Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Brief Summary:
Participants with rheumatoid arthritis with recommendation to physiotherapy.
Created 2 study groups:
- Kinesiotherapy with static magnetic field
- Kinesiotherapy with low-frequency pulsed magnetic field
Pulsed magnetic field give better effects then static magnetic field.
详细描述
Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand. Before entering the study, all patients were examined by a rheumatologist, who determined the degree of radiological and functional changes and measured blood pressure. Patients with II° and III° of radiological and functional changes were qualified for the study. All the patients gave their informed consent to participate in the study. The examination included an overall assessment of functional status. Patients were examined immediately before and after the intervention.
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, Outcomes Assessor)
盲法说明
Assessor evaluating the patients' condition had no knowledge of the outcome of randomization of patients to the study groups.
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed voluntary consent to participate in the study
- •II ° and III ° of advancement of radiological changes
- •II ° and III ° of advancement of functional changes
- •Remission, low or moderate RA activity: DAS28
- •Medical referral for physiotherapy treatment
排除标准
- •Additional physiotherapy treatments for the hands
- •Contraindications for magnetotherapy treatments
- •Lack of informed, voluntary consent to participate in the study
结局指标
主要结局
Visual Analogue Scale
时间窗: Change from baseline VAS value immediately after therapy.
Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10.
Health Assesment Questionaire
时间窗: Change from baseline HAQ-20 value immediately after therapy.
Subjective assesment of level of disability. Value of each of 8 subsections: minimum value 0, maximum value 3. total score is averaged. The best total score is 0, the worst is 3.
Displacement hand volume measurement
时间窗: Change from baseline volume value immediately after therapy.
Measurement of hand volume using the displacement method \[mm3\]. The higher score means less swelling.
Range of motion
时间窗: Change from baseline range of motion value immediately after therapy.
Computerized measurement of the range of motion of the joints of the hand \[mm\]. A higher score value meant a greater range of motions.
Persistence time of morning stiffness
时间窗: Change from baseline time of morning stiffness value immediately after therapy.
Patient's subjective assessment of the duration of morning stiffness \[min\]. The longer durations means more hand dysfunction.
Severity of morning stiffness
时间窗: Change from baseline time of severity of morning stiffness value immediately after therapy.
Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness.
次要结局
未报告次要终点
研究者
Jolanta Zwolińska
Doctor of Philosophy
University of Rzeszow