Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blinded, sham-controlled, randomized clinical trial.Masking: Double (Participant, Investigator)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 85 years
- Gender
- Both males and females
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) appl...
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 72 adults, older than 45 years old, diagnosed with osteoarthritis of the knee who meet the inclusion criteria will be recruited by voluntary admission.
Tracking Information
- NCT #
- NCT04866745
- Collaborators
- Centro de Salud Talavera Centro y Centro de Salud La Algodonera.
- Clínica Radiodiagnóstico Marazuela
- Empresa Helios Electromedicina S.L.
- Investigators
- Not Provided
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