Treatment of Rheumatoid Hand With Magnetotherapy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment

Conditions
-----------------
Rheumatoid Arthritis, Hand Rheumatism

Intervention / Treatment
-----------------
* Other: Kinesiotherapy with magnetotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Additional physiotherapy treatments for the hands Contraindications for magnetotherapy treatments Lack of informed, voluntary consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotherapy with Static Magnetic Field<br>Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs. | Other: Kinesiotherapy with magnetotherapy<br>* Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse<br>* Other names: Kinesiotherapy with low-frequency pulsed magnetic field;|
| Experimental: Kinesiotherapy with low-frequency pulsed magnetic field<br>Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs. | Other: Kinesiotherapy with magnetotherapy<br>* Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse<br>* Other names: Kinesiotherapy with low-frequency pulsed magnetic field;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Pain severity rating scale. only one value. Minimum value is 0, maximum value is 10. The best is 0, the worst is 10. | Change from baseline VAS value immediately after therapy. | 
| Health Assesment Questionaire | 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. | Change from baseline HAQ-20 value immediately after therapy. | 
| Range of motion | Computerized measurement of the range of motion of the joints of the hand [mm]. A higher score value meant a greater range of motions. | Change from baseline range of motion value immediately after therapy. | 
| Displacement hand volume measurement | Measurement of hand volume using the displacement method [mm3]. The higher score means less swelling. | Change from baseline volume value immediately after therapy. | 
| Persistence time of morning stiffness | Patient's subjective assessment of the duration of morning stiffness [min]. The longer durations means more hand dysfunction. | Change from baseline time of morning stiffness value immediately after therapy. | 
| Severity of morning stiffness | Assessing the severity of morning stiffness using a 100-point scale. The higher score means a greater severity of morning stiffness. | Change from baseline time of severity of morning stiffness value immediately after therapy. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetotherapy, Rheumatoid arthritis, Hand function