Clinical trial NCT05920746: Treatment of Rheumatoid Hand With Magnetotherapy
Official title: Type of Magnetic Field and the Effects of Rheumatoid Arthritis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Hand Rheumatism
Keywords: Magnetotherapy
Rheumatoid arthritis
Hand function
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Change from baseline VAS value immediately after therapy.
measure: Health Assesment Questionaire
timeFrame: Change from baseline HAQ-20 value immediately after therapy.
measure: Range of motion
timeFrame: Change from baseline range of motion value immediately after therapy.
measure: Displacement hand volume measurement
timeFrame: Change from baseline volume value immediately after therapy.
measure: Persistence time of morning stiffness
timeFrame: Change from baseline time of morning stiffness value immediately after therapy.
measure: Severity of morning stiffness
timeFrame: Change from baseline time of severity of morning stiffness value immediately after therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
state: Podkarpackie
Study officials:
affiliation: University of Rzeszow
name: Jolanta Zwolinska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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. 2022 May 9;2022:9939891. doi: 10.1155/2022/9939891. eCollection 2022.
citation: 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 Cells Harmed by Cigarette Smoke. Int J Mol Sci. 2021 Jun 29;22(13):7036. doi: 10.3390/ijms22137036.
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: 10.1111/1756-185X.12565. Epub 2015 May 8.
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.