgesic and antidepressant medication will be recorded at baseline. Taking into account the therapeutic steps of the World Health Organization and the dosage, 4 values will be established concerning the basal state: "increases, decreases, it is eliminated or it is maintained".
Time frame: Change from baseline at 4 weeks.
Plan to share: Yes — Congress presentation in a poster format Publication in a scientific journal Social media
Supporting information: Study protocol, Sap, Csr
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University of Castilla-La Mancha