Treatment of Rheumatoid Hand With Magnetotherapy

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: NCT05920746
• Other study ID #: Universyty of Rzeszow
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 5, 2023

Study information

• Verified date: July 2023
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brief Summary:

Participants with rheumatoid arthritis with recommendation to physiotherapy.

Created 2 study groups:

1. Kinesiotherapy with static magnetic field

2. Kinesiotherapy with low-frequency pulsed magnetic field

Pulsed magnetic field give better effects then static magnetic field.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 5, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Informed voluntary consent to participate in the study

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

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

4. Remission, low or moderate RA activity: DAS28

5. Medical referral for physiotherapy treatment

Exclusion Criteria:

1. Additional physiotherapy treatments for the hands

2. Contraindications for magnetotherapy treatments

3. Lack of informed, voluntary consent to participate in the study

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= 10-20 Hz, type of impulse: bipolar, rectangular pulse

Locations

Country	Name	City	State
Poland	Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badan Innowacyjnych Uniwersytetu Rzeszowskiego	Rzeszów	Podkarpackie

Sponsors (1)

Lead Sponsor	Collaborator
Jolanta Zwolinska

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Chen Y, Aspera-Werz RH, Menger MM, Falldorf K, Ronniger M, Stacke C, Histing T, Nussler AK, Ehnert S. Exposure to 16 Hz Pulsed Electromagnetic Fields Protect the Structural Integrity of Primary Cilia and Associated TGF-beta Signaling in Osteoprogenitor Ce — View Citation

Dundar U, Asik G, Ulasli AM, Sinici S, Yaman F, Solak O, Toktas H, Eroglu S. Assessment of pulsed electromagnetic field therapy with Serum YKL-40 and ultrasonography in patients with knee osteoarthritis. Int J Rheum Dis. 2016 Mar;19(3):287-93. doi: 10.111 — View Citation

Parate D, Franco-Obregon A, Frohlich J, Beyer C, Abbas AA, Kamarul T, Hui JHP, Yang Z. Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep. 2017 Aug 25;7(1):9421. doi: 10.1038/s41598-017-09892-w. — View Citation

Tong J, Chen Z, Sun G, Zhou J, Zeng Y, Zhong P, Deng C, Chen X, Liu L, Wang S, Chen J, Liao Y. The Efficacy of Pulsed Electromagnetic Fields on Pain, Stiffness, and Physical Function in Osteoarthritis: A Systematic Review and Meta-Analysis. Pain Res Manag — View Citation

Wu Z, Ding X, Lei G, Zeng C, Wei J, Li J, Li H, Yang T, Cui Y, Xiong Y, Wang Y, Xie D. Efficacy and safety of the pulsed electromagnetic field in osteoarthritis: a meta-analysis. BMJ Open. 2018 Dec 14;8(12):e022879. doi: 10.1136/bmjopen-2018-022879. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.