Clinical trial NCT04866745: Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis.
Official title: Effectiveness of Magnetotherapy and Microwaves Combined With Therapeutic Exercise in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Pain
Keywords: Knee osteoarthritis
Pain
Function
Phychosocial
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Centro de Salud Talavera Centro y Centro de Salud La Algodonera.
name: Clínica Radiodiagnóstico Marazuela
name: Empresa Helios Electromedicina S.L.
First posted: 2021-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, sham-controlled, randomized clinical trial.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in knee pain
timeFrame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Change in function
timeFrame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Daily knee pain
timeFrame: Before each treatment session. 3 sessions per week (total 4 weeks)
measure: Daily level of functionality
timeFrame: Before each treatment session (during 4 weeks)
measure: Daily quality of sleep
timeFrame: Before each treatment session (during 4 weeks)
measure: Daily intake of oral non-opioid analgesic medication
timeFrame: Before each treatment session (during 4 weeks)
measure: Change in balance and fall risk
timeFrame: Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.
Secondary outcomes:
measure: Change in patient quality of life
timeFrame: Index change from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Change in lower limb strength
timeFrame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Blinding assesment
timeFrame: Post treatment at 4 weeks
measure: Number of participants with adverse effects
timeFrame: Post each treatment session (during 4 weeks)
measure: Change in knee range of motion
timeFrame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Change in perceived generic health status
timeFrame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
measure: Doses of analgesic and antidepressant medication
timeFrame: Change from baseline at 4 weeks.
Other outcomes:
Locations:
city: Talavera De La Reina
country: Spain
facility: Juan Avendaño Coy
state: Toledo
Study officials:
References: