Magnetotherapy in Rheumatoid Arthritis Treatment

Rheumatoid Arthritis Clinical Trial

Official title:

Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426513
• Other study ID #: Magnetotherapy/ RA
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2021
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 3 study groups:

1. Only kinesiotherapy

2. Kinesiotherapy with unipolar magnetic field

3. Kinesiotherapy with bipolar magnetic field

Kinesiotherapy with magnetic field give better effects than only kinesiotherapy.

Description:

Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants have dysfunction and pain of hand.

Inclusion criteria:

1. II ° and III ° of advancement of radiological changes

2. II ° and III ° of advancement of functional changes

3. Remission, low or moderate RA activity: DAS28

4. Medical order

1. Magnetotherapy and kinesiotherapy

2. Kinesiotherapy

3. Consent to participate in the study

4. Completion of the research program

Exclusion criteria:

1. Additional physiotherapy treatments for the hands

2. Change in type or dose of pharmacotherapy used

3. Taking steroid anti-inflammatory drugs

4. Malaise and side effects in the subject

Outcome Measures:

1. Duration of morning stiffness

2. The degree of severity of morning stiffness

3. Pain intensity assessment (VAS)

4. Test Box & Blocks

5. Measurement of the palmar surface of the hand

6. Measuring the range of motion in the joints of the hand

7. Measurement of compression force in a cylindrical grip

8. Time to maintain maximum pressure during cylindrical grip

9. Hand volume measurement

10. HAQ-20 test

Intervention:

1. Group 1: Only kinesiotherapy

2. Group 2: Kinesiotherapy with bipolar magnetic field

3. Group 3: Kinesiotherapy with unipolar magnetic field

Assessment:

1. Immediately before start therapy

2. Immediately after therapy (10 treatments in 2 weeks)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• II ° and III ° of advancement of radiological changes

• II ° and III ° of advancement of functional changes

• Remission, low or moderate RA activity: DAS28

• Medical order

• Magnetotherapy and kinesiotherapy

• Kinesiotherapy

• Consent to participate in the study

• Completion of the research program

Exclusion Criteria:

• Additional physiotherapy treatments for the hands

• Change in type or dose of pharmacotherapy used

• Taking steroid anti-inflammatory drugs

• Malaise and side effects in the subject

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Hand Rheumatism
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

Other:
• Kinesiotherapy with magnetotherapy
Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse

Locations

Country	Name	City	State
Poland	St. Hedvig Clinical Provincial Hospital No. 2, ul. Lwowska 60	Rzeszów	Subcarpathian

Sponsors (1)

Lead Sponsor	Collaborator
Jolanta Zwolinska

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Erol K, Gok K, Cengiz G, Ozgocmen S. Hand functions in systemic sclerosis and rheumatoid arthritis and influence on clinical variables. Int J Rheum Dis. 2018 Jan;21(1):249-252. doi: 10.1111/1756-185X.13044. Epub 2017 Mar 21. — View Citation

Nasonov VA, Murav'ev IuV, Kuz'mina NN. [Can local therapy of joint syndrome with Dolgit cream be used as an alternative to systemic nonsteroid antiinflammatory drugs in rheumatic diseases?]. Ter Arkh. 1998;70(11):64-6. Russian. — View Citation

Richmond SJ. Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial. Trials. 2008 Sep 12;9:53. doi: 10.1186/1745-6215-9-53. — View Citation

Srikesavan C, Williamson E, Cranston T, Hunter J, Adams J, Lamb SE. An Online Hand Exercise Intervention for Adults With Rheumatoid Arthritis (mySARAH): Design, Development, and Usability Testing. J Med Internet Res. 2018 Jun 27;20(6):e10457. doi: 10.2196/10457. — View Citation

Zwolinska J, Gasior M, Sniezek E, Kwolek A. The use of magnetic fields in treatment of patients with rheumatoid arthritis. Review of the literature. Reumatologia. 2016;54(4):201-206. Epub 2016 Oct 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	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
Primary	Health Assesment Questionaire (HAQ)	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 value immediately after therapy
Secondary	Test Box&Blocks	Objective assessment of level of disability of hand. Number of blocks transfer from box 1 to box 2 during 1 minute.	Change from baseline number of blocks immediately after therapy.