Effectiveness of Magnetotherapy and Microwaves Combined With Therapeutic Exercise in Patients With Knee Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Daily knee pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Daily knee pain
时间窗: Before each treatment session. 3 sessions per week (total 4 weeks)
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.
Daily quality of sleep
时间窗: Before each treatment session (during 4 weeks)
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.
Change in knee pain
时间窗: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
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 in function
时间窗: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
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.
Daily level of functionality
时间窗: Before each treatment session (during 4 weeks)
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.
Daily intake of oral non-opioid analgesic medication
时间窗: Before each treatment session (during 4 weeks)
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.
Change in balance and fall risk
时间窗: Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.
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.
次要结局
- Change in lower limb strength(Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.)
- Number of participants with adverse effects(Post each treatment session (during 4 weeks))
- Change in patient quality of life(Index change from baseline at 4 weeks, 1 month and 4 months after intervention.)
- Blinding assesment(Post treatment at 4 weeks)
- Change in knee range of motion(Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.)
- Change in perceived generic health status(Change from baseline at 4 weeks, 1 month and 4 months after intervention.)
- Doses of analgesic and antidepressant medication(Change from baseline at 4 weeks.)