Treatment of Rheumatoid Hand With Magnetotherapy

NCT05920746 | Completed

• 1 other identifier: Universyty of Rzeszow
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Participants with rheumatoid arthritis with recommendation to physiotherapy. Created 2 study groups:

1. 1.Kinesiotherapy with static magnetic field
2. 2.Kinesiotherapy with low-frequency pulsed magnetic field

Conditions

Rheumatoid Arthritis; Hand Rheumatism

Keywords

Magnetotherapy; Rheumatoid arthritis; Hand function

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

Kinesiotherapy with Static Magnetic Field

EXPERIMENTAL

Patients have kinesiotherapy of hand and static magnetic field. All patients without steroid anti-inflammatory drugs.

Other: Kinesiotherapy with magnetotherapy

Kinesiotherapy with low-frequency pulsed magnetic field

EXPERIMENTAL

Patients have kinesiotherapy of hand and low-frequency pulsed magnetic field. All patients without steroid anti-inflammatory drugs.

Other: Kinesiotherapy with magnetotherapy

Interventions

Kinesiotherapy with magnetotherapy OTHER

Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse

Also known as: Kinesiotherapy with static magnetic field, Kinesiotherapy with low-frequency pulsed magnetic field

Kinesiotherapy with Static Magnetic Field; Kinesiotherapy with low-frequency pulsed magnetic field

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Additional physiotherapy treatments for the hands
• Contraindications for magnetotherapy treatments
• Lack of informed, voluntary consent to participate in the study

Sponsors & Collaborators

• Jolanta Zwolińska: lead

Study Sites (1)

Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego

Rzeszów, Podkarpackie Voivodeship, 35-310 Rzeszów, Poland

Location

Related Publications (5)

• 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.

  PMID: 28842627 BACKGROUND

• 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.

  PMID: 35586276 RESULT

• 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.

  PMID: 34210094 RESULT

• 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.

  PMID: 25955771 RESULT

• 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.

  PMID: 30552258 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jolanta Zwolinska, PhD

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessor evaluating the patients' condition had no knowledge of the outcome of randomization of patients to the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Philosophy

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: March 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 5, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)